PHARMACEUTICAL & BIOTECHNOLOGY
INDUSTRY UPDATE
April 2012
McIlvaine Company
TABLE OF CONTENTS
Nutramax Laboratories to Expand
SHL-Medical Renovated Building
Massachusetts Sees $2B Construction Boom from the Biopharma Industry
Cambridge Campus Expansion for Novartis
JILA Expands on CU-Boulder Campus
DuPont Opens $40 Million Plant Genetics Facility
Providence Medical Group Becomes Large-Scale Patient-Centered Medical
National Institutes of Health Awards U of L Grant
HDS Designs Mount Auburn Hospital’s New Center
Suffolk Completes Phase One of Baystate Medical Center Expansion
Shimadzu Opens New Center at UT Arlington
Science Undergoing Big Building Boom
Genesis Plastics Welding Completing Expansion
The Richmond Group Completes Expansion of Cubist Pharmaceuticals Headquarters
MannKind's Afrezza Manufacturing Facility, California, United States of America
Research Park Expansion in Virginia
Teva to Sell Quebec Plant and Transfer to US CMO Halo
Health Diagnostic Laboratory Expansion
Jones Lang LaSalle Completes Construction of Regional Medical Center
SHL Expands U.S. Operations with SHL Pharma Systems
Nutramax Laboratories Expand to South Carolina
Grifols Starts Construction of Plasma Fractionation Plant in Barcelona
Marine Biological Laboratory's Loeb Lab Opens Renovations
Advantar Labs Moving to New Site
Biopharma Technology Adds Cleanroom
Jubilant Life Sciences Expands
Omkar Speciality Chemicals Prepares for API Factory
Genzyme Expands after Acquiring Sanofi
Aesica Queenborough Plant Secures FDA Approval
Freeze Drying Specialists BTL Announce New Cytotoxic Capability
Sigma Aldrich Opens Wuxi Plant
Med School in El Paso Offers Blueprint for Austin Facility
Redx Oncology Opens in Liverpool
Lilly Plans Expansion in Kinsale, Ireland
Novasep Opens New Facility in Shanghai
New Turkish Manufacturing Plant for Novartis
Aptar Pharma Opens Facility in Navi Mumbai, India
GEA Niro Pharmaceutical Spray Drying Facility, Copenhagen, Denmark
The Francis Crick Institute, London, UK is Expanding
Translational Research Institute (TRI), Brisbane, Australia
Intertek Adds GMP Assay Service
Fujifilm Diosynth Biotechnologies Expands R&D Capabilities
Gerresheimer Expands Packaging Capabilities
Marken Commissions New and Expanded London Operational Hub
Novasep to Invest in Purification-Based Manufacturing
Novasep Opens Shanghai Facilities
Catalent Completes UK Lab Expansion
The National Institute for Bioprocessing Research and Training (NIBRT) Opens in Ireland
Bayer, Tsinghua University Expand Partnership with Focus on Structural Biology
Qiagen, Bio-X Center Establish Translational Medicine Lab in Shanghai
Grifols Starts Construction of Plant in Parets del Vallès
GlaxoSmithKline Plans Biopharmaceutical Manufacturing Investment in the UK
Eli Lilly's New Bio Manufacturing Plant, Cork, Ireland
BioMalta Life Sciences Park, San Gwann, Malta
Aptar Pharma's Manufacturing Facility, Navi Mumbai, India
Baccinex - Contract Manufacturing Expands
AB SCIEX Expands Commercial Operations in Brazil
Haupt Pharma Expands Supply Chain Quality
Israel Announces New Life Science Incentives
Sigma-Aldrich Expands Capabilities in India
Lancaster, South Carolina, was the spot for Nutramax Laboratories to invest $10.5 million to expand its manufacturing operations. The company bought the ZF Lemferder building in Lancaster, with plans to relocate headquarters and expand production of both consumer products and veterinary science developments operations. Project team members included AME Incorporated (Fort Mill, South Carolina), which is construction manager, and Charlotte's Compass Development.
Another $10 million went to the construction of an autoinjector plant in Deerfield Beach, Florida. SHL-Medical USA (Florham Park, New Jersey) renovated an existing 45,000-square-foot building for the final assembly and packaging of autoinjectors and other drug delivery systems. Turner Construction (Miami, Florida) headed up the construction activities at the site.
Spain’s Grifols S.A. completed a $15 million, 80,000 sq. ft. blood plasma testing facility. Steed Construction of Eagle, Idaho built the new facility and Habitec of Boise, Idaho designed it. Future plans for the site call for possible construction of a $61 million fractional plant for the production of plasma-derived medicines.
Shire Human Genetic Therapies recently vacated a Cambridge, MA site, moving employees to its campus in Lexington, MA, but the 115,000 square foot space won’t stay vacant for long. Pfizer will occupy it temporarily while a new permanent lab-office for it rises just 0.1 miles east.
Shire and Pfizer are among nearly a dozen biopharma companies, research institutions, and developers building a combined 3.5 million plus square feet of lab and office space totaling more than $2 billion across Massachusetts. The newest project emerged March 28, when Alexandria Real Estate Equities announced plans for a 414,000 square foot building in Boston’s Longwood Medical Area.
The Longwood site will be anchored by a 154,000 square foot lease with Dana-Farber Cancer Institute and also includes headquarters for Biogen Idec and Vertex Pharmaceuticals, lab space for Novartis and Broad Institute, a speculative building in Cambridge, and a pilot-scale biomanufacturing training center at Worcester Polytechnic Institute.
Massachusetts leads the nation in construction starts for new biopharma facilities across North America, according to Industrial Info Resources (IIR). The Massachusetts projects are among 42 across New England totaling $3.3 billion, followed by the Great Lakes with 108 projects totaling $2.3 billion, and the West Coast with 69 projects totaling $2.2 billion, the IIR report found.
The West Coast includes the nation’s largest biocluster, the San Francisco Bay Area. Its biggest project has Gilead Sciences pursuing a $600 million expansion of its 30-acre Foster City, CA, campus. Plans call for the company to double its space to 1.1 million square feet, starting with a $140 million, 192,054 square foot R&D facility. The firm broke ground for this site in October.
New Facilities
By contrast, the largest Massachusetts project under construction is the $900 million pair of 18-story buildings being built for Vertex Pharmaceuticals. Vertex will rent about 1.1 million square feet under a 15-year lease to start when the space is completed, expected to occur in late 2013, at a cost of $72.5 million. Vertex can renew its lease for 10 additional years. The company is temporarily leasing 56,000 square feet near one of the two new locations for accounting support and information systems functions.
Biogen Idec is also developing new headquarters. It will sublease the headquarters it opened in the Boston suburb of Weston, MA, just two years ago and move its HQ to two Cambridge office buildings totaling nearly 500,000 square feet. Both broke ground in October.
The relocations of Biogen Idec and Vertex could, but may not, benefit smaller companies long hard-pressed by the region’s dearth of available space. “Up until a few months ago, 2014 was viewed as a little bit of a relief valve year,” Brendan Carroll, svp of research for Boston commercial real estate firm Richard Barry Joyce & Partners, told GEN. “It’s still two years away, and there’s a lot of organic growth that’s likely to occur between now and the time that those sites will actually become available. It does seem like good new product to be able to have online, but at the same time it’s difficult to see that as a benefit to tenants that are space-constrained today.”
Another Cambridge project has Novartis developing a $600 million, 550,000 square foot addition to its Novartis Institute for Biomedical Research. The project consists of two lab-office buildings above a common underground foundation with a 400–450 space parking garage and other facilities. Site excavation and removal of existing building foundations began last week. Novartis’ construction manager, Skanska USA, is also self-financing a nearby $70 million 120,000 square foot lab-office building, which broke ground in September.
Also in Cambridge, Broad Institute will nearly double its lab and office space when it completes construction in 2014. The new roughly 250,000 square foot building will consist of 12 floors, six of which will connect to floors in Broad’s existing building. Broad funded the construction through $353.4 million in bonds issued by MassDevelopment, the state’s finance and development agency.
Another project breaking ground last year was the 240,000 square foot building where Pfizer plans to lease 180,000 square feet over 10 years for its cardiovascular, metabolic, endocrine diseases, and neuroscience research units. The cardiovascular and neuroscience units will move there this year from Groton, CT, from where the other units moved last year. Pfizer is also testing the real estate market in Massachusetts as a potential seller. The company recently placed for sale one of three buildings it inherited after acquiring Wyeth for $68 billion in 2009.
Beyond Cambridge and Boston, Shire is increasing its production capacity for Vpriv eight-fold, following approval from EMA to produce the drug for type 1 Gaucher disease at its new manufacturing plant in Lexington, MA. The $200 million, 200,000 square foot plant boosts capacity from the 1,000 L capacity of its other facility in Cambridge to 8,000 L. However, Shire has yet to win FDA approval to produce the drug for U.S. patients.
The plant is one of five buildings Shire occupies at a 96-acre Lexington campus it purchased for $165 million in 2010. The campus consists of the plant, three buildings built before Shire’s arrival, and a 170,000 square foot fourth building completed last year. The manufacturing facility will also handle purification of Replagal, the only human-cell-line-derived form of enzyme replacement therapy for long-term treatment of Fabry disease, and production of all pipeline products, Shire spokeswoman Jessica Cotrone told GEN.
Additionally, Shire along with Abbott and Bristol-Myers Squibb assisted Worcester Polytechnic Institute (WPI) in facility planning and curriculum design for its $32 million Biomanufacturing Education and Training Center (BETC), a 10,000 square foot commercial-scale pilot plant now under construction at Worcester’s Gateway Park. All three BETC partner companies have manufacturing operations: Abbott’s Bioresearch Center is in Worcester, while BMS completed a $750 million bulk biologics manufacturing site in 2009.
Keeping MA Ahead
BETC received a $5.1 million capital grant from the Massachusetts Life Sciences Center (MLSC), the quasi-public agency that implements the 10-year, $1 billion Massachusetts Life Sciences Act, enacted in 2008 by Governor Deval Patrick. It includes $500 million in borrowed capital spending, of which $165 million has been spent on WPI and nine other projects, plus $250 million in research grants, and $250 million in tax incentives.
In February, Massachusetts Life Science Center awarded a total $21.2 million in tax incentives to 28 life sciences companies promising in return to create a combined 940 jobs. Shire won $3 million tied to adding 100 jobs, Vertex won $2.449 million for the 100 jobs it added since last year, and Biogen Idec, $1.836 million for 75 jobs.
A past MLSC beneficiary, a U.S. subsidiary of France’s Ipsen, Biomeasure, is in talks with Milford, MA, officials to amend its tax-increment financing agreement for a $45 million expansion of its R&D and technical operations facility. Biomeasure plans to build a new three-story, 62,000 square foot building and renovate one of its two existing buildings for research and process sciences labs, expected to allow the company to deliver five NMEs and three proofs-of-concept by 2015. Biomeasure has projected a mid-2012 groundbreaking, with completion in early 2014.
In 2008, Biomeasure joined Richard Lee, M.D., and Parth Patwari of Brigham and Women’s Hospital and Harvard Medical School in securing a three-year, $250,000 per year MLSC grant, matched by the company, toward preclinical tests of the company’s IGF-1 heparin-binding protein, designed to enhance cartilage regeneration after traumatic injury and treat osteoarthritis.
MLSC funds, fortuitously borrowed before the Great Recession, have stoked the biopharma building boom as well as earlier projects benefiting from tax breaks, such as BMS’ Devens plant, which won $60 million in state and local incentives. Yet for BMS, another important incentive involved time: State and local governments approved permits in less than six months.
Massachusetts is literally building a base of biopharma businesses on the solid foundation of its top-tier universities and research institutions. But for those employers, options for where to locate now stretch beyond the Bay Area into China and other emerging markets where manufacturing costs are much lower, regulatory red tape is much shorter, and the supply of researchers is growing in quantity and quality. How Massachusetts retains biopharma companies as global competition ramps up over the next decade will decide whether the Bay State can lead the construction lists of future years.
Skanska USA announced that its building business unit, which is a leading provider of construction management, preconstruction, and design-build services, was selected to provide construction management services for a new 550,000-square-foot expansion of Novartis Cambridge campus.
The campus expansion project includes the construction of two new biomedical buildings, comprised of mixed-use laboratory, office and retail space. Both buildings are designed to include laboratories, collaborative work areas, administrative space, auditorium and dining facilities. The buildings will be constructed upon a common underground foundation that includes a 400-450 space parking garage, loading dock, building support spaces and a central utilities tri-generation plant.
Maya Lin Studio and Bialosky + Partners are the architect and design team for the master plan and building to be located on 181 MA Ave. Toshiko Mori Architect is the designer for the building to be located on 22 Osborn Street. Cannon Design is the architect of record. Michael Van Valkenburgh Associates is the landscape architect. The campus will be environmentally responsible and sustainable, and is expected to achieve LEED Gold Certification.
Skanska’s most recent pharmaceutical construction projects include an $80 million contract with Merck to renovate its 250,000-square-foot research and development laboratory at its facility in Kenilworth, NJ. Skanska also built the Almac Group’s new state-of-the-art North American Headquarters, which consists of a 240,000-square-foot building comprised of a 165,600-square-foot production facility, 74,400 square feet of administrative office space in Lower Salford Township, PA.
Direct selling giant Amway is to build a new 48,000-square-foot extraction and concentration facility in Quincy, WA, as the company restructures it supply chain.
The new facility, expected to begin operations in 2014, fits Amway’s plans to move processing facilities closer to its growers.
Jim Brundidge, the company’s director of nutritional product operations, said: “Building a plant in Quincy creates supply-chain efficiencies that will benefit Amway distributors and their customers through new processing technology and faster order delivery.
“[It also] allows direct shipments of plant concentrates to manufacturing operations, including facilities in California, China and India.”
The 48,000-square-foot extraction and concentration facility will process ingredients for nutritional products sold under its Nutrilitebrand. The company also has the option for an additional 15 acres at the same industrial park.
JILA, a joint institute of the University of Colorado Boulder and the National Institute of Standards and Technology that has produced three Nobel Prize winners since 2001, has opened a new wing with advanced laboratories for its world-renowned science.
“With the laboratory environment so much better controlled -- and I'm talking about vibrations, room temperature, electromagnetic noise, more stable cooling water and power, everything -- our researchers can concentrate on what really matters, the experiments themselves,” said Nobel laureate Eric Cornell, chair of JILA. “Everything we could do in the old labs, we’ll be able to do a little, maybe a lot, better in the new labs.”
The new six-story wing of the joint institute located on the CU-Boulder campus will add 56,065 gross square feet including laboratory space in the basement and first floor. Because highly precise laser experiments require a highly stable environment, the basement laboratories are built on special 2-foot-thick concrete that transmits less vibration than regular concrete. In addition, each of these labs has access to a special hallway with completely separate spring-loaded flooring where pumps and other mechanical equipment can operate without disturbing experiments in the laboratory.
NIST contributed $22.5 million and CU-Boulder contributed $10.2 million to the $32.7 million project. CU’s portion came from dollars from indirect cost recovery or other sources restricted to research facilities.
“Our long-standing partnership with NIST has produced many of the world’s leading scientists in atomic, molecular and optical physics and 11 companies currently operating in Colorado,” said Stein Sture, CU-Boulder vice chancellor for research. “We’re excited that this expansion will enhance the research staff’s capacity to train graduate students to develop cutting-edge laser applications, nanoscale manipulation tools, and other technologies needed to keep U.S. industry at the forefront of science.”
In the latest U.S. News and World Report rankings, JILA and the CU-Boulder physics department are tied with MIT as the nation’s No. 1 graduate program in atomic, molecular and optical physics.
The growing number of JILA graduate students was another reason behind the need for more space. The number of graduate students at JILA in 2000, 69, has grown to 104 today, along with 57 postdoctoral researchers and 94 scientists and support staff.
JILA will celebrate the 50th anniversary of its founding this summer and the last previous expansion of its facilities opened during its 25th anniversary in 1987. With the new wing, JILA now totals 162,959 gross square feet.
“The new JILA wing will further strengthen the CU/NIST partnership that fosters innovation through research, new measurement tools, and training future generations of inventors and scientists,” said Tom O’Brian, chief of the Quantum Physics Division, the NIST part of JILA.
After the 1995 creation in a JILA laboratory of the world’s first Bose-Einstein condensate, a new form of matter created at a few hundred billionths of a degree above absolute zero, the institute appropriately became known as “the coldest place in the universe.”
The JILA fellows behind the Bose-Einstein condensate, Cornell and Carl Wieman, illustrate the collaboration between NIST and CU-Boulder scientists that JILA was intended to foster. Wieman is a distinguished professor of physics at CU-Boulder and Cornell is a NIST scientist and an adjoint professor of physics at CU. They were awarded the 2001 Nobel Prize in physics for their discovery.
Retired JILA/NIST fellow and adjoint CU physics professor John “Jan” Hall received the 2005 Nobel Prize for contributions to laser-based precision measurement techniques, including frequency combs -- a tool with an increasing array of applications in medicine, astronomy, telecommunications and many other areas. And two other JILA fellows, Deborah Jin and Margaret Murnane, are recipients of prestigious MacArthur Foundation “genius grant” awards.
In addition to a wide range of studies in atomic, molecular and optical physics, JILA also makes extremely precise measurements of ultrafast processes and at ultralow temperatures, Cornell said. These efforts could result in better materials for data storage and computation, improved imaging of biologically and medically relevant molecules, progress toward quantum information technology and a better understanding of the early universe.
JILA scientists and discoveries have generated 11 companies currently operating in Colorado, including a Boulder firm developing ultracold matter technology centered on Bose-Einstein condensate.
Because the institute is known around the globe for its pioneering work with lasers, lasers are a theme that runs throughout the new addition. The core of the new wing features a dramatic staircase leading up to a skylight with laser-like lights illuminating the darker undersides of the stairs. And a unique wall made of brick and “sensitile” transmits light when a light source is placed next to it.
JILA scientists will gradually move their laboratory equipment into the new “X-wing” over a period of months as they reach natural stopping points in their experiments. The wing also will free up additional lab space in the older portions of the building.
From the outside, it is difficult to tell where the 1987 addition stops and the new X-wing begins because the brickwork is so seamless, with the first four floors of the old JILA building extending directly into the new addition. While the older portions of JILA featured narrow hallways, the new wing offers wide common areas with numerous informal seating areas and nearby whiteboards to encourage greater interaction and collaboration among scientists.
New 1,500-square-foot cleanrooms will enable materials to be manufactured without dust and other contaminants, a huge improvement from the previous JILA cleanroom that totaled just 250 square feet. The new rooms also will house an electron microscope.
As a tribute to the JILA instrument shop, renowned for its ability to create precision equipment for a vast array of custom-made JILA experiments, countertops throughout the wing are made from recycled metal shavings. The instrument shop will remain in the older building.
The top floor features a small library and quiet space where all doctoral dissertations done at JILA since the very first was completed in 1965 will be stored. JILA has produced 417 dissertations to date.
All JILA graduate students, just like the 27 JILA Fellows, are also affiliated with a CU-Boulder academic discipline such as physics; astrophysical and planetary sciences; chemistry and biochemistry; molecular, cellular and developmental biology; or engineering.
The new wing is on track to receive a gold rating under the national Leadership in Energy and Environmental Design, or LEED, standards. The architect was the Denver office of HDR Architecture Inc. and the general contractor was Saunders Construction of Centennial, Colo.
Jila X-Wing Expansion Facts:
The new six-story wing adds 56,065 of gross square feet of space to JILA’s existing 106,894 gross square feet. The total JILA facility now totals 162,959 gross square feet.
NIST contributed $22.5 million and CU-Boulder contributed $10.2 million to the $32.7 million expansion project. CU’s portion came from dollars from indirect cost recovery or other sources restricted to research facilities.
The new wing is on track to receive a gold rating under the national Leadership in Energy and Environmental Design, or LEED, standards.
The new wing features vibration-resistant laboratories with special flooring, better shielding from electromagnetic noise, better electrical power and special corridors behind each lab where noisy, vibrating equipment like pumps won’t interfere with sensitive experiments. It also houses 1,500-square-foot “cleanrooms,” where materials can be manufactured without dust and other contaminants.
The new wing has spacious hallways with informal seating and nearby whiteboards designed to foster collaboration between scientists.
The top floor features a small library and quiet space where all doctoral dissertations done at JILA since the very first was completed in 1965 will be stored.
The new addition is about 25 percent more energy efficient and 30 percent more water efficient when compared with similar types of recently built, code-compliant buildings, according to campus sustainability Director Moe Tabrizi.
--Extensive use of local and regional construction materials was made in the addition and large portions of construction waste were diverted from landfills and recycled, Tabrizi said.
The new wing features low-flow water fixtures, increased insulation, high-performance windows and a highly efficient heating and cooling system.
JILA Facts:
JILA was founded as a joint institute between the University of Colorado Boulder and the National Institute of Standards and Technology in 1962 and will celebrate its 50th anniversary this year. It is located on the CU-Boulder campus.
JILA scientists are a mix of CU faculty and NIST federal employees who work together for the mission of JILA and for education. One example is the highly successful partnership of CU faculty member Carl Wieman and NIST scientist and CU adjoint professor Eric Cornell to create the world’s first Bose Einstein condensate, for which they were awarded the Nobel Prize in 2001.
JILA scientists develop new research and measurement tools that substantially advance science, technology and the economy. For example, development of the laser frequency comb in the late 1990s has led to an ever-expanding array of applications in atomic clocks, medicine, telecommunications, astronomy and many other areas. John “Jan” Hall of JILA and NIST, and an adjoint professor of physics at CU, shared the 2005 Nobel Prize for pioneering this unique new tool.
JILA research spins off into new companies, technologies and jobs, including 11 companies currently operating along Colorado’s Front Range.
JILA, along with the CU-Boulder physics department, is tied with MIT as the nation’s No. 1 graduate programs in atomic, molecular, and optical physics according to the latest U.S. News and World Report rankings. JILA trains graduate students each year who go on to work in industry, government labs and universities.
The new X-wing provides advanced laboratories that will support JILA’s next 50 years of research breakthroughs, and collaboration space to further encourage training and interdisciplinary research. Like JILA overall, the X-wing is a collaboration between CU and NIST, with each organization sharing in the costs of the $32.7 million building.
The chair of JILA alternates every two years between a NIST scientist and a CU-Boulder scientist.
DuPont has opened a $40 million plant genetics research facility in Johnston, Iowa as part of its efforts to increase agricultural productivity and improve food security, the company announced.
The 200,000-square-foot facility brings together experts in plant physiology, molecular biology, and bioinformatics to focus work on plant breeding and developing new transgenic products, DuPont said, adding it is expected to create 400 new jobs.
Paul Schickler, president of DuPont business Pioneer Hi-Bred, said in a statement that the facility "will take DuPont's research and development efforts in seed and plant genetics to the next level and ensure we are consistently providing new solutions and products to farmers and communities around the world."
The facility is part of plans by DuPont to invest $10 billion globally in R&D directed at food, agriculture, and nutrition by the end of 2020 as part of the firm's targeted food security goals.
Providence Medical Group (PMG) sped up their planned move toward becoming Dayton’s first large-scale patient-centered medical home (PCMH), due in part to a request by a large local employer, GE Aviation. GE Aviation recently brought a number of jobs to the Dayton area and will soon require employees’ primary care provider to be a certified PCMH. Now that PMG has nearly completed new PCMH accreditation and electronic medical records (EMR) implementation, those employee patients will see increased conveniences and care quality. For example, patients no longer need referrals for a number of services, including cardiovascular diagnostic imaging tests, because Diagnostic Partners provides those services on-site.
Jennifer Carroll, Providence’s PCMH project manager, commented, “Our patients are often relieved to hear they can receive many of their tests and services here, under our roof, rather than travel to other locations. They can have their primary care physician oversee their complete medical picture. It often saves patients on co-pays as well. What’s more, our doctors prefer as little interruption as possible when it comes to patient care, and providing diagnostic services in-house contributes to streamlining this care. If a specialist is still needed after tests performed here, now we can provide additional information to those specialists.”
Susan Becker, PMG’s chief operating officer, said, “The new PCMH and EMR platforms change the dynamics for both patients and doctors, and it can be a bit of an education process for both. However, the sooner our 55 in-house providers go paperless, the more money we will save. We see a $60,000 savings a year for charts alone. People will not be laid off, but their jobs are changing. We are now able to target more of our providers’ time towards patient care, and we have built an extensive ‘Providence Patient Portal,’ for access to scheduling, medical information and questions for staff.”
“And working with outside providers like Diagnostic Partners for those services we don’t have in-house is an added convenience for our patients, and an additional revenue stream for us,” added Becker.
Follow this company announced today it is receiving a seven-year, $3.4 million grant from the National Heart, Lung and Blood Institute to establish one of seven regional centers across the United States in the Cardiac Cell Therapy Research Network.
The network conducts early clinical trials of adult stem cell therapies in patients with heart disease, according to a news release.
This is the first grant for clinical research Dr. Roberto Bolli has received for U of L. Bolli has generated more than $100 million in grants for basic research from the National Institutes of Health.
In September, U of L announced that he had received a $12.7 million grant from the National Institutes of Health for adult stem cell research.
“Basic research explores new theories and measures the effectiveness of new therapies in preclinical animal modes of human disease,” Bolli said in a statement. “Clinical research takes what has been learned in basic research and applies it to examine whether therapeutic interventions work to heal the body or arrest disease in patients.”
HDS Architecture provided design services for all the Mount Auburn Healthcare suites including coordination of HVAC and FP engineering.
The new 28,000-sf Mount Auburn Healthcare Facility located in Waltham, Mass. is now open for patients.
The new center includes primary care, obstetrics and gynecology, midwifery services and a comprehensive weight management program. The facility also includes a Department of Public Health (DPH) Certified phlebotomy and radiology suite. Patient parking is provided at grade with medical staff parking below the building in a secure garage.
HDS Architecture provided design services for all the Mount Auburn Healthcare suites including coordination of HVAC and FP engineering. BD+C.
As part of the Baystate Medical Center, Suffolk Construction adhered to the sustainable design principles of The Green Guide for Health Care and incorporated green elements, including a seven-story light well and green roof. Suffolk Construction recently joined Baystate Health in celebrating the opening of phase one of its expansion and facility-replacement project at Baystate Medical Center. Located in Springfield, Mass., the $296 million, 641,000-sf new clinical facility houses a heart and vascular center as well as critical-care and inpatient rooms designed in collaboration with patients and families. Suffolk has already begun work on phase two, a new Emergency Department, which will triple the size of Baystate’s existing emergency room, one of the busiest in the nation.
The new MassMutual Wing features the Davis Family Heart and Vascular Center, which includes six cross-functional surgical/endovascular suites. Representing the latest in patient-focused design, a new 20-room CARE (Cardiovascular Assessment, Recovery, and Evaluation) unit allows patients undergoing outpatient procedures to go from pre-op to discharge in the same room, with the same nursing team. The facility also consists of 96 private inpatient rooms and 32 cardiovascular critical-care rooms.
Suffolk provided preconstruction and construction management services for the project, which is part of a 15-year master plan for the hospital—the largest medical facility in Western Massachusetts. The project is predominantly new construction, including multiple tunnels and bridges, with tie-ins to two existing buildings. Of the new construction, approximately 40% remains as shell space for future development. Suffolk maintained vehicular and pedestrian traffic flow while relocating sidewalks, utilities, and the hospital’s main patient valet entrance. Permanent and temporary earth retention systems were required as the new building foundation was much lower than the existing adjacent buildings. The facility features its own central heating and cooling plant with three chillers, two cooling towers, and three boilers.
Using Building Information Modeling (BIM), Suffolk saved significant time and money on the project. The team is also working with Baystate Health to develop 6D facility maintenance options that will best suit the hospital’s needs in order to operate the building in the most efficient and economical ways possible. Suffolk adhered to the sustainable design principles of The Green Guide for Health Care and incorporated green elements, including a seven-story light well and green roof.
For more than three and a half years, Suffolk worked with Baystate Health to ensure that local workforce goals were achieved. The project created an average of 300 construction jobs, and 77 percent of the total hours worked was by Springfield residents, people who live within 50 miles of Baystate’s Springfield campus, women, or minorities.
Shimadzu Scientific Instruments announced the opening of the Shimadzu Center for Advanced Analytical Chemistry at the University of Texas at Arlington.
The center is equipped with $6 million of chromatography, mass spectrometry, and spectroscopy equipment, making it the largest installation of Shimadzu analytical instrumentation in the Western Hemisphere, Shimadzu said.
The new center will allow researchers at the UT Arlington College of Science and the College of Engineering "to access the enhanced capabilities for trace qualitative and quantitative analysis," the company said, adding its instruments will be used in research aimed at preventing and treating illnesses such as cancer and malaria, and developing nanofabrication materials.
Mass spec-based research will be performed to test ways of analyzing cuticular lipids that can tell the age of a species of mosquitoes known to spread malaria, for example. Also, mass specs will be used to analyze chemicals in the environment that may interfere with normal hormone functions and cause cancer.
In conjunction with the opening of the center, Kevin Schug was named the Shimadzu Distinguished Professor of Analytical Chemistry. Schug, an associate professor of chemistry and biochemistry at UT Arlington, will oversee the center.
The latest boom involves some of San Diego’s biggest interconnected industries — science, medicine, biotechnology and engineering.
At least nine major structures are nearing completion, under way, or soon to start. The projects will cost at least $785 million to build, and will provide the region with about 1.1 million square feet of research, office, manufacturing and conference space.
Facilities include:
1. Gilead Sciences, Inc.
2. Palomar College Planetarium
3. Structural and Materials Engineering Building
4. Altman Clinical and Translational Research Institute
5. Center for Innovative Therapeutics (Proposed)
6. Health Sciences Biomedical Research Facility II
7. J. Craig Venter Institute
8. Southwest Fisheries Science Center
9. Marine Ecosystem Sensing, Observation and Modeling Laboratory.
The growth greatly varies; UC San Diego will soon build a 300,000-square-foot, $269 million center to promote clinical and translational research. Said another way, scientists will try to quickly transform discoveries made at a lab bench into tools, treatments and drugs delivered up at a person’s bedside.
There are small, but far-reaching events as well. Later this month, Palomar College in San Marcos will open a state-of-the-art 146-seat planetarium to replace an old one run down by time.
Private industry also is hustling to expand; Gilead Sciences is building a facility in Oceanside to develop and manufacture biopharmaceuticals, while star scientist J. Craig Venter moves to open a nonprofit lab at UC San Diego for the study of genomic science.
“We went through a long period of consolidation (in biotech), but now the vacant space is pretty much filling up,” said Joseph Panetta, president of Biocom, an industry trade group. “We’re beginning to see an investment in facilities, and a willingness to grow these industries.”
Here is a sample of the major buildings that are under construction, and expected to be built in the near future.
Construction crews build the new Structural and Materials Engineering Building which will be part of the Jacobs School of Engineering in at UCSD in San Diego, CA.
Purpose: Structural engineering, nanoengineering, mechanical and aerospace engineering, and visual arts.
Location: UC San Diego Jacobs School of Engineering
Size: 180,000 square feet
Cost: $83 million from state general obligation bonds
Status: Nearing completion, will open in summer or fall 2012
The new Palomar College Planetarium can seat up to 146 people. Palomar College
Purpose: Planetarium shows, astronomy education
Location: Palomar College, San Marcos
Size: 6,300 square feet
Cost: $8 million, Proposition M (initiative passed in 2006 by North County voters to maintain and modernize the infrastructure of Palomar College)
Status: Opening this month.
The new J. Craig Venter Institute, which is under construction at UC San Diego, Venter's alma mater. J. Craig Venter Institute.
Purpose: Genomics research
Location: UC San Diego
Size: 45,000 square feet
Cost: $37 million to be raised through donations and the sale of tax-exempt bonds.
Status: Completion expected in September 2012.
The Altman Clinical and Translational Research Institute UC San Diego.
Purpose: Clinical and translational research
Location: La Jolla
Size: 300,000 square feet
Cost: $269 million, which will be primarily paid for with external funding sources rather than state dollars
Status: Groundbreaking 2013, completion in 2015.
Targeting more medical work, Genesis Plastics Welding is completing construction and facility improvements valued at about $2,075,000, said Tom Ryder, president and CEO.
The work includes an additional 27,000 square feet in space, warehouse racking and electrical panels for about $1.75 million, componentry for $250,000 and doubling of a cleanroom for $75,000.
Liberty Industries Inc. of East Berlin, Conn., installed an initial 1,000-square-foot Class 7 Standard 14644 medical cleanroom years ago and returned during 2011 to build an additional 1,000-square-foot clean room, also a Class 7.
Looking ahead, Ryder foresees adding more cleanroom space—perhaps 2,600 square feet—at a future time to be determined by market growth.
Family-owned Genesis opened in 1996 in a 15,000-square-foot facility on 1.75 acres in Fortville, Ind., near Indianapolis. Recently, Genesis had rented another 13,000 square feet but will no longer need the space.
The idea of an expansion emerged in 2008 and led to the start of construction in September 2011.
Progress on the new building allowed all Genesis operations to occupy the new space in January. The original offices and plant are undergoing extensive refurbishing for completing during May or June.
Genesis employs 72 now and, over four to five years, projects adding 50 new positions, Ryder said.
The Richmond Group (Richmond), a planning and construction management company specializing in the program management and construction of biotechnology, pharmaceutical, medical device, clean tech and clean room facilities, announced that it has completed the expansion of Cubist Pharmaceuticals' (Cubist) headquarters in Lexington, Massachusetts. Richmond managed the design/build project, which provides an additional 104,000 square feet of state-of-the-art laboratory space for Cubist's staff focused on the development of antibiotics and acute care products.
Due to site restrictions and the existing building's footprint, the most cost effective solution for expansion was to build vertically. Richmond oversaw the planning and construction of two floors of laboratory, administration, and technical support space, a new central utility plant, a new mechanical penthouse, and renovations to existing laboratories on the building's first floor. The project also incorporated a pre-cast 299-car parking garage. High-efficiency plumbing and light fixtures, distribution-controlled heating and cooling systems and updated mechanical equipment combine to offset the constant operations of the lab facility, which is designed to LEED® Silver certification.
Previously, Richmond managed construction of the Level 1 laboratories in 2007. The concrete footings and steel columns incorporated during construction made it possible to complete this most recent expansion above the occupied first floor lab and avoid additional cost and schedule impacts. By conducting work in the afternoon and evening hours, Richmond also minimized disruptions to employees performing critical research activities.
Other project team members include R.G. Vanderweil Engineers, Spagnolo Gisness & Associates, Inc., Olson Lewis + Architects, Highpoint Engineering, Goldstein-Milano, and Rolf Jensen & Associates, Inc.
MannKind Corporation is a bio-pharmaceutical firm located in the city of Santa Clarita, California, in the US. It works on the discovery, development and commercialization of drugs used to treat diseases such as diabetes and cancer.
Afrezza, a rapid-acting insulin therapy being developed for the control of hyperglycemia in adults with type one or type two diabetes is the company's lead product candidate. MKC1106 and MKC204 are two other products being developed for the treatment of different types of cancer.
Afrezza requires a unique formulation and drug delivery system. The production process is so specialized that no existing manufacturing facility was capable of producing it. The company designed and built its own manufacturing facility in Danbury, Connecticut, for commercialization of Afrezza.
The Afrezza manufacturing facility required an investment of $163m. It was dedicated in September 2008.
In January 2010, the plant won two Facility of the Year Awards (FOYA), one for Process Innovation and another for Equipment Innovation. FOYA is sponsored by the International Society for Pharmaceutical Engineering (ISPE), INTERPHEX and Pharmaceutical Processing Magazine. It is given each year to honor and recognize the best of pharmaceutical manufacturing facilities in seven different categories.
"Afrezza, a rapid-acting insulin therapy being developed for the control of hyperglycemia in adults with type one or type two diabetes, is the company's lead product candidate."The Danbury project broke ground in early 2007 and was completed in the second half of 2008. The plant has a total floor space of around 23,400 square meters (251,784 sq. ft.).
The project was part renovation and part new construction. Approximately 20% of the facility is apportioned to facilitate future expansion, which can be undertaken to increase production of insulin therapy or start production of new Technosphere-based products.
Renovations were undertaken within the same building as the company's ongoing clinical manufacturing suite. New manufacturing operations were accommodated by renovating about 6,503 square meters of the existing space and an attached central utility plant was also upgraded.
New construction work involved the addition of 16,723 square meters (179,939 sq. ft.) to the plant. This phase of work involved installation of two fill and two packaging suites with associated support rooms. Each of these suites can accommodate three fill / packaging lines.
The new building houses 882 square meters (9,490 sq. ft.) of material and product storage space, most of which is refrigerated. The total area of the second floor of the new building is outfitted for operations such as offices, meeting, dining and support.
MannKind's Afrezza production plant has an advanced, custom manufacturing process line from beginning to end.
The first stage in the process is the creation of the Technosphere(R) particle. The particle is mixed with insulin in a specialty mixer, after which the mixture is frozen to separate the powder. The dried powder is shifted to fillers, where it is then filled into capsules and packaged.
In order to meet the unique production needs, new technology was designed and innovative adaptations were applied to the existing technology.
"The Afrezza manufacturing facility required an investment of $163m. It was dedicated in September 2008."One such innovative adaptation was made to specialty reactor which is used to blend Technosphere particles with insulin.
The plant has a high speed filling system and applies a cost-effective mode of moving bulk powder from the lyophilizer to the filler.
A recognizing feature of the facility is the first-ever pharmaceutical adaptation of a cryopelletizer in solid-dosage form. The modified cryopelletiser produces uniform pellets. During the bulk lyophilisation process, water from the uniform pellets can be removed quickly in a systematic manner.
Central utilities comprise a steam boiler system. There is also a chill plant with a primary / secondary pumping system.
In order to support the Central Utility Building and keep the facility working, even during a power failure, the plant is equipped with a new 2,500kW substation and emergency generator.
Philadelphia-based KlingStubbins was the architect of the inhalable dosage manufacturing facility. Clark, Richardson & Biskup Consulting Engineers (CRB) of Plymouth Meeting, Pennsylvania, was the prime consultant for architectural and engineering design. Construction manager for the plant was Torcon, a construction management and general contracting services provider based in New Jersey.
Automated Control Concepts (New Jersey), Dynamic Systems (North Carolina), Cryogenic Equipment Systems (Belgium), Integrated Process Technologies (Massachusetts), Serail (France) and Siemens Building Technologies (New Jersey) were some of the major suppliers.
Human antibodies discovery company Adimab LLC has closed a $13.8 million Series F round of equity financing, according to documents filed with the U.S. Securities and Exchange Commission.
According to Adimab Co-founder and COO Errik Anderson, the over-subscribed fundraise was a private round that came from existing investors.
Lebanon, N.H.-based Adimab LLC raised the funds from Google Inc. and venture arm Google Ventures, Polaris Venture Partners of Waltham and SV Life Sciences Fund IV, for additional applications such as the development of bi-specific antibodies, antibody-drug conjugates, targeting cell based antigens and ion channels. It also plans to use the funds to expand its pre-clinical manufacturing and mammalian cell line development.
In addition, Adimab has acquired a new 21,500 square foot research facility at 7 Lucent Dr. in Lebanon. The new location will be Adimab’s headquarters.
“These additional funds enhance our already strong balance sheet, allowing us to pursue several complementary opportunities more aggressively,” Adimab CEO Tillman Gerngross said in a release.
Adimab has collaborated on more than 20 antibody discovery projects in the last three years with several partner companies including Biogen Idec, Genentech, Novartis, Roche and others. Adimab inked a deal with Biogen Idec and Novo Nordisk in August 2011.
The Series F round comes after Adimab raised $4 million in December in 2010. Existing backers gave the company a $520 million pre-money valuation in the deal, doubling the value of its October 2009 Series D round.
Health Diagnostic plans a $68.5 million, two-phase expansion that will demolish two buildings along Jackson and North Fifth streets.
A trackhoe with a giant, mechanical claw started tearing apart the BioTech 3 building in the Virginia BioTechnology Research Park, as a crowd of onlookers enjoyed wine and hors d'oeuvres from the top of a nearby parking deck.
The mood was celebratory because the leveling of the building at Fifth and Jackson streets is part of a big expansion project for Health Diagnostic Laboratory Inc., a fast-growing company that is adding hundreds of jobs in downtown Richmond.
"To our surprise and our pleasure, we have been expanding a little bit faster than expected," Health Diagnostic President and chief executive Tonya Mallory told the guests at an event the company dubbed "The Big Chomp," which included a jazz band and refreshments beneath a tent on the parking deck.
Health Diagnostic provides diagnostic testing for physicians around the country to detect early risk factors for such conditions as cardiovascular disease and diabetes. The company also provides health counseling to patients to help reduce their risk of developing those diseases.
The company started out less than three years ago with just a handful of employees in a 10,000-square-foot office and lab in the research park. The company now has 487 employees, and it expects to reach 850 by 2014.
Mallory said the company has 57 job openings right now. "They're across the board — lots of different positions," including medical billing, lab assistants, health counselors and human resources staff, she said.
The company's $68.5 million, two-phase expansion will involve demolishing two buildings along Jackson and North Fifth streets in the research park — BioTech 3 and BioTech 5. Those buildings are across Jackson Street from Altria Group Inc.'s Center for Research and Technology.
The BioTech 3 and BioTech 5 buildings will be replaced with two six-story structures. They will connect with Health Diagnostic's existing home in the three-story BioTech 8 on North Fifth Street.
Equity partners in the development include Health Diagnostic, the Virginia BioTechnology Research Park, McKinney & Co. and Lingerfelt Development.
"It's a good economic return. HDL is a great company," said Al Lingerfelt, a principal at Lingerfelt Development, a real estate development firm based in Henrico County.
The first phase of the Health Diagnostic project is expected to be complete in December, with the construction of the second six-story building to begin in 2013. The project architect is McKinney & Co., and the contractor is The Whiting-Turner Contracting Co.
Robert T. Skunda, president and CEO of the Virginia BioTechnology Research Park, said the expansion will bring total development of the park to 1.2 million square feet and will push total employment to more than 2,500 jobs in the next two years.
Teva is to sell its Quebec, Canada manufacturing facility and transfer 150 employees to US CMO Halo Pharmaceuticals.
Halo Pharmaceuticals and Teva have agreed to a deal to transfer the production plant in Mirabel, near Montreal, and its employees to the New Jersey-based contract manufacturing organization (CMO).
“Through this strategically important acquisition we gain a pool of skilled people with wide ranging experience, the opportunity to provide continuing employment to many present employees and to grow our global business”, Clive Bennett, president and CEO of Halo, said.
Inking the deal marks the culmination of “continued efforts” to offload the facility, Barry Fishman, president and CEO of Teva Canada, said. Before completion of the deal, which is slated for June 30, Teva and Halo must negotiate manufacturing agreements and gain Competition Bureau approval.
The mention of manufacturing agreements suggests Teva intends to outsource some production it now does at the Quebec plant to the CMO. Halo plans to add to this business by expanding its commercial manufacturing and product development businesses outside of North America.
“With the acquisition of this state-of-the art facility, Halo's market reach will expand to Europe in addition to the US and Canadian markets”, Mohd Asif, chief financial officer at the CMO, said. The plant will also give Halo new distribution capabilities and development services.
Halo also has a manufacturing and packaging facility in Whippany, New Jersey.
The 167,000 sq. ft. site houses a kilo lab for API (active pharmaceutical ingredient) synthesis and equipment for solid dosage form manufacturing.
Upon completion of the sale Teva will have three production plants in Canada. The facilities, all of which are in Ontario, give Teva capacity for production of solid dosage forms and penicillin, plus packaging capabilities.
Beginning with the opening of William R. Greiner Residence Hall last August and continuing through this September, UB will have opened four major new buildings across its three campuses, in addition to completing several other projects, such as the innovative UB Solar Strand at the Flint Road entrance to the North Campus.
In dollar amounts, that translates to more than $300 million in construction during this one-year span alone. It’s all part of the university’s long-range vision of excellence, a mission that, in President Satish K. Tripathi’s words, includes “raising UB’s international prominence, enhancing the student experience and bolstering UB’s faculty with still more world-class researchers and teachers.”
“We are not just planning for the future. We are actively realizing our vision,” says Tripathi. “The UB landscape is changing every day, on all three campus centers. Even in an era of economic challenges, UB has been able to achieve progress that is remarkable in a national context: four major buildings online in a span of 12 months, along with the solar array and major overhauls of student housing and historic campus buildings.”
The current projects, combined with other plans in the pipeline—including a new $375 million home for the School of Medicine and Biomedical Sciences on the Buffalo Niagara Medical Campus in downtown Buffalo—bring UB’s construction investment closer to $1 billion.
Tripathi pointed out the impact all of this will have on students, faculty, staff and visitors. “While the new building taking place on all three campuses is one of the most visible aspects of this progress, what’s really important is the people who will live, learn and work in these buildings,” Tripathi notes. “Every element in our comprehensive plan is about investing in our people—our students, our faculty, our staff and our communities.”
UB’s building boom is significant not just for the volume of work occurring, but because it comes at a time when universities across the U.S. are looking to scale back or forgo their building plans.
“Certainly for UB, since (the North Campus) was built out in the 1980s, there’s been more construction activity now than we’ve experienced in a long time. In these down times, it’s probably a lot of construction for any campus,” says Robert G. Shibley, dean of the School of Architecture and Planning.
Moreover, UB’s building progress distinguishes the university as a national leader in campus sustainability. Five of the new additions at UB are designed to meet U.S. Green Building Council Leadership in Energy and Environmental Design (LEED) standards.
UB has achieved all of this using multiple funding sources and forging private partnerships, such as its collaboration with Kaleida Health on the Clinical and Translational Research Center and the Gates Vascular Institute on the Buffalo Niagara Medical Campus. Philanthropic efforts also have played a significant role in UB’s ability to secure funding for new construction—a testament to the university’s immense impact in the community.
Here’s a chronological look at 12 months of UB’s building success:
Aug. 19, 2011: William R. Greiner Residence Hall opens. The $57 million, 198,000-square-foot project blends residential, academic and recreational spaces in a “learning landscape.” Its architecture follows the principles of “universal design,” meaning the building and its amenities are designed to be accessible to people with diverse abilities. The building is the first in Western New York designed to meet the LEED “Gold” standard.
April 23: Official opening of the UB Solar Strand, a 3,200-panel solar array designed by world-renowned landscape architect Walter Hood and meant to serve as a fusion of art and science. A key partner in this project has been the New York Power Authority, which is funding the Solar Strand and overseeing its construction with UB.
May 10: Official opening of Barbara and Jack Davis Hall. A significant investment on the North Campus, this $61-million, LEED Gold designed facility houses 130,000 square feet of laboratory and classroom space for the School of Engineering and Applied Sciences.
Designed by Chicago-based Perkins + Will, Davis Hall boasts a 5,000-square-foot clean room and a “cybertorium” equipped with sophisticated communication devices for interactive classes, multimedia presentations and video conferences. Significant funding for the project was provided by well-known industrialist Jack Davis, a 1955 graduate of UB’s engineering school.
May 24: Ribbon cutting for the Clinical and Translational Research Center (CTRC) on the Buffalo Niagara Medical Campus. This project brings together under one roof both the Gates Vascular Institute, which merges Kaleida’s cardiac, stroke and vascular operations and an expanded emergency department, with UB’s CTRC, a 170,000-square-foot research center. A major tenant of the CTRC is the Jacobs Institute, which will support research and clinical collaboration on the causes, treatment and prevention of heart and vascular diseases.
The CTRC will help position UB as a leader in building a thriving life sciences economy in the region. In addition to the May ribbon cutting, the CTRC and Kaleida Health are hosting a research open house and conference on Sept. 20.
Aug. 23: Opening of a revitalized Red Jacket Dining Hall, which will provide diverse new meal options, including a “churrascaria,” a Brazilian steakhouse-style eatery. It also will feature stations for Italian food, sandwiches and salads, comfort food and a wok.
Sept. 28: John and Editha Kapoor Hall is scheduled to open as the new, 160,000-square-foot home for the School of Pharmacy and Pharmaceutical Sciences. It boasts green design features, including the fact that 75 percent of all space in the building will receive natural light. Significant funding for this project was provided by John Kapoor, who earned his doctorate in medicinal chemistry from the school in 1972.
In addition to these projects, UB has been bustling with renovation work, including Kimball Tower on the South Campus. Home to the School of Public Health and Health Professions, Kimball Tower underwent an interior and exterior overhaul, giving the building a modern new look.
The project also consolidated the school’s programs, once scattered among seven different buildings, into one facility, creating an environment that fosters even greater academic and research collaboration.
That came on the heels of $7.5 million in renovations to Wende and Beck halls for the School of Nursing.
Hayes Hall, home of the School of Architecture and Planning, also on the South Campus, has been gutted and is undergoing $25.4 million of renovations.
UB’s “Heart of the Campus” plan seeks to renovate key spaces in Capen Hall and Lockwood Memorial Library with the goal of creating a new “learning landscape” where students can learn everywhere on campus, not just in lecture halls and labs.
The university’s construction plans don’t stop with the Sept. 28 grand opening of Kapoor Hall. The NY SUNY Challenge Grant that UB received from New York State will help kick off funding for the new home for the medical school, a move that is scheduled to begin in 2016.
While this is certainly an exciting time for the health sciences at UB, Buffalo’s building progress is good for the entire university, officials say, because it strengthens the humanities, arts and social sciences by elevating UB’s stature and broadening its impact in the Buffalo Niagara region and beyond.
There will be more to celebrate in the coming years, including the 2013 opening of the new $26 million home of the Educational Opportunity Center on the downtown campus, where a significant amount of construction activity is occurring. And the Buffalo Niagara Medical Campus will welcome Women and Children’s Hospital. The new medical school will be in close proximity to both Women and Children’s Hospital and the Buffalo General Medical Center, allowing for better collaboration of education, research and clinical care.
UB’s contributions toward re-energizing downtown Buffalo can’t be overlooked, officials stress. “There’s well over a billion dollars between Kaleida and UB alone in new capital work in play on the northern edge of downtown Buffalo,” says Shibley. “We are bringing new economic vitality and an improved quality of life to the city of Buffalo.”
UB’s construction also is unique for its eye toward architecture and what can be achieved through planning and design. “If architecture is anything, it’s the ability through one family of actions to achieve multiple returns,” Shibley says. “All of these projects, in their pursuit of academic mission, environmental stewardship and economic efficiency, have managed to create what I think are aesthetically good statements on our campus, while delivering on each of those returns.”
Quality architecture is at the heart of the plans for the new medical school facility downtown—so much, in fact, that UB announced an international design competition in March that has resulted in four firms being selected as finalists. An announcement of the winner is expected to be made in the next week.
Of the impact UB is having on downtown, Shibley says, “That’s a very unique circumstance that deserves to be celebrated widely and better understood as a model for other cities to consider.”
The sum of the many parts of UB’s building progress is the university’s pursuit of excellence in everything it does, a point Tripathi has stressed in his first year as president.
“Each new step is part of a long-range, comprehensive plan that we have been pursuing together as part of UB 2020,” Tripathi says. “In essence, that vision is about creating the climate for excellence—and building the innovative campus spaces that enable our faculty and students to thrive is an essential component.”
Health Diagnostic Laboratory, Inc. (HDL, Inc.), Virginia BioTechnology Research Park, and Lingerfelt Development announced a groundbreaking ceremony, named The Big Chomp, to be held on March 29, 2012 as part of a $68.5 million, two-phase expansion project.
This tented-event, held rain or shine, will be located on the top level of the parking deck (third floor directly behind the BioTech 5 Building) at 737 N. 5th Street. Parking for this event will be located in the UNOS gravel lot at 622 N. 4th Street (one block west of the parking deck)
HDL, Inc., which is currently located in the BioTech 8 building within the Virginia BioTechnology Research Park, will begin removing the three-story BioTech 3 building at The Big Chomp event and replace it with a six-story structure in order to expand its footprint as the company continues its average 5-8% weekly growth rate.
"Since Health Diagnostic Laboratory was founded in 2009, we've grown from a staff of 11 people to almost 500 employees, with immediate plans to hire many more to work at our expanded facilities in the BioTech Park," said Tonya Mallory, co-founder and chief executive officer of HDL, Inc.
The Virginia BioTechnology Park, which houses 62 tenants on its 34-acre campus, will partner with Lingerfelt Development, a real estate development firm headquartered in Richmond, VA, to begin the two-phase expansion project this month. The anticipated completion date for the first phase is December 2012, followed by the construction of a second six-story building in 2013. The project architect is McKinney & Company and the contractor is The Whiting-Turner Contracting Company.
"The planned expansion of Biotech 8 and dynamic growth of Health Diagnostic Laboratory, Inc. are transforming the Virginia BioTechnology Research Park," said Robert T. Skunda, President and CEO of the Virginia BioTechnology Research Park. "The expansion will bring total development of the Park to 1.2 million square feet and will push total employment to over 2,500 jobs in the next two years."
About Health Diagnostic Laboratory Inc. Health Diagnostic Laboratory, Inc. (HDL, Inc.), a CAP accredited leader in health management, offers a comprehensive test menu of risk factors and biomarkers for cardiovascular and related diseases. Our systematic approach identifies factors contributing to disease and provides a basis for effective treatment, allowing physicians to more effectively manage patients. As an added value, patients receive a personalized overview of their risk factors along with intensive counseling from expert Health Coaches at no additional cost, improving compliance and enhancing satisfaction.
The Virginia BioTechnology Research Park is currently home to a unique mix of over 60 public and private bioscience companies, research institutes affiliated with the VCU Medical Center, and major state and national medical laboratories. These companies are housed in nine buildings totaling more than 1.1 million square feet of space, representing an employee base that exceeds 2,000. The Park's nationally recognized biosciences business incubation program, the Virginia Biosciences Development Center (VBDC), has successfully graduated more than 40 client companies, including three publicly traded firms. VBDC's client companies and graduates have attracted more than $400 million in equity, grant and strategic capital. The Park's Virginia Biosciences Commercialization Center was created to assist international life sciences companies locating at the Park with commercialization activities through M&A or IPO, giving these Park's tenants full-scale business assistance as they enter the US market. The Commercialization Center is working with 9 bioscience companies with technologies ranging from medical devices to diagnostics and therapeutics.
Jones Lang LaSalle teamed with HKS Architects of Dallas and contractors Weigand Construction of Fort Wayne and Pepper Construction of Indianapolis for the building of the hospital and site development. Jones Lang LaSalle announced that it has completed construction of Parkview Regional Medical Center (PRMC), a new 410-bed, 975,000-sf hospital in Fort Wayne, Ind. The Jones Lang LaSalle Project and Development Services team served as program manager for the $536 million project and used proven collaborative healthcare best practices and program management experience to help realize multi-million dollar cost savings.
The hospital was designed to offer patients the best possible environment for medical care, and to support the expertise of Parkview’s medical professionals with sophisticated building systems and technology. For example, the new hospital is equipped with smart rooms, smart beds and materials handling robots. Each patient room includes an over-bed lift system that enables nursing staff to easily raise and move patients safely with minimal back strain.
Throughout the building process, the Jones Lang LaSalle-led team implemented collaborative best practice techniques to effectively manage the permitting process, expedite the construction schedule despite a labor strike and environmental complications, and to segment the bidding and purchasing processes. In part thanks to significant cost savings achieved during the program management process, Parkview was able to add two new operating rooms and install additional advanced technology.
Construction of the hospital included a park and environmentally-friendly features throughout the facility. Through the energy efficient windows, patients enjoy a view of local plantings and rain gardens that are irrigated naturally through a water control and filtration system – all disguising underground parking structures. Further supporting hospital sustainability, construction teams used low and no VOC-emitting materials where possible, and practiced construction waste recycling. Limited amounts of petroleum-based products went into the building.
Jones Lang LaSalle teamed with HKS Architects of Dallas and contractors Weigand Construction of Fort Wayne and Pepper Construction of Indianapolis for the building of the hospital and site development. The first patients were admitted to the new hospital on March 17.
Jones Lang LaSalle’s Project and Development Services (PDS) group employs 1,100 project managers throughout the Americas, who conducted 2,300 projects valued at $10.9 billion in 2010. PDS offers a range of services to corporations, real estate owners, healthcare organizations and public sector entities. Capabilities include management of new construction, renovations and expansions; development services; interior fit-out assignments; energy retrofits; LEED assessments and certification; multi-site program management; brand strategy rollouts; and other services. BD+C.
SHL is continuing to expand operations in the United States with the establishment of SHL Pharma Systems, a state-of-the-art final assembly and packaging operation. Located in South Florida, this new facility will offer final assembly, labeling, and packaging services to SHL's pharmaceutical and biotechnology customers.
“We are excited about this latest expansion project as it is very customer driven,” says Lucio Giambattista, executive VP, SHL Group, and managing director, SHL Medical USA. “We have built up close relationships with some of the world's largest pharma and biotech companies over the years and this facility will allow us to offer even more services to these partners. Now, with packaging, labeling and distribution services available in-house, SHL will truly be a one-stop-shop for drug delivery devices, from product design to delivery.
SHL has been significantly expanding facilities and recruiting new employees as the result of several recently signed long-term supply agreements. SHL has publicly announced capital expenditures of more than $100 million. The company is forecasting to hire an additional 1,000 new employees during the next few years in addition to the 1,500 members of existing staff. The new Florida facility is scheduled to be operational in the first quarter of 2011.
SHL is a privately owned designer, developer, and manufacturer of advanced drug-delivery devices. The company employs more than 1,500 staff globally with about 1,000 employees in Taiwan. Primary design centers are located in the United States and Sweden and manufacturing centers located in Asia. SHL supplies auto injectors, pen injectors, and inhaler systems to global pharmaceutical and biotechnology companies.
Significant investment in R&D has enhanced the company’s broad pipeline of next-generation, drug-delivery systems. These devices include a range of disposable and reusable injectors with fixed or variable dosing, enhanced precision, and the ability to accommodate high viscosities.
The organization comprises three distinct group companies. SHL Medical Designs develops and manufactures advanced drug-delivery devices for pharmaceutical and biotechnology companies. SHL Healthcare develops and manufactures equipment solutions for home, hospital and long term care use. SHL Technologies provides contract manufacturing and engineering services for the production of complex medical technology and industrial products.
Nutramax Laboratories, Inc. announces their new location in Lancaster, South Carolina is open and manufacturing animal health products.
Due to increased demand for Nutramax Laboratories' veterinary products, Nutramax Laboratories, Inc. expanded to South Carolina, with a focus on emerging technologies and veterinary product manufacturing. Our new location on Quality Drive in Lancaster County not only provides the facilities necessary to expand the animal health business, but also provides ample room for future growth of Nutramax Laboratories.
The new facilities will be located at Grifols Industrial Estate at Parets del Valles (Barcelona) and will deliver up to an additional maximum of two million liters of plasma fractionation capacity in Spain, raising total capacity from the current figure of 2.1 million liters to 4.1 million liters.
Grifols, the Spanish group which specializes in the hospital-pharmaceutical sector and is one of the world's leading producers of plasma products, will shortly start construction of a new plant representing an investment of 20 million euros that will employ about 100 people, as soon as it obtains local permits and licenses. The new facilities will have the capacity to fractionate 1 million liters of plasma a year (with potential to expand to 2 million), allowing the group to double its existing fractionation capacity in Spain. The Grifols plant in Los Angeles, California, currently has a capacity of 2.2 million liters, giving the group total capacity of 6.3 million liters in 2014.
The construction work is scheduled to take 18 months, after which the process of obtaining licenses from the FDA (Food & Drug Administration) in the United States and from the EMA (European Medicines Agency) will begin. This is expected to take no more than two years, as the new plant will fractionate plasma through to the intermediate product stage. The purification, inactivation and sterile filling stages for the different proteins will be performed at Grifols' existing facilities at Parets del Valles, which have already been adapted to absorb this increased level of production.
The new plant will use the very latest technology and will make maximum use of automation. Grifols Engineering S.A., a group company which specializes in the engineering of biotechnological and pharmaceutical processes, has designed the new facilities and will manage the construction project. The plant will also serve as a model for the future construction of another fractionation plant in the United States (San Marcos, Texas) due to start in 2014, and delivering a maximum capacity of 4 million liters.
The new plant forms part of the 433 million euro investment plan for the period 2008-2012, approved at the end of 2007 by the Board of Directors. Key features of this investment plan, which is running to schedule, include the new intravenous immunoglobulin (IVIG) production plant in Los Angeles, completed in 2010 and now at the validation stage, together with the new plasma testing laboratory in San Marcos, Texas, also completed in 2010 and at the validation stage.
This means that Grifols has completed over 90% of the projects included in the investment plan for the period, projects which are designed to underpin the company's growth plans for the period 2014-2018/2020.
Marine Biological Laboratory (MBL) is an internationally recognized not-for-profit research, education and training institute for environmental, biomedical and biological sciences.
The educational campus is located on a coastal site in Woods Hole, Massachusetts, in the US. Founded in 1888, MBL is the oldest private marine laboratory in the country.
The MBL institute provides research and development facilities to world renowned scientists in cell and developmental biology, ecology, aquaculture, marine biotechnology, molecular biology, reproductive biology, global infectious diseases, neurobiology and sensory physiology to improve human conditions.
The Loeb Laboratory, built in 1970, is the main research training facility of the institute. It is named after the prominent physiologist of the 20th century, Jacques Loeb.
It offers various laboratory courses in the field of life sciences including embryology, microbiology, neuroscience and cell biology, among others.
About 450 scientists and students undergo training at the Loeb lab every year. The state-of-the-art facility is a national resource for discovery and training and expands the scope of life sciences research.
The Loeb lab facility has been completely renovated with an investment of $25.2m. The three-storey, 66,000ft² laboratory facility was modernized by modifying the interior design and infrastructure.
The renovated facility incorporates modern building systems and research laboratories, a centralized microscopy facility for commercial vendors, a resource centre to allow research in to regenerative biology and medicine, as well as a computer training centre with bioinformatics, imaging and computational biology equipment.
The project integrated various training programs into the new facility with separate spaces for all the disciplines, offices and support spaces.
The interiors are designed to promote collaborations and interactions by researchers. It has also added new kitchenettes and lounge areas with laptop stations, projectors, seating and marker boards.
The facility includes the Eugene Bell Center for Regenerative Biology and Tissue Engineering, a centre aimed to develop suitable medical therapies for debilitating diseases and injuries in humans. The centre will promote multidisciplinary research on marine invertebrates and other aquatic organisms to understand and reduce the natural process of ageing and regeneration of tissues.
Groundbreaking ceremony for the gut renovation of the facility was held in September 2009. It was completed in July 2010.
"Loeb Laboratory, built in 1970, is the main research training facility of the institute. It is named after the prominent physiologist Jacques Loeb."The project created about 250 construction jobs in the Cape Cod region at the peak.
The building incorporates several sustainable features such as low consuming electrical and water installations, energy efficient HVAC and lighting systems, Tecogen 200t STx series chillers and heat recovery, envelope insulation, a reflective white roof, usage of certified wood and low emission materials for the indoors, saving about 37% energy when compared to a similar building.
About 98% of the waste materials produced from the demolition of the interiors were recycled.
Retaining the existing exterior concrete wall structure and floor plates was considered to be one of the most important green features in the renovation.
The renovated building achieved Leadership in Energy and Environmental Design (LEED) Gold certification from the US Green Building Council in January 2011.
The project is part of a ten-year master plan for the Cape Cod campus to cope with the growth of the MBL. The comprehensive master plan was prepared by Tsoi / Kobus & Associates in 2003.
Both the Woods Hole Village campus and the Oyster Pond Road campus of MBL are being developed to allow year-round research, improve research and supporting facilities, classrooms, parking and storage infrastructure.
The renovated Woods Hole lab was designed by Tsoi / Kobus & Associates. Shawmut Design and Construction was the construction manager and Odeh Engineers was the structural engineer.
AHA Consulting Engineers was the mechanical systems, electrical, plumbing and fire protection engineer.
MBL received a grant of $10m from the Massachusetts Life Sciences Center and $15m in private funds from the Howard Hughes Medical Institute (HHMI) towards project fruition.
Advantar Laboratories is moving to a bigger facility in San Diego to expand its relationships with CROs.
The analytical development and formulation service provider will use the bigger facility, which covers 18,000 square foot in California, to develop its business with CROs (contract research organizations).
“The larger facility will also allow for the development of new business relationships with a specific emphasis on collaborating with [preclinical and clinical CROs]”, Advantar Labs said in a statement.
Advantar Labs is already working with other service providers. In September it inked a non-exclusive deal with DavosPharma, a provider of discovery, chemistry, and formulation services, to collaborate on helping biopharma clients.
As well as increasing emphasis on CROs, the site will allow Advantar Labs to grow its headcount and add business with manufacturers of finished products and active pharmaceutical ingredients (APIs).
“We anticipate that the new facility will accommodate approximately 70 scientists and support staff. Strategically, this move will allow for continued growth, increased efficiency and overall lower costs for our operations”, Richard Kenley, CEO of Advantar Labs, said.
The Tradition Center for Innovation (TCI) and the Vaccine & Gene Therapy Institute (VGTI) Florida announced the opening of a new, 100,000-sq.-ft. (9,290-sq.-m.) facility within TCI's 150-acre (61-hectare) research park located in the planned community of Tradition in Port St. Lucie, Fla. Since breaking ground in 2006, TCI has attracted top research institutes and healthcare facilities making it one of the fastest growing immunology research hubs in the country.
"Having the opportunity to expand our portfolio and work alongside leading institutes, such as Torrey Pines, solidified our decision to expand to Florida and house our new facility at TCI," said VGTI CEO Mel Rothberg. "We are thankful for the support from our fellow anchor members at TCI and the city of Port St. Lucie and look forward to being a part of the community."
Since TCI's first anchor member, the Torrey Pines Institute for Molecular Studies, expanded its San Diego-based facility to Tradition in 2006, TCI has brought an estimated 170 new jobs to the community and created an estimated 1,000 construction jobs. In addition, business service companies that provide life science products such as cylinder gas, biological reagents, gowning, IT, office furniture, scientific equipment and others, have all seen tremendous increases in sales.
Lighthouse Worldwide Solutions, a world leader in particle counting and contamination monitoring, has moved into a new corporate headquarters in Fremont, California.
The new building increases R&D space and has a dedicated customer and applications training center. The customer and applications training center is equipped with a fully functional and working cleanroom. This cleanroom will be used to support R&D and be available for cleanroom and environmental monitoring training. The new headquarters also increases service and calibration capacity.
“The new facility provides us room to continue growing and reaching out to customers in need of specific application support or training in contamination control,” says Morgan Polen, Vice President of Application Technology. “It is one thing to show a picture or presentation of how to monitor a cleanroom. We move to a whole new level with a working cleanroom that we can use as a lab to provide better training with the ability for hands-on demonstrations of the concepts of cleanroom environmental monitoring.”
Biopharma Technology Ltd (BTL) says its new standalone cleanroom with freeze drying R&D (research and development) capabilities will cut and costs.
The new suite includes a range of characterization and analysis equipment as well as a pilot-scale freeze dryer, allowing for small scale production runs for cytotoxic products.
Commercial director Laura Ciccolini said by providing an efficient platform, it is easier to cut costs for freeze drying – used to stabilize high value products.
“When freeze drying cycles are inefficient they become long and costly,” she said.
“This is why many developers choose to partner with an organization specializing in this field. However there are a limited number of companies with this expertise, and few have the capability to handle cytotoxic compounds.”
The UK-based firm is now offering the tech to SMEs as well as Big Pharma.
Jubilant Life Sciences has launched a 300-acre special economic zone (SEZ) for the chemical industry in Gujarat, India.
The launch follows a 2007 Memorandum of Understanding (MOU) with the Gujarati Government as part of its drive to boost development of chemical manufacturing facilities in the area.
Indian-based Jubilant will produce Vitamin B3 and 3-Cyanopyridine on a global scale from the facility, making it the largest producer of the supplement in the country. The firm said it has plans for more facilities on the SEZ in the pipeline.
Hari Bhartia, co-chairman and managing director, said Government backing made the move an obvious one.
He said: “Gujarat being the natural choice to set up this facility, we are thankful to the State Government under the leadership of the Honorable Chief Minister, for their constant encouragement, guidance and support.”
Omkar Speciality Chemicals (OSCL) has broke ground on plans for a $20 million (€15.2m) speciality API (active pharmaceutical ingredients) factory at in Maharashtra, India.
The firm has traditionally produced specialty chemicals like derivatives of selenium, iodine, molybdenum, cobalt, bismuth, but it recently branched out into the pharma world with the takeover of LASA Laboratory.
Omkar has since produced intermediates for drugsmakers, and CMD Pravin Herlekar said – with the latest investment - the future is pharma for the firm.
“There is a colossal demand in the API manufacturing space, and with Indian drug manufacturing sector gaining international prominence, the acquisition of LASA Laboratory was the right move for our group to venture into the pharma business,” he said.
Genzyme will expand its on-site storage of oxidizing gas at its Northborough, US, facility to support a boom in demand following its acquisition by Sanofi.
The plant will be boosted from 9,000 to 25,000 sq. ft., including 6,000 sq. ft. allocated for oxidizing gas within the warehouse, and 16,000 sq. ft. of gas cylinders in storage.
Michael Pippos, manager of health and safety at the Northborough Genzyme facility, said the gases will be used in the manufacturing process across all sites.
It is expected the facility will open its doors by the end of the year, with a boosted work force of up to 185 people.
UK contract manufacturing organization Aesica has strengthened its links with the US market after its site at Queenborough, Kent passed its first FDA inspection for the production of solid dosage forms.
The successful inspection paves the way for the pharmaceutical manufacturer to transfer production of its US clients’ solid dosage form product to Queenborough, the firm said.
This audit follows a history of successful inspections by the FDA for Active Pharmaceutical Ingredients (API) production. Jeremy Drummond, sales director, Formulated Products, said: ‘This is a particularly significant development for Aesica and will help us gain credibility in the US market.’
The Queenborough plant has been FDA approved for the manufacture of APIs for more than 20 years. Aesica is already transferring other solid dosage form products for the US market to the plant, including one based on bi-layer tablet technology.
The Queenborough audit follows recent positive repeat audits by the FDA at the firm’s European sites in Zwickau and Monheim, Germany and Cramlington, UK.
Biopharma Technology Ltd (BTL) has completed construction of a new standalone cleanroom, enabling them to provide freeze drying R&D services for cytotoxic products.
Freeze drying is a complex operation and many drug developers outsource development to contract research organizations specialist in this field. However, few CROs with freeze drying expertise have the ability to handle cytotoxic drugs safely.
Cytotoxic therapies are most commonly used in cancer chemotherapies and work by preventing the growth of cells. However normal cells can also be damaged both in patients and anyone else exposed. Cytotoxics are highly potent which means that from R&D to actual administration there is a need for secure handling.
In R&D, the safe handling of cytotoxic drugs requires measures that are significantly more stringent than standard practice. Cleanroom containment, protective clothing and additional handling procedures are used to protect staff, to prevent product from escaping from the laboratory, and to prevent cross-contamination with any other products that may be under investigation. These factors make it common for cytotoxics to be handled in a separate suite specifically designed for handling them.
Rather than take on the costs of an additional laboratory, many drug developers benefit from partnering with contract research organizations with existing facilities and additional expertise.
Freeze drying is a process used to stabilize high value products including pharmaceuticals.
However, freeze drying can be an expensive process.
“When freeze drying cycles are inefficient they become long and costly,” says BTL’s Commercial Director Dr Laura Ciccolini. “This is why many developers choose to partner with an organization specializing in this field. However there are a limited number of companies with this expertise, and few have the capability to handle cytotoxic compounds.”
BTL’s new standalone cytotoxics laboratory has been built to provide both an outsourcing capability to smaller developers, and specific product development expertise to more established enterprises. The suite contains a full range of characterization and analysis equipment as well as a pilot-scale freeze dryer. This enables BTL to offer its full range of freeze drying product and process development services and small scale production runs for cytotoxic products.
Dr Ciccolini says, “BTL are now able to provide a really exceptional combination of world-wide reputation for freeze drying expertise and safe cytotoxic processing.”
USP plans to open a laboratory and training centre in Ghana to strengthen quality control and offer services in sub-Saharan Africa.
Creation of the US Pharmacopeia (USP) Sub-Saharan Africa Center for Pharmaceutical Advancement and Training (CePAT) will add capacity and capabilities for bolstering quality control in the region. When operational CePAT will fund itself by offering quality control services to local manufacturers.
USP has committed $1.5m (€1.1m) to the project and is now seeking additional funds from donors to cover costs related to construction, instrumentation, and staffing. Funding will also subsidize use of the centre by locals for the first three years.
After three years of subsidized operations USP expects the centre to achieve self-sufficiency. USP is looking to outsourcing deals with local manufacturers and regulators to drive revenue growth at the centre.
Planned services include: good manufacturing practice (GMP) training; quality control testing for local manufacturers, donor agencies, or procurement organizations; and supply chain integrity and laboratory design consulting.
Using CePAT in Accra, Ghana as a model, USP plans to set up centers in Asia and Latin America. The centers have the potential to compensate for a lack of education and laboratory capacity in the regions.
USP noted this deficiency in sub-Saharan Africa when running its pilot Technical Assistance Program (TAP) last year. The project provided training at reduced pricing but “it became clear that there was a need for a more permanent presence that could deliver training on-demand, tailored to local needs”.
At the end of last month USP said the Clinton Global Initiative (CGI) had invited it to create a plan to address the problem of substandard and fake medicines. CGI holds meetings with world leaders to create and carry out ways to fix such problems.
“Joining the CGI community is a critical step in furthering our efforts, particularly as we seek partners to help us maximize the benefit our experience can provide to underserved nations and populations”, Brian Hendrix, chief operating officer at USP, said.
Sigma Aldrich says new packaging facility in China will shorten supply chains and help it build in an increasingly important regional market.
The plant – on a 20 acre site near drug manufacturing hub Wuxi – offers packaging services for a range of products and is intended to be a distribution centre for Sigma Aldrich's activities in China and across the entire Asia-Pacific region.
Eric Green VP and managing director of international operations at Sigma Aldrich said the investment is a continuation of the firm's efforts to grow its business in the region but with shorter supply chains.
“Since 2006, we have been building a strong local presence in China that relied on an extensive import supply chain model dependent upon our US and European operations.
“The investment we’ve made in Wuxi enables us to broaden our product portfolio and further supports our localization strategy. These investments will improve service to our customers in Asia-Pacific.”
He explained that packaging operations at the plant have been designed to handle the wide range of hazardous compounds used by both Sigma Aldrich's research materials business and by the non-GMP production unit of its fine chemicals division, SAFC
The facility will also house Sigma Aldrich's regional analytical services, however - as Green explained - these will be focused on the food safety and environmental testing customer segment.
‘Localization’ has been a focus in recent times according to Green, who said that: “The emerging markets remain robust and attractive geographies due to the continued growth in GDP, increased government funding for R&D and infrastructure investments being made by our global customers."
The Rock Kiss bar, with its neon pink walls, stands a few steps from the Paul L. Foster School of Medicine, the state's newest medical school. Although a sign advertises happy hour, the bar is shuttered, having been acquired by the growing school to make way for a parking lot, trees and shrubs. Across the street, a children's hospital opened earlier this year, as did an adjacent women's hospital within a recently renovated county hospital.
Thus, in ways large and small, a sizable medical complex is emerging in El Paso, a high-desert city of 649,000 people along the border with Mexico and New Mexico.
Political, business and nonprofit leaders reached a consensus more than 10 years ago that educating medical students, treating patients and exploring biotechnology are essential to the future well-being of this area's people and economy. Several hundred million dollars — from local tax proceeds, legislative appropriations and philanthropic donations — have flowed into the effort.
"Probably the singular thing here was to have a very consistent message that this is the most important thing to us," said Woody Hunt, a businessman and philanthropist who helped organize a 1998 economic summit that focused attention on the health care field following the collapse of the garment industry, which had been an economic mainstay.
Hunt added, "You've got to have vision. You've got to be organized. You've got to be patient."
El Paso's experience could offer lessons for efforts in Austin to land a medical school and expand the capital city's footprint in health care. The industry accounts for nearly a fifth of the nation's economic output.
After waxing and waning for years, efforts got a major boost last year when the University of Texas and its governing board formally declared a goal of establishing a medical school.
State Sen. Kirk Watson, D-Austin, is leading a panel of university administrators, elected officials, hospital executives and others pursuing a 10-point wish list that also includes a new teaching hospital, a comprehensive cancer treatment center, expanded mental health services and upgrades at the Travis County medical examiner's office — all to be achieved within 10 years.
El Paso has realized many similar goals, but challenges remain — especially in securing state money for the medical school and attracting biotech companies.
The Foster School of Medicine, a unit of the Texas Tech University System's Health Sciences Center, is in many ways the jewel of what officials have dubbed the Medical Center of the Americas, a public-private complex east of downtown that could eventually encompass 440 acres. The school seated its first class in 2009.
A Texas Tech nursing school opened in a leased building downtown two years later and will eventually move to the medical complex. Longstanding elements of the complex include Texas Tech medical clinics in various specialties, a state-run psychiatric hospital, the El Paso County coroner's office and the county hospital, University Medical Center of El Paso.
Planning is under way for a graduate school of biomedical sciences as well as a public-private research park that officials hope will spawn biotech startups and clinical drug trials. In February, the City Council earmarked $3.2 million a year in fees paid by electric utility customers for nurturing the research park and other life science initiatives.
Texas Tech Chancellor Kent Hance said a crucial step was the formation by local civic and business leaders of the Medical Center of the Americas Foundation, a nonprofit group helping to coordinate development of the medical complex.
"It shows the commitment of local people," Hance said. "It helps you get organized and get funding."
El Paso's medical portfolio is expanding in other ways as well.
A $60 million health sciences and nursing building opened at UT-El Paso in 2011, the same year that ground was broken for the $966 million William Beaumont Army Medical Center, an eight-building complex scheduled to open in 2016 at Fort Bliss, one of the largest military installations in the country. The Foster school plans to send some students to the Army hospital for clinical training, said Kathryn Horn, the school's associate academic dean for student affairs.
Landing the medical school and other elements of the Medical Center of the Americas wasn't easy.
Squabbling over the size of the complex, the use of local tax dollars and other matters erupted in 2002. A $120 million bond issue for the children's hospital passed by just 768 votes out of more than 44,000 cast in a 2007 election held by the El Paso County Hospital District.
Although Texas Tech began sending some third- and fourth-year students from its medical school in Lubbock to El Paso for clinical training in 1973, the pieces of a full-fledged, four-year medical school didn't begin to come together here until the state Legislature authorized $40 million in bonds for a research building in 2001. Two years later, lawmakers approved $45 million for an education building.
The Foster school has seen setbacks at the Legislature as well. Lawmakers balked in 2005 at appropriating sufficient funds to hire faculty members and equip the school, despite exhortations from Gov. Rick Perry. Funding was approved two years later. The Legislature declined in 2009 and again in 2011 to authorize bonds for numerous campus construction projects around the state, including two more buildings that officials of the Foster school say are needed for research and clinics.
"We've been able to achieve a dream for El Pasoans," said Jose Manuel de la Rosa, dean of the Foster school. "We have yet to figure out the long-term funding for this program. I don't think we can continue to count on the Legislature" to the same degree in the future.
Local funding, research grants, patient revenues and philanthropy must be continuing parts of the mix, de la Rosa said.
The Austin effort faces similar challenges as well as different ones. As in El Paso, the overarching task is to raise hundreds of millions in public and private dollars.
Central Health, Travis County's health care district, is studying how it might use its local tax proceeds, reserves and federal dollars to support a medical school or a new teaching hospital. It's unclear whether UT could count on any bond authorization from the Legislature in a time of tight budgets.
However, the UT System Board of Regents has an option not available to Texas Tech: tapping the multibillion-dollar Permanent University Fund for a loan or cash, or a combination of the two. The fund is constitutionally restricted to certain institutions in the UT System and the Texas A&M University System.
Still another challenge is justifying a four-year medical school in Austin when the A&M Health Science Center has been given legislative approval — although not all of the funding it needs — to develop one about 25 miles away in Round Rock. Moreover, the UT regents have pledged to develop a medical school in South Texas.
To avoid playing favorites and incurring political wrath, officials are pursuing the Austin and South Texas schools simultaneously.
Like El Paso, Austin already has a thriving clinical program for third- and fourth-year medical students, with about 100 dispatched from medical schools in Galveston and Dallas to Seton Healthcare Family hospitals. Seton also has about 200 residents — recently minted doctors undergoing additional training.
UT officials say philanthropists are waiting to see a medical school in Austin move closer to reality before stepping forward. In El Paso, the political ties of business leaders, as well as their philanthropic donations, have proved to be important.
Hunt's family foundation gave $10 million to the Texas Tech nursing school. Paul L. Foster, executive chairman of Western Refining Inc., gave $50 million to the medical school that now bears his name. Rick Francis, executive chairman of WestStar Bank, established an endowed chair for the medical dean.
Francis is a Texas Tech regent and former chairman of the regents. Foster is a UT regent, and Hunt is a former UT regent. Regents are gubernatorial appointees.
"El Paso had always been out of sight, out of mind with the Legislature," said Foster, who moved to El Paso in 2000. "We had to figure out how to get appointments to important boards in the state to have a better relationship and a better role.
"That's been a lot easier since we've had the same governor the whole time. A number of us have a really good relationship with the governor," hosting fundraisers for Perry and attending his fundraisers in other cities, said Foster, who has donated more than $400,000 to Perry over the years.
El Paso Mayor John Cook said the evolving medical complex is the city's most important long-term priority. A close second is lifting UT-El Paso into the ranks of the nation's top research universities, he said. The UT and Texas Tech campuses collaborate in various ways.
"We work with biomedical engineers at UTEP because they don't have patients and we don't have engineers," said Charles Miller, associate dean for research at the Foster school.
Federal funding for research at the school has grown to $12.5 million annually from less than $1 million in 2009.
Miller said recruiting can be a challenge; El Paso, with a poverty rate nearly double the national average, lacks some of the cultural amenities of other big cities in Texas and elsewhere. But with too few doctors and a high rate of diabetes among a mostly Hispanic population, El Paso offers an opportunity for scientists and physicians to make a difference, he said.
Jillian Sanford, a third-year medical student who was seeing patients with a faculty member at the Texas Tech breast care center the other day, said she might well end up practicing in El Paso.
A pioneering cancer research firm has opened in Liverpool, UK.
Redx Oncology, a subsidiary of early stage drug development company Redx Pharma, which is already in Liverpool, has been supported by £5.9m from the Government’s Regional Growth Fund.
The new firm will initially be based at the University of Liverpool, but will move to a new £28m BioInnovation Centre, which is due to open in 2014.
This Centre is a partnership between the Royal Liverpool Hospital, the University of Liverpool and the Liverpool School of Tropical Medicine. It will have 70,000ft2 of lab space and was granted planning permission last month.
Redx Oncology has so far created 120 jobs in Liverpool comprising chemists, analytical scientists, biology scientists, administrative staff and up to 24 trainees.
It starts life with a five-year program based on Redx Pharma’s pipeline of research cancer drugs, which cover a variety of cancer types, and will deliver a flow of experimental drugs for progression into human clinical trials.
‘Our approach is based on modifying existing drugs to create novel therapies which have their own IP value,’ says Dr Neil Murray, chief executive of Redx Pharma.
‘We have created a substantial library of original compounds. A significant number of these compounds have passed the proof of concept stage. They promise a variety of patient benefits such as greater efficacy, fewer side effects or offer a different means of delivery – a pill, for example, as opposed to an injection.’
The company's Redox Switch technology is at the heart of this process. It allows for rapid assessment of new drug candidates, which can go forward to development programs with lower risk and greater speed through clinical trials.
‘We’re a discovery engine for big Pharma,’ says Murray.
In addition to its cancer portfolio, Redx Pharma has a pipeline of new compounds in several other therapeutic areas including cardiovascular medicine, influenza and antibiotics.
Eli Lilly & Co. joined with Irish officials in announcing plans to expand its Kinsale campus with a new €330 million (about $442 million) manufacturing plant. The 240,000 square foot plant would be the company's second to be built at Kinsale, in Ireland’s County Cork within the past five years. A €300 million (roughly $402 million) biopharmaceutical manufacturing and new product commercialization facility finished construction and came online in 2010.
Lilly and officials said the new plant would create 300 construction jobs followed by “up to 200 permanent jobs” after the newest plant is completed. Irish officials from Richard Bruton TD, minister for jobs, enterprise and innovation, said the newly announced plant marked a success for Ireland’s Action Plan for Jobs, which calls for expansion of the nation’s high-end manufacturing and health/life sciences sectors as well as a deepening presence and greater economic impact for multinational companies in Ireland.
To that end, on February 9, Abbott announced plans for an €85 million ($114 million) expansion of its Sligo manufacturing site, slated for completion in 2014, with 175 new jobs to add to its nearly 4,000-person workforce in Ireland, spread among 13 manufacturing, commercial, and shared services sites across the country. Lilly by comparison employs some 700 people in Ireland at four sites: Kinsale, Cork City, Sligo, and Dublin. The facilities are involved in operations that include bulk pharmaceutical and biopharmaceutical manufacturing, animal vaccines, financial shared services, marketing, and sales.
Lilly has operated at Kinsale since 1981 and has a bulk manufacturing site focused on producing APIs for drugs that include Alimta®, Evista®, Strattera®, and Zyprexa®. Alimta was originally approved for malignant pleural mesothelioma, and more recently for non-squamous non-small-cell lung cancer. Evista is targeted to postmenopausal women with indications for prevention or treatment of osteoporosis and for reduction in risk of invasive breast cancer with osteoporosis or high risk for invasive breast cancer. Strattera treats ADHD in children, adolescents, and adults; while Zyprexa treats schizophrenia and acute bipolar mania.
Lilly didn’t spell out in its announcement what APIs would be made at the new plant, which the company described as a commercialization and manufacturing facility. But in a press release by Lilly and the economic development agency IDA Ireland, the plant was described as one that “will further enhance the company’s ability to bring treatments for illnesses such as cancer and diabetes to patients worldwide.”
Novasep is reporting the opening of a new 2,000 square meter (21,520 sq. ft.) facility in Shanghai’s Pudong district. The site is expected to boost Novasep's process development and engineering capabilities to cater to Chinese and East Asian demand.
Novasep launched its previous facilities in Shanghai in 2006 and says that it quickly outgrew the site as it doubled its staff to almost 50 between 2010 and 2012. The expanded site now includes 800 m2 (8,608 sq. ft.) dedicated to innovation and process development through new laboratory, piloting, and FAT testing areas.
Novasep has seen continued growth in demand in East Asia for its design and supply of purification technologies and integrated processes in batch and continuous membrane filtration, ion exchange, and chromatography. Novasep is also facing increasingly challenging purification requests, driven by the need for life science industries to reach maximum throughput with low capital and production costs as well as minimum environmental impact.
The increased innovation capabilities at the Shanghai site will allow Novasep to meet this demand and advance on the 50 purification processes already developed by Novasep in Shanghai. By increasing engineering capabilities, Novasep will expand output for its turnkey purification process solutions for its key markets of biologic drugs, pharmaceuticals, and industrial biotech.
Novasep is a global provider of solutions to produce active molecules at the required purity. Its offerings include process development services, purification equipment and turnkey processes, contract manufacturing services, and complex active molecules to serve pharmaceutical, biopharmaceutical, agrochemical, fine chemical, food and functional ingredients, as well as white biotechnology industries. Besides Shanghai the company has 12 global synthesis and process sites in France, U.S., Germany, Belgium, and the Bahamas.
Novartis has established a new headquarters in Turkey, and says its hopes to build a manufacturing plant in the area.
The news came from Turkey's Science, Industry and Technology Minister Nihat Ergun.
During the visit, Novartis board member Alexandre Jetzer-Chung announced that the Swiss firm would look at Turkey as a "regional base" which would provide a foothold on markets in Central Asia, the Middle East and Africa.
He said plans for the area include a new manufacturing facility for products in Africa and Asia.
Jetzer-Chung also said Novartis’ new facility in Turkey could act as a replacement for its failed attempts to establish Egypt as a health centre for Eastern territories, which fell down following the country’s recent unrest.
“Turkey may become the health centre of North Africa in the future,” he told the press.
However contrary to Jetzer-Chung, a spokesperson for the firm contacted in-PharmaTechnologist to say no solid plans have yet been laid for a new facility, and that it all hangs on the firm's success in a "challenging environment".
"Current market conditions and dynamics in Turkey create a challenging environment for major investments by Novartis," said the spokesperson.
"No commitments have been made by Novartis to date to expand the current manufacturing capacity in Turkey. If current conditions improve, Novartis will evaluate expansion of its collaborations around R&D and manufacturing in Turkey.”
When in-PharmaTechnologist contacted Novartis to ask why Turkey is the decided hub for Asia, Africa and the Middle East the firm was unavailable for comment.
However during the meeting, the chief of the Swiss federal department of economic affairs, Johann Schneider-Ammann, earmarked the Turkish market as one of the most promising, saying: “We have come here to boost ties with Turkey”. He added the market is also an important “door to others”.
According to Business Monitor International the Turkish pharmaceutical market is expected to hit $10.3 billion (€7.7bn) in 2012, although data from IMS Health suggests it hit this value back in 2009.
“It was not a coincidence for over 600 Swiss companies to operate in Turkey. Turkish market offers diverse opportunities and Turkey's geographical position offers an option to enter regional markets,” he told a reporter.
Ergun added that Novartis investment is “crucial” for Turkey, and hopes more companies will follow suit.
He said that although the benefits of investment in the country may be in the long-term, companies should consider the Turkish pharma market as a “strategic investment”.
He added: “The new incentive system to be announced soon will bring incentives for the medical sector as well”.
Aptar Pharma, which is part of the AptarGroup, inaugurated its new manufacturing site in Mumbai, the commercial capital of India. It is the first plant of the company in India and the second in Asia. Aptar Pharma's first plant in Asia is located in Suzhou (near Shanghai), China.
The company is engaged in the development and manufacturing of nasal and pulmonary drug delivery devices, including aerosol, spray and dispensing systems used for asthma, allergies and related symptoms. The company's products are marketed to many of the Indian biotechnology, healthcare and pharmaceutical companies.
The new Indian plant is the first of its kind and is located at Rabale, Navi Mumbai. The company currently employs 30 people in India and is planning to increase that further with the new plant.
"The new Indian plant is the first of its kind and is located at Rabale, Navi Mumbai. The company currently employs 30 people in India."Aptar Pharma has a strong customer base in India. The Mumbai plant has been established with the aim of serving the Indian customers better by establishing a local manufacturing base for drug delivery devices.
The project was self-financed by the AptarGroup and is a proprietary asset of the group.
The new manufacturing facility is built up over an area of 2,000 square meters (21,520 sq. ft.). It includes an ISO 7 cleanroom measuring 380 square meters, a warehouse, maintenance / tooling suites and offices.
The plant features product assembly lines, inspection and testing equipment and filling and crimping machines. The molded components were sourced from Suzhou, China and Le Vaudreuil, France. The filling and crimping machines were supplied by DH Industries.
The facility took six months for construction from the existing buildings and involved multiple local contractors.
"Aptar Pharma's first plant in Asia is located in Suzhou (near Shanghai), China."The company has established the Mumbai manufacturing site in a step to expand the operations in order to benefit from opportunities available in the Indian market.
Aptar Pharma plans to further expand its activity in India, as well as the rest of Asia, and become a key local employer.
The company also plans to leverage its network of local partners including those in research, industry, academia and regulatory bodies to strengthen its business.
The Mumbai plant will mainly produce spray pumps for nasal and topical delivery assemblies and the DF30 metering valve platform for pulmonary delivery (asthma). The DF30 valve platform is manufactured to the highest standard, claims Aptar Pharma.
The valve product has been in market for more than 20 years. It offers a wide range of metering volumes, from 25µl to 75µl.
Spray pumps and metering valves are drug delivery devices composed of ten to 15 components made of plastic, metal and elastomer. Metal parts are sourced from external suppliers, while plastic and elastomer components are manufactured in-house.
Precision injection molding of plastic components takes place in other Aptar Pharma facilities located in Europe and China, while automatic assembly and controls are handled within the Mumbai facility.
Headquartered in the U.S. in Crystal Lake, IL near Chicago and traded on the NYSE, AptarGroup is global with manufacturing sites in different parts of the world, including North America, South America, Europe and Asia.
The Indian pharmaceutical market is large (ranked 12th worldwide) and very dynamic (+15%) thanks to the high population and increased access to healthcare (eight percent GDP in 2011). It is also a key market for asthma drugs with strong pharmaceutical players selling their products in the domestic market and successfully exporting.
Aptar Pharma is well positioned to benefit from the expansion in India.
GEA Niro's GMP pharmaceutical spray drying facility is part of the company's Test Centre located in Copenhagen, Denmark. Opened in April 2010, the state-of-the-art facility has a clean room, with a Class rating of 100,000.
The facility enables testing of spray drying process and contract manufacturing of materials used in clinical trials. It is approved by the Danish Medicines Agency and is compliant with European Union standards for production of investigational medicinal products (IMP).
GEA Niro's Test Centre includes more than 40 pilot plants, apart from the pharmaceutical spray drying facility. These plants provide several facilities for developing processes for use in the chemical, dairy and food sectors.
The Test Centre is staffed with experienced members who work with consumers on a case-to-case basis to develop optimal production processes.
"To further improve its spray drying technology, GEA Niro formed a partnership with BASF in February 2010, under which BASF provides synthesis services. "GEA Niro's facility enables pharmaceutical companies to determine if spray drying is the right technology for the manufacturing of a new drug. It includes both micro-plants to produce small samples for clinical trials and full scale plants for commercialization of product.
Spray drying technology provides several advantages, including increased bioavailability of active pharmaceutical ingredients (APIs), controlled release for physical protection of APIs, production of fine powders, aseptic production and production of solid dosage formulations.
The technology is a fast and effective method of particle formation and manufacture of free-flowing powders. It is already widely used in chemical and food industries and has been adapted by GEA Niro for the pharmaceutical sector.
Pharmaceutical companies can develop spray dried products without making any major investment before commercialization of the product. The facility also reduces the time between drug development and commercial production. As a result, patients can benefit from faster availability of drugs in the market.
The spray drying plant is equipped with both non-GMP and GMP facilities. The product is first refined under non-GMP conditions before being produced under GMP conditions. Non-GMP facilities include bench analysis and trials wherein DRYNETICS process technology is used to determine the correct drying process.
"GEA Niro's Test Centre includes more than 40 pilot plants, apart from the pharmaceutical spray drying facility."This technology uses just a single droplet of the product to establish the correct spray drying process.
Spray drying processes include four steps - atomization, drying, particle formation and powder recovery. Atomization is a process wherein the liquid product is atomized into droplets using a nozzle. The droplets are brought into contact with a gas dispenser to evaporate the liquid present. Once the liquid evaporates, a solid particle or powder is formed which is recovered. The entire process takes just a few seconds to complete.
The best spray drying process is then developed and samples are produced for technical analysis. Qualified personnel review the process to suggest any modifications, if necessary. Before GMP testing of the optimum spray drying process, it is tested on large-scale plants similar to those of the final production plant.
The GMP facility of the plant is equipped with two PHARMASD spray dryers, type PSD-1 and PSD-4, to produce the required quantity of samples. The PSD-1 spray dryer can be used for production in small quantities and PSD-4 for large scale production.
Spray dryers are equipped with a chamber, cyclone, bag filter, HEPA filters, condenser and electrical heaters. Type PSD-1 uses two-fluid nozzle for atomization while PSD-2 dryer uses two atomization techniques using a pressure nozzle and a two-fluid nozzle. Both dryers use nitrogen for drying. They operate separately and have different HVAC systems.
The spray dryers can be used for cGMP production of clinical trial materials or for commercial production. The size of the PSD-4 dryer is similar to that of an actual production facility, enabling easy transfer from testing to commercial production.
The Francis Crick Institute (previously known as the UK Centre for Medical Research and Innovation, or UKCMRI), is an interdisciplinary medical research centre being developed in London, UK.
It is located in Somers Town in the borough of Camden. The institute will be the largest centre for research and development on biomedical sciences in Europe. The project was conceived in December 2007 and construction began in July 2011. It is expected to be operational in 2015.
The institute will have about 1,250 scientists from various disciplines across the globe and 250 other staff. The institute will research on interpreting the causes of heart diseases, stroke, cancers, infections and neurodegenerative diseases, plus develop innovative solutions for their treatment. The centre will work with leading UK hospitals. Physicists, biologists, engineers, chemists, mathematicians and computer scientists will focus on rapidly turning the discoveries at laboratories into treatment developments.
The UKCMRI was renamed the Francis Crick Institute in May 2011, in the honor of the British neuroscientist, biophysicist and molecular biologist Francis Crick.
The institute will be a world-class medical research facility. It is expected to improve lives and attract medical research innovation investments into the UK.
The Francis Crick Institute will be set up by consortium partners, including University College London (UCL), the Medical Research Council, Cancer Research UK, the Wellcome Trust, Imperial College London and King's College London. The consortium will fund the estimated investment of £650m for the project. The Francis Crick Institute is expected to require spending of about £100m a year for its operations.
The 15-storey Francis Crick Institute is being built on a 3.6-acre site at Brill Place, in the Somers Town and St Pancras area. It is located beside the St. Pancras International Station and British Library in Central London.
The institute will provide about 91,000 square meters of space for biomedical research and development. The facility will be designed to exceed the biosafety level three standards.
"The UKCMRI was renamed the Francis Crick Institute in May 2011, in the honor of the British neuroscientist, biophysicist and molecular biologist."It will conduct research on cancer cells, various flu viruses, tuberculosis, malaria and HIV to develop vaccines.
The terracotta clad facility is designed to portray its significance in the prime historic location and also create favorable working conditions for the staff. The laboratories will be housed in four quadrants of the building. A scaled transverse atrium provides views of the building interiors and allows flow of natural light. Its lowered roof design will reduce the scale of the project and house cooling and heating units along with solar panels. A sequence of double height rooms connected by the transverse atria will provide employees with meeting areas. Ground level will be occupied with public elements.
The sustainable research centre will also house a two-storey, 450 square meter healthy living centre. The facility overlooking the Ossulston Street will be dedicated to improving health and well being of local inhabitants. It is planned to include two training and meeting rooms, health-check rooms, sports and physical activity areas, a kitchen and a reception. It will be run by the local residents, The Francis Crick Institute, Hopscotch, New Horizon Youth Centre, Training Link, Camden Council and Somers Town Community Centre.
The project will include allocation of £1.7m towards improvement of housing in the council through Camden's Better Homes program, a £3.8m on-site power plant, provision of apprentices during construction, funding on safety of the community, a teaching laboratory to school students, involvement of public in science programs, a 450-seat auditorium and exhibition space, improvements to community spaces, voluntary educational programs, a pedestrian and cycle access way and aid for local businesses through the purchasing goods and services.
Contractors involved with the interdisciplinary medical research centre project
The striking building of the Francis Crick Institute has been designed by HOK in partnership with PLP Architecture. Local public consultation and views from the scientists, community groups and residents were considered for its design.
Laing O'Rourke is the main contractor and the contract value is about £350m. URS is the environmental engineer. Arup is the mechanical, electrical, public health engineer and is also responsible for project management. Adams Kara Taylor is the structural engineer and Turner and Townsend is the cost consultant.
Translational Research Institute (TRI) is a medical research facility located at the Princess Alexandra Hospital campus in Woolloongabba in Brisbane, Australia. It was constructed as a seven-storey building for providing support for medical research, administration and teaching.
Next to the main TRI building, a 70,000 square feet bio-pharmaceutical manufacturing facility is being constructed, which will accommodate a mammalian biopharmaceutical production facility. The TRI facility is located near the Pharmacy Australia Centre of Excellence. It will cost $354m to construct.
Groundbreaking for the construction was held in October 2010 and the project is expected to be completed by October 2012. The land for the facility was donated by the Queensland government.
The biopharmaceutical plant is estimated to cost A$65 million ($50m) for construction. It is expected to be commissioned in 2013.
"The TRI facility is located near the Pharmacy Australia Centre of Excellence. It will cost $354m to construct."The Translational Research Institute project is sponsored by a joint venture between the University of Queensland's Diamantina Institute, Mater Medical Research Institute (MMRI) and the Princess Alexandra Hospital's Centres for Health Research, along with the Queensland University of Technology's Institute of Health and Biomedical Innovation.
The purpose of the project is to increase the investment as well as commercialization of the medical breakthroughs in Australia, to improve disease-specific research networks of researchers and clinicians, as well as to improve the health standards of the Australians by introducing new medical prophylactic therapies and treatments.
The TRI facility will be used for the discovery, production and testing of biopharmaceuticals and treatments. The research focus will be on cancer, diabetes, obesity and liver diseases, as well as on inflammatory diseases like HIV, malaria and bone and joint diseases.
The biopharmaceutical manufacturing facility will assist new biologic drug developers to outsource the development, as well as provide technical and economical assistance. It will house a pilot plant to bring newly discovered drugs to pilot commercialization.
It aims to ensure Australian bioresearch progresses quickly from the lab work to late-stage research in a clinical setting using high-purity material.
The TRI building will have a space of 32,000 square feet. It will have seven stories, which include four floors of laboratory research, administration and teaching facilities. It can house about 700 researchers.
It will also have an animal house, a cell therapies facility, staff support spaces, a large lecture theatre and advanced education facilities.
The facility will be equipped with two in-building 11kV/415V substations, a 3.2MW, 11kV standby generator, plus 70kW of photovoltaics and intelligent energy. It also will be provided with electrical and ICT components, such as a Tier 2.5 tertiary data centre and F/UTP Category 6A structured cabling infrastructure.
Watpac Construction was awarded the building construction contract for the TRI facility in May 2010. The building was designed by Wilson Architects and Donovan Hill.
Aurecon was awarded a contract to provide structural, façade, electrical, dry fire engineering and information and communications technology services for the facility.
The mechanical services contract was awarded to MultiTech Solutions. The contractor is also responsible for design, documentation and contract administration.
In May 2010, Netherlands-based medical treatment manufacturer DSM Biologics agreed with the Australian Institute for Bioengineering and Nanotechnology to design, build and operate the biopharmaceutical manufacturing facility at the TRI.
The TRI project is being financed by $140 m from the Australian Government, $107m from the Queensland government and $50m from Atlantic Philanthropies. Queensland University of Technology will provide $25m and University of Queensland will fund $10m.
Australia's Government has agreed to provide funding of $10 million for the biopharmaceutical manufacturing.
Intertek has introduced cGMP cell based assay services to support product release and stability studies for biologics.
Addition of the services at its European biopharmaceuticals centre in Manchester, UK allows Intertek to help clients with stability studies for regulatory submissions by determining biological potency.
“We will work with our clients to provide a fully validated cell based assay suitable for regulatory submission one which performs reproducibly throughout the entire drug development process”, Ashleigh Wake, biotechnology team leader, at Intertek, said.
Fujifilm Diosynth Biotechnologies has completed the first phase of a £3m ($4.5m) investment in new equipment and laboratories at its Billingham, UK site.
This expansion reinforces the commitment to lead the global Biologics CMO industry through continuous innovation and implementation of new technologies, service delivery and quality, as announced by Japan-based parent company, FUJIFILM Corporation.
The investment includes a complete refurbishment of its microbial fermentation laboratory, which has been totally refitted, including eight new in-situ sterilisable 20l Sartorius Stedim Biotech fermenters, as well as a number of fully-instrumented DASGIP parallel bench-top high-throughput units.
In addition, a new suite of research and development laboratories has been installed for process development work, with a corresponding increase in the company's R&D workforce by 50 to over 150 in the last 12 months to support its growing business. The company expects to add to this further over the coming year at both its Billingham and North Carolina sites.
Mark Carver, PhD, senior vice president research, development and innovation said: "This investment is in response to our growing innovation activity and to increasing demand from customers for our expertise fast-track development of cost-effective processes for the manufacture of biologics.
"We are committed to continue to develop leading technology which will deliver benefits to our customers and their patients."
Gerresheimer Medical Plastic Systems is expanding its range of services to offer more complete solutions. In addition to injection molding, assembly, packaging and finishing, the service portfolio now includes pharmaceutical product assembly and packaging. Gerresheimer Regensburg GmbH facility in Germany now has a pharmaceutical packaging and assembly area. The area is comprised of three cleanrooms classified and validated in accordance with GMP Class D (ISO 8), ranging in size between 70 and 90 square meters (753 – 968 sq. ft.).
“When producing different products, the production areas must be physically separate,” said Armin Henning, director of production sites in Europe. “The packaging and assembly area therefore consists of modular production cells, which are separated from each other through pressure cascades. The rooms are equipped with assembly, filling, and test equipment that complies with the guidelines of the German Pharmaceuticals Act. Compliance with the quality standards is guaranteed through regular audits by the government of Upper Bavaria. The pharmaceutical filling process is supervised by a ‘qualified person,’ a pharmacist with 25 years of experience in the area of the production of pharmaceutical products.”
Also, Gerresheimer Medical Plastic Systems has completed a pharmaceutical packaging and assembly area at its facility in Pfreimd, Germany.
The area has a modern, flexible zone design and comprises three Class D (ISO 8) cleanrooms ranging in size between 70 and 90m2 (753 – 968 sq. ft.)..
The modular production cells are separated from each other by pressure cascades and the rooms are equipped with assembly, filling, and test equipment that complies with the German Pharmaceuticals Act. A Qualified Person supervises the pharmaceutical filling process.
Gerresheimer Medical Plastic Systems has 10 years of experience in the filling and packaging of active ingredients in various application systems.
In 2001, clinical test samples and stability batches of a dry powder inhaler were being filled, but the filling permit was limited to the handling of clinical test samples. It included the production of powder mixtures as well as the assembling, packaging, and labeling of dosing devices that came with the powder mixtures.
In 2007, this filling permit was expanded to include the loading and packaging of applicators with implants. Last year, Gerresheimer Medical Plastic Systems obtained a manufacturing permit, which entitles the company to package and assemble in accordance with the German Pharmaceuticals Act.
Marken announced that it has completed all commissioning work for its new operational hub in Feltham, UK. The new location at 648 River Gardens in Feltham is within 4 miles (6 KM) of Heathrow Airport and part of the North Feltham Trading Estate Industrial Centre.
The 18.5k sq. ft. facility is completely occupied by Marken operational personnel and will be one of the company’s flagship facilities joining an expanding network. The facility is equipped with space for product staging, re-icing, automatic scanning, quarantined goods, secure storage for dangerous goods, import and export operations and IT support. It will also have ample office space for the London branch operations which also has responsibility for all clients operating within the UK and Ireland.
“This new facility is in direct response to recent expansion requirements in the UK to support our growing client base”, said CEO, Wes Wheeler. “We have designed this facility to accommodate all of the needs of the life science industry including inbound shipments of clinical samples and outbound shipments of drug product, active pharmaceutical ingredients and patient kits. We have allowed ample room for growth and for expanded services. We are very excited to be upgrading our facilities in the UK.”
Nigel Connolly of Marken remarked “Our move to North Feltham Trading Estate expands our European resources to support increasing client demand on our already extensive pharmaceutical service depot network.”
The facility boasts 9000 sq. ft. of warehouse storage, 600 sq. ft. of controlled ambient storage, over 1400 sq. ft. of secured and caged controlled substance storage and over 250 cubic feet state of the art monitored walk in cold and frozen storage space dedicated to support the life science industry. Combined with our new offices and facilities in Asia-pacific, India and the Americas, Marken is among the fastest growing Life science supply chain companies in the industry.
Novasep says it may invest in active pharmaceutical ingredients (API) bioproduction and purification technology citing growing industry demand.
The comments follow Novasep’s announcement that it has €40m ($53m) to spend on expansion projects after completing a €310m refinancing round that involved France’s strategic investment fund – the Fonds Stratégique d'Investissement (FSI) – and investment group Azulis.
A spokeswoman said that while precise investment plans are not being disclosed “API contract manufacturing, biopharmaceutical manufacturing, as well as purification technology development may benefit.”
She added that: “Novasep has decided to focus its market positioning on purification-based manufacturing,” citing management’s belief that the increasing complexity of life science molecules will drive demand for this type of contracting.
“A good example is HPAPIs, where the manufacturing of these molecules requires the combination of synthesis and purification in confined areas. With its large HPAPI capabilities in a SafeBridge certified facility [in Le Mans], combining synthesis and chromatographic purification, Novasep is well positioned in the world competition.”
She also confirmed that Novasep is hiring additional staff at a number of facilities but did not go into detail.
In other news, Novasep has opened an expanded facility in China, again citing growing demand for APIs and biopharmaceutical manufacturing - as well as the expansion of the region's food production industry - as a motivation for the investment.
The plant – in Shanghai’s Pudong district – has operated since 2006 as a regional hub for Novasep’s biotech unit – which produces sugars, sweeteners, bulk antibiotics, functional ingredients and omega 3 - as well as its biopharmaceutical and drug actives manufacturing operations.
Novasep said that the expanded plant – which now houses 2002 sq. meters (21,542 sq. ft.) of production capacity - will boost process development and engineering capabilities to cater for ever-increasing Chinese and East Asian demand.
Jean de Lataillade, general manager of Novasep Asia said: “The Shanghai site will further enable Novasep to compete globally in both low volume pharma markets, as well as large volume industrial biotech markets.”
New site increases Novasep’s process development and engineering capabilities to supply turnkey purification processes in East Asia
Novasep, a leading supplier of manufacturing solutions to the life sciences industries, today announces the opening of a new 2,000 m² (21542 sq. ft.) facility in Shanghai Pudong district, China. The site will boost Novasep's process development and engineering capabilities to cater for ever-increasing Chinese and East Asian demand. These facilities will also add to Novasep’s existing 12 global synthesis and process sites in France, US, Germany, Belgium and the Bahamas.
Novasep launched its previous facilities in Shanghai in 2006, and quickly outgrew the site whilst the company doubled its staff to almost 50 employees between 2010 and 2012. The new 2,000 m² (21542 sq. ft.) expanded facilities includes 800 m² (8,608 sq. ft.) dedicated to innovation and process development trough new laboratory, piloting and FAT testing areas.
The ongoing growth of life sciences industries in China and Asia stretches local demand for domestic production and innovation capabilities. Novasep has seen continued growth in demand in East Asia for its design and supply of purification technologies and integrated processes in batch and continuous membrane filtration, ion exchange, and chromatography. Novasep is also facing increasingly challenging purification requests, driven by the need for life science industries to reach maximum throughput with low capital and production costs and minimum environmental impact. The increased innovation capabilities at the Shanghai site will allow Novasep to meet this demand, and advance on the 50 purification processes already developed by Novasep in Shanghai.
By increasing engineering capabilities, Novasep will expand output for its turnkey purification process solutions for its key markets:
Industrial biotech: fructose, starch sweeteners, organic acids, amino acids, bulk antibiotics, nucleotides, polyols, white biotech applications, functional ingredients including whey products, oligosaccharides, and omega 3,
Biopharmaceuticals including recombinant proteins, peptides and biosimilars including monoclonal antibodies and insulin,
Pharmaceuticals: especially optical isomers and certain anti-cancer APIs.
"Novasep, as the leader in the supply of purification processes for industrial biotech and biopharmaceutical applications in China, has ensured that its supply capabilities can satisfy ever increasing demands in China and East Asia," said Antoine Baule, president of Novasep Process, the biomolecule division of Novasep.
"With food and feed industry ingredient volumes rising above 100,000 tons per year in some Chinese productions, this requires more cost effective and environmentally friendly processes, and strong engineering capabilities,” said Jean de Lataillade, general manager of Novasep Asia. “The Shanghai site will further enable Novasep to compete globally in both low volume pharma markets, as well as large volume industrial biotech markets.”
Biomar Microbial Technologies has invested 2 million Euros in the expansion of its León factory to produce kilograms of APIs for the pharmaceutical, cosmetics, food, agriculture and energy industries. The factory’s capacity for the production of active raw materials is now more than 3,000 liters.
Managing director Antonio Fernandez Medarde said, “We have the necessary infrastructure to become the lab for the development of production methods for new therapeutic entities. We have met GMP quality standards applying to international external labs and the large-scale production of pharmaceuticals, complying with international regulations in this area.”
Biomar prevents contamination by working with a single product line per campaign in the api processing and fermentation phases. Also, 20% of the investment went to the creation of a white room containing purified air in order to prevent the external pollution of the different substances.
According to the company, this expansion allows for a reduction of research production and development times for third party companies, allowing them to optimize scale-up processes, bolstering effectiveness with low performance compounds and reducing response times to customer orders. According to the company, 95% of its capacity will be employed to serve foreign multinationals, and 5% will be for companies on the domestic market.
Catalent Pharma Solutions has completed the new development and analytical Solutions’ laboratories at its facility in Swindon, UK. The new lab suite will offer analytical testing, development support and regulatory services to pharmaceutical and biopharmaceutical companies. Also, the lab suite includes expanded facilities for the storage and testing of controlled and cytotoxic substances.
Additional services offered at the new Swindon labs include European import testing, Qualified Person (QP) and regulatory consulting services, methods development, and microbial, sterility and stability testing for a range of advanced dose forms including for inhaled and orally administered substances.
“This additional capacity, coupled with our international network, means Catalent can offer an unparalleled range and scale of services to the development and testing of large and small molecules,” said Graeme Lowe, director of Analytical Solutions for Catalent in Swindon.
“The enhanced facilities here in Swindon are complimented by Catalent’s acquisitions of Aptuit’s Clinical Trials Supply business and the full ownership of the Eberbach softgel facility. We are now offering a broader range of pharmaceutical and biopharmaceutical testing services from five locations in the US, UK and Germany. We have the expertise and the global reach to help our customers bring more products to market faster,” said Christine Dolan, vice president and general manager of Catalent’s Development and Analytical Solutions.
The National Institute for Bioprocessing Research and Training (NIBRT) officially opened its New Greenfield facility in Dublin, Ireland in June 2011. The plant’s success was achieved through collaboration, impeccable project execution, stunning design and a unique approach.
With a dynamic combination of inventive partnerships and a unique methodology, the facility has helped Ireland develop its role in the biopharma industry, providing both support and development to a previously undernourished sector.
The facility’s victory did not go unnoticed by the 2012 Facility of the Year Awards (FOYA): NIBRT's New Greenfield facility has been presented with FOYA’s Special Recognition for Novel Collaboration award.
In the early 2000s, the Irish government realized that biologics manufacturing would be greatly important for the pharmaceutical industry. According to Killian O’Driscoll, Director of Projects for NIBRT, the government realized that “the requirement was immediate and would continue to rise for at least a decade.”
To discern the most appropriate response, the government “convened a team of key stakeholders from industry and academia.” After some discussion, they “concluded that only a dedicated prototype manufacturing facility on the fringes of a university would satisfy the need,” says O’Driscoll.
During the planning stages, they determined that the facility would be comprised of 68 percent cleanroom manufacturing and in-process laboratory support, while the remaining 32 percent would be reserved for administration, plant rooms and social functions.
They recognized that employees would need to be skilled at working in a highly controlled cleanroom, familiar with bioreactor control and the harvesting of delicate components, and confident with a complex array of bioanalytical techniques.
The next step was to decide on a location for the facility: “The consensus was to ensure a strict GMP manufacturing culture could be fostered in the facility, but also to ensure the facility was integrated within the academic community.” O’Driscoll explains that “a very special site was chosen in Dublin, on the perimeter of University College Dublin, Ireland’s largest university,” a site which was “previously an early 18th-century walled kitchen garden that had in recent years been the location of the University soccer pitch, facilities and terraces.”
Although being located on the fringes of a university was an ideal setting for NIBRT, its location did pose some challenges: namely the challenge of preserving the historic walled garden and the nearby Merville House, which were historical, protected structures
The creators worked hard to retain and incorporate the historic brick walling, the tiered earthen terrace, the ‘ha-ha’ feature (a ditch formed with one earthen bank and one vertical wall, designed to enclose livestock) and the 18th-century stone gates. The NIBRT site is now enclosed by the original 18th-century wall and incorporated into the landscape of the Merville House.
In addition to historic preservation, NIBRT’s goal was to create a stimulating learning and working environment that would promote positive and regular interaction between students, academics and industry. They wanted to utilize a sustainable, energy-conscious and cost-effective design that would adhere to good engineering and manufacturing practices.
This extensive to-do list is challenging enough in more typical manufacturing situations, but NIBRT’s situation was unique — “the building in essence had to be designed from a blank sheet. No facility like this exists elsewhere. How would the building be scoped to budget? How big should it be? What manufacturing technologies should it accommodate? How would it be managed as a resource for Industry?” O’Driscoll explains.
NIBRT was able to reach their initial goals, and then some. The facility includes both an upstream plant and a downstream plant. The upstream plant features one 30-liter and two 150-liter bioreactors and can facilitate batch, fed-batch and perfusion technology for animal cell culture.
The facility is designed to help the industry streamline the process of getting their product to market, without hindrances such as laboratory validation, the training of personnel and process de-bottlenecking.
The medium-scale bioprocessing plant was delivered ahead of schedule and under budget.
The facility includes a fill-finish suite, which exposes trainees to aspects of a sterile media trial; they are able to prepare sterile media and perform line checks, connections and cleaning. Viable and non-viable particle and environmental monitoring is undertaken during training, as well as rapid-microbial and objectionable-organism testing. At the end of each course, each trainee’s performance is checked to make sure that they successfully perform a successful sterile media fill that conforms to GMP, quality-assurance and quality-compliance standards. Customized training programs are also offered by the facility.
The plant has been GMP qualified, but not validated, enabling trainees to fully engage and interact with the equipment and technology while being thoroughly instructed in GMP best practice. For fast-track development, computer simulation of all automation systems is used extensively.
Team management greatly contributed to the facility’s successful completion. The project was delivered three months ahead of schedule and 37 percent below the original budget estimate — with zero safety incidents.
According to O’Driscoll, “a subcommittee of the NIBRT Board was appointed to oversee the building project.” In additional to the board, an “Industry Advisory Panel was established, which advised on the key criteria for the new facility. The following teams were then appointed via the appropriate tender process to manage the successful implementation of the project: a Client Representative Team, Integrated Design Team, Bioprocess Specialist Team and Construction Contractors.”
Safety was of upmost importance during the facility’s construction. As part of the bid process, bidders submitted their intended Safety Plan for the work, which provided considerable detail about their approach to the project and how they would deal with the expected hazards and risks. “This plan reviewed each element of the plant in detail,” O’Driscoll explains. It “also included a Constructability Review Module that investigated the overall construction effort from terms of accessibly for men and material, coordination, and vertical separation during the commissioning and construction phases.”
O’Driscoll explains that “total manpower peaked at 160 personnel with 300,000 man hours during the construction and commissioning phases to complete the project.” Amazingly, “during this time there were zero accidents, zero lost times, zero medical aids and zero recordable accidents.”
“This project, despite the constraints of fast-track schedule, was managed in a proactive manner to manage risks and coordinated to reduce the impact of simultaneous construction and commissioning activities,” says O’Driscoll.
Ireland now has a competitive advantage when it comes to biopharma production. The facility’s clients are able to share the load of plant start-up, training personnel, technical research and development.
The facility acts as a central hub to enable interaction between the various stakeholders within the biopharma community. It has hosted numerous events, research collaborations and classes, including biopharma manufacturing and training programs, seminars and workshops on the latest technology, applied research programs and more. The completed facility provides all stakeholders with access to a purpose-built training and research-building.
O’Driscoll summarizes the importance of the facility: “In effect, the great achievement of the NIBRT facility is to provide a manufacturing template for all biopharma industry, ensuring a customized and accredited training for the needs of all stakeholders.”
Bayer Healthcare announced an expansion of its joint research partnership with Tsinghua University in Beijing.
The partnership and its expansion involve the Bayer-Tsinghua Joint Research Center for Innovative Drug Discovery, created in 2009. Bayer and the university have signed a collaborative agreement covering biomedical sciences during the next three years.
Shi Yigong, professor and dean of the School of Life Sciences at Tsinghua University, said that a new focus of the expanded collaboration will be on structural biology. Scientists from the university and Bayer will work together to elucidate the 3-D structure of biological molecular targets for new drug discovery projects.
Since its creation, joint projects at the Bayer-Tsinghua center have honed in on "different research aspects starting from early research programs to gain deeper understanding of disease mechanisms, identification of new drug targets, and spanning further to joint structural biology research and medicinal chemistry programs," Bayer said in a statement.
Bayer also said that a new endowed chair at the Tsinghua University-Institute of Biomedicine — the first chair in life sciences funded by Bayer in China — will be established with Dong Chen as the first chair.
Qiagen announced it and the Bio-X Center of Shanghai Jiao Tong University will jointly create a translational medicine laboratory in Shanghai.
The lab, which is the first of its kind between Qiagen and a major research institution in China, will be outfitted with Qiagen's Pyromark Q24MDx pyrosequencing instrument and QIAcube instruments, as well as related products. Bio-X Center will use the products in various research projects including biomarker validation and analysis.
"Through this agreement with the Bio-X Center we can leverage our leading positions as a solutions provider in biological research, drug discovery, and personalized healthcare to help develop better diagnostics and therapies for the Chinese people," Victor Shi, Asia Pacific president of Qiagen, said in a statement.
Though the deal is Qiagen's first in China creating a translational medicine lab, the company has forged other deals in Asia. In 2007, it opened a subsidiary in Hong Kong to be a hub for further expansion in the region. The same year, Qiagen formed a joint venture with Bio*One Capital in Singapore focused on developing molecular diagnostic assays.
Grifols will shortly start construction of a new plant representing an investment of 20 million Euros that will employ about 100 people, as soon as it obtains local permits and licenses. The new facilities will have the capacity to fractionate 1 million liters of plasma a year (with potential to expand to 2 million), allowing the group to double its existing fractionation capacity in Spain. The Grifols plant in Los Angeles, California, currently has a capacity of 2.2 million liters, giving the group total capacity of 6.3 million liters in 2014.
The construction work is scheduled to take 18 months, after which the process of obtaining licenses from the FDA (Food & Drug Administration) in the United States and from the EMA (European Medicines Agency) will begin. This is expected to take no more than two years, as the new plant will fractionate plasma through to the intermediate product stage. The purification, inactivation and sterile filling stages for the different proteins will be performed at Grifols´existing facilities at Parets del Vallès, which have already been adapted to absorb this increased level of production.
The new plant will use the very latest technology and will make maximum use of automation. Grifols Engineering S.A., a group company which specializes in the engineering of biotechnological and pharmaceutical processes, has designed the new facilities and will manage the construction project. The plant will also serve as a model for the future construction of another fractionation plant in the United States (San Marcos, Texas) due to start in 2014, and delivering a maximum capacity of 4 million liters.
The new plant forms part of the €433 million investment plan for the period 2008-2012, approved at the end of 2007 by the Board of Directors. Key features of this investment plan, which is running to schedule, include the new intravenous immunoglobulin (IVIG) production plant in Los Angeles, completed in 2010 and now at the validation stage, together with the new plasma testing laboratory in San Marcos, Texas, also completed in 2010 and at the validation stage.
This means that Grifols has completed over 90% of the projects included in the investment plan for the period, projects which are designed to underpin the company’s growth plans for the period 2014-2018/2020.
Also, Grifols has officially opened its new corporate head offices in Sant Cugat del Vallés (Barcelona). The event was presided over by the Minister of Industry, Tourism and Commerce, Miguel Sebastián who visited the new installations in the company of the Chairman and CEO of the group, Víctor Grifols and the rest of the team of directors.
Grifols is now the third largest plasma derivative producer in the world with a presence in more than ninety countries and its own subsidiaries in twenty-four. The group’s new corporate head offices are made up of three separate buildings, connected at basement level, with a total surface area of 45,900 m2 (493,884 sq. ft.). The site which is known as Trioparc, is located in the Can Sant Joan business park in Sant Cugat del Vallès (Barcelona).
Grifols acquired the installations when construction work was almost completed, and at the end of 2009 management, corporate services departments, scientific management and the different marketing areas moved to the new site. Likewise, one of the buildings is now home to Gri-Cel, the group’s company which coordinates research projects for the development of advanced therapies. Over the last year building work has been carried out on the communal areas, the gardens have been landscaped and other final details completed.
The opening ceremony of Grifols’ corporate head offices coincides with the company’s 70th anniversary. Founded in 1941, Grifols has managed to become one of the most important companies in the Spanish pharmaceutical hospital sector. After the recent acquisition of the North American company Talecris, Grifols now starts a new era as a worldwide point of reference for the research, development, production, and marketing of plasma-derived biological medicines.
GlaxoSmithKline (GSK) plans to invest more than £500 million ($798 million) in the United Kingdom across its manufacturing sites to increase production of key active ingredients for its pharmaceutical products and vaccines. The company announced selection of Ulverston in Cumbria as the location for the first new GSK manufacturing facility to be built in the UK for almost 40 years. Investment also will also be made at the company’s two manufacturing sites in Scotland at Montrose and Irvine.
GSK’s announcement follows plans by the UK government to implement a “patent box” to encourage investment in R&D and related manufacturing in the UK by introducing a lower rate of corporation tax on profits generated from UK-owned intellectual property. “The introduction of the patent box has transformed the way in which we view the UK as a location for new investments, ensuring that the medicines of the future will not only be discovered, but can also continue to be made here in Britain,” said GSK’s CEO Andrew Witty, in a Mar. 22, 2012, statement. “Consequently, we can confirm that we will build GSK’s first new UK factory for almost 40 years and that we will make other substantial capital investments in our British manufacturing base. In total, this will create up to 1000 new jobs over the lifetime of the projects. We are also actively considering other investments in our UK manufacturing network, which would create further jobs and reinforce the UK’s international competitiveness and as a world leader in life sciences.”
Following a feasibility study conducted through 2011, GSK said it will locate a new £350 million ($559 million) biopharmaceutical manufacturing facility in Ulverston, Cumbria. Four existing GSK sites across the UK were assessed—Barnard Castle and Ulverston in northern England and Irvine and Montrose in Scotland—with consideration of factors such as sterile-processing skills, technical capability, and existing links with local suppliers and academic partners. Detailed planning and design of the new facility will begin now with an anticipated start date for construction of 2014–2015, dependent on portfolio timing and obtaining necessary planning and related consents. Once construction starts, it is likely to take at least six years before the plant is fully operational, according to GSK.
GSK announced it is considering further significant manufacturing investment at Ulverston which could double the total investment at the site to approximately £700 million ($1.1 billion). GSK also announced that it will invest more than £100 million ($160 million) in its two manufacturing sites in Scotland. This investment includes new funding at Montrose to enable the manufacture of key materials for GSK’s portfolio of respiratory medicines. Investment will also be made at Montrose to produce aluminium adjuvants used in the manufacture of vaccines. This investment will be the first time a UK GSK site will participate in the company’s vaccine-manufacturing supply chain. At Irvine, GSK will increase production capacity for antibiotics, reflecting growing demand for these medicines in emerging markets.
GSK will also invest in sustainable green-energy production and environmentally friendly manufacturing technologies at both sites. The company is making other investments totaling £80 million ($128 million) at its sites in Ware in Hertfordshire to increase manufacturing capacity for its respiratory-inhalation device and at Barnard Castle in County Durham to establish a dermatology-manufacturing center of excellence.
Overall, GSK employs around 15,000 people in the UK, including almost 6000 in manufacturing.
Eli Lilly announced it was to set up a new bio manufacturing plant in Ireland, in February 2012. The plant will be located at the company's campus in Kinsale, Cork.
Eli Lilly broke ground for a biopharmaceutical development and manufacturing facility at Kinsale in 2006. The facility was inaugurated in 2010 and is set to begin full scale commercial production in 2013. The latest manufacturing plant announced in 2012 will add another commercialization and manufacturing facility to the Kinsale site.
The new project is expected to create 300 jobs during the onsite building works. It will employ 200 pharmaceutical professionals upon commencement of operations. It will thus generate 500 jobs, including high skill and low skill.
Construction is expected to begin later in 2012 and the facility will be opened in 2016. The staff recruitment will begin in 2013.
"IDA Ireland, the organization responsible for bringing foreign direct investments to Ireland, has worked closely with Eli Lilly to attract investment. "The project is undertaken as part of Eli Lilly's planned growth strategy in biopharmaceutical business.
IDA Ireland, the organization that is responsible for bringing foreign direct investments to Ireland, has worked closely with Eli Lilly to attract the company's further investment into the republic to foster employment and industrial growth.
The Action Plan for Jobs, announced by the Irish Government, included the measures it will take to create new jobs in the country in 2012.
It was principally targeted at attracting investments by multinational companies operating in high-end manufacturing and health / life sciences sectors, such as Eli Lilly.
IDA Ireland achieved a significant start up to achieving the targets of the Action Plan by encouraging Eli Lilly's expansion in the country.
The new biopharmaceutical commercialization and manufacturing facility will be built over an area 240,000 square feet near the existing facility at the Kinsale site.
Announcement of the new manufacturing plant is Eli Lilly's second big investment at Kinsale. The company announced the first investment of €300 million ($400m) at the location in 2006. The total investment made by the company in the Kinsale facility reached more than €1 billion by 2012.
The main focus areas for the new plant will be cancer and diabetes drugs. The drugs manufactured will not be in final dosage form.
They will be shipped to finishing plants of the company located in different parts of the world. The finishing plants will convert them to tablets, capsules or injectibles, depending on the drug's approved dosage form.
Eli Lilly's manufacturing history in Ireland dates back to 1981 when the company established its first manufacturing facility in the republic.
"The manufacturing plant is Eli Lilly's second big investment at Kinsale. The company announced the first of €300m ($400m) in 2006. "Eli Lilly is headquartered in Indianapolis, U.S. The Irish branch of the company is located in Dunderrow, Kinsale.
The company currently has four manufacturing sites in the country, including Kinsale, Cork City, Sligo and Dublin.
These production facilities manufacture bulk quantities of active pharmaceutical ingredients (API), biopharmaceutical products and animal vaccines.
Some of the drugs manufactured by these sites include Alimta, Evista, Strattera and Zyprexa.
The existing facility at Kinsale is involved in development as well as commercialization of new products.
The pharmaceutical sector plays a key role in the Irish industrial and economic growth as the industry is the second largest in Ireland. The republic has witnessed more than €7bn investment in pharmaceuticals in the last decade.
It has eventually grown to become the world's biggest net exporter of pharmaceuticals.
Eli Lilly has attracted and invested significantly in a skilled workforce at the existing Kinsale manufacturing facility, therefore, expanding the site will provide synergistic benefits.
The Government of Malta is funding a state-of-the-art life sciences centre named the BioMalta Campus, in San Gwann. The centre is being developed to foster the growth of the country's life sciences industry.
The Life Sciences Centre will provide laboratory space to new as well as existing companies. It will also extend business advisory services, financial incentives and tangible support to companies intending to set up operations.
The development plan of the project was approved by the Malta Environment & Planning Authority in June 2011. The construction of BioMalta campus is expected to be completed in 2014. The project will create more than 500 jobs by 2019.
"Construction of the BioMalta campus is expected to be completed in 2014. The project will create more than 500 jobs by 2019."The BioMalta Life Sciences Centre project was launched in May 2010 by the Finance and Economic Development Ministry. The project is aimed at attracting foreign direct investment into the bio-technology and life sciences sectors of the country.
Malta Enterprise is the government agency responsible for attracting foreign investors and promoting industrial development in Malta.
The project will be completed in two phases. It will form part of a larger biotechnology park proposed to be built in the Sam Gwann Industrial Estate.
The project is estimated to cost €29m. It will be co-financed by the Government of Malta, Malta Enterprise and the European Regional Development Fund (ERDF). The European Union alone will fund 80% of the project cost.
The BioMalta Campus is being built over ex-Yorkie and disused VF jeans factories in the San Gwann Industrial Estate. Malta Enterprise also has an office building at the site. The office will be relocated to create space for the BioMalta campus. The existing buildings are being demolished to make way for the construction of the research and development park.
The project site is strategically located in proximity to the University of Malta and Mater Dei Hospital, enabling operating companies to work in collaboration with the university staff and the hospital.
The BioMalta Campus will initially consist of four buildings comprising 10,000m² of laboratory space and 3,500m² of business incubation facilities. There will be 61 lab units, including 11 incubation units.
"The BioMalta Life Sciences Centre project was launched in May 2010 by the Finance and Economic Development Ministry."One of the four buildings will be dedicated for retail, conference and meeting facilities. It will also have food and beverage outlets, exhibition space and an auditorium with 150 to 200 seats capacity. The lab space will be leased to companies involved in biological and chemical research.
The campus is proposed to include wet laboratories designed in accordance with the standards of BS/EN 12128:1998, which suggests the containment levels to be maintained in biotechnology laboratories.
The design of the labs will be modular so that contracting companies can modify the space arrangement to suit their requirements. The containment level of the labs will be maintained by using ventilation and extraction systems with high efficiency particulate air (HEPA) filters.
The contract for the design of the campus was awarded to TBA Periti. Enabling works are in progress as of the first quarter of 2012. The main construction work is planned to begin in June 2012. Construction is expected to be completed by March 2014.
The research laboratories at the BioMalta campus will carry out Containment Level 2 fields of research, which means working with biological agents, hazardous chemicals and genetically modified organisms with a medium level of risk.
The BioMalta Campus will be involved only in research and development activities. Malta Enterprise plans to set up a similar facility near the campus to attract biotechnology manufacturers to the country.
Aptar Pharma, which is part of the AptarGroup, inaugurated its new manufacturing site in Mumbai, the commercial capital of India. It is the first plant of the company in India and the second in Asia. Aptar Pharma's first plant in Asia is located in Suzhou (near Shanghai), China.
The company is engaged in the development and manufacturing of nasal and pulmonary drug delivery devices, including aerosol, spray and dispensing systems used for asthma, allergies and related symptoms. The company's products are marketed to many of the Indian biotechnology, healthcare and pharmaceutical companies.
The new Indian plant is the first of its kind and is located at Rabale, Navi Mumbai. The company currently employs 30 people in India and is planning to increase that further with the new plant.
"The new Indian plant is the first of its kind and is located at Rabale, Navi Mumbai. The company currently employs 30 people in India."Aptar Pharma has a strong customer base in India. The Mumbai plant has been established with the aim of serving the Indian customers better by establishing a local manufacturing base for drug delivery devices.
The project was self-financed by the AptarGroup and is a proprietary asset of the group.
The new manufacturing facility is built up over an area of 2,000 square meters (21,520 sq. ft.). It includes an ISO 7 cleanroom measuring 380 square meters, a warehouse, maintenance / tooling suites and offices.
The plant features product assembly lines, inspection and testing equipment and filling and crimping machines. The molded components were sourced from Suzhou, China and Le Vaudreuil, France. The filling and crimping machines were supplied by DH Industries.
The facility took six months for construction from the existing buildings and involved multiple local contractors.
"Aptar Pharma's first plant in Asia is located in Suzhou (near Shanghai), China."The company has established the Mumbai manufacturing site in a step to expand the operations in order to benefit from opportunities available in the Indian market.
Aptar Pharma plans to further expand its activity in India, as well as the rest of Asia, and become a key local employer.
The company also plans to leverage its network of local partners including those in research, industry, academia and regulatory bodies to strengthen its business.
The Mumbai plant will mainly produce spray pumps for nasal and topical delivery assemblies and the DF30 metering valve platform for pulmonary delivery (asthma). The DF30 valve platform is manufactured to the highest standard, claims Aptar Pharma.
The valve product has been in market for more than 20 years. It offers a wide range of metering volumes, from 25µl to 75µl.
Manufacturing processes taking place in the AptarGroup's Aptar Pharma plants include spray pumps and metering valves. They are drug delivery devices composed of 10 to 15 components made of plastic, metal and elastomer. Metal parts are sourced from external suppliers, while plastic and elastomer components are manufactured in-house.
Precision injection molding of plastic components takes place in other Aptar Pharma facilities located in Europe and China, while automatic assembly and controls are handled within the Mumbai facility.
Headquartered in the US in Crystal Lake near Chicago and traded on the NYSE, AptarGroup is global with manufacturing sites in different parts of the world, including North America, South America, Europe and Asia.
The Indian pharmaceutical market is large (ranked 12th worldwide) and very dynamic (+15%) thanks to the high population and increased access to healthcare (eight percent GDP in 2011). It is also a key market for asthma drugs with strong pharmaceutical players selling their products in the domestic market and successfully exporting.
Aptar Pharma is well positioned to benefit from the expansion in India.
Baccinex is a full-service pharmaceutical contract manufacturing organization (CMO) of sterile liquid and lyophilized dosage forms. Its field of expertise spreads from pharmaceutical development and manufacturing of clinical trial material, to commercial manufacturing, packaging, analytical services and logistics.
Thanks to its large number of projects with different partners, Baccinex has developed special competences in aseptic fill / finish and lyophilisation of small molecules and biological products in vials and ampoules.
Baccinex is a Swiss independent pharmaceutical CMO founded in 1999 that obtained its GMP manufacturing license in 2004. Customer satisfaction is the first aim of the company and all departments work closely together to reach it.
Baccinex's main focus is to adapt to customers' requirement and offer customized contract manufacturing activities, including:
Scale-up from laboratory conditions to GMP-conforming manufacturing conditions
Aseptic filling / finishing
Lyophilisation
Clinical packaging
Physico-chemical and microbiological analysis
Stability studies
GMP storage
Sterile manufacturing (aseptic process or terminal sterilization) / lyophilisation
Baccinex manufactures a wide range of liquid or freeze-dried sterile products such as:
Technical / pilot or non-GMP batches for non-human purpose
Clinical trial material (from phase I to phase III)
Commercial batches.
Baccinex is able to manufacture sterile products either through aseptic processing or terminal sterilization according to the following filling capabilities:
Ampoules size: 1ml - 5ml (up to 25,000 units per batch)
Vials size: 1ml - 100ml (up to 12,000 lyophilized units per batch).
Cleanroom design is adapted to enable freeze-drying of vials and also ampoules. We can provide development and optimization of freeze-drying cycles.
Because of its adapted facilities, Baccinex is specialized in clinical trial material production, from investigational medicinal products (IMP) or non-IMP GMP manufacturing for Phase I - III studies to clinical labeling, packaging and shipping. Visual inspection, labeling and packaging are performed manually, which allows tailor-made activities depending on each customer.
Baccinex has developed a specific know-how related to manufacturing of clinical material supplies:
Minimized loss of the bulk solution during manufacturing steps in order to transfer a maximum of solution in vials as usable drug product
Sharp management of different products and batch segregation in order to avoid any risk of cross-contamination between products
Use of exclusively disposable and dedicated material in direct contact with product
Highly trained operators in order to safely switch from one customized process to the next
Pharmaceutical development and optimization services
Thanks to its closely related production and quality control activities, Baccinex can offer different development and/or optimization services such as:
Consultancy for transition from research laboratory to GMP environment
Optimization of freeze-drying cycles
Scale-up to GMP process
Compatibility / adsorption studies with filter / medical devices
Transfer of analytical methods
Stability studies according to ICH conditions
Physico-chemical and microbiological activities for release / stability testing
Baccinex is able to perform a wide range of analysis in its quality control laboratory, from the analysis of starting materials to the in-process controls (IPC) and the release analysis of the finished sterile products. Pharmacopoeial methods can be carried out, and other methods can be validated and subsequently used in routine.
The quality control laboratory is divided into two parts:
A physico-chemical laboratory
enabling most of the analysis commonly used: pH, osmolality, HPLC, IR-spectroscopy,
UV/VIS spectrometry, sub-visible particles, conductivity, potentiometry,
viscosity, Karl-Fischer, TOC, etc.
A microbiological laboratory in charge of sterility, endotoxins and bioburden testing, but also reading of media fill tests, analysis of environmental monitoring during GMP production, in-house identification of microorganisms, etc.
Part of the quality control activities is dedicated to ICH stability studies: all equipments are in place to conduct stability studies according to regulatory requirements for the storage conditions and customer requirements for the analysis.
We comply with highest international quality standards. Our quality assurance system is configured to allow continuous improvement of all departments. Our manufacturing site is regularly inspected by local health authorities and audited by customers.
We can perform the final release of GMP batches through our in-house Qualified Person.
Baccinex's facilities and cold storage allow GMP storage of primary materials and finished products at ambient temperature, 2°C to 8°C, -20°C or -80°C. The storage conditions are continually monitored.
Working with carriers specialized in temperature-controlled shipment, we can organize worldwide shipments of samples, finished products or clinical trial supplies.
The expansion will support the increasing use of mass spectrometry for food safety testing, environmental analysis, academic research, drug development, forensic toxicology and clinical research.
This expansion represents AB SCIEX’s increasing investment in Brazil, which is a rapidly emerging leader for scientific advancements in Latin America.
With a growing base of mass spectrometry customers already in Brazil, AB SCIEX is investing to enhance customer service and support, set up a customer training center in São Paulo and expand the application demo facility with state-of-the-art laboratory products currently not available for demonstration in the country. AB SCIEX is replacing indirect distribution with a direct model of sales and support within Brazil to create new opportunities for customer interactions, collaborations and innovation.
“AB SCIEX is a trusted partner with thousands of scientists around the world, including many Brazilian researchers,” said Mateus Campos, country manager, AB SCIEX Brazil. “Our commercial expansion in Brazil is a positive step forward to better enable Brazilian scientists to push the limits of analytical science in their fields. Our working more closely with an increasing number of scientists locally is intended to help Brazil ensure a safer food supply and environment, develop more effective drugs and achieve much-needed biomedical breakthroughs, ultimately improving life for the Brazilian people.”
AB SCIEX has a more than 20-year history of innovation and is a market leader in mass spectrometry. The company has been selling its best-in-class mass spectrometry technologies in Brazil for more than a decade through different channels, including Life Technologies, under the “Applied Biosystems” brand. Going forward, AB SCIEX is now combining its global resources, scientific expertise and product development leadership under the “AB SCIEX” brand with a highly qualified, experienced local team in Brazil to support existing and new mass spectrometry users.
AB SCIEX excels by listening to and understanding the ever-evolving needs of its customers to develop reliable, sensitive and intuitive LC/MS/MS solutions that continue to redefine what is achievable in routine and complex analysis. These solutions consist of a broad portfolio of industry-leading products, including TripleTOF systems, QTRAP® systems and Eksigent LC systems as well as a comprehensive suite of application-specific software and methods. Supporting these workflow solutions are AB SCIEX’s world-class service and support.
Haupt Pharma has initiated a comprehensive project to optimize its supply chain.
The aim is to further boost the efficiency, quality and monitoring of the supply chain processes as part of a continuous optimization process.
At the same time, economic efficiency is to be increased through the reduction of reject quantities. In order to show accurate and prompt initial results, Haupt Pharma is collaborating with the Fraunhofer Institute for Material Flow and Logistics IML. This well-known partner organization has already achieved success with comparable requirements at other major pharmaceutical companies.
"By optimizing our supply chain processes, our throughput time will be further reduced and made easier to plan. This will enable us to reduce our lead times and respond even more flexibly to the requirements of our customers. At the same time, we shall reduce our inventory levels. A real win-win situation,” says Dr. Hubert Bensmann, the member of the extended management board responsible for, amongst other things, Supply Chain Optimization and Managing Director of the Münster site.
"As an institute specialized in all questions relating to integrated logistics and optimization of production processes, we have already advised on a large number of projects,“ says Dr. Sebastian Wibbeling, department head of Health Care Logistics at the Fraunhofer IML.
Dr. Wibbeling continued, "We are looking forward to the exciting challenge and to be able to have Haupt Pharma fully benefit from our expertise."
Using the operational excellence approach as a basis, Haupt Pharma and the Fraunhofer IML will first of all work out a generic, ideal value-added process at two sites.
Here the focus will be on the entire supply chain, including supporting process areas, in order to achieve an improvement in process quality and profitability.
The improved value-added process will be the basis for process optimization at the two selected Haupt Pharma sites and, as a next step, at all the remaining sites.
The Office of the Chief Scientist (OCS) at the Israeli Ministry of Industry, Trade and Labor launched two new programs to help promote foreign investment in Israeli R&D in the life sciences sector.
Under the first initiative, international corporations will commit to establishing an R&D center in Israel that will employ more than 60 workers for a period of no less than 5 years. R&D centers established in the center of the country will receive government support of about 19 million shekels (US$5.1 million), whereas R&D centers set up in Israel's periphery in the north or south will receive about 32 million shekels ($8.6 million).
Under the second initiative, international corporations invest no less than $20 million in projects by Israeli companies in the life sciences sector over the course of five years. The OCS will then offer support of up to 50 percent of the projects. The corporations will also be required to contribute to R&D activity through professional guidance, managerial advice and exposure to knowledge and work methods at the international corporation.
Global R&D organization Battelle has begun construction of an advanced research-and-development facility in Chelmsford, U.K., that will expand its global footprint and capacity to provide advanced science and technology solutions for the agriculture, food and health care industries.
The new, 20,327-sq.-ft. (1,888-sq.-m.) facility at Chelmsford Business Park is an expansion of Battelle's existing operations in the United Kingdom and will open in April 2013. The new facility will augment Battelle's established global scientific expertise in formulation development, toxicology and biotechnology programs that help agriculture and food customers accelerate product development and meet multi-national regulatory requirements. It also opens additional opportunities to serve the research and development needs for pharmaceutical, medical device and other health and life science companies across Europe and around the world.
Sigma-Aldrich Corp. has completed a 57,000-sq.-ft. expansion of its Bangalore, India campus, which includes an expanded distribution center and new packaging facility, enhancing its distribution capabilities in the Asia-Pacific region.
The new addition features approximately 49,000 sq. ft. of distribution space and 8,000 sq. ft. of packaging space. The existing 10-acre campus will continue to house the administrative offices, sales, marketing and distribution functions, and manufacturing.
“Sigma-Aldrich has built a strong foundation, achieving consistent double-digit sales growth driven by our first-to-move advantage, our approach in providing excellent service, our investments and our high standards for operation. A key focus in the Asia-Pacific and Latin America regions has been to accelerate localization to continue to drive further growth,” said Eric Green, vice president and managing director, International at Sigma-Aldrich.
NAMSA, the Northwood, Ohio-based medical device research organization, has said guten tag to Germany. The company has opened its newest office near Frankfurt. Staff with regulatory and quality expertise, clinical managers and local monitors will provide support for European clinical trials as well as European device makers seeking approvals in the United States, according to the company.
This isn’t, however, the firms first foray into Europe. NAMSA’s testing laboratory near Lyon, France, has been conducting non-clinical safety and efficacy studies for medical device companies since 1986.
“U.S. companies can have confidence that the high quality support they’ve valued in NAMSA’s U.S. clinical and consulting operations are now available in Europe, ensuring the same responsiveness and thoroughness on both sides of ‘the pond,’” said Elizabeth Kempen, chief operating officer of NAMSA's clinical research and consulting groups.
European market approval has emerged as a preferred pathway for medical device manufacturers primarily due to more efficient approval processes, Kempen claimed.
“The placement of this office reinforces NAMSA’s commitment to helping our clients design and execute global regulatory and clinical strategies, develop new therapies, and launch them in the most efficient manner possible,” said John Gorski, NAMSA’s president and CEO. “The combination of non-clinical and clinical research expertise at our European locations enables NAMSA to provide our clients with a higher level of continuity, consistency and convenience throughout the product development process.”
NAMSA provides range of services to prove efficacy, non-clinical and clinical safety of medical devices, IVDs and combination products.
Oberg Medical, a full-service medical device contract manufacturer providing implants, instruments, and complex assemblies, recently announced plans for the expansion of its Costa Rica manufacturing operation.
Company officials said the move was to better serve the expanding device market in Central America and provide "cost optimization solutions" for U.S. OEMs.
“We have been a manufacturer in Costa Rica since 2001 and have seen firsthand the growth of the medical device sector in country. As more of our OEM partners look to Central and South America for growth opportunities, we are expanding our presence in the country to provide them cost-effective manufacturing solutions,” said David Bonvenuto, executive vice president and general manager of Oberg Medical.
The company has more than 100 employees in Costa Rica today and officials noted that trade school programs have been used to attract talented employees. In addition, good relationships with investment, government and in-country supply chain partners for materials and services have given the company "the confidence" to expand Costa Rica operations, Bonvenuto added.
Oberg will expand from 24,000 square feet to more than 50,000 square feet within its current home, the Metro Park located just outside of San Jose. The larger facility will support the firm's growing precision implant and instrument manufacturing, with added capacity in the milling, wire EDM, turning, quality inspection, and related secondary operations areas. The expansion is expected to be completed in the third quarter of 2012.
The growth in Costa Rica comes on the heels of more than $5 million of capital investment into its United States-based medical business over the past year along with an additional $2 million of capital investment in Costa Rica. The U.S. investment included the completion of its facility-wide process validation initiative and the addition of approximately 15 CNC milling machines, EDMs, and lathes.
“As a manufacturing partner in the medical device market, we have made a significant commitment to expanding our manufacturing capacity and production footprints both in the U.S. and Costa Rica,” said Shawn Schafer, vice president of Sales and Market Development for Oberg Medical. “We believe our commitment to both the U.S./North American market as well as to the Central/South American market provides OEMs the ability to better integrate and optimize their supply chain and product costs in these respective markets,” Schafer added.
The company’s U.S. operations are located in the suburbs of Pittsburgh, PA.
McIlvaine Company
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Tel: 847-784-0012; Fax: 847-784-0061
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