PHARMACEUTICAL/BIOTECHNOLOGY
INDUSTRY UPDATE
November 2011
McIlvaine Company
TABLE OF CONTENTS
Medicago Opens Vaccine Facility
Rottendorf Pharma Expands into U.S.
BGI, CHOP Partner at Philly Genome Center
Florida Innovation Hub at the University of Florida Completed
FDA Establishes Two Centers for Regulatory Science
Michigan Univ. Builds State-of-the-Art, Green Hospital
New Orleans BioInnovation Center
Big Genomics Center to Launch in Big Apple
La Jolla Institute Joins Stem Cell Consortium
HWI Global to Begin Construction of Stem Cell Therapy Cleanroom at Mt. Sinai
SAFC Verona Facility Receives SafeBridge Certification
Legislature Approves Controversial Jackson Lab Deal
UPMC to Build $300M Center for 'Innovative' Biomedical Science
South Korean Food Company Invests in U.S.
Ryan Cos. Completes Cleanroom for Northern Illinois Food Bank
BGI, UC Davis Building Sequencing Facility
UPM Expands Manufacturing Capability
Norwich Doubles Capacity for Pilot Production
Bayer Expects to Open in New Jersey in 2013
DPT Continues Facilities Expansion
IRX Therapeutics Moves from NY to FL
Saltigo Builds in HPAPI Manufacturing Space
Biodesign Institute Expand Biorepository
Broad Institute Breaks Ground on New Cambridge Building
Gladstone to Announce New Stem Cell Center
J&J Launches Incubator for Biotechs in San Diego
GATC Expanding Sequencing Operations
Corning Opens Life Sciences Manufacturing Facility in China
Pharma Companies Team with Russian Manufacturer
AGC to Open Intermediate & API Plant in Japan
Bosch Packaging To Build Second Plant in China
Teleflex Medical OEM Grows in Ireland
Tetra Pak Opens in Shanghai PDC Centre
Pfizer to Retain 650 Jobs at UK R&D Facility
Concordia Launches Genomics Center in Montreal
Living Laboratory Building in North America
InterVacOpens at University of Saskatchewan
Pharmaniaga Small Volume Injectables (SVI) Facility
Almac to Boost Manufacturing Capacity at Craigavon
India Opens Textile Research Center
Entegris Establishes Facility in Taiwan
Medlac Pharmaceutical Plant, Hoa Lac Hi-tech Park
3B Blackbio Biotech India Manufacturing Plant Opens
Saltigo Builds HPAPI Manufacturing Space
bioMérieux Increases Production Capacity
PSL to Supply FilterBoxes to New Helsinn Facility
Merck Plans Singapore Expansion
Metabolon has Opened New Lab in Shanghai, China
Rusnano and Nearmedic Team on Nanomedicine Manufacturing Plant
Carbogen Amcis Expands High Potency Manufacturing
Sri Lanka to Increase Local Drug Production with Pharma Hub
Maropack Facility Built for Biologicals
Lundbeck Outsourcing in China with New Shanghai R&D Centre
CMO Angel & Russian Pharma Plan Production JV
Solvias and RohnerChem Join API Development and Manufacturing
Medicago Inc., a wholly owned subsidiary of Medicago Inc., a biotechnology company focused on developing highly effective and affordable vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs), announced that company executives, along with Governor Beverly Perdue, U.S. Senator Richard Burr, and Congressman David Price, are holding an official ribbon cutting ceremony on Monday, Nov. 14 at 11 am for its U.S. plant-based vaccine facility in Research Triangle Park. The company initially announced that it commenced operations at this 97,000-square-foot vaccine facility.
With this ribbon cutting ceremony, Medicago will officially open its state-of-the-art vaccine facility in the Park. This VLP plant-based vaccine facility includes a fully automated greenhouse and a state of the art extraction and purification unit. The facility is targeted to produce 10 million doses of pandemic influenza vaccine per month. On an annual basis, the facility will have the production capacity of 40 million doses of seasonal Influenza vaccine or 120 million doses of pandemic influenza vaccine.
Medicago previously signed a Technology Investment Agreement with the Defense Advanced Research Projects Agency (DARPA) to develop a 97,000-square-foot vaccine facility in the Research Park. This state of-the-art facility is a large, cost-effective and scaled-up facility for Medicago's VLP plant-based vaccine technology ultimately for the delivery of current good manufacturing practice (cGMP)-grade vaccine. Medicago intends to demonstrate its capacity to produce 10 million doses/month of influenza vaccines with the potential for further expansion in the future.
This DARPA project is part of the Blue Angel influenza vaccine rapid response demonstration project which seeks to identify new ways to produce large amounts of high quality vaccine grade protein in less than 3 months in response to emerging and novel biologic threats. The company reported positive phase II results for its clinical trial with its H5N1 avian influenza vaccine in June 2011. The vaccine was found to be safe, well tolerated and also induced a solid immune response which is among the most effective of the industry. The company also recently reported positive U.S. phase I results in its clinical trial with its H1N1 / seasonal influenza vaccine candidate. All tested doses were found safe and well-tolerated. A single dose of 5 µg met the 3 CHMP (The Committee for Medicinal Products for Human Use) immunogenicity criteria. This phase I trial is expected to lead to Medicago's U.S. phase IIa trial for its seasonal trivalent vaccine with the recommended H1N1, H3N2 and B influenza strains. Medicago is committed to provide highly effective and competitive vaccines based on proprietary Virus-Like Particle (VLP) and manufacturing technologies.
Medicago is developing VLP vaccines to protect against H5N1 pandemic influenza, using a transient expression system which produces recombinant vaccine antigens in non-transgenic plants. This technology has potential to offer advantages of speed and cost over competitive technologies. It could deliver a vaccine for testing in about a month after the identification and reception of genetic sequences from a pandemic strain. This production time frame has the potential to allow vaccination of the population before the first wave of a pandemic strikes and to supply large volumes of vaccine antigens to the world market.
Rottendorf Pharma GmbH has continued its global expansion with the addition of offices in Chicago and the establishment of the Rottendorf Pharma, Inc. subsidiary. Gordon Haines has been appointed chief executive officer of Rottendorf Pharma. Inc., which will initially focus its efforts on developing markets through business development and supply chain activities in the U.S. Manufacturing operations in Germany and Europe will initially support these efforts, with plans for a U.S.-based packaging operation. The company will keep its technical areas of formulation, development and bulk manufacturing in Europe for now.
Rottendorf has supplied products for the U.S. market for the last four years from its FDA-approved production facility in Germany. According to the company, the establishment of Rottendorf Pharma, Inc. demonstrates its commitment to expanding the U.S. market presence and providing "home-based" services to U.S./American customers.
The Children's Hospital of Philadelphia (CHOP) and BGI have partnered to conduct large-scale human genome sequencing and bioinformatics analysis at CHOP's Joint Genome Center at Children's Hospital.
The BGI@CHOP partnership will focus on using BGI's next-generation sequencing capabilities and CHOP's biobank and clinical phenotyping resources to discover which genes are involved in rare and common pediatric diseases.
CHOP "has built the largest pediatric biobank in the world, and because many of these samples have been linked to clinical data using an electronic medical record, we can now follow disease processes into adulthood," Hakon Hakonarson, director of the Center for Applied Genomics at Children's Hospital, said in a statement. "Through our partnership with BGI, we now have a clear path forward into the genomics-based personalized medicine arena."
"The ultimate goal is to change the way we diagnose and treat diseases that affect children and families, and our work with BGI is an important first step toward that end," added CHOP's CSO Philip Johnson.
"Given BGI's expertise in genomic sequencing and bioinformatics, we expect our partnership with Children's Hospital and the establishment of the BGI@CHOP Joint Genome Center to lead to significant breakthroughs that may be translated into improved patient care," said Greg Wang, CEO of Cambridge, Mass.-based BGI Americas.
The new Florida Innovation Hub at the University of Florida was designed to achieve LEED Gold. Charles Perry Partners, Inc. (CPPI) completed construction of the new Florida Innovation Hub at the University of Florida, a business incubator, under an $11 million design-build contract with the university. Designed by Ponikvar & Associates to achieve LEED Gold certification by the USGBC, the facility houses the UF Office of Technology Licensing, UF Tech Connect, other entities, and more than 30 startup technology tenants.
As the first building located in the Innovation Square urban research park environment, the Innovation Hub offers close proximity to UF, shared facilities, all-inclusive leases, room for expansion, modern laboratories, high-speed data and more. The 46,000-sf facility also features a lobby/atrium with adjacent conference rooms, a coffee bar, kitchen and lunchroom.
Idexx has acquired the research and diagnostic laboratory (RADIL) business of the College of Veterinary Medicine from the University of Missouri for $43 million in cash, the Westbrook, Maine-based firm announced.
RADIL is based in Columbia, Mo., and provides health monitoring and diagnostic testing services, including services using molecular diagnostics, serology, pathology, microbiology, and parasitology.
All RADIL employees will be transitioned to Idexx and continue at the Columbia site.
The deal is expected to be immaterial to Idexx's financial results for 2011. In 2012, the acquisition is anticipated to add $12 million in revenues and to be neutral to fully diluted earnings per share, Idexx said.
Jonathan Ayers, chairman and CEO of Idexx, said in a statement that the purchase is an "excellent strategic fit" for the firm, allowing it "to leverage our expertise in veterinary diagnostics, as well as our integrated offering of reference laboratory and in-clinic testing solutions."
On Oct. 26, 2011, FDA dedicated $2 million to support two regional Centers of Excellence in Regulatory Science and Innovation (CERSI). The centers, which will be located at the University of Maryland and at Georgetown University, will focus on the scientific knowledge and training needed to modernize and improve the ways the agency reviews and evaluates drugs and medical devices.
“These partnerships represent a critical, necessary, and creative investment—one that will benefit not just FDA and academia, but also American consumers and industry,” said FDA Chief Scientist Jesse L. Goodman in a press release. “The Centers of Excellence will create new scientific research, training, and staff-exchange opportunities for FDA and leading area institutions.”
CERSI researchers will cooperate with FDA scientists to stimulate innovation in medical-product development. The scientists also will aim to advance laboratory, population, behavioral, and manufacturing sciences. FDA chose to pilot the CERSI in the Washington, DC, area to allow for face-to-face collaboration and training with FDA staff.
FDA defines regulatory science as the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all FDA-regulated products. For the past year, the agency has focused on improving regulatory science by launching various initiatives. Earlier this month, FDA launched an initiative titled “Driving Biomedical Innovation: Initiatives for Improving Products for Patients.” The initiative is an effort to increase the number of new-drug submissions by bringing stakeholders together to identify and overcome the challenges of product development and assessment.
In August 2011, FDA released its “Strategic Plan for Regulatory Science,” which describes the agency’s intent to improve the process for developing and evaluating new products from fields such as cell therapy, tissue engineering, genomics, personalized medicine, advanced computing, and information technology. It also emphasizes FDA’s intention to study and improve how it communicates health information to consumers.
ISPE, a global not-for-profit association of 22,000 pharmaceutical science and manufacturing professionals, announced during the Keynote Session at its 2011 Annual Meeting in Grapevine, Texas, USA, that MedImmune’s Frederick Manufacturing Center (FMC) Expansion Facility is the Overall Winner of the 2011 Facility of the Year Awards (FOYA) program.
Sponsored by ISPE, INTERPHEX, and Pharmaceutical Processing magazine, the Facility of the Year Awards (FOYA) program recognizes state-of-the-art pharmaceutical manufacturing projects that utilize new and innovative technologies to enhance the delivery of a quality project, as well as reduce the cost of producing high-quality medicines. Now in its seventh year, the awards program effectively spotlights the accomplishments, shared commitment, and dedication of individuals in companies worldwide to innovate and advance pharmaceutical manufacturing technology for the benefit of all global consumers.
To enable production of forthcoming products, MedImmune chose to build and license a flexible, large-scale mammalian cell culture-based production facility adjacent to their existing Frederick Manufacturing Center (FMC) in Frederick, Maryland, USA. This complex and challenging project was delivered in an aggressive timeline with an outstanding safety record – over 2.3 million man-hours without a lost-time incident. The result was a facility capable of handling a wide variety of product titers supported by a fully integrated Process Control System (PCS).
MedImmune implemented innovative strategies to assure project success. The project team used a military-inspired, four-tiered training methodology to help transition the workforce to the new facility. The team supplemented the training program with a comprehensive shakedown schedule that maximized practice runs prior to process validation. The team also developed a simulator that enabled them to execute commissioning and qualification of the PCS offline, freeing up physical equipment for shakedown runs. Despite the aggressive project schedule, the team successfully completed over 13 shakedown runs and three PV runs without a single contamination or lost batch.
The FOYA judging panel was impressed by the solid planning, innovative problem resolution, and fast-paced but efficient execution that allowed MedImmune to build and validate a world-class, flexible manufacturing facility with a state-of-the-art automation system. For this, MedImmune was named the 2011 Facility of the Year Awards Overall Winner.
In addition to MedImmune, the Facility of the Year Awards recognized six other companies in 2011. They were:
F. Hoffmann – La Roche, winner of the Facility of the Year Award for Operational Excellence for their MyDose Clinical Supply Facility in Kaiseraugst, Switzerland
Merck & Co., Inc., winner of the Facility of the Year Award for Facility Integration for their Global Clinical Supplies Manufacturing, Packaging, and Warehouse Expansion project in Summit, New Jersey, USA
Novartis Vaccines and Diagnostics GmbH, winner of the Facility of the Year Award for Equipment Innovation for their MARburg Site (MARS Project) in Marburg, Germany
Pfizer Health AB, winner of the Facility of the Year Award for Operational Excellence for their Pegasus – Bio 7 Manufacturing Facility in Strängnäs, Sweden
Pfizer Manufacturing Deutschland GmbH, winner of the Facility of the Year Award for Sustainability for their Strategic Plant Restructuring and Energy Master Plan (SPRING and E-MAP) project in Freiburg, Germany
Shire HGT, winner of the Facility of the Year Award Honorable Mention for their Project Atlas, Building 400 project in Lexington, Massachusetts, USA
More information about each of the winning projects, as well as the Facility of the Year Awards program in general, can be found at www.FacilityoftheYear.org.
Michigan Univ. is preparing to let the public take a peek at its massively expanded hospital complex, which includes an indoor playground in the 1.1 million-square-foot facility.
Mott Children’s and Von Voigtlander Women’s hospitals are set to hold an open house in what is likely to be the first and last public tour at the 1.1 million-square-foot facility.
“We can’t have tours once we have our patients in,” says Pat Warner, the facility’s executive director.
Patients will be moved Dec. 4 from the old Mott, which was built in 1969, to the sparkling new $754 million hospital next door, where ground was broken in February 2008.
Officials showed off the features of the complex, which they boast is the largest construction project in the state. “We know we will live in this facility for 50 years,” Warner says.
The 887,000 square feet of space for patients includes 348 single rooms, 50 maternity rooms, 16 operating rooms and state-of-the-art technology in a facility that already ranks among the nation’s best for children and women.
“With the size of the rooms, we can bring the technology to the patients instead of taking the patients to another room to access the technology, as we have to do now,” John Charpie says. “And with all private rooms, we can bring down the rate of infections and increase the satisfaction of our patients and their families.
The new 1.1 million square feet hospital includes a 12-story inpatient wing and a nine-story outpatient wing, 348 beds, including 50 private maternity rooms and 46 private NICU rooms, 16 operating rooms and two interventional radiology rooms.
The new pediatric emergency department and urgent care center includes its own private entrance and kid-friendly waiting area, 31 exam rooms and observation bays, hazmat capabilities, staffing by pediatric subspecialists 24/7 and a dedicated Mott helipad providing direct, uninterrupted access for transport patients.
The facility will also include three all-private-room intensive care units: a newborn intensive care unit (NICU), a child and adolescent intensive care unit (PICU), and a dedicated cardiac intensive care unit (PCTU).
Additional features include a state-of-the-art operating room suite featuring intra-operative MRI capabilities, blood and marrow transplant (BMT) suite with on-site infusion pharmacy, an entire floor for the Michigan Congenital Heart Center, and many more unique clinical features.
Incorporating many architecturally innovative and environmentally responsible features, the building was designed and built in accordance with the Leadership in Energy and Environmental Design (LEED) Green Building Rating System.
LEED is an internationally recognized green building certification system, providing third-party verification that a building was designed and built using strategies aimed at improving performance across all the metrics that matter most: energy savings, water efficiency, CO2 emissions reduction, improved indoor environmental quality, stewardship of resources and sensitivity to their impacts.
Environmentally-friendly features of the new Mott Children's Hospital include:
The new "green roof" on C.S. Mott Children's Hospital filters rainfall as part of a natural storm-water management system. Planted with sedum, a drought-resistant perennial groundcover, the living roof helps insulate the building and reduce energy loss, reduces heating and cooling costs by 50%, and improves air quality by trapping airborne dust and dirt. Because the new hospital is built on what was previously a parking lot, the green roof essentially reduces the amount of paved surfaces on campus. The eco-friendly roof is also expected to last two to three times longer than a conventional roof.
An astounding 93% of the material harvested from the site the new hospital was built on has been recycled for use in the new Mott Children's Hospital. More than 200 tons of concrete and asphalt were recycled from the project site. In addition, the new facility will be paper-light and wireless upon opening.
The floors in the new Mott Children's Hospital are special no-wax, no-buff floors. These mineral-based, PVC-free and chlorine-free floors require minimal maintenance or wax-stripping, therefore requiring fewer natural resources for upkeep. In addition, the floors can be recycled without releasing harmful chemicals.
Other green elements include the following that 95% of wood materials in the new hospital are certified in accordance with FSC (Forest Stewardship Council) principles for wood building components and construction equipment used on the new children's hospital is running on biodiesel. The interior materials such as carpet, paint, adhesives and composite woods were chosen for low-emittance characteristics to ensure the high indoor air quality and HEPA filters will enhance air quality for immuno-compromised and other high-risk patients.
The University of Texas Health Science Center (UTHSC) opened the new South Texas Research Facility (STRF) at its campus in San Antonio, TX, in October 2011. Built with an investment of $150m, the new facility will serve UTHSC's growing research activities.
"The City Council of San Antonio announced in June 2011 it is providing $3.3m funding for the construction of the facility."The STRF project was approved in August 2007 and construction commenced the following year in August 2008. The facility will house more than 350 researchers and scientists who will conduct research on cancer, aging, diabetes, neurosciences and regenerative medicine.
UTHSC is one of the biggest health sciences universities in the US. The STRF will help in transforming new discoveries made by the university into potential cures for various diseases. It is expected to support the growth of the local economy and generate new jobs.
The new three-storey facility has a built up area of 190,000 sq. ft.. It has a horizontal design to encourage interaction between researchers and facilitate new idea generation. It includes a durable coated concrete masonry wall system which provides an impermeable surface ideal for laboratory activities.
The first floor of the STRF includes a main entrance, four lobbies, a conference room and other meeting rooms.
An ultra-modern laboratory, support space, vivarium spaces and offices are located on the second floor. The laboratory space is spread over 125,000 sq. ft. and primarily includes wet labs.
About 20% of the area is provided for dry labs. A corridor runs through the centre of the floor connecting all the facilities. The support space is located on either side of the corridor.
The laboratory has an open-space design which can be shared by various research teams to promote interaction. The labs are fitted with modular casework which provides maximum flexibility. They can be reconfigured according to the research needs.
The laboratory space features state-of-the-art equipment such as an ultra-high-resolution optical N-STORM microscope. It is the first such microscope to be installed in Texas and enables researchers to view 3-D molecular structures of a cell. It was installed at a cost of $377,000.
The microscope can capture up to 50,000 image frames and transform them into a single, super-resolution image. Researchers can use the microscope to examine the interaction between human cells and viruses.
The third floor includes offices, meeting rooms and a bioinformatics core. The Institute for Integration of Medicine & Science and South Texas Technology Management are also located on the third floor.
Electricity for the facility will be generated by 758 solar panels installed on the building's roof and over parking spaces. The solar panels were installed with the grant received under the American Recovery and Reinvestment Act. The panels are expected to generate energy savings of 210,000kWh or $15,000 annually.
Only 62% of the space will be occupied while the remaining space will be left for accommodating out-of-town teams of scientists.
About $100m was provided by the state's Permanent University Fund and tuition bonds.
"The University of Texas Health Science Center (UTHSC) opened the new South Texas Research Facility (STRF) at its campus."Another $42m was raised through philanthropy.
The City Council of San Antonio announced in June 2011 that it is providing $3.3m funding for the construction of the facility.
The funds will be provided over three years in three installments through the San Antonio Economic Development Corporation (SAEDC).
The first installment of $1.1m is expected to be given towards the end of October 2011.
Under an agreement with SAEDC, the STRF will return 15% of its profits earned from equity investment in start-up companies. The companies are established to commercialize the discoveries made at the facility.
Contractors involved in the South Texas Research Facility development
The facility was designed by Rafael Vinoly Architects. Vaughn Construction was the general contractor.
E&C Engineers & Consultants was the mechanical, electrical and plumbing contractor.
Technology infrastructure was supplied by DataCom Design Group. Byrne Metals was contracted to supply metal panels and aluminum louvers.
New Orleans BioInnovation Center (NOBIC) was opened in June 2011 and officially inaugurated in September 2011. Spread over 66,000 sq. ft., the four-storey building will act as a biotechnology and research incubator. It was built at a cost of $47m.
The new facility will provide infrastructure to university researchers and biotechnology start-ups to commercialize technologies. It is situated in the New Orleans life sciences hub called the Greater New Orleans Biosciences Economic Development District.
"The NOBIC project was funded by the Louisiana Department of Economic Development."NOBIC's close proximity to two hospitals, three universities and a cancer research facility will help in promoting collaboration within the community.
Biotech companies currently occupying the facility include the Southern Research Institute, InnoGenomics, NuMe Health, NOvate Medical Technologies, MiniVax and TMS Bioscience among others. Argent Technology Ventures, a venture capitalist firm, is also operating at the facility.
NOBIC also provides opportunities for educational institutions such as Louisiana State University Health Sciences Center, Tulane University Health Sciences Center, the University of New Orleans and the Xavier University to commercialize technologies.
The facility is expected to generate 10,000 direct jobs and 7,000 to 10,000 indirect jobs.
NOBIC was conceptualized nearly ten years ago after a feasibility study identified the huge potential in life sciences research. Local research institutions and biotech companies were unable to commercialize their research into profit-yielding products due to lack of the right resources. The state government approved the development of the facility in order to address this problem.
The two-storey Wirth Building constructed in the late 1950s was chosen as the site for the construction of NOBIC. The old building was demolished to enable construction of the new facility. Hurricane Katrina, however, hit New Orleans in 2005 just after the demolition of the building, delaying the start of construction.
Rise in construction costs by nearly 40% forced the developers to delay the construction of the NOBIC. The construction was resumed in August 2008.
Test pilings driven at the site led to the discovery of storage tanks which were part of a gas station that operated at the site from 1938 to 1949. Removal of these storage tanks required state and federal environmental approvals, leading to further delays in construction.
Actual construction of the facility started in October 2009.
The facility has space for conference rooms, universally adaptable wet-lab suites and 2,000 sq. ft. of retail space. It has a lobby with an open atrium, 3,000 sq. ft. courtyard area and ceiling-to-floor glass windows. The facility can accommodate about 40 to 50 companies in the top three floors.
The conference rooms can accommodate 100 people and feature state-of-the-art audiovisual equipment.
The NOBIC project was funded by the Louisiana Department of Economic Development. Additional funds were provided by the Economic Development Administration.
NBIOC was designed by Eskew+Dumez+Ripple in collaboration with NBBJ.
"New Orleans BioInnovation Center (NOBIC) is located on Canal Street in New Orleans, US."Turner Construction was the general contractor. Gibbs Construction was the local contractor. Adams Management provided project management services while Morphy Makofsky was the civil / structural engineer.
TMG was responsible for contract administration services during demolition activities at the site. Mechanical, electrical and plumbing contractor was Newcomb & Boyd.
Laboratory equipment was provided by Fisher Hamilton. Frischhertz Electric supplied electrical components including motion sensors, access controls, lighting, security cameras and video conferencing facilities.
NBIOC is the first LEED Gold project to be developed in New Orleans. It incorporates several environment friendly features. It is clad with precast panels fitted with glass, which reduces the amount of heat entering the building. Operable sunscreens on the glazing provide lighting and storm protection and reduce energy costs. The white reflective roof of the building also reduces the energy costs.
Other sustainable features of the facility include a rainwater retention system to collect water from the roof and electric vehicle charging stations.
New Orleans BioInnovation Center is part of the New Orleans Central Business District.
NOBIC will act as a biotechnology and research incubator for companies in New Orleans.
The new facility will partner educational institutions, such as Tulane Health Sciences.
A team of research institutes, hospitals, and life sciences businesses unveiled a plan to create a genomics center in New York City that they said will become one of the largest in North America.
The New York Genome Center (NYGC) is comprised of 11 collaborators, mostly hailing from New York City but also including Cold Spring Harbor Laboratory and The Jackson Laboratory, and it plans to use an initial $125 million investment to build the 120,000 square-foot center once it settles on a location in Manhattan.
NYGC will focus on sequencing, bioinformatics, and genomic medicine, and will be outfitted with technology from Illumina, one of its founding members, the non-profit center's executives said at a launch today in Manhattan.
Through the unique collaboration, researchers and doctors will share clinical and genomic data on a large scale in studies aimed at identifying and validating biomarkers, understanding the molecular basis of diseases, and speeding up the development of new diagnostic and therapeutic technologies.
NYGC plans to begin operations as early as the spring of 2012, and it has an architect to design the center, which likely will be built in a pre-existing building, said NYGC Founding Executive Director Nancy Kelley.
"We believe that this will revolutionize both science and medical delivery in the city and it will impact new discoveries, drugs, and diagnostics for cancer, brain disorders, metabolic disease, and other kinds of chronic diseases," Kelley said.
"The launch of the New York Genome Center represents an exceptional step forward in gaining a deeper understanding of the clinical relevance of genetics and ultimately improving human health," Illumina CEO Jay Flatley said in a statement. "Illumina and NYGC have a shared vision, and we're confident Illumina's innovative technologies will play a major role in enabling the facility's success in achieving its goals."
Roche has joined Illumina as a corporate member. The other founding members include Cold Spring Harbor Laboratory; Columbia University; Cornell University/Weill Cornell Medical College; Memorial Sloan-Kettering Cancer Center; Mount Sinai Medical Center; New York-Presbyterian Hospital; New York University/NYU School of Medicine; North Shore-LIJ Health System; The Jackson Laboratory; The Rockefeller University; and Stony Brook University. The Hospital for Special Surgery is an associate founding member.
Taken together, these partner institutions serve more than five million patients and offer scientists a broad and diverse palette of genetic variation that would be difficult to find in any other single region, NYGC said.
The center's core components will be its sequencing capabilities and its bioinformatics labs, but it also will be home to a CLIA-certified lab for clinical research, an innovation center for developing new genomic technologies, educational and training programs in genomics, and a philanthropic unit.
Those involved in the project see a big opportunity to help New York catch up to other bioscience hubs in the country while taking advantage of the many benefits the city can offer through its institutions and patient population.
"The idea was that in many respects, although New York is one of the global centers for healthcare, medical delivery, and bioscience research, it has really lagged behind in genomics research in particular," Kelley told GWDN. "In order to regain its competitive edge and really take global leadership in this area it was important to establish a collaborative entity that would provide the operational foundation through sequencing, bioinformatics, innovation, testing new innovative technologies, and translational research."
Although Kelley and her partners found that NYC had gotten behind some other regions in the life sciences, particularly Boston and Southern California, they felt that there were compelling reasons why the city offered a natural habitat for a big genomics center.
"It's the largest concentration of medical and academic research of anywhere in the world. So if you can mobilize that strength it would be unbelievable," she said. "Also, the diversity of the patient populations here is really important. It really provides a place where new products and tests can be developed for a variety of ethnic groups and different age groups for which different drugs and approaches might be appropriate. There's nowhere else in the world like New York where that can happen.
"Finally, you've got an unbelievably strong financial community here that I believe is ready and willing to finance new companies," Kelley added. "So creating the space for [spinoff companies] to grow and develop will be the key."
NYGC said that it has already gathered "a substantial portion" of the $125 million required to launch the center, with the funds coming from the institutional founding members; the Simons Foundation; Bloomberg Philanthropies; Russell Carson; the New York City Economic Development Corporation and the New York City Investment Fund; Anthony Evnin; WilmerHale, as well as other private foundations and philanthropists, and pharmaceutical and technology collaborators.
NYGC also has applied for funding from a New York City program called Applied Sciences NYC, which is offering the use of city-owned land and up to $100 million from the city for an institution, university, or consortium to develop and operate a research campus.
The center estimates that its economic impact in New York will amount to $1.1 billion in 10 years and $2.9 billion by 2025, and that it will create 500 jobs over the next five years.
The La Jolla Institute for Allergy & Immunology joined the Sanford Consortium for Regenerative Medicine, along with the Salk Institute, The Scripps Research Institute, UCSD and the Sanford-Burnham Medical Research Institute.
Slated to open the new collaborative research facility in November, the Consortium aims to improve human health through stem cell research.
“We are pleased that the La Jolla Institute has accepted our invitation to join the Sanford Consortium,” said Edward W. Holmes, M.D., the Consortium’s president and chief executive officer, adding that the La Jolla Institute’s strong immunology expertise will complement and expand that of the collaborating organizations.”
Mitchell Kronenberg, Ph.D., La Jolla Institute president and chief scientific officer, said the Consortium “will foster the kind of cross-disciplinary, cross-institutional research that accelerates discovery and leads to breakthroughs.
La Jolla Institute faculty member Anjana Rao, Ph.D., a prominent genetics and cell biology researcher, will move part of her lab into the new Consortium building. Dr. Kronenberg becomes a member of the Consortium’s 10-member Board of Directors, which includes UCSD Chancellor Marye Anne Fox, Ph.D., and leaders from the other collaborating organizations. The board is co-chaired by Irwin M. Jacobs, Malin Burnham and John Moores, and South Dakota-based philanthropist T. Denny Sanford, who provided a $30 million naming gift to the Consortium.
HWI Global, the Pittsburgh-based cleanroom design builder, has been awarded the contract to provide specialized design and build construction services for the new KCC B2-Stem Cell Cellular Therapy Laboratory Renovations at Mt. Sinai Medical Center. Set to begin in December, this project will run simultaneously with a second project HWI recently awarded, a USP 797 sterile compounding cleanroom renovation. HWI currently holds the annual preventative maintenance contract for the 6th Floor Pharmacy cleanroom.
HWI was specified for this project by Mitchell Architectural Group of Southbury, Connecticut. The company is subcontracted by Hunter Roberts Construction Group's New York City branch.
SAFC's commercial scale High-Potency Active Pharmaceutical Ingredients (HPAPI) facility in Verona, Wisconsin, has completed an assessment by SafeBridge Consultants and has been granted SafeBridge Certification. As a widely accepted industry benchmark for handling highly potent pharmaceuticals, the SafeBridge program assessment focuses on four primary areas: management; hazard identification and evaluation; hazard controls; and communication, education and training.
Constructed at a cost of US$30m and officially opened in April 2010, the Verona site was built specifically to support pharmaceutical manufacturers with their Phase III and commercial HPAPI needs. The state-of-the-art facility is designed to increase efficiencies and safe handling in high-potency production and to adhere to Category IV standards, the highest guideline for HPAPI handling and containment. The SafeBridge assessment, which also included a successful recertification of SAFC’s nearby high-potency facility at Madison, took place over three days in September 2011. The process included review of health and safety programs, containment equipment testing results, as well as appraisal of material handling and GMP production areas.
'The latest SafeBridge Certification status for our Verona facility builds on successful accreditations at our Madison HPAPI plant, which we originally received in 2003, and our HPAPI bioconjugation suite in St Louis, which was awarded in 2009,' commented Dave Bormett, SAFC Director of Operations. 'SafeBridge Certification reflects SAFC's ongoing commitment to the safety of our staff, and to handle our customers' potent compound projects safely and efficiently.'
Over the last three years, SAFC has seen a continual increase in the number of projects for HPAPIs and other high-potency pharmaceutical services, including late stage projects that will need commercial scale manufacturing. This demand is behind the construction of the Verona facility, which houses commercial scale reactors capable of producing HPAPI batch sizes up to 4,000 liters and features specially designed quality control laboratories, warehouse and office space, including space for expansion.
While oncology is currently the main driver for HPAPI development, SAFC has manufactured HPAPIs for indications beyond the cancer field, including low-dose Vitamin D analogues for the therapeutic areas of autoimmune and cardiovascular diseases. This range of indications may continue to grow as additional potent compounds are identified and developed in future years.
After sharp clashes throughout the day, the state legislature voted Wednesday in favor of Gov. Dannel P. Malloy's controversial plan to recruit the nonprofit Jackson Laboratory to Farmington with a $291 million offer to construct a new building in return for creating 300 direct jobs over the next 10 years.
The University of Pittsburgh Medical Center said that it plans to invest $294 million in building a research center in Pittsburgh that will focus on personalized medicine and the biology of cancer and aging.
The 350,000-square-foot Center for Innovative Science will be located at the site of the former Ford Motor Co. Building on Centre Ave., which UPMC bought in 2007, and will support 375 new scientific and administrative jobs.
UPMC said it has started a national recruitment campaign with the University of Pittsburgh to find a leader in genetics and genomics to focus on research into the biological underpinnings of cancer, the role of viruses, and the cellular changes that are part of the aging process.
“This major investment in good science will help us to develop the personalized treatments necessary to improve the effectiveness of health care. For diseases like cancer, we will identify the genetic and environmental factors that determine the susceptibility of each individual and the best course and type of treatment," UPMC Chief Medical and Scientific Officer Steven Shapiro said in a statement.
“With recent advances that have been made in such fields as genetics, genomics and computational biology, the time is right to challenge the conventional paradigms that have guided most medical research to this point,” Shapiro continued.
He said the medical center's large population of patients and its investments in gathering and analyzing large volumes of data make it "uniquely positioned" to pursue this type of science.
The South Korean food manufacturer, CJ CheilJedang, will invest $324m into a new amino acid production plant in Iowa, America. The investment comes after hefty initiatives from the local government, as it attempts to drive economic development in the region.
The Iowa Economic Development Authority Board has approved $1.8m in assistance and tax incentives for the project. The local government has been in talks with the Korean company since January regarding the new facility, and Iowa government minister, Terry Branstad, said that it is an exciting and major investment.
Construction of the plant is set to begin in April next year, with production set to begin by December 2013.
With a large stronghold in South Korea, CJ CheilJedang is currently considered the country’s number one food manufacturer that focuses on the domestic and export markets.
Its new Iowa plant will produce amino acids through fermentation technologies.
Ryan Companies US, Inc. has completed the construction of a new 147,000-square-foot Community Nutrition and Food Distribution Center for Northern Illinois Food Bank (NIFB). NIFB has moved into its new space, located at 273 Dearborn Ct., Geneva, IL, which is essentially double the size of its former headquarters in St. Charles, IL.
Northern Illinois Food Bank, a member of Feeding America, is a non-profit organization that provides food to hungry people in 13 Illinois counties through its more than 600 partner agencies. NIFB acquires, gathers, handles and distributes donated, government and purchased food to more than 60,000 different people each week through local food pantries, soup kitchens, shelters, youth activity centers and other food assistance sites. In Fiscal Year 2011, NIFB distributed more than 34.8 million pounds of food, the equivalent of 29 million meals.
In working toward achieving LEED-NC Gold status, NIFB and its design and construction team has incorporated a variety of sustainable and energy-saving elements into the new building, including a white roof, air-cooled heat pumps, motion-controlled lighting, high-performance glass, an energy-efficient envelope and recycled and re-used products, among other things. The facility’s HVAC system uses the rejection heat emitted from the refrigeration and freezer systems to heat the warehouse. Bike racks as well as preferred parking for electric and hybrid cars and carpooling encourage alternative transportation.
The facility’s 11-acre site is situated north of Illinois State Route 38, between Kirk and Kautz Roads, within the Geneva Business Park. Additionally, it is immediately west of the DuPage Airport, and just south and west of Pheasant Run.
The new refrigerated food warehouse and distribution center features 47,000 square feet of office space, 60,000 square feet of dry storage, 20,000 square feet of freezer/cooler space and20,000 square feet of volunteer circulation area.
The new building, as compared to the NIFB’s former facility, doubles the dry storage and triples freezer capacity; increases the number of docks and provides refrigerated dock space; and includes a “clean room” for safe repacking of food. It also provides a commercial demonstration kitchen and classrooms where healthy cooking and nutrition classes can be hosted for NIFB’s partner feeding programs and community groups. There also were future considerations built in, including the option for building out a production kitchen that would allow foods to be packaged and prepared for hungry people in northern Illinois.
Tekni-Plex has opened a dedicated facility to serve as a new technology and product development center. Situated in Holland, OH, Tekni-Plex’s Global Technology Center will focus on devising new films, tubing, liners, and lidding stock and optimizing existing ones for pharmaceuticals, medical devices, foods, and beverages.
“We will focus on new product development and look at new processes to enhance product performance,” explains Dr. Phil Bourgeois, vice president of global technology and regulatory affairs. “We intend the center to serve as a source of excellence for our business units, and we also look to partner with our customers to bring their ideas to market very quickly.”
Focusing on multiple markets offers advantages. “To have so much capability covering numerous markets under one roof is unique, and it will allow for cross pollination of ideas across industries,” said Bourgeois. “In addition, the center will draw on regional polymer talent from the relatively large number of polymer and packaging professionals in the Ohio region.”
The 32,000-sq-ft site already has its performance testing lab up and running, which can be used to subject structures to the variety of conditions that pharmaceutical films and other products may experience in the field. It also employs the latest polymer analysis equipment.
Later this year, the facility will see the installation of large-scale pilot equipment to develop a variety of mono- and multiple-layer structures for films, liners, lidding stock, and flexible tubing. The various lines will be able to produce extrusions, extrusion coatings, and laminations. Auxiliary processing equipment will also be available. The lines are designed so that technology can be easily transitioned to Tekni-Plex plants for production.
The pharmaceutical industry in particular is looking for innovation, notes Bourgeois. “There is much more demand on packaging for product protection, from the manufacturing site to patient administration,” he says. “Companies are also looking at transitioning away from multiple-dose packaging to unit-dose options. The sensitivity of today’s new drugs ranks among the biggest challenges for pharma.”
At the same time, pharmaceutical manufacturers are grappling with demands for more sustainable packaging and cost savings. “Our center is geared toward helping customers tackle these challenges,” said Bourgeois.
Despite being separate from Tekni-Plex’s other facilities, the new site will remain in close contact with its business development, marketing, and production teams. “One mistake a center like this could make is isolating scientists from the market, which could result in products that are technical successes but market failures. Our engineers are focused on meeting and anticipating market needs, so we have an intimate tie-in with business development managers and packaging engineers to discover unmet needs. It is then up to us to solve them,” he concludes.
Building on an earlier partnership, BGI and the University of California, Davis today announced a deal to create a sequencing facility at the school.
A facility is being established for immediate use on the UC Davis Health System campus in Sacramento, while a permanent BGI@UC Davis Joint Genome Center encompassing about 10,000 square feet is planned.
The facility will support research and collaborations and "leverage existing strengths" across the university in human and animal health and medicine, food safety and security, biology, and the environment, the partners said in a statement. About 20 new jobs are being created as a result of the facility's creation, with that figure rising to 200 jobs when it is completely up and running.
The deal provides UC Davis faculty and students access to the capabilities and expertise of BGI, and in return BGI will have access to the university's diverse resources and expertise in education and research, "especially in biology, human and veterinary medicine, agriculture, and the environment," the partners said.
"UC Davis brings to this partnership phenomenal faculty conducting cutting-edge research on food, health, energy, and the environment, while BGI is a world leader in genome sequencing and analysis," UC Davis Chancellor Linda Katehi said in a statement. "Together as partners, UC Davis and BGI will be able to take on the biggest challenges in biology, medicine, and the environment – right here in Sacramento."
BGI and UC Davis said this past June that they would share resources and conduct large-scale sequencing and functional genomics programs on a broad array of research areas.
UPM Pharmaceuticals will expand their existing manufacturing capacity with an OEB 4 processing room, a low humidity processing suite, and a dedicated Xcelodose production facility. The overall expansion will add 50% more manufacturing space for current production.
UPM’s president, James Gregory, said, “To meet our client’s growing needs, UPM is making a major capital commitment to enhance client services. In response to an increasing number of requests for production of compounds with more stringent environmental safety requirements, UPM is building a unique suite for handling of manufacturing processes associated with OEB 4 compounds. We are also building a dedicated suite for handling and production of low humidity compounds. Finally, UPM will be developing a unique segregated four-room suite to handle Xcelodose processing and encapsulation activities associated with the 600 and 600S equipment systems. We intend to provide these services under the strictest handling conditions up to and including OEB 4 compounds. This expansion will allow us to keep pace with our clients’ needs and continue our commitment to speed and quality in the services we provide.”
Norwich Pharmaceuticals is expanding its pilot scale production capabilities at its Norwich, NY facility. The expansion will double current capacity for pilot scale development and manufacturing and includes equipment, surface area, and staff.
“We’re providing a world class experience for customers seeking product development and pilot scale manufacturing services,” said Terry Novak, president of Norwich Pharmaceuticals. “Through this significant capital investment, Norwich is not only adding production capacity, we also are strengthening project management, increasing on-time delivery and further expanding our capability to provide customers with one comprehensive solution for all stages of the product lifecycle.”
Development and pilot scale facilities include 12,000 sq.-ft. of dedicated space with DEA, solvent and potent compound capabilities, including two analytical labs dedicated to support R&D and GMP development projects. The facilities, instrumentation and technology are designed to complement the company’s commercial capabilities, allowing direct transfer from analytical services to quality control, enabling a fast track to trade production.
“This expansion provides the flexibility to run multiple projects simultaneously,” said Robert O’Connor, Ph.D., vice president, product development and technical services, Norwich Pharmaceuticals. “With the additional GMP processing rooms and newly installed equipment, Norwich is able to provide greater capacity for solvent high shear granulation, fluid bed granulation, drying, column coating, and tablet coating.”
The project will be completed early next year and includes the installation of a 300L Collette Gral high shear granulator with solvent capability, GEA/Niro 2/3 fluid bed granulator/dryer with solvent capability, GEA/Niro 4/5 fluid bed granulator/dryer with solvent capability, O’Hara 24/36” Labcoat III coating pan with solvent capability, and MG Planeta Encapsulator with dual pellet feeders.
Staffing additions are also underway to support the increased plant capacity and broaden the engineering capabilities offered through Norwich product development and technical services.
The global drug giant Bayer AG plans to close its Wayne facility and move the workforce there to a campus in the Whippany section of Hanover Township, beginning in 2013, the company said.
The closing of the Passaic County offices, the U.S. headquarters of the Bayer subsidiary Bayer HealthCare Pharmaceuticals, is part of its consolidation of 2,500 employees from three New Jersey locations and one in New York into a single campus.
"Everyone here in Wayne will eventually be moved to Whippany," said Rosemarie Yancosek, a spokeswoman for the division.
She said the moves would start in 2013, but she could not say how long it would take to close the Wayne facility at 6 West Belt Parkway. She declined to say how many employees work in Wayne.
The consolidation will be assisted by more than $38 million in state tax breaks awarded to ensure that the company does not move out of state. Company officials said the New Jersey Economic Development Authority had been looking at the possibility of putting the new campus in New York State.
A statement by the Hanover Township administration said Bayer would buy 95 acres of the 194-acre site formerly occupied by the telecommunications company Alcatel-Lucent, and Bayer would undertake renovation and reconstruction of some buildings there.
Yancosek said the developer from whom Bayer is buying the Whippany property, Vision Properties, may now buy the drug company's Wayne and Montville real estate.
The other regional Bayer locations from which employees will be consolidated are in Morristown and in Tarrytown, N.Y.
DPT Laboratories plans to invest another $14 million in its manufacturing facilities. Last year the company completed a $45 million capacity expansion and equipment upgrade for its San Antonio, TX and Lakewood, NJ facilities.
At its Center of Excellence for Semi-solids & Liquids in San Antonio, DPT will invest about $4 million in additional upgrades to its compounding and packaging facilities, including a washroom expansion for capacity and process flow improvement. Equipment upgrades will include a new small-scale compounding suite with two new dissolvers, as well as new infrastructure to handle larger deliveries from suppliers to support increased production at the facility.
DPT will invest another $10 million in the Center of Excellence for Sterile & Specialty Products facility in Lakewood. Equipment upgrades include the installation of a new small-volume parenteral filler that is designed to be fully automated, integrated and isolated from vial wash through tray filling. Based on consolidated filling technology, IMA’s Modular Aseptic Compact (MAC) System offers a fully automated line in 20% of the space. According to the company, the MAC System will reduce the likelihood of introducing microbiological contamination and make the entire process more efficient.
“These facility and processing upgrades expand our capacity and, most importantly, increase our ability to better serve customers with high-speed, cost-effective manufacturing runs,” said Paul Johnson, president and chief operating officer. “Continued investment at this level represents our commitment to maintaining our position as the leading provider of pharmaceutical development and manufacturing services for semi-solid and liquid products.”
A biotechnology company that develops treatments for cancer and infectious diseases announced that it is moving to St. Petersburg, eventually adding about 280 jobs.
IRX Therapeutics Inc., which is relocating from New York City starting at the end of the year, has already licensed a broad patent portfolio from the University of South Florida, where early technology was developed. Under a letter of intent signed by the parties involved, IRX and the Florida High Tech Corridor Council will fund $2.5 million in research to be performed at USF for developing therapeutic vaccines and clinical trials.
"This is exactly what ought to be happening in St. Pete and in Florida," said Gov. Rick Scott, who attended the announcement. "Florida is second in the nation in biotech research facilities."
IRX has raised $90 million in capital for research, manufacturing and clinical development. The company's lead product, IRX-2, is an active immunotherapy designed to treat cancer by restoring the patient's immune system and enabling an immune attack on tumors.
IRX will initially employ 40 people and within five years intends to fill more than 280 positions with an anticipated average salary of more than $90,000 - more than double the average wage in Pinellas County. Those figures don't include additional jobs that will be created for commercial-scale manufacturing and a potential product launch.
The relocation package, approved at state and local levels, includes $600,000 from the state's innovation fund; $275,000 from Pinellas County Economic Development; a $275,000 credit toward land owned by the City of St. Petersburg; and $50,000 from the USF Research Foundation. All cash incentives will be repaid by IRX as the company meets specified revenue targets.
Fine chemicals manufacturer Saltigo is looking to expand its high potency API (HPAPI) business by targeting the pharmaceutical industry in the US and Japan.
The Frankfurt, Germany-based firm will add manufacturing capacity at its facility in Redmond in Washington State, US – specifically for the production of compounds classed as category III under the SafeBridge toxicity categorization system.
Andreas Stolle, head of the firm’s pharma business unit, said: "Once the expansion project has been completed, we will be able to respond even more extensively and flexibly to our customers` requirements.”
The US expansion, which is due to be completed in 2012, comes hot on the heels of Saltigo’s receipt of accreditation by Japanese regulators for its API and intermediates manufacturing site in Leverkusen, Germany.
The “Certificate of Foreign Drug Manufacturers" issued by the Japanese Ministry of Health, Labor and Welfare (MHLW) applies to all non-sterile APIs made at the plant and is very important to Saltigo’s expansion according to Stolle.
"For us, its value is similar to that of a certificate from the US Food and Drug Administration (FDA). It is an essential milestone for further expanding our business activity in Japan and safeguarding it on a sustainable basis" he said.
The Biodesign Institute at Arizona State University will use a $6.5 million grant from the National Institutes of Health to expand its biorepository that supports researchers working under the Protein Structure Initiative's (PSI) structural genomics consortium.
The Biodesign Institute's biomaterials storehouse, called DNASU, contains more than 147,000 plasmids, including 55,000 human and mouse plasmids, as well as genome collections from a number of organisms and proteins that are associated with human diseases. It also holds the protein expression plasmids in the PSI:Biology-Materials Repository (PSI-MR)and collections from individual researchers.
Located at the Virginia G. Piper Center for Personalized Diagnostics, the PSI-MR is tasked with collecting, annotating, storing, maintaining, and distributing plasmids to support the multi-institutional NIH-funded structural genomics consortium.
The repository delivers plasmids to researchers worldwide and provides information about the genes they contain, annotations about the full length sequence, vector information, and publications for cross-referencing, all of which are stored in its database.
The core technology at DNASU and the PSI:Biology-MR is its Nexus Universal Biostore Freezer, a storage and robotic system that was acquired with funding from the American Recovery and Reinvestment Act.
According to Joshua LaBaer, the Biodesign Institute's chair in personalized medicine who runs the repository, DNASU provides the plasmids at low cost and that it has simplified the legal process for acquiring plasmids for study by streamlining the required material transfer agreement.
The Broad Institute broke ground Wednesday on a new research facility at Kendall Square in Cambridge, Mass., that will dramatically boost its lab and office spaces and connect with its main science building.
The new 250,000-square-foot, 12-floor building will adjoin with Broad's 7 Cambridge Center site through six of its floors, creating a collaborative work space that will foster and maintain "key scientific adjacencies" between research groups, Broad said yesterday.
The Broad sold $353.4 million in bonds to help finance the new building. Those bonds were issued by the Massachusetts Development Finance agency and include $269.9 million in tax exempt Series 2011A revenue bonds and $83.5 million in taxable Series 2011B revenue bonds, an institute spokesperson confirmed.
The new facility "provides a permanent space for teams to assemble and work together on important problems. That kind of flexibility is essential to our continued success," Broad Institute Director Eric Lander said in a statement. "There is simply no other place where the Broad Institute could flourish like it has here in Kendall Square."
When completed, which is expected to be in early 2014 around the time the lease on another Broad facility on Charles St. is set to expire, the institute's expanded research campus will span some 480,000 square feet.
The Broad is still not certain exactly which labs, resources, and operations will be housed at the new space at 75 Ames St., but a spokesperson told GWDN that the goal is for the research operations and staff to be consolidated into the two contiguous buildings.
For nearly three decades, the Gladstone Institutes has played a largely behind-the-scenes role in studying some of the world's most pressing health crises: Alzheimer's, heart disease and AIDS, just for starters.
But stem cells, increasingly part of the institute's studies, are putting Gladstone in the spotlight. It is announcing a new stem cell center, funded with a $5 million donation from the Roddenberry Foundation.
Creating the new Roddenberry Center for Stem Cell Biology and Medicine - named after the man who created "Star Trek" - underscores Gladstone's new emphasis on shepherding potential treatments beyond the labs and into patient hands, researchers there say.
"Very basic research is exciting, but the most satisfying thing is translating what we've learned into a cure," said Sheng Ding, a chemist in Gladstone's cardiovascular disease group who was recruited from the Scripps Research Institute earlier this year.
"This donation is one of the reasons I came here," Ding said. "It will enable us to do work that is very risk-taking and innovative. We're not making incremental progress anymore, we're making leaps."
Gladstone, an independent research institution that is affiliated with UCSF, has been evolving into a small but efficient powerhouse of stem cell research, experts say.
Scientists there are studying ways to regenerate heart and brain tissue that has been damaged by degenerative diseases. They're trying to create the first-ever cellular models of Alzheimer's disease - which, if successful, could speed up the agonizingly slow process of developing drug treatments - and hunting for molecules that could someday be used in drug cocktails and sold at pharmacies to treat a variety of diseases.
"Gladstone is small, but it's incredibly effective, and it's ranked very high by scientists around this country as one of the best institutes," said Alan Trounson, president of the California Institute for Regenerative Medicine, which provides grants using bond money approved by voters in 2004. "If you counted their productivity by the head, it would be incredibly high in this group. It would probably eclipse everyone else."
In fact, Gladstone has collected more than $25 million in CIRM funding in the past four years. That's only 10 to 20 percent of what's been given to UCSF and Stanford - but those are two of the largest stem cell institutions in the state, and Gladstone is a fraction of their size.
The institute is located at the edge of UCSF's Mission Bay campus, in a single building with floors devoted to three areas of research: heart disease, neurological disorders and HIV/AIDS.
Stem cell research infiltrates every floor, and signs of the investments that have already been made are pervasive. In one lab, a $300,000 machine that can scan hundreds of molecules at once to test their ability to transform cells sits next to a piece of equipment that hasn't even been fully unwrapped yet.
Perhaps the first and most public foray into stem cell research at Gladstone came with the 2007 recruitment of Dr. Shinya Yamanaka, the Japanese scientist who pioneered efforts to turn adult human skin cells into stem cells - making it possible, in theory, to turn any cell in the body into any other cell.
With Yamanaka on board, Gladstone scientists began serious investigation into how to use these new adult stem cells - called induced pluripotent stem cells - to better understand and someday treat a whole host of degenerative diseases.
"Over the last five or six years we've built what's been recognized in the stem cell community as one of the top programs in the country," said Dr. Deepak Srivastava, director of the Gladstone Institute of Cardiovascular Disease. "We are the leaders right now in the next generation of cellular reprogramming. And with significant investment in this area, we have the opportunity to get these things into people."
Srivastava is focused on transforming one type of adult cell directly into another type of cell, skipping over the in-between step of making it a stem cell first. Because his area of interest is heart disease, Srivastava is looking for ways to turn the structural cells of the heart into the muscle cells that actually keep the heart beating.
That's where Ding's research might come into play. He's studying ways to more easily transform one type of adult cell into another using drugs that signal the cells to change. Someday, he said, patients with heart disease could even get a prescription for medication that triggers their own body to generate heart cells.
Ding, like many of his Gladstone colleagues, said what he needs more than anything is the ability to quickly and efficiently make large batches of stem cells to study. Scientists may have developed techniques for transforming cells, but they're still working out the best ways to manufacture them - and that's where money counts.
"We don't fool ourselves into thinking we're going to cure Alzheimer's or heart disease overnight, but if they tell us they are breaking ground and moving forward, we definitely want to help them do it," said Rod Roddenberry, son of "Star Trek" creator Gene Roddenberry and co-founder of the Roddenberry Foundation.
"It was amazing to go up to Gladstone and look through a microscope and see a sheet of beating heart cells, and know they came from skin cells," Roddenberry said. "Walking around the institute, we met scientists who were passionate and excited by what they were doing. And as corny as it sounds, a lot of them believed in the 'Star Trek' future, a beautiful future."
Johnson and Johnson has launched a biotechnology incubator at its La Jolla research center that offers web laboratory and office space to as many as 20 tenants.
Johnson and Johnson has turned a wing of its La Jolla drug research center into an incubator for startup drug development and medical device companies, said the pharmaceutical giant.
The move comes at a time when funding for early-stage companies in the life sciences industry has slowed to a trickle from private and public sources.
“Given the fact that the biotech sector is not doing great, we decided we would use our existing capital infrastructure to help reinvigorate the sector,” said Diego Miralles, who heads the Johnson and Johnson research center.
At the same time, another pharmaceutical company, Pfizer, is winding down an incubator that it opened in 2007 at its La Jolla research campus. The building housing the space has been put up for sale, and two of its three tenants have moved out, said company spokeswoman Lauren Starr.
Johnson and Johnson plans to recruit as many as 20 small companies to occupy 35,000 square feet of space that was left vacant when the pharmaceutical company consolidated its local operations, Miralles said.
Each of the biotechs will pay rent for their portion of the incubator, which has been named Janssen Labs at San Diego.
In return, the tenants will get their own office and laboratory space, and share access to a number of high-priced research devices that they wouldn’t be able to purchase on their own.
The arrangement will let the startups focus their limited cash on the research needed to move their products forward rather than spending it on costly capital investments, Miralles said.
It also could speed the time it takes for companies to move new drugs and devices from the research lab to clinical trials in patients.
The space is being managed by Prescience International of San Francisco, which operates two biotech incubators in the Bay Area.
The San Diego venture differs from incubators set up by other Big Pharma companies in several way: Tenants won’t be required to give Johnson and Johnson preferential rights to acquire products coming out of the lab, and their leases will run in three-month segments, short enough to abandon the space if development work doesn’t go as planned.
“There are no strings attached,” Miralles said. “We have absolutely no control over the companies. If they want to make a deal with Merck, that’s great.”
The innovative structure of Janssen Labs could provide fertile ground for growing companies, said Joe Panetta, chief executive of the San Diego industry group Biocom.
With the region creating a new biotech company every week, on average, there should be no shortage of potential tenants for the incubator, said Camille Saltman, president and chief operating officer of Connect San Diego, a nonprofit support group for fledgling technology companies.
Contec cuts the ribbon to open its new offices and manufacturing facilities in Suzhou Industrial Park in China
Contec, a manufacturer of contamination control products such as wipes, swabs and mops headquartered in Spartanburg, SC, US, has expanded its offices and manufacturing facilities in Suzhou Industrial Park in China to serve its growing customer base in the Asia/Pacific market.
Contec has been manufacturing in China for the last five years and has added approximately 70,500 sq. ft. of manufacturing space, including ISO Class 4 and Class 6 cleanrooms, laundry and saturation areas, and there is room for future expansion.
“We took many things into account with the design of this new facility,” said Cornelius Choi, general manager for Contec China.
“From increasing our manufacturing to additional R&D capabilities, our new space allows us to meet the needs of the growing Asian cleanroom market.”
SL Pharma Labs recently expanded its Class 100 (ISO Class 5) - Class 100,000 (ISO Class 8) cleanroom for client needs in early Phase (I & II) clinical manufacture of parenterals and topicals, and broadened product development, analytical and microbiological capabilities to support large molecule projects. The company has launched a new company brand, website and communications materials highlighting its expanded capabilities.
SL Pharma Labs offers product development, analytical, microbiological and early phase clinical manufacturing services for generic and innovator parenterals, liquids and topicals.
SL Pharma Labs can handle cytotoxic compounds and Controlled Substances Schedules II through V.
Our facility is FDA registered and cGMP compliant and has maintained a clean record with the FDA since the establishment of the company in 1997.
Vetter says it will reduce API wastage through its new US production facility for the filling of syringes, cartridges and vials.
Based at the Illinois Science and technology Park, Chicago, the 24,000-square-foot site is the German contract development and manufacturing organization’s (CDMO) first in America.
The site includes microbiology and chemical analysis labs, material preparation and compounding functions, three cleanrooms for aseptic filling, and visual inspection, and will premier Bosch’s new MHI 2020 B fully automated vial filler.
And the machinery performs a 100 percent in-line check-weigh system to ensure accurate fill volume, eliminating the need for sampling to verify volume which, Vetter is confident, will reduce API wastage.
Other streamlining features include minimum tubing lengths, and the use of disposable components in material preparation, compounding and filtration areas – which eliminates the need for cleaning validation.
The business says its automated vial filler can run up to 10,000 liquid or 6,000 lyophilized vials per batch, and the semi-automated 500 units per batch.
The new plant comes as part of Vetters plans to expand its reach within the US market, where nearly half of its clients are based.
Vetter MD Peter Soelkner said: “Our Chicago facility provides customers with a top-of-the-line clinical manufacturing site located in the heart of the United States.”
Last year the firm also signed a packaging agreement with Indiana-based Sentry BioPharma Services.
GATC Biotech announced an expansion of its operations with the build-out of its existing facility, the creation of a new facility, and the hiring of new personnel.
As part of the planned expansion, the sequencing and bioinformatics service provider is expanding its headquarters in Konstanz, Germany and creating a new site in Cologne, Germany. The company said it will add 30 new jobs at the two sites in the coming year, which would bring the total number of employees to 170.
The Konstanz site will become the new European Genome and Diagnostics Center and be outfitted with next-generation sequencers such as Illumina's HiSeq 2000 and Pacific Biosciences' PacBio RS platforms, GATC said. The company will focus work at the site on sequencing projects, "offering its customers true multiplatform sequencing strategies."
Additionally, laboratories at GATC subsidiary LifeCodexx in Konstanz will be expanded to facilitate work centered on Trisomy 21. The firms announced during the summer they had begun a clinical validation study for a next-gen sequencing-based Trisomy 21 test being developed by LifeCodexx.
LifeCodexx also signed a deal with Sequenom in August to provide Trisomy 21 testing services based on Sequenom's technology.
The laboratory at Cologne will focus on single sample sequencing "due to its central location in Europe.”With the improved logistics and closeness to customers, the company will be able to offer [the] shortest delivery times and highly competitive prices," GATC said.
Corning Incorporated announced the official opening of a new state-of-the-art manufacturing and distribution facility for Corning Life Sciences in China’s Yangtze River Delta. The grand opening ceremony was held just over a year after Corning’s Board of Directors approved the approximately US$40 million capital expenditure plan in July 2010.
“The lab consumable market in China is growing significantly as the country’s pharmaceutical industry and the region’s research and development spending continue to grow and flourish.”
The facility located in the Wujiang Economic Development Zone, combines labware manufacturing capacity with a full-service distribution center. This combination will enable Corning to provide customers in China its broad portfolio of cost-competitive labware solutions with high levels of service. In doing so, Corning is well positioned to support the growth of the life sciences market in China, which is expected to exceed 20% annually through 2015.
“Today’s official opening represents another milestone for Corning in China. It reinforces our strategy to locate facilities in growth regions,” said Eric S. Musser, chief executive officer of Corning Greater China. “With the opening of this facility, Corning is one of the first U.S. manufacturers of locally produced labware products with improved market access and local distribution in China. It further reflects our commitment to grow with the customers and to support the country’s life sciences industry through a combination of strategic investments, innovative technologies, and leadership.”
“The lab consumable market in China is growing significantly as the country’s pharmaceutical industry and the region’s research and development spending continue to grow and flourish,” said Lydia A. Kenton, vice president and general manager of Corning Life Sciences Base Business. “As a leading developer, manufacturer and global supplier of scientific laboratory products for more than 90 years, Corning is well positioned in China to provide a full range of innovative solutions that improve productivity and enable breakthrough discoveries by using its unique expertise in the combined fields of optics, materials science, surfaces, and biology.”
Douglas L. Lohse, general manager, Corning Life Sciences Greater China, hosted the grand opening celebration. Leaders from the Chinese government, employees, and customers attended the ceremony.
ViiV, GSK and Pfizer’s HIV joint venture, has partnered with Russia’s JSC Binnopharm to boost manufacturing capacity in the country.
Under the accord Moscow-based Binnopharm, a unit of Sistema, will act as a local secondary producer and packager of drugs for ViiV.
The deal builds on the relationship GSK established with Binnopharm last year , which saw the Russian firm agree to produce the UK drug major’s range of cervical cancer, pneumococcal and rotavirus vaccines for the local market.
Under the November accord GSK supplied Binnopharm with bulk supplies of the vaccines and transferred some production technology and expertise to the firm’s plant. In return Binnopharm was responsible for gaining the necessary regulatory approvals.
Pfizer too has recently boosted its manufacturing activities in Russia, forming a partnership with Petrovax Pharm in March. Under that agreement Petrovax will make Pfizer’s pneumococcal vaccine at its facility, which is also in Moscow.
All three agreements fit with the recent the trend that has seen a number of international manufacturers add production capacity in Russia after the country’s government launched its Pharma 20-20 plan.
Dmitriy Spitsin, ViiV Healthcare Country Manager, Russia said that: "This agreement with Binnopharm reflects two priorities for ViiV Healthcare in Russia. Firstly, it is an example of our flexible approach we are taking to deliver our commitment of making antiretroviral medicine more available in countries like Russia through local partnerships.
"Secondly it is our reflection of the Russian Government priorities and the need to support increased investment in local production. At ViiV Healthcare, we are committed to delivering innovation for people living with HIV wherever they are in the world, and this is one of the ways in which we are doing this.”
He explained that ViiV Healthcare will supply bulk products, technology and expertise to enable Binnopharm to undertake the secondary manufacture, including packaging, of Combivir, Kivexa and Epivir in accordance with international current Good Manufacturing Practice (cGMP) standards.
Spitsin added that: "This is the start of a project of full manufacturing transfer of core antiretroviral products for people living with HIV in Russia from overseas to the Russian Federation. The local manufacture of Combivir, Kivexa and Epivir means that up to 70% HIV positive patients would be treated with products manufactured in country.”
Binnopharma general manager Alexey Chupin, agreed, and set the collaboration with ViiV in the context of his firm's wider manufacturing expansion.
AGC is to open an API and intermediate production plant in Japan to meet increased demand from the aging population.
Japan-based AGC is investing JPY3.7bn ($48m) in the 28,400 sq. m. (305,584 sq. ft.) manufacturing site to ramp up its active pharmaceutical ingredient (API) and intermediate business. The facility is due to open in a year and help sales at the business unit hit JPY15bn by 2014.
AGC is using its chemical technology to provide fluorinated compounds and is now adding a fourth API and intermediate plant to meet the expected growth in demand.
Bosch Packaging Technology has plans to invest $23.4 million to build its second production facility in Chengdu, China. An agreement for the use of a 66,000-sq. m. (710,160 sq. ft.) site has been signed. "Ten years ago, we started up in China with 14 associates. Since then, our sales have continuously increased,” said Friedbert Klefenz, president of Bosch Packaging Technology. The company currently employs 400 associates in China at its site in Hangzhou.
With its production facility in China, Bosch primarily serves the regional packaging machine market. Mr. Klefenz said, "Considering the enormous growth of the Chinese market, we will use the new location in Chengdu to create additional capacities, as our existing facility in Hangzhou will reach its limit within the next two years.”
Bosch Packaging Technology will start operations in Chengdu at the beginning of 2012 in a leased production facility. Construction on the new plant will begin in 2014. A year later, the first expansion phase will be completed when a building of 13,500 sq. m. (145,260 sq. ft.) of floor space will be ready for occupation. The production area will include 7,200 sq. m. (77,472 sq. ft.) of the total floor space. The site in Chengdu will employ 300 associates. The new facility allows Bosch to serve the Pharma, Food and Confectionery sectors with packaging machines of medium output capacity.
Teleflex Medical OEM, a manufacturer of catheter fabrication, precision extrusion, and medical devices, is planning an expansion at its facility in Ireland.
The Kenosha, Wis.-based firm says its plans for growth at its location in Limerick already are underway. The project includes a 21,000-square-foot addition to boost manufacturing capacity as well as provide additional space for expanded engineering and research and development activities. The project will also bring upgrades and enhancements to existing operations.
According to company executives, the expansion is driven by accelerated global demand for precision extrusion and medical devices used in cardiology, neurology, radiology and urology.
The project is supported by the Irish government with the aid of IDA Ireland, a federal agency responsible for industrial development.
“Expanding our capacity will enable Teleflex Medical Limerick to continue our success and serve as a key partner with our OEM customers,” said Ed Boarini, senior vice president and general manager of Teleflex Medical OEM. “Our business has been strengthened over the years with IDA support, and this is yet another example of how IDA Ireland helps us invest in the future.”
Teleflex Medical OEM anticipates the expansion project will increase its workforce by approximately 80 jobs over the next five years. Currently, 143 people are employed at the Limerick facility.
Aseptic packaging giant Tetra Pak has opened a product development centre (PDC) in China to provide beverage and dairy companies with specialist equipment and expertise to cater for a boom market.
As part of the company’s Chinese Technology Development and Manufacturing Centre, the new PDC in Shanghai will provide processing, packaging and powder handling equipment to the firm’s customers.
Tetra Pak said that its new PDC, a “one-stop shop for product development and manufacturing” would enable clients to respond to growing diversity demanded by Chinese beverage and dairy markets
Since the creation of new product lines could entail both long development times and high costs, Tetra Pak said it was applying its expertise to help Chinese customers create new products.
With advanced processing equipment for extraction, mixture, addition and filling, the firm said its PDC would provide milk and beverage formulation and testing services, and packaging of finished products.
Onsite expertise will also include product and technology development, concept development, product processing technology and equipment optimization, product packaging innovation, market evaluation.
Hudson Lee, president of Tetra Pak China, said: “The PDC is designed to support our customers’ formula research, and help shorten their product development time (from laboratory to pilot production) and to reduce product development costs.”
The Chinese PDC centre is Tetra Pak’s ninth worldwide. The firm, headquartered in Sweden, has similar sites in France, the Netherlands, Brazil, Sweden, the US, India, Singapore and Japan.
Pfizer is planning to keep on 650 staff at its R&D centre in Kent, UK, following an announcement to close the facility earlier this year.
In February, the company said that all 2,400 people employed at the Sandwich facility would lose their jobs, before announcing that 350 people would be retained to support the development of products in the mid and late-stage pipeline.
Now, Pfizer plans to keep on an extra 300 staff.
About 800 members of staff have already left their positions at the renamed Sandwich Discovery Park and a further 700 are set to leave by the end of 2012.
Concordia University has launched a new center at its Loyola Campus in Montreal's west end that will focus on using structural and functional genomics to develop ways to transform green waste into biofuels.
The Centre for Structural and Functional Genomics was funded with a C$29.3 million ($28.8 million) grant from the federal and provincial governments' Knowledge Infrastructure Program, as GenomeWeb Daily News reported in 2009.
The three-story facility includes a total of around 60,000 square feet and will include genomics and bioinformatics labs that will focus on interdisciplinary studies in molecular and cellular studies of biomass conversion, cellulosic biofuels, and systems biology.
The CSFG facility will house 150 graduate students, postdoctoral fellows, and professors.
The center was inaugurated along with another new center that will merge behavioral research, nutrition, athletic therapy, exercise, psychology, and physiology.
The Univ. of British Columbia has opened the most sustainable building in North America, a $37-million “living laboratory” that will help to regenerate the environment and advance research and innovation on global sustainability challenges.
The Centre for Interactive Research on Sustainability (CIRS) is one of only a handful of buildings worldwide that will provide “net positive” benefits to the environment. It reduces UBC’s carbon emissions, powers itself and a neighboring building with renewable and waste energy, creates drinking water from rain and treats wastewater onsite.
CIRS will be an international centre for research, partnership and action on sustainability issues, including green building design and operations, environmental policy and community engagement. Researchers will study users’ interactions with the facility to improve building performance, maximize the happiness, health and productivity of its inhabitants and advance best green building practices at UBC and beyond.
“With the world’s urban population projected to jump by two billion people in 20 years, universities have a crucial role to play in accelerating solutions for the sustainability challenges facing society,” says UBC President Stephen Toope. “CIRS is a flagship project in UBC’s ‘living laboratory’ concept, where researchers, students, operational staff and partners develop sustainability innovations on campus to be shared with society.”
Partners have committed more than $23 million in support for CIRS, including the federal government ($8.4 million), the provincial government ($5.7 million), BC Hydro ($5 million), and Modern Green Development, China’s largest green real estate developer ($3.5 million). CIRS also has strategic partnerships with corporations such as Haworth, for adaptable workspaces, and Honeywell, for building controls and automation—both of which made in-kind contributions to the facility.
“Our Government is pleased to be celebrating today’s opening of the CIRS,” says Lynne Yelich, Minister of State for Western Economic Diversification, on behalf of the federal government, which provided support through the Canada Foundation for Innovation ($4.5 million), Sustainable Development Technology Canada ($2.4 million) and Western Economic Diversification Canada ($1.5 million). “This facility will be crucial to the continued growth of our emerging clean technologies sector as a driver of the Canadian economy, opening up new avenues of opportunity, creating jobs and delivering environmental benefits.”
“B.C. is a climate-change leader, and CIRS brings together the people and the technology to take that leadership to the next level,” says Moira Stilwell, Parliamentary Secretary for Industry, Research and Innovation, on behalf of the B.C. government, which contributed $5.7 million from the B.C. Knowledge Development Fund ($4.5 million) and other grants. “Our investment in CIRS will pay dividends in jobs for British Columbians as new technologies are developed, and improved environmental stewardship the world over.”
Built to exceed LEED Platinum and Living Building Challenge standards, CIRS is one of the few commercial buildings constructed primarily of certified wood and beetle-killed wood (currently B.C.’s largest source of carbon emissions). Its wood structure locks in more than 500 tons of carbon, offsetting the GHG emissions that resulted from the use of other non-renewable construction materials in the building such as cement, steel and aluminum.
Major features of the four-storey, 60,000 square-foot facility include: the BC Hydro Theatre, which has advanced visualization and interaction technologies to engage audiences in sustainability and climate change scenarios, the 450-seat Modern Green Development Auditorium, indoor environmental quality and building simulation software labs, a building management system that shares building performance in real-time and a café that uses no disposable packaging and serves local and organic food.
Designed in collaboration with Perkins+Will architects, CIRS will house more than 200 inhabitants from several academic disciplines, including applied science, psychology, geography, forestry and business, and such operational units as the UBC Sustainability Initiative (USI), which works collaboratively to integrate the university’s academic and operational efforts on sustainability. CIRS website makes building technical information and performance available to the public.
“This is a place for big ideas with global impacts,” says USI Executive Director John Robinson, a co-author of the Intergovernmental Panel on Climate Change report that shared the Nobel Prize with Al Gore in 2007, and the leader behind CIRS creation.
“Unsustainable buildings are 100-year mistakes that affect us all, so accelerating the adoption of green building practices is crucial,” adds Robinson, a professor in UBC’s Dept. of Geography and Institute of Resources, Environment and Sustainability. “CIRS will serve as an agent of change, providing cities and builders a model to learn from, improve on and ultimately surpass.”
CIRS is one of four flagship projects—valued collectively at more than $150 million—of UBC’s transformation into a living laboratory for sustainability. Innovations that result from CIRS and other UBC sustainability projects will help UBC to achieve the most aggressive carbon-reduction targets at any major research university: a 33 per cent reduction in Vancouver campus institutional GHG emissions by 2015, a 67 per cent reduction by 2020 and 100 per cent by 2050.
The University of Saskatchewan (U of S) opened a new vaccine research and development centre at its campus in Saskatoon, Canada, in September 2011. Known as International Vaccine Centre (InterVac), the facility is a part of the Vaccine and Infectious Disease Organization (VIDO).
"The University of Saskatchewan pumped in C$1.2m and the city of Saskatoon provided C$250,000. "InterVac is the first of its kind in western Canada, being designed with biosafety level 3 laboratories. It also has bio-containment level 3/3Ag for animal pathogens.
VIDO is a not-for-profit organization owned by the university. It conducts research on prevention of emerging infectious diseases in humans and livestock using emerging life science technologies. Both VIDO and InterVac operate as a single entity.
The facility will be used by the international bioscience scientific community, the government, academic scientists, producers and other companies.
Construction work on VIDO-InterVac was started in November 2007. The facility is currently in its commissioning phase and is expected to receive certifications from the Public Health Agency of Canada and the Canadian Food Inspection Agency in Autumn 2011. It will begin full operations in early 2012.
Established with an investment of C$140m, InterVac is one of the largest vaccine research centers in the world. It is also the largest in North America. It is located adjacent to the VIDO laboratory building and is connected by a walkway.
The facility complements the already large cluster of research and development in life sciences at U of S. It will develop vaccines and facilitate research for the treatment of infectious human diseases such as tuberculosis, hepatitis C, West Nile virus, HIV / AIDS, SARS and avian influenza, as well as large animal diseases.
It will support development of vaccines for new and re-emerging infectious diseases and also allow international collaborations to resist global pandemics. The facility is expected to create several jobs for skilled researchers and provide training opportunities to students.
The U of S International Vaccine Centre is a three storey building with an area of 145,000ft2. It has two wings - the training and research wing with contaminant laboratories (CL2 and CL3); and the animal wing with containment suites and multispecies accommodation.
The facility houses biochemistry, bacteriology, immunology and virology laboratories. The open layout of the building will encourage knowledge sharing. The modular design of the laboratories will facilitate the combination of experiments and research flexibility.
The InterVac has 18 isolation rooms for accommodating livestock. All the rooms can handle animals such as pigs, horses, cows, cattle and mice as well as birds.
The equipment rooms house state-of-the-art laboratory equipment and associated support spaces. The research centre has backup electrical and mechanical systems to allow its full-time operation.
Bio-containment is maintained by the air pressure resistant doors installed for all the key laboratories. The exhaust air is passed through two high efficiency particulate air filters (HEPA) and recycling is completely avoided.
The study of emerging disease causing pathogens such as West Nile virus, SARS H1N1 and H5N1 is possible only in CL3 laboratories.
The InterVac will increase the efficacy of existing vaccines and develop new vaccines to treat infectious diseases in both humans and animals, develop new methods of vaccine administration, and improve the diagnostic efforts of new emerging diseases and the water and food safety.
The current VIDO / InterVac developments include E. coli O157:H7, prion diseases, listeriosis, needle-free vaccines, emerging and re-emerging diseases and influenza in swine, poultry and birds.
The Government of Canada funded C$49m for the project through various agencies. The Canada Foundation for Innovation put forward C$32.5m and the Province of Saskatchewan provided C$57.1m. The University of Saskatchewan pumped in C$1.2m and the city of Saskatoon provided C$250,000.
The facility was designed by Aodbt Architecture + Interior Design in collaboration with Smith Carter Architects and Engineers. PCL Construction Management was the general contractor and Robb Kullman Engineering was the structural engineer.
Daniels Wingerak Engineering was the mechanical consultant and PWA Engineering was the electrical works consultant. Hemisphere Engineering was the biocontainment consultant for the facility.
Laboratories at InterVac are well equipped for handling CL2 and CL3-rated pathogens.
Pharmaniaga LifeScience's small volume injectables (SVI) facility in Puchong, in the Selangor district of Malaysia, commenced commercial production in January 2011.
The Puchong factory will carry out SVI fill and finish contract manufacturing for both regional and global companies. Built at a cost of RM149m, the plant has a production capacity of 40 million units a year.
The new facility is compliant with the good manufacturing practices (GMP) of the European Union, US Food and Drug Administration (FDA) and Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S).
Pharmaniaga constructed the SVI facility to expand its manufacturing base and accommodate future manufacturing capabilities. As a long term strategy, Pharmaniaga plans to relocate its entire manufacturing operations to the new site.
Pharmaniaga LifeScience is a subsidiary of Malaysian investment holding company Pharmaniaga.
The concept design and the plant specifications were completed in 2002 and 2003 respectively, by a UK-based consultant.
Construction of the plant commenced in July 2004. Officials from National Pharmaceutical Control Bureau (NPCB) visited the facility in 2007 and recommended improvements necessary to begin production.
The factory acceptance test (FAT) was undertaken in early 2008 after implementing the NPCB recommendations. An engineering trial run was conducted in the third quarter of the same year.
The facility obtained the cGMP certification from the Ministry of Health in August 2010. The first product licensed for commercial production was obtained in December 2010.
The SVI plant has been constructed on a 17.5ha plot and has a built up area of 9,000m2 (96,840 sq. ft.). It is the first facility in Malaysia to feature cleanrooms of classes A, B, C and D.
The main building includes a warehouse, manufacturing and packaging area, equipment workshop, quality control and microbiology laboratories and an office.
The Puchong factory is equipped with European processing equipment such as a solution preparation line, ampoule filling line, terminal and parts autoclave, external washer and inspection machine, leak tester machine and a purified water system.
The engineering, procurement, construction management and validation works contract was awarded to Bovis Lend Lease in 2004.
Scope of work included design and construction of the facility as per Pharmaniaga's product list, sales forecast and future extensions, while making the best use of available land.
Installation and qualification (IQ) and operational qualification (OQ) tests of the purified water system were conducted by Synertech.
Mechanical and piping services were provided by Engmech + Pharmaserv.
OLSA supplied the solution preparation machine, Bausch and Strobel supplied the ampoule filling line, Fedegari the autoclave sterilization systems, Seideneder external washing and inspection systems and Bonfiglioli supplied the leak testing machine.
The project received external and internal funds. The SVI facility was part-financed by the Islamic Financing Facility (IFF). RHB Sakura Merchant Bankers was the lead banker.
The IFF committed a RM60m loan raised through the Islamic Medium Term Notes Program.
Construction of the new plant is part of Pharmaniaga's growth strategy aimed at tapping both regional and global markets.
"The Puchong factory will carry out SVI fill and finish contract manufacturing for both regional and global companies."Malaysia has been importing more than 90% of its SVI products from India and Australia.
The new SVI plant help the company participate in the RM400m market for SVIs in the country. Pharmaniaga has 15-year concession up to 2019 to supply medical products to government hospitals. The contract was renewed in 2010.
Pharmaniaga aims to become a world-class SVI fill and finish contract manufacturing company. It has identified Europe and South East Asian regions as priority markets. The Puchong facility's compliance with international GMP will enable Pharmaniaga to export products to developed regions such as the US and Europe.
Shonan Research Center is a new drug discovery and development centre located in Fujisawa City, Kanagawa prefecture, Japan. Built at a cost of ¥147bn ($1.9bn), the plant was officially inaugurated in February 2011.
"Construction of the Shonan Research Center was started in June 2009 and mechanically completed in February 2011."Full-scale operations at the facility will begin in November 2011. Takeda Pharmaceutical Company (Takeda) is the owner and operator of the facility.
The Shonan Institute will facilitate medicine research and development (R&D) in early stages. It will also collaborate with academic universities and bioventure companies to develop innovative medicines. The centre will support collaborative research programs.
Takeda is the largest research-based pharmaceutical company in Japan and one of the largest in the world. The company was founded more than 230 years ago. Takeda works on the development of medicine through its R&D pipeline, producing several pharmaceutical products such as Candesartan Cilexetil, Lansoprazole, Pioglitazone Hydrochloride and Leuprorelin Acetate. The in-house drugs are exported to more than 90 countries.
Takeda also operates research facilities in the US, UK and Singapore. The Shonan Research Center will act as the control base for Takeda's global research operations. It will lead the basic research such as discovery of drug targets, research of synthesis, pharmacology and pharmacokinetics.
The main therapeutic areas of new drugs development include gastroenterological diseases, central nervous system diseases, urological and oncology diseases and immunology / inflammatory and metabolic (diabetes and obesity) diseases.
Takeda's new research facility is located at the centre of Kamakura and Fujisawa cities, about 50km west of Tokyo. It consolidates the research facilities of the company at Tsukuba, Ibaraki prefecture, and Osaka, Osaka prefecture. It will bring together about 1,200 researchers under one roof and accommodate 800 support staff.
The location of the facility is in proximity to several pharmaceutical institutions in the Kanagawa prefecture, which is expected to increase the research related opportunities.
The ten-storey building is constructed on a 250,000m2 greenfield site. Laminated rubber foundations reduce the impact of earthquakes on the building.
The facility has a built-up area of more than 72,000m2 (774,720 sq. ft.) and boasts about 308,000m2 (3,314,080 sq. ft.) of floor area with flexible layout for R&D. It has five research wings and a Center Station wing. The layout of the synthetic chemical, animal and biochemical research facilities eases the coordination between similar functions.
The building houses a P3 laboratory with exhaust HEPA filters, high-pressure sterilizer and wastewater treatment processing facilities for genetic recombination experiments. It also has a library and refreshment area for employees. Interstitial space on all the research floors is used as equipment flooring, which also eases maintenance.
Taikisha supplied the heat source and HVAC facilities of the plant. The environmentally friendly equipment and energy-saving HVAC technologies include hyper drydeco decontamination system and heat source optimal control system.
Sustainable design features at Takeda Pharmaceutical Company's facility
The centre is surrounded by woodland and waterside area. The isolated structure increases safety and reliability of the building.
"Shonan Research Center is a new drug discovery and development centre located in Fujisawa City, Kanagawa prefecture, Japan."The centre also has many green features such as a landscaped rooftop, energy-saving ventilation system and extensive use of natural light.
The facility is installed with CO2 emission control equipment to curb emissions. It also has a flood control basin. The building fully complies with the Japanese environmental protection, human safety laws and regulations requirements.
Construction of the Shonan Research Center was started in June 2009 and mechanically completed in February 2011. The forest landscape and waterbody were preserved during construction.
Construction management services for the facility were provided by Yamashita PM Consultants and Yamashita Sekkei. The design and construction supervision services were provided by Plantec Architects. The detailed design, construction and management were carried out by Takenaka Corporation and other subcontractors.
Almac is expanding its manufacturing capacity to more than 30m3 at its European headquarters in Craigavon, UK to satisfy increasing demand for active pharmaceutical ingredients (APIs).
The upgraded facility will include reactor vessels with state-of-the-art cleanroom product isolation and drying equipment to allow highly potent API (HPAPI) manufacture in up to 600kg batch sizes.
Almac currently has six API and advanced chiral intermediates in Phase III clinical development and has been steadily increasing its market penetration in late phase clinical development.
Denis Geffroy, VP of Business Development at Almac said the capacity increase would allow a smooth transition from late phase clinical development to full commercialization.
‘Scale was becoming a limiting factor for some of our client projects and this new capacity is a strong commitment to offer project continuity. It opens up a new chapter in Almac's API manufacturing capability,’ he said.
Almac anticipates that the facility will be built, commissioned and validated within the next two years. In the meantime, the firm will continue progressing late stage manufacturing projects within its existing facilities.
Dr Rick Dyer, Almac’s VP of Operations added: ‘This expansion allows us to build on our expertise in early phase clinical development projects and further continue our success within late phase projects so clients need not transfer some of our well developed processes elsewhere due to lack of scale.’
Almac has also seen an increase in chiral late stage projects, which it attributes to its selectAZyme technology. This technology has significantly improved yields, productivity and the time taken to perform multi-step syntheses.
Initially launched in 2009 with the sale of six enzyme kits, Almac's biocatalysis capabilities have expanded to the supply of hundreds of kilos of both chiral intermediates and APIs.
India is embarking on specialized technical textile research with applications in cleanrooms and healthcare.
The research is to be conducted at the Centre of Excellence for Medical Textiles at the South India Textile Research Association (SITRA), an autonomous organization funded by the Indian government and the textile industry.
SITRA is based at Coimbatore, a major hub of the Indian textile industry.
“We will try to incorporate anti-microbial compounds in medical textiles to prevent cross infections,” said Dr. Prakash Vasudevan, director of SITRA.
SITRA will study the relative advantages of nano finishes over conventional finishing chemicals in terms of air permeability, water vapor transmission and wickability. It aims to identify appropriate materials for providing anti-bacterial and blood-repellent characteristics for wovens.
There is growing demand in Indian hospitals and laboratory cleanrooms for improved protection against blood and liquid borne pathogens, especially viruses such as Hepatitis B.
SITRA estimates, for example, that 90% of India's operating theatres use surgical gowns made of woven products that have no functional finishes and are washed and sterilized before every use.
Dr Vasudevan said that other related industries are interested in the technologies.
The UK’s University of Bolton is training Indian scientists for SITRA, which is also negotiating to set up collaborative research with other European educational and research institutions.
Entegris, a US supplier of contamination control solutions for demanding manufacturing environments, has opened a new manufacturing and research facility in Hsinchu City, Taiwan.
The new facility will be used for the design and manufacture of advanced filtration and materials handling components for the semiconductor and other high-tech industries, and will provide lab services to customers in Taiwan and across Asia.
Once the new facility is fully operational, Entegris expects to employ up to 160 manufacturing, sales, service and engineering staff in Taiwan. The firm employs around 2,800 people worldwide.
Taiwan is an important market for Entegris, representing 16%, or nearly US$110m, of sales in 2010. Last year total sales were $688m.
“This expansion adds to our existing presence in this region and extends our ability to address growth opportunities in the semiconductor, solar, energy storage, and other emerging markets across Asia,” said Gideon Argov, president and chief executive of Entegris.
Paul Yang, Entegris’ regional director for Greater China, added: “Our decision to open this facility reflects our commitment to be close to our customers in Taiwan and around Asia. We can now support these customers with products that are produced locally, as well as jointly develop filtration technology needed for their most advanced manufacturing processes.”
Medlac is an Italy-based pharmaceutical company specializing in dermatological products. The company officially inaugurated a new 10,000m² (107,600 sq. ft.) manufacturing plant in Vietnam in April 2011. The facility will manufacture and supply dermatological and transdermic products to the domestic and international markets.
Located in the Hoa Lac Hi-tech Park, 50km away from the Vietnamese capital of Hanoi, the plant is Medlac's first facility in Vietnam. The Hi-tech Park is strategically located and built as the centre of development for research and hi-tech applications at national level. It is the first and the largest industrial park in Vietnam and is spread over an area of 1,586ha.
Projects that are constructed at this site are expected to meet stringent requirements such as the construction quality, beauty, landscape and environmental surrounding while adhering to the construction timelines.
The plant consists of two blocks including the main office building and the production house. The office building has two floors. Each floor is divided into management and administrative sections.
The entire complex is surrounded by trees, lawn and access roads, and has enough space for car parking. It is built over 15,000m² of land surface with a provision for the construction of second complex with a mirror-inverted layout. It is rectangular in shape and has a façade built of transparent structural U-profile glass walls of different widths and sizes.
The glass walls are randomly placed and can be opened when needed. The sunshades are adjustable and made of white lacquered wood panels, which provide outside views.
The entrance of the building dominates the complex. It is long, with the side walls running up to the ceiling of the building. The front walls of the entrance are clad with glass panels while the side walls are colored orange.
The ground floor is divided into two parts. The first part features reception, guest lounge and a parapet staircase of metal frame and glass. The management area located in this part includes a dedicated secretariat and two large executive offices. A large corridor leading to the conference hall, a second secretariat, administrative offices and service area form the second part of the management area. The remaining ground floor area is occupied by the canteen staff.
The parapet staircase leads to the second floor. The entire floor can be temporarily converted into two large conference rooms by joining one small meeting room and one office room.
The new Medlac facility produces Betalactam products and non-Betalactam products in jar, pipe and tablet form. It conducts activities such as research, and measurement and control of the quality of products produced at the factory. It also provides quality control services to individuals and organizational clients, both internal and external.
The production area is situated behind the office building. It is connected to the front building with a low, orange colored passage. It is larger than the office building and has a floor area of 3,400m² (36,584 sq. ft.).
The production plant is made of lacquered sandwich panels. The inside area is square in shape and has two large cantilevered roofs with a bright orange ceiling. The entrance to the production area is not misaligned with the building façade in order to create a yard look. The entrance is also colored orange.
Medlac broke ground for the construction of the plant in mid-2010.
Rome-based architects Alvisi Kirimoto + Partners designed the facility. The primary engineering and construction contract was awarded to 105 Construction Joint Stock Company (105JSC), a Hanoi based firm.
105JSC subcontracted the electrical works to Vietnam-based Thang Tien Technical Material in 2010.
The Indo-Spanish joint venture (JV) company 3B Blackbio Biotech India opened a new biotech plant in Bhopal, Madhya Pradesh state in April 2011. The plant is a joint venture between Indian agrochemical company Kilpest India (51%) and Spanish biotechnology companies 2B Blackbio (29%) and Biotools B&M Labs (20%).
"Construction of the facility was started in January 2011 and was completed for inauguration in April." Biotools B&M Labs is focused on research, development and manufacture of recombinant enzymes and molecular biology reagents.
2B Blackbio is focused on the personalized medicine market, developing and marketing molecular diagnosis kits and microarray products.
The 3B BlackBio Biotech India plant focuses on several proteomic and genomic technologies. It will develop, manufacture and market molecular biology products and provide integral solutions in the areas of pharmacogenetics and life sciences.
The plant is located in the 7-C Industrial Area in Govindpura town of Bhopal. It consists of production, R&D, quality control, cleanroom, laboratories and other facilities. It has a well qualified team of scientists and technicians. The estimated investment in the plant was INR 30m ($609,810).
The target industries include pharmaceutical, clinical diagnostic, research, development and agro-food. The company will collaborate with the government and NGOs for R&D in molecular biology. It also aims to custom develop solutions for pharma, agro-food and biotech companies, hospitals and academic and research institutions through its R&D portfolio.
The plant features a 180ft2 pre-PCR (polymerase chain reaction) lab equipped with laminar air flow, double distillator, deep freezer, microwave oven, vacuum cleaner and micropipettes. It also has a 100.8ft2 I PCR lab equipped with thermalcycler, laminar air flow, gel doc system and vortex mixer.
Another 180ft2 II PCR lab is equipped with an RT PCR machine, gradient PCR machines, laminar air flow, electrophoresis assembly, micropipettes, spinwin microfuge, UV transilluminator and a computer.
A 90.6ft2 electrophoresis lab at the plant consists of horizontal and vertical electrophoresis assemblies, micropipettes, vortex mixer and gel rocker. A 180ft2 quality control lab is equipped with laminar air flow, oven, centifuges, micropipettes and precision weigh machine.
A 216ft2 extraction lab is available with biosafety cabinet, cooling centrifuge, microfuge, deep freezer and refrigerator, gel rocker, bacteriological incubator, humidifier cum fumigator, microwave oven, water bath and a vortex mixer.
The 195ft2 scientist room has computers, projector and other furniture and fixtures. A -20 degrees Celsius, 65ft2 storage facility consists of deep freezers and control panel for clean rooms. A 180ft2 computer room consists of computers and refrigerator.
A 520ft2 cleanroom for molecular biology work includes a dispensing room, reagent preparation room, buffer preparation room and production room.
The equipment of the cleanroom include eppendorf electronic pipette, micropipettes, static deep freezers of -20 degrees celsius, vortex shaker, magnetic stirrer, spinwin microcentrifuge, gel rocker, sonabox, jack stand, ultrasonic homogenizer / sonicator, eppendorf centrifuge, new brunswick shaker and eppendorf biophotometer.
A 170ft2 media preparation and autoclave room comprises of a magnetic stirrer, UV cabinet, hot air oven, KF Titrator, UV-VIS spectrophotometer, VIS spectrophotometer, flash point, electronic balances, kipps apparatus, rotary vacuum evaporator and centrifuge.
The facility also consists of a 132.8ft2 chemical store room with -20 degree celsius deep freezers, millipore water system, analytical and precision weigh machines, micropipettes, air conditioner and chemical storage racks and cupboards.
The facility will produce molecular biology products such as PCR enzymes, PCR reagents, real time kits, reverse transcriptase kits, cloning vectors, electrophoresis reagents, nucleic acid purification, accessories and plastic products, molecular diagnostics, AGFoods kits, BIOFood ID kit, BIOFood mixed kit, BIOGenics standard kit and 3B control DNAs.
It will also manufacture equipments such as end-point thermal cyclers, real-time thermal cyclers and gradient thermal cyclers. 3B Blackbio Biotech India has the license for patented gelification technology, owned by Biotools B&M Labs.
"Biotools B&M Labs is focused on research, development and manufacture of recombinant enzymes."The R&D team will focus on proteomic and genomic biomarkers and technology development to global standards. Its focus areas also include oncology, microbiology, nutrition, metabolic disorders and pharmacogenetics.
The customer services will include DNA & RNA extraction, sample isolation, microbial identification, including fungal identification services, microsequencing and genotyping complying with the latest GMP practices. Other services include the development of companion diagnostic tests, human genetic tests, prognostic tests, critical referral tests or nutrigenetic studies.
The plant has a capacity to produce 30l to 35l of enzymes and 5l to 10l of kits a year. It also has buffers production capacity of 500l to 600l per annum.
Construction of the facility was started in January 2011 and was completed for inauguration in April. The project was designed by the company itself. Mumbai-based Kleanzone Systems (India) was the cleanroom supplier.
Fine chemicals manufacturer Saltigo is looking to expand its high potency API (HPAPI) business by targeting the pharmaceutical industry in the US and Japan.
The Frankfurt, Germany-based firm will add manufacturing capacity at its facility in Redmond in Washington State, US – specifically for the production of compounds classed as category III under the SafeBridge toxicity categorization system.
Andreas Stolle, head of the firm’s pharma business unit, said: "Once the expansion project has been completed, we will be able to respond even more extensively and flexibly to our customers` requirements.”
The US expansion, which is due to be completed in 2012, comes hot on the heels of Saltigo’s receipt of accreditation by Japanese regulators for its API and intermediates manufacturing site in Leverkusen, Germany.
The “Certificate of Foreign Drug Manufacturers" issued by the Japanese Ministry of Health, Labor and Welfare (MHLW) applies to all non-sterile APIs made at the plant and is very important to Saltigo’s expansion according to Stolle.
"For us, its value is similar to that of a certificate from the US Food and Drug Administration (FDA). It is an essential milestone for further expanding our business activity in Japan and safeguarding it on a sustainable basis" he said.
In vitro diagnostics and microbiological control company bioMérieux is expanding its culture media expertise centre in Craponne, France, with a dedicated b6m manufacturing unit for its biopharmaceutical customers.
Equipped with cutting-edge manufacturing technologies, the new, fully automated, unit has been built to support product demand and the global launch of the revolutionary LockSure plate. Designed for environmental control in pharmaceutical cleanrooms and isolators, this patented technology secures the lids on culture media to ensure optimal quality, from sampling to results.
‘This new manufacturing unit for Count-Tact and LockSure plates enables us to satisfy our customers’ needs for greater performance, flexibility and innovation,’ said Jean-Marc Durano, corporate vice president, Industrial Microbiology.
‘We now have culture media manufacturing sites in the US and France, entirely dedicated to the pharmaceutical industry, to meet global demand.’
Culture media are critical for quality control and requirements from pharmaceutical companies towards their suppliers are therefore very strict in terms of quality and service. With multiple new manufacturing lines, the Craponne production unit operates in compliance with the FDA cGMP 21 CFR Part 820 (current Good Manufacturing Practices), as well as with bioMérieux’s Corporate Quality Assurance policy and Quality System, which is certified ISO 9001:2008 and EN ISO 13485:2003.
Helsinn Advanced Synthesis is currently building a new facility in Biasca, Switzerland to manufacture highly potent active pharmaceutical ingredients (HPAPIs). The challenge was to build a factory capable of handling the actual HPAPI but also to handle even more potent products in the future.
The pharma industry is developing more and more potent oncology drugs, hormones and other products. This trend is expected to shift to even more potent products in the near future, which will cause production, cleaning and safety issues. Equipment must therefore meet this criterion now to ensure suitability to increased potent handling in the future.
Powder Systems (PSL) has been chosen by Helsinn to provide two PSL FilterBoxes – agitated nutsche filter dryers (ANFDs) with high containment that fulfill the requirements of HPAPI production. The FilterBox is an ANFD with a contained discharge and base.
The HPAPI production process demands a very low exposure level. PSL’s experience with handling highly potent products brought the decision that the production and cleaning operation would be completely contained.
The filter dryers that are currently being engineered will achieve cleaning below 2ppm after reflux. A further critical consideration was to be able to clean additional parts, such as the drainpipe, which could potentially contain some HPAPI. With the ANFD inside a containment system, the user can easily dismantle these critical parts in a contained manner, clean them and reinstall them safely.
Helsinn has been working with PSL products for 12 years. In further support of the new facility in Biasca, PSL will also provide a full process, complex high containment system that will house complete small-scale synthesis. The system will include reactions, filtration and drying, incorporating PSL’s new CakeStand Tray Dryer technology.
PSL will be exhibiting a laboratory glass filter dryer GFD within a high containment glovebox on stand 40H59 at P-MEC Europe.
Tristel, the manufacturer of infection and contamination control products, has expanded.
The Group has invested heavily in its expansion program in the first half and looks forward to an acceleration in turnover growth in the second half in accordance with its internal plan and market expectations. The Group continues to expand internationally, obtaining its first regulatory approval in China and achieving its first sales, and it has also entered the German market. In January, 2011, The Group announced the completion of the construction and fit-out of its clean- room and its handover by the contractor Clean Room Construction Limited. The cleanroom enables the manufacture of sterile packed disinfectants, which form an integral part of Tristel’s newly created portfolio of disinfectants and cleaning products, branded “Crystel”. These products have enabled Tristel to expand into the Pharmaceutical, Cosmetics and Toiletries (“PCT”) market.
In line with its expansion plan, the company has continued to invest in sales and manufacturing infrastructure and the second half result is, therefore, bearing a much enlarged cost base. The Company remains debt free and will continue with its expansion plans. Significant growth is anticipated in 2012 and beyond. In September, 2011 the Group announced that it has received the administrative license to sell its medical instrument disinfectant "Fuse" and surface disinfectant "Jet" from the Chinese Health authorities. With the inclusion of Tristel Jet within the Group's offering it is now addressing two important areas of infection control in China: medical instrumentation and hospital surfaces.
Worldwide export sales are forecast to be a major contributor to Tristel top-line growth this year. FinnCap expects the Group’s revenues to be at £9.30 million for the FY 2011 and £11.60 million for the FY 2012 with net profits (pre except) of £0.40 million and £0.70 million. Pre-tax profits (pre except) are expected at £0.50 million and £1 million and profit earnings per share at 2.20 pence per share for FY 2011 and 3.30 pence for FY 2012. Dividend per share is expected to be at 0.60 pence per share and 1 pence per share for the FY 2011 and FY 2012 respectively.
Alkermes plc recently established corporate operations in Ireland, with headquarters located in Dublin. The company, including its HQ and operations in Athlone, County Westmeath, has more than 450 employees based in Ireland and more than 1,200 employees worldwide. Alkermes plc was created following the merger of Alkermes, Inc. with Elan Drug Technologies (EDT), the profitable drug formulation and manufacturing business unit that was formerly a part of Elan Corp.
Alkermes has also announced a multiyear, multimillion dollar manufacturing agreement with "one of the world's top ten pharmaceutical companies," according to a company statement. Alkermes will manufacture the company's finished pharmaceutical product, which will be produced at the Athlone, Ireland facility. The company projects $15 million to $20 million in annual manufacturing revenues by 2016 from this deal.
"We are a strong, global company with a diversified product portfolio, and we look forward to accelerating our growth to create value in our business and for the patients we serve," said Richard Pops, chief executive officer of Alkermes. "Alkermes is excited to have our operations based in Ireland, which we view as a gateway to the European Union and global pharmaceutical market."
Catalent Pharma Solutions (booth 1827) has opened a new European Development and Clinical Services Lab in Swindon, UK, expanding its geographic reach for Analytical Development Services.
“This is part of Catalent’s continuous investment to strengthen our position as the #1 global partner for drug development and formulation services,” said Scott Houlton, president of Catalent’s Development & Clinical Services business. “Our customers have asked for expanded testing services in Europe, and value the expertise and security that come from working with a company with the depth and breadth of Catalent. This expansion will enable us to better meet customer needs in Europe for analytical testing, including clinical and commercial release testing of their products.”
The new lab is located within Catalent’s Swindon campus, joining the development and commercial supply operations for Catalent’s oral fast dissolve Zydis technology.
The lab systems being implemented are designed to meet regulatory requirements in the EU, U.S. and other major markets. The lab services initially offered include: raw material and finished product release testing, qualified person release, method development and validation, compendial testing, microbiology, and stability testing and storage.
Merck & Co is investing $250m (€180m) in its Singapore manufacturing capabilities as part of an expansion push.
Since entering Singapore in 1998 Merck has built active pharmaceutical ingredient and finished dosage plants. Operations will expand over the next 10 years as Merck invests $250m as part of an agreement with the Singapore Economic Development Board (SEDB).
“Merck is pleased to expand its already substantial operations in Singapore with new, far-reaching commitments”, Willie Deese, executive vice president and president, Merck Manufacturing Division, said.
A further S$700m (€550m) is being invested in local research activities. Merck also plans to expand its biotech operations, add technology to support new product launches, and collaborate with local universities to develop its workforce.
Merck’s expansion in Singapore coincides with Lonza floating on the country’s stock exchange. Lonza has added Asian operations in recent years but growth in investment from the region has failed to keep pace.
“The successful listing on the SGX-ST will…enable [Lonza] to further tap into the market growth in Asia. We look towards broadening our investor base in Asia and creating a ‘local currency’ for future growth in the region”, Stefan Borgas, CEO of Lonza, said.
Metabolon has opened a new metabolomics lab in Shanghai, China in collaboration with Shanghai Jiao Tong University. Research Triangle Park, NC-based Metabolon said that it has licensed its metabolomics platform to the university to enable a biochemical profiling lab there. The lab is funded by the university and personnel have been trained by Metabolon.
Rusnano and Nearmedic Plus will build a ‘nanomedicine’ production facility in Russia in a collaboration that fits with Government efforts to boost local drug manufacturing.
The new plant in Obninsk in the country’s Kaluga Oblast region will manufacture Nearmedic’s Kagocel, which is an over-the-counter (OTC) antiviral consisting of plant-based active ingredient attached to a half-life boosting nanopolymer.
Nearmedic will relocate production from a rented facility in Moscow. The firm said the move is necessary to cope with increased demand for the product, sales of which have increased 13-fold since it was launched in 2003.
For its part Rusnano will invest RUB1.2bn ($34m) in the construction of the facility, which is expected to cost more than RUB4bn to build and be fully operational in late 2013.
Olga Shpichko, Rusnano MD, said: "The antiviral medicines segment is the most dynamically growing in the Russian pharmaceutical market," suggesting that "The project will facilitate product expansion for this promising antiviral drug developed by Russian scientists."
The move, like a similar collaboration Rusnano signed with Novouralsk-based pharma firm Medsintez in 2010, is in keeping with the Government-owned organization’s brief of supporting the development of Russia’s nanotechnology sector.
The investment also fits with the Government’s wider efforts to reduce Russia’s reliance on drug imports and boost the amount of manufacturing in the country – the Pharma 20:20 plan launched in December last year.
A central tenet of Pharma 20:20 is that production be brought into line with international standards through the adoption of good manufacturing practice (GMP) standards by 2014 – which is perhaps why the Nearmedic plant is described as being ‘GMP-tailored.’
In other news, Rusnano has partnered with US biotech firm Cleveland Biolabs in a four year project designed to help the firm develop a portfolio of nanotech cancer drugs.
The collaboration, which could see Rusnano invest up to $26m, will see the Russian organization buy a 55 per cent stake in Cleveland’s Panacela Labs, which has five drugs in development.
Carbogen Amcis has signed a strategic deal with formulations specialist Polymun Scientific in a agreement designed to support the development of its high potency manufacturing business.
The deal – terms of which were not disclosed – will grant Carbogen access to Austria-based Polymun’s liposomal formulation technology for use in the formulations of active pharmaceutical ingredients (APIs).
In return Polymun will be able to use Carbogen’s development and manufacturing capabilities.
Carbogen CEO Mark Griffiths set out the rationale for the agreement, explaining that: “We believe that our customers are interested in finding new ways to better deliver highly potent active ingredients. This alliance expands our portfolio of offering and moves us one step closer to achieving this goal.”
The Switzerland-based API maker has been expanding its high-potency API manufacturing business since February this year under a restructuring plan launched by Indian parent organization Dishman in response to ‘inadequate profitability’ at the Swiss CMO.
Under that plan the active pharmaceutical ingredient (API) chose to focus operations at its Aarau, Switzerland on development projects and shift pilot production for early-stage compounds to its facility in Huzenschwil.
Large volume production for standard APIs and highly active agents continued at Carbogen's facility in Bubendorf.
There was more news for Carbogen’s HPAPI business this month process after the firm successfully completed a US Food and Drug Administration (FDA) pre-approval inspection for the manufacture of a HP API on behalf of an unnamed multinational pharmaceutical organization.
Sri Lanka is setting up a 48 acre pharma manufacturing industrial zone to boost local production.
Creating a pharma manufacturing hub 5km from Kurunegala City in central Sri Lanka will help the government, which accounts for 35 per cent of demand, source more drugs from local suppliers.
The Sri Lankan Ministry of Industry and Commerce has distributed a leaflet promoting the hub to potential occupants. Priority is being given to companies making large investments and land will be leased under 50-year agreements.
More than 10 companies have shown an interest in setting up plants, the government said. To attract investment the government is offering “buy back guarantees”, Lanka Business Online reports, and creating the infrastructure needed to support pharma manufacturers.
Development of the industrial zone and associated infrastructure will begin soon, the government said. Connecting the hub to wide roads, water, electricity, and telecommunications is a priority. Colombo University will support testing of product quality using its laboratories.
Making these investments will help the government cut reliance on imports. The government spends around LKR15bn ($135m) a year on pharmaceuticals. Rishad Bathiudeen, Minister of Industry and Commerce, said Sri Lanka sources 10 per cent of its drugs locally.
Over the past two years the Sri Lankan State Pharmaceutical Manufacturing Corporation (SPMC) has invested to boost output. In January 2010 SPMC sought a $10m loan to upgrade equipment and add capacity.
Using the funding SPMC planned to increase output to 4bn tablets and capsules a year. The SPMC site was designed to produce 550m tablets and capsules but by lengthening operating hours output was increased to more than 1bn.
GlaxoSmithKline (GSK) has also invested in Sri Lanka to double production capacity at its Panadol (paracetamol) plant in Moratuwa. Output of 2bn tablets a year was targeted post-expansion.
Maropack AG is building a facility in Switzerland to be dedicated to biological products. The U.S. FDA inspected facility will be the first to place a Bottelpack blow-fill-seal machine from sister company Rommelag into a BSL-2 environment, reports Tim Kram, general manager of Rommelag USA Inc. The first construction phase entails completing the main facility as well as the first BSL-2 filling suite. Three more modular filling suites can be added to support additional products.
“The Maropack facility gives biological product manufacturers the option to use blow-fill-seal technology,” explains Kram.
“Manufacturers of vaccines and other biological products are looking for single-dose packages, and blow-fill-seal packages offer convenience and dosing control as well as tamper evidence, minimizing the chance for counterfeiting. BFS containers feature a single contact material and are more robust than glass, minimizing breaking issues.”
Maropack’s installation will feature advanced aseptic filling capability modified to accommodate products that require low temperatures, such as 2° to 8°C. “We can bring down the product temperature prior to filling to negate any heat added to the product by the blow-fill-seal process. After filling the product can quickly be brought down to refrigerated or frozen condition. The process minimizes product exposure to temperatures above ambient conditions.”
In addition, BFS containers have been shown to be stable at low-temperature freezing, such as that for liquid nitrogen, says Kram. “Rommelag has tested temperature-sensitive biological products frozen in LDPE. Monolayer plastic containers do not experience the adverse thermal expansion conditions that containers made from multiple materials do, such as glass vials with rubber stoppers and aluminum crimped caps.”
In addition, the blow-fill-seal process offers high-capacity, low-cost production, Kram adds.
The facility will enable customers to perform stability, clinical trial, and registration runs using BFS technology.
Maropack can supply long-term contract manufacturing services, and Rommelag can provide container design and scale-up support.
Danish neurodrug developer H Lundbeck is cutting back its Chinese outsourcing after establishing an R&D centre in Shanghai.
The firm will now perform several of the tasks previously farmed-out to contract research organizations (CRO) in house, but says it will continue to outsource “certain research tasks” in China.
It insists that the new move will not affect its current partnerships in other areas of the world.
A spokesperson said: “The new research centre will primarily perform tasks which have currently been outsourced to China, and the opening of the centre will therefore not have a direct consequence for Lundbeck's other research centers.”
Now through its new facility, Lundbeck hopes to establish more research alliances in Asia.
"It is important to be present where the potential collaborative partners operate in order to effectively identify and pursue partnership opportunities,” said Peter Høngaard Andersen, head of external scientific relations and patents.
“We have previously formed a number of good and important alliances in Asia, but our new centre will allow us to build even more partnerships.”
The Danish business’ new facility – which will initially be staffed by 30 people – has been established in conjunction with the Investment Fund for Developing Countries (IFU), who has been involved with both advisory services and financial backing.
The collaboration also comprises a small packaging plant for finished goods in China, which will be ready for commissioning in 2012.
Through its packaging capabilities, Lundbeck says it hopes to prove it has a firm grasp on its Chinese supply chain management.
Angel Biotechnology is negotiating a joint-venture with a Russian firm that would see it add dedicated production space at a UK site.
Details of the joint-venture are being discussed by Russia-based Materia Medica Holding (MMH) and Angel. The current plan is for Scotland-headquartered Angel to add a GMP (good manufacturing practice) unit dedicated to producing MMH drugs at its Cramlington, UK plant.
“This deal opens a new and important chapter of the continuing growth and development of Angel, cementing an alliance between the company and its major customer and giving greater visibility of work and income well into the future”, Paul Harper, executive chairman of Angel, said.
Angel will add 230 sq. m. (24,748 sq. ft.) of space for manufacture of MMH products as part of the re-commissioning of its Cramlington, UK site. MMH will fund the cost of the expansion, capital equipment and production activities. The joint-venture will also occupy a 93 sq m non-GMP development laboratory at Cramlington.
Operation and staffing of the dedicated facility will be handled by Angel which plans to hire between eight and 15 people in relation to the project. The joint-venture will place orders and manage work performed in the dedicated unit, with Angel receiving fees for use of its facility, staff and infrastructure. Based on work previously done for MMH Angel predicts earnings of around £10m ($16m).
MMH will give funds for commissioning new programs and profits retained by the joint-venture will be split between the partners. Angel and MMH will own 49 per cent and 51 per cent of the venture respectively and profits will be split in this proportion.
The agreement will be reviewed after five years and over this period MMH expects to manufacture at least seven products. Working with Angel will give MMH capacity to grow its biologics business.
“Through the formation of this joint venture company, we expect to move into a secure, long term supply agreement with Angel for the manufacture of advanced biologicals that form the core of our business”, Oleg Epstein, general director of MMH, said.
MMH has three programs ready to go and work will begin under a current agreement with Angel. Details of the joint-venture are still being negotiated. MMH will transfer control of the programs to the joint-venture if it is formally created.
Akorn is doubling capacity and hiring “as fast as [it] can” after drug shortages sent demand for its injectables soaring.
Drug shortages have swept across the US and sent hospitals searching for other sources. Akorn said the “unprecedented and daunting problem” has driven “sudden growth” in demand for its injectables and pushed existing production capacity to the limit.
“[We have revived] products we could not sell in the past due to economic feasibility”, Raj Rai, CEO of Akorn, said in a call with investors. Akorn is expanding its Somerset, New Jersey facility but the $52m (€39m) move into India is the big shift.
All five facilities, three of which are still being built, are based at one site in northern India. When all the plants are operational capacity at Akorn will more than double. Rai said Akorn is investing $15m to complete the projects and expects to have all the facilities running by the end of 2012.
None of the plants have U.S. Food and Drug Administration (FDA) approval but, Rai said, they are modern and follow good manufacturing practices (GMP). Akorn will install its quality systems and expects to have FDA approval by early 2014.
After gaining approval Akorn will use the capacity to meet US demand for injectables. Anti-infectives, oncology and cardiac-related injectables are opportunities, Rai said, and the Indian capacity will help Akorn in all three areas.
Addition of 230,000 sq. ft. of capacity in India is accompanied by expansion in New Jersey and hiring at a plant in Decatur, Illinois. Rai said Akorn can “barely keep up with demand” and is “hiring as fast as [it] can”.
Akorn considered outsourcing production, instead of adding in-house capacity, but was put off by bad experiences in the past. Manufacturing plants in the US were also looked at, Rai said, but Akorn was unable to find a suitable site.
Believing building capacity would cost more Akorn looked overseas for extra capacity. Entering India also provides other advantages, such as the opportunity to increase sales in emerging markets.
“The company has just started to aggressively pursue an international strategy”, Rai said. Akorn will target specific overseas opportunities and could also sell its ophthalmic portfolio globally. Takeover of a US production site remains a possibility though. Akorn still has some cash available, Rai said, and if an opportunity became available the company would consider making the acquisition.
Solvias and RohnerChem have set up a research and manufacturing services partnership designed to accelerate the production, scale-up and commercialization of APIs.
The idea is to combine Solvias’ chemistry, analytical services and solid-state development offering with RohnerChem’s scale up and commercial manufacturing capabilities for the development and production of active pharmaceutical ingredients (API) for drug industry clients.
The new non-exclusive accord builds on a ‘long history’ of collaboration between the firms according to Solvias CEO Hansjorg Walther said that customers stand to benefit from a single point of contact for project management.
He highlighted “use of high throughput screening (HTS) in route screening, optimized interfaces within project work, no loss of know-how and information in a tech-transfer, process development focused on a suitable process for an industrial scale” as some of the advantages.
Walther went on to explain that: “Joint project quotes will be based on the focused project management and the optimized up-scaling process which will result in cost savings for the customer.”
He also forecast that the partnership with fellow Switzerland-based firm RohnerChem would generate additional business for Solvias, suggesting that: “As a first step we should see an increase of at least 10 per cent.”
Much of the analytical chemistry and API development work generated by the partnership will be conducted at the laboratory facility Solvias opened in January with RohnerChem carrying out scale-up and production at its plant in Pratteln, near Basel.
Solvias has no plans to increase its workforce to service the collaboration according to Walther, who said: “We streamlined our capacity and focused our expertise, so that we are ready to grow by increasing our productivity with the existing workforce.”
He also rejected the suggestion the firms’ close working relationship could evolve into a more permanent arrangement or even an acquisition, telling in-Pharmatechnologist.com that: “A merger would only make sense, if there would be additional benefits for both companies.”
AstraZeneca is investing $200 million in a new manufacturing site in China Medical City (CMC), Taizhou, Jiangsu province, China. The new site represents AstraZeneca’s largest investment in a single manufacturing facility globally.
The site will produce intravenous and oral solid medicines for the company’s business in China. Construction of the site is scheduled to be complete at the end of 2013.
AstraZeneca first established a presence in China in 1993 and generated more than $1 billion in revenues in that country in 2010. AstraZeneca’s other facilities and project work in China include a manufacturing and supply site in Wuxi New District, Jiangsu Province; the AstraZeneca Innovation Center China, a translational science center; an established sales and marketing operation; large-scale clinical development capabilities; and a network of collaborations with academic and medical institutions.
AstraZeneca’s plans for its new manufacturing site in China follow recent investment in emerging markets. In June 2011, AstraZeneca unveiled plans to establish a Predictive Science Center in St. Petersburg, Russia. The center will be staffed with 30 employees and focus on developing bioinformatics, data-analysis methods, software, and systems to help predict the safety and efficacy of potential new medicines. Earlier this year, the company began constructing a $150-million manufacturing facility in the Kaluga region to supply locally manufactured medicines in Russia.
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