PHARMACEUTICAL & BIOTECHNOLOGY
INDUSTRY UPDATE
March 2012
McIlvaine Company
TABLE OF CONTENTS
NY State University Planning Medical and Research Translation Facility
Abbott to Build Nutrition Manufacturing Facility in Ohio
Cubist Opens Expanded Research and Development Facility
Nelson Laboratories Expands Capacity
BASi Announces Restructuring Plan
Lighthouse Worldwide Solutions has New Headquarters
Chronix Opens South Dakota Sequencing Lab
Consigli Completes Building for Bigelow Laboratory Center for Ocean Sciences Campus
Wake Forest Baptist Medical Opens Biotech Research & Innovation Center
Shire Facility Gains EMA Approval for Production
Rollprint Packaging Products to Build Class 8 Cleanroom
Mack Adds Cleanroom for Orthopedic Devices
Novo Nordisk's Type I Diabetes Research Facility to Open
Marine Biological Laboratory's Loeb Lab Renovation, United States of America
BASi Discovery Center, Indiana, United States of America
New Geochemistry Lab for Cutting-Edge Research
Biomerics Adds Cleanroom Space
Penn State Launches Personalized Medicine Institute
BASF Moves GM Crop Research to U.S.
Kraft Opens R&D Centre at Bournville
Mayo Clinic to Spend $3.5 Billion on Projects
Lab21, Greenville Hospital System Launch Genomics Center
Center for Training & Evaluating Health Professionals
Moffitt Cancer Center Launches New Personalized Medicine Institute
Enzymedica Expands to Tampa Bay
Micronic Sets up US Division in Philadelphia
ThromboGenics Opens New U.S. Headquarters
MRPC Expands with Class 100,000 Cleanroom
North Dakota Funds Life Sciences Center
BASF to Invest in RTP Facilities
CSI Testing Certifies Perfecseal Medical Pouch Converting
Westpak to Expand San Diego Lab Facility
H3 Biomedicine New Research Facility, United States of America
Vince and Associates Gains Certification
Florida Biologix Meets EU Compliance
Aenova Moves Production from Berlin to Bavaria
Sanofi to Shut Newcastle Manufacturing Plant
Marken to Open Four New Offices in India
SCM Pharma Expands Vial Filling Capabilities
Ranbaxy Has New Moroccan Plant
BI Expands Biomanufacturing Capacity in Europe
Netherlands Provides $18 Million for New Proteomics Facility
2012 Olympics Anti-Doping Laboratory, United Kingdom
Eisai Knowledge Centre, Visakhapatnam, India, Wins Facility of the Year
Penn Pharma Expands Manufacturing Capabilities in Wales
Frontage Expands CMO Consultancy Offering in China
Asymchem Plans Investments to Expand China Plant
Roche’s New Tower will be Switzerland’s Tallest Building.
Chinese Newsummit Plans Expansion
China Opens National Center for Food, Drug Complaints
SciLifeLab to Expand in Uppsala
Haselmeier to Establish Facility in India
Sterling Instrument Receives Cleanroom Certification
Almac Expands With Commercial Packaging Facility
Biosimilars Joint Venture Samsung Bioepis
Quintiles Sets Sights on Russian R&D
Abbott's Expands in Sligo, Ireland
Asymchem Invests in New Plant in China
Pioneer Hi-Bred to Build in Beijing
New Medical City Unveiled in Abu Dhabi
Vela, Anagnostics to Offer Cylinder-Based DNA/Protein Microarray Platform
Gulf Pharmaceutical Industries (Julphar) Opens Insulin Production Facility
Excella Plant Gains SafeBridge Certification
Catalent Completes Aprilia Expansion
Norwich Expands Clinical Capabilities
Klöckner Pentaplast Breaks Ground for New Chinese Production Facility
Medicago to Expand Research Facility
The State University of New York at Stony Brook is planning to build the Medical and Research Translation (MART) Building. The project entails building an eight-story, 250,000-sq-ft building to house 25 cancer biology-oriented labs, a 30-room cancer clinic, a 30-station clinical infusion center, a 300-seat auditorium, and classrooms. The project is valued at $85 million.
Abbott announced plans to build a nutrition manufacturing facility in Tipp City, Ohio, to produce two of the company's fastest-growing adult brands, Ensure® and Glucerna®, for the North America market. Abbott will invest $270 million in the facility and will employ approximately 240 people. Groundbreaking is expected in April with the plant operational in late 2013.
"As the U.S. population continues to age, particularly baby boomers, this new plant will enable us to meet the fast-growing demand for our leading adult liquid nutrition products, Ensure and Glucerna," said John C. Landgraf, executive vice president, Global Nutrition, Abbott. "It will be a key addition to our global manufacturing network that will allow the company to gain important operational efficiencies."
"Abbott Nutrition's U.S. headquarters and other operations are in Columbus, and we look forward to expanding our presence in the state with this facility," said Landgraf. "We appreciate the collaborative efforts of Gov. John Kasich and Tipp City Manager Jon Crusey and their development teams."
The state-of-the-art plant will specialize in aseptic packaging technology. Aseptic packaging has many benefits including the ability to expand the use of new ingredients, shortened product development time and reduced energy use during manufacturing.
Abbott's nutrition business currently generates approximately $6 billion in sales, which is expected to grow to more than $9 billion by 2015. This growth is supported by attractive pediatric and adult nutrition market fundamentals, increasing global awareness of the importance of nutrition to overall health and well-being, and the rise of an emerging-market middle class. The nutrition business is one of the cornerstones of Abbott's diversified portfolio.
Arthrex plans on building the first phase 160,000 sq ft state-of-the-art surgical device facility on Oil Well Road near Ave Maria in eastern Collier County, Florida.
Construction of the building, with 160,000 square feet on the first floor will take 14 months to complete, said David Bumpous, director of operations for the Naples-based company.
Arthrex specializes in minimally invasive orthopedic surgery products and physician education. The construction cost for the plant is $25 million; another $8 million or more will be spent on equipment.
The building will have 190,000 square feet of usable space because of 30,000 square feet of office space on a second floor. Between 400 and 500 jobs will be established at the Ave Maria location by June 2016. The project will create a similar number of jobs during construction.
"Arthrex is pleased to expand its economic diversification investments to eastern Collier County with our commitment to build a state-of-the-art surgical device and implant manufacturing facility near Ave Maria," Reinhold Schmieding, Arthrex president and founder, said in a statement. "We are grateful to Barron Collier for donated land and to (Collier) County government for the impact fee performance rebate – both helped facilitate this $25 million first phase investment that will provide new high-wage, high-tech, non-seasonal career opportunities for the citizens of Collier County."
Barron Collier Cos. donated 21 acres on Oil Well Road to Arthrex for the plant and began site work for it in mid-February, said Blake Gable, vice president of Barron Collier.
"Right now, our job is to get the site ready for Arthrex," Gable said, adding that the arrival of the company in Ave Maria will be a great step for further economic development in the area. "We have one focus right now — to get that site completed."
In January, the Collier County Commission approved $2.2 million in financial incentives to Arthrex for the Ave Maria project and for an expansion at the company's primary campus on Creekside Boulevard in North Naples.
Fred Thomas, an Immokalee civic leader, welcomes Arthrex to Ave Maria, knowing it creates job opportunities for Immokalee residents.
"I think it is an outstanding project," Thomas said.
About 100,000 square feet will be for manufacturing and 60,000 square feet will be "clean room" operations for inventory and packaging products for shipping, said Andy Owen, director of manufacturing for Arthrex.
The manufacturing plant will have a two-year training program with the Immokalee Technical Center and a four-year apprenticeship program for participants to become machinists operating computer-based manufacturing systems.
The plan is for the Ave Maria plant to make the high-volume products and the existing manufacturing plant on Creekside will be focused on new products, Owen said.
The jobs at Ave Maria will range from janitorial services to upper-level production and administrative managers. Going forward with the project in Ave Maria is a testament to Schmieding's commitment to the community, he said.
"It will be a good opportunity for jobs," Owen said.
An official groundbreaking will be held in early April and Gov. Rick Scott has been invited, said Lisa Gardiner, Arthrex spokeswoman.
The general contractor is DeAngelis Diamond Construction Inc., which built Arthrex's administration building on Creekside, Bumpous said.
"They anticipate having 500 people for construction — that includes subcontractors," Bumpous said.
Pharmaceuticals, Inc. announced the official opening of its expanded research and development facility at its headquarters at 65 Hayden Avenue in Lexington, Massachusetts. The 104,000 square-foot expansion includes state-of-the art laboratory space
for research and development around antibiotics and other acute care products, a molecular modeling room, office space, and conference rooms.
Built to the LEED Silver Standard, the building features high efficiency plumbing and lighting fixtures, distribution controlled heating and cooling systems, and updated mechanical equipment and Energy Star-rated appliances.
As we celebrate our 20 anniversary this year, it is our belief that this state-of-the-art R&D facility will be at the center of a wave of future growth and innovation for Cubist, said Mr. Bonney. We look forward to many years of translating exciting science into real therapeutic options for patients in the acute care and hospital environment.
Cubist Pharmaceuticals, Inc. is a biopharmaceutical company focused on the research, development, and commercialization of pharmaceutical products that address significant unmet medical needs in the acute care environment. Cubist is headquartered in Lexington, Mass.
Covidien has significantly expanded its research and development (R&D) footprint.
The company recently opened four (R&D) centers, located in: Irvine, California; Boulder, Colorado; Trevoux, France; and Hyderabad, India.
"Our investments in these new R&D centers represent a strong commitment to delivering healthcare solutions that improve patient outcomes,” said José E. Almeida, president and CEO. “To remain a market leader, we must broaden our innovation focus and create a competitive edge by continuing to expand our business globally.
Almeida said the company plans to release 50 new products in the next two years.
"Innovation is at the core of everything Covidien does and we devote significant resources to research and development," he said. "We are creating new products and business models that will help healthcare providers worldwide improve patient care and extend healthcare delivery to more people and more places.”
Covidien has invested more than $40 million in the new centers, which will house scientists, clinicians, engineers and product development specialists. The facilities also add 50 research laboratories. Covidien now has 24 R&D centers throughout the world, focusing on new growth platforms in its endomechanical and energy devices, soft tissue repair, vascular therapies, respiratory, monitoring, pharmaceuticals and medical supplies product lines.
“In the last five years, the company has more than doubled its R&D investments and introduced more than 100 new products,” said Paul Hermes, chief technology officer, Surgical Solutions, Covidien. “By expanding our R&D infrastructure and capabilities, we will be able to enhance our collaborative efforts, improve the product development time to market and create valued innovation. This will allow us to accelerate our new product launches and bring clinically relevant and economically valuable innovation to the global marketplace.”
Covidien is based in Mansfield, Massachusetts.
Nelson Laboratories has acquired a new building adjacent to its current facilities to accommodate immediate and future requirements for capacity and new capabilities. With this building addition, the company now has more than 122,000 sq.-ft. of office and lab space. Renovation of the new building will be completed in April and operations will begin in May.
Nelson Laboratories provides testing to support the development and production of safe medical devices, tissue, drugs, cosmetics and natural products. The newly acquired 12,000-sq.-ft. building will be used to add additional sterilizers used in validation testing, aging chambers for packaging testing and additional space for testing products designed for reuse.
“Nelson Laboratories continues to grow and expand,” said Jeffery R. Nelson, president and chief executive officer of Nelson Laboratories. “This building acquisition will provide increased space to meet the growing demands of our clients, and will also allow us to add more of what our clients need.”
(BASi) announced that it plans to restructure its bioanalytical laboratory operations, a program expected to reduce operating costs by more than $2 million annually. BASi said that it plans to consolidate its laboratory in McMinnville, Oregon into its 117,000 square foot headquarters facility in West Lafayette, Indiana. Additionally, the company is evaluating actions to improve the financial performance of its laboratory in Warwickshire, UK. The company expects to record a charge of approximately $2 million in its second fiscal quarter ending March 31, 2012 associated with the restructuring.
President and CEO Tony Chilton said, "BASi is known for providing outstanding bioanalytical
services for our clients. By eliminating redundancies in expensive laboratory equipment and
improving laboratory utilization, we expect this restructuring to strengthen our ability to meet our clients' needs even as it dramatically reduces our operating costs.
"We are pleased to announce that Dr. Lori Payne, PhD, who joined BASi in 2003 as general
manager of our Oregon laboratory, has accepted the position of Vice President, Bioanalytical
Operations, in our West Lafayette location. Lori has done an outstanding job of improving efficiency and reducing costs at our Oregon facility, and we are excited to have her join our senior management team in this key position."
Lighthouse Worldwide Solutions, a world leader in particle counting and contamination monitoring, has moved into a new corporate headquarters in Fremont, California.
The new building increases R&D space and has a dedicated customer and applications training center. The customer and applications training center is equipped with a fully functional and working cleanroom. This cleanroom will be used to support R&D and be available for cleanroom and environmental monitoring training. The new headquarters also increases service and calibration capacity.
"The new facility provides us room to continue growing and reaching out to customers in need of specific application support or training in contamination control," says Morgan Polen, Vice President of Application Technology. "It is one thing to show a picture or presentation of how to monitor a cleanroom. We move to a whole new level with a working cleanroom that we can use as a lab to provide better training with the ability for hands-on demonstrations of the concepts of cleanroom environmental monitoring."
Chronix Biomedical opened a mass sequencing laboratory in Brookings, South Dakota, to offer sequencing services to academic and industry researchers carrying out biomarker programs in cancer, orphan diseases including autoimmune and neurologic disorders, or diseases for which diagnostics currently aren’t available. The new facility effectively expands the sphere of Chronix’ existing services, which it currently provides to the clinical, academic, industrial, and government sectors for breast, prostate, and colorectal cancers, brain injuries, bovine spongiform encephalopathy, and chronic fatigue syndrome.
Chronix has worked closely with the South Dakota State University research community to establish its new facility, explains Joh DiPietro, svp of finance and administration. Financing assistance was provided by First Bank & Trust of Brookings, South Dakota, and the Area Development Corporation of Brookings, South Dakota. “We anticipate that the success of this first specialty laboratory in Brookings will enable us to launch additional satellite sequencing facilities in collaboration with major research cancer centers around the country.”
The Chronix platform can sequence the trace amounts of cell-free disease-related DNA circulating in a patient’s blood. Initially developed for the development of patient-specific cancer diagnostics, monitoring, and predictive assays, the platform has utility in a broad range of disease areas, the firm claims. It has reportedly already demonstrated the utility of its approach in chronic fatigue syndrome, breast and colorectal cancer, and in multiple myeloma.
“We have been working with Chronix for several years and have been pleased to see their technology and applications develop from use in production animal diseases into human diseases,” comments Kevin Kephart, vp for research at South Dakota State University. He claims the platform will “open the door to provide greater insight into the underlying causes of many mysterious and orphan diseases … Their progress has been tremendous in the use of sequencers to provide valuable medical information in the area of personalized medicine.”
Consigli Construction Co., Inc. announced its Portland, Maine office has completed construction of the Bigelow Center for Blue Biotechnology (BCBB), the first building at the new Bigelow Laboratory for Ocean Sciences campus in East Boothbay, Maine.
The new $10.3 million BCBB is one of three complementary and interconnected research centers that Consigli, along with WBRC Architects · Engineers, in association with Perkins + Will, planning and design architect, are completing at the 64-acre Ocean Science and Education Campus.
The 25,600 square-foot, three-story building, which houses the world's first microbial single cell genomics center and the largest collection in the world of marine phytoplankton, contains various laboratories, offices, a café and conference space. Research in the BCBB focuses on harnessing the potential of the ocean's microbial life to benefit society through new technologies and product development. Projected to receive LEED Gold designation, the BCBB's energy-efficient design includes interior and exterior building materials chosen for their low carbon footprint, high use of recycled content, sustainable manufacturing process and lifecycle durability.
"Construction of the BCBB, completed 14 months after groundbreaking in the fall of 2010, was made possible by a major award from the Maine Technology Asset Fund and the people of Maine who voted to pass a $50 million research and development bond in 2007," said Graham Shimmield, Laboratory Executive Director.
The second science facility, currently in construction and slated for completion in summer 2012, is the $6.6 million Center for Ocean Biogeochemistry and Climate Change (COBCC). The 17,197 square-foot Center includes laboratory space for research on the interface between the planet's atmosphere, ocean, and sediments, and the ocean's role in climate variability.
The $9.9 million Bigelow Center for Ocean Health (COH) represents the third phase of the new campus and is to be completed in November of 2012. The Center conducts research on marine microbial ecosystems and their role in maintaining the health of the oceans. The 16,600 square-foot building will be augmented by a 1,400 square-foot shore facility, with seawater pumping facilities and pier and dock space for research vessels to support field research and SCUBA operations.
When fully completed, the Ocean Science and Education campus will provide over 60,000 square feet of laboratory, education and administrative space; bringing scientists together in a unified facility to develop a multi-disciplinary, multi-scale approach to ocean health, and provide improved management tools to support healthy, productive and resilient ocean ecosystems.
Wake Forest Baptist Medical Center has opened the doors to Wake Forest Biotech Place, a new state-of-the-art, world-class 242,000 square foot biotechnology research and innovation center designed to allow more growth of Wake Forest Baptist's many renowned research departments and create incubator space to promote start-up companies generated by researchers' discoveries and space for established biomedical research companies.
Biotech Place is Wake Forest Baptist's newest research facility and its sixth building in the growing Piedmont Triad Research Park (PTRP), a large section on the eastern edge of downtown that has seen low utilization for decades. The premier facility is located at the corner of Fifth Street and North Patterson Avenue and is comprised of two completely restored former tobacco facilities once owned by R.J. Reynolds Tobacco Co. and donated by the tobacco giant to PTRP. Baltimore-based Wexford Science & Technology, LLC, completed the careful restoration and retrofitting of the buildings, creating a unique structure in only 18 months at a cost of more than $100 million, making Wake Forest Biotech Place the largest capital investment for a construction project in the history of downtown Winston-Salem.
"The opening of this modern, high-tech research and innovation center represents a major milestone in Wake Forest Baptist's development and growth of a new biotechnology-based economy in Winston-Salem designed for the 21st century," said John D. McConnell, chief executive officer of Wake Forest Baptist Medical Center. "We are heralding a new era of social and economic progress for current and future generations that will bring new jobs, new businesses, and medical breakthroughs to the people of Winston-Salem, Forsyth County, North Carolina and beyond."
To create the modern biotech research and innovation center, the two former tobacco buildings were gutted and stripped to the basic structure on the interior and then refitted with all new mechanical, HVAC, electrical systems, fire protection, and vertical transportation systems to bring them up to current commercial code standards. The world class facility incorporates green technology and follows the principles of Leadership in Energy and Design (LEED).
The new Wake Forest Biotech Place features a 7,500 square foot glass atrium that illuminates the building's center, is five stories tall on the south side and three stories high on the north side. The south end of the building was originally constructed in 1937 and features a distinctive glass block exterior that was painstakingly restored. The northern end of the building has a brick facade and was completed in 1962.
The redevelopment was made possible through the North Carolina Mill Rehabilitation Tax Credits program and the federal New Market and Historic Tax Credits program. "This is a very effective tool for sustainable redevelopment and provides considerable benefits to the local economy while enabling the preservation of a former manufacturing area in downtown Winston Salem," said Doug Edgeton, president, Piedmont Triad Research Park. "The new facility is a wonderful example of the benefits of public-private partnerships designed to breathe new life into once blighted areas." To that end, in 2010, Blue Cross Blue Shield of North Carolina invested in the project, using the Mill Tax Credit program.
Wake Forest Baptist is the building's largest tenant. The first floor/basement consists of a pedestrian entrance, space for a cafe, Allegacy Federal Credit Union, office space to house the Childress Institute for Pediatric Trauma, business accelerator space, and the Department of Biomedical Engineering and their associated research labs. The second floor serves as the main entrance/lobby and houses the Departments of Biochemistry and Microbiology and Immunology. The third floor features space for the to-be-named Centers of Excellence laboratories and the Department of Physiology/Pharmacology. The fourth floor is home to Carolina Liquid Chemistries and additional pre-built lab space for future private companies. The fifth floor houses the Piedmont Triad Research Park marketing center and offices and additional build-out space for private companies.
The project architects from Gaudreau, Inc. and the development team worked closely with North Carolina's State Historic Preservation Office and the National Park Service on the historic review of the project and the criteria to be followed during the construction process. The Whiting-Turner Company served as the general contractor on the project.
The Wake Forest Biotech Place construction project has employed more than 1,400 individuals and 75 percent of that workforce is from the local Triad area. The project employed 28 minority/female-owned companies, about 12 percent of contracts.
In Forsyth County, the Research Park's $201.7 million construction spending on the six buildings completed to date has generated a total of $313.3 million in economic activity supporting 2,897 jobs with a labor income of $120.1 million, according to the new Battelle Memorial Institute's economic analysis. PTRP's current tenant employment of nearly 1,000 and the estimated 450 jobs at Wake Forest Biotech Place will generate an estimated $298.3 million in economic activity in Forsyth County annually. Statewide annual economic activity from the Research Park will be approximately $339.1 million.
According to the Battelle analysis, construction in the Research Park, and the life sciences and technology-based businesses it attracts, will have a transformative impact on the city and county economy. Ongoing development of PTRP is a major catalyst for regional economic development and is a match to emerging trends and preferences in decisions about where to locate bioscience businesses.
Shire has received approval from the European Medicines Agency's (EMA) for the production of VPRIV (velaglucerase alfa) at its new manufacturing facility in Lexington, MA. The company also has an EMA approved facility in Cambridge, MA, for the manufacture of VPRIV drug substance. This additional capacity allows the company to significantly increase global supply of VPRIV and provides additional manufacturing flexibility. The new facility increases bioreactor capacity from 1000 to 8000L, and is among the first commercially licensed facilities to use single-use bioreactor and disposable technology throughout cell culture processing.
"I am delighted to announce the EMA approval of our facility. Shire has invested strategically in new manufacturing facilities and state-of-the-art technology because we recognize the critical importance of ensuring the continuity of treatment for patients with rare and life-threatening diseases," said Bill Ciambrone, senior vice president of Technical Operations, Shire HGT. "The EMA approval of VPRIV in this manufacturing plant, only three years after breaking ground, is a testament to the hard work and dedication of Shire employees, and represents crucial additional capacity for manufacturing our enzyme replacement therapies for Gaucher and Fabry patients."
Rollprint Packaging Products, a global supplier of packaging materials to the healthcare sector, is building a 6,000ft2 ISO Class 8 cleanroom at its plant in Addison, Illinois, US.
The firm says the cleanroom will be fully operational in the second quarter making it the first sterile packaging manufacturer to convert pouches in a certified cleanroom environment in the US.
The ISO Class 8 cleanroom will be enhanced by Rollprint’s vertical integration, which means the rollstock from which the pouches are made is also produced at the same facility. The firm claims no other pouch manufacturer has both vertical integration and cleanroom capabilities in the US.
“We started preparing for this two years ago with investments in vision systems, web cleaners and other equipment and procedures to minimize particulates in our film converting area. We wanted to address upstream criteria properly before taking the next step,” said Dwane Hahn, vice president of sales and marketing at Rollprint.
The upgraded capability has been driven by customer demand for domestic supply that has been produced in a cleanroom environment.
“There is a big difference between ‘cleanroom environments’ that some manufacturers claim they have, and actual cleanroom certification. In a few months time, we expect to be able to announce to the industry that we have met the rigorous certification criteria and are producing pouches in our cleanroom,” added Hahn.
The cleanroom will house five production lines capable of producing a variety of pouch structures, including header bags, chevron, vented, three-side weld seals and corner peels.
Rollprint Packaging Products offers a range of flexible, heat-sealable materials incorporating film, ClearFoil, foil, Tyvek and paper. Structures can be designed to accommodate any sterilization method. Available in rollstock, pouches and die-cut lids, Rollprint’s materials can meet the needs of most peel able, chemical resistant and barrier applications.
Nypro Inc. has temporarily put on hold two previously announced expansions for the finished product assembly and packaging business of its medical sector.
Temporarily shelved are a 90,000 square foot expansion of its plant in Mebane, N.C., and the creation of a development and design center for that business at its headquarters in Clinton, Mass. But Nypro has added to the drawing boards a plan for a small cleanroom in Clinton to support that sector.
“The plans [for the expansion in Mebane] have been sketched out, but the money has not yet been allocated for that,” said Jason Durkin, global director at Nypro Healthcare for finished product assembly and packaging -- the business that was previously known in Nypro as pharmaceutical packaging.
“Likewise, the plans for a development and design center in Clinton are in place, but are not being executed at this time. Both projects will be driven by need,” Durkin said.
The Mebane expansion — announced in August — had been scheduled for completion this June, and the design center in Clinton had been scheduled to open this month.
However, Durkin said that a 75,000 square foot expansion at the company’s Asheville, NC,
plant — which makes injectable insulin pens — has been completed. In addition, his group had submitted a capital expenditure request to build a 20,000 square facility in Clinton to support the finished product assembly and packaging business.
He said the request had not yet been approved, but that his expectation is that the clinical portion of the proposed expansion could be completed by the middle of this year, and the production segment could be up and running by the first quarter of next year.
He said the expansion includes a 10,000 square foot Class 8 cleanroom, and 5,000 square feet each for inventory and office space.
“The space is needed to support business we have already won,” Durkin said. ”We have had many successful wins in that space in the past 18 months.” He said the cleanroom would also have a cold chain management area for customers whose drugs require refrigeration.
He said a number of people in Clinton are working on development and design, but the vast majority of that effort is concentrated in Ireland, where Nypro also has a manufacturing plant that it is considering expanding.
“We have the drawings in place for an additional expansion of that site,” Durkin said.
Overall, Durkin said the company’s medical business is growing.
“We are seeing decent revenue growth,” Durkin said. “We are on par or slightly ahead of the market.”
Currently, the medical business accounts for roughly one-third of Nypro’s annual sales, which Durkin said are “still hovering around $1.1 billion to $1.2 billion. We want to grow the medical sector to be larger. It takes more time for projects to deliver revenue, but the business is more stable and you end up with 5-10 years of production from a project.”
With an eye toward giving a boost to its fast-growing orthopedic business, Mack Molding has created a new business unit dedicated to orthopedics and disposable medical devices and added a Class 100,000 cleanroom in its headquarters plant in Arlington, VT., to support that market.
The new 2,000 square foot modular cleanroom will have dual air-lock, rapid roll-up doors for easy product flow and quick tool changes, and six 110-tons all-electric Toshiba injection molding machines--three of them brand new; the others purchased in the last two years.
The presses will have high-pressure water containers to allow more versatility in resin selection, and use 60 percent less energy than equivalent hydraulic presses, Mack said.
“It is right next to our white room molding,” which has hydraulic presses, said Jeff Somple, president of Mack’s Northern operations. “With many orthopedic products moving to disposables, this is a great opportunity for us.”
Somple said Mack created a business unit for orthopedics because products for that market “requires a little different skill sets and a lot more validation” than some other medical markets. It also will give customers the ability to interact with people specifically dedicated to that business segment, he said.
“Our customers will now have people at Mack with specific expertise who understand hips and knees, machined parts, plastic parts,” Somple said. “There is an awful of effort underway to try and replace metal parts with plastics, and we will have people with strong background in both who can bring unique solutions to the marketplace.”
“We understand how the parts are used and understand their tolerances,” said Dwalin DeBoer, an 11-year Mack employee promoted to head the new unit. “We understand the specifications for the parts and, in some cases, are the only manufacturers of these parts.”
Because Mack has sheet metal, machine and plastics capabilities, “we can help customers cut costs, and design the products that work best,” she said.” It gives us a lot of options” on how to develop the best solutions for orthopedic markets.
To further boost its orthopedic business, Mack is doubling its laser-welding capacity, as lasers are used to put brackets into cases and trays for orthopedic surgical case and tray market.
“We will have another laser welding cell operable by the first week of March,” said Somple. The cell will use a Litron Series 30 Welding system that can laser weld the brackets that hold the surgical instruments in the trays. The self-contained system produces a hermetically sealed weld bead free of gas, air and contaminants.
Mack, which has approximately $300 million in sales, derives roughly 40 percent of its business from medical. It has 1,800 employees in 10 locations. The company operates 126 injection molding machines ranging in size from 28 to 4,000 tons of clamping force.
The largest city in the north-western United States, Seattle, has become a hub for pharmaceutical research activity with the world's leading pharmaceutical companies establishing their research and development (R&D) centers there.
Denmark-based Novo Nordisk announced it was to set up a new R&D centre for immunological research in the city in January 2012, more than three years after announcing an inflammation R&D centre in 2008.
The company opened the inflammation research centre in Seattle in September 2009.
The research focus of the new R&D centre announced in January 2012 will be on type 1 diabetes.
The company expects to open the facility in summer 2012. The research activity at the facility will be supported by a team of 20 researchers.
Novo Nordisk is establishing the type 1 diabetes R&D centre with the intention of taking the lead in advancing the scientific research in the area to the next level, given the significant rise in type-1 diabetes patients.
"The largest city in the north-western United States, Seattle, has become a hub for pharmaceutical research activity."The type 1 diabetes R&D centre in Seattle will be located on the same premises as the inflammation research centre which was opened in 2009.
The company believes that the collocating of the two research centers will bring about synergies in the R&D activities. The existing research centre complements the biopharmaceutical research activities of two of the company's R&D sites in Denmark and China.
Novo Nordisk's corporate offices in the US and Denmark will support and oversee the activities of the new diabetes R&D centre.
Matthias von Herrath, who will head the research team at the facility, is a scientist specializing in auto-immune diseases.
The R&D centre will combine basic research and early proof-of-concept trials on type 1 diabetes under one roof, which is a unique translational approach.
This approach will enable the company to speed up the transition of early-stage discovery projects based on animal models to small clinical exploratory trials.
Novo Nordisk has developed many innovative products for the treatment of diabetes.
"Novo Nordisk specializes in diabetes research and has 88 years of experience in diabetes care."Most researchers and pharmaceutical companies, including Novo Nordisk, have however focused majorly on developing treatments for type 2 diabetes in the last ten years.
Type 1 diabetes, as a result, lacks major scientific progress.
According to the International Diabetes Federation's 2011 estimates, 5% to 10% of diabetics worldwide are suffering from type 1 diabetes. The report also estimates that there are 366 million diabetics worldwide.
Novo Nordisk believes the establishment of a dedicated R&D centre for type 1 diabetes research will enable it to transform its medical research expertise in immunology to the successful development of life saving treatments for diabetes patients.
Type 1 diabetes is caused by the body's natural defense system impeding insulin production in an auto-immune reaction. Insulin is a hormone produced by the pancreas.
The hormone controls the glucose level in the blood by causing the body cells to take up the excessive glucose from the blood. This action is essential to regulate the carbohydrate and fat metabolism in the body.
Lack of insulin production in diabetics causes the glucose levels to rise, which causes chronic complications or even death. Diabetics hence need to be injected with insulin to control the blood glucose levels.
The Seattle R&D facility will conduct research to discover treatments for type 1 diabetes. It will first put these discoveries to laboratory testing on mice and then conduct human clinical trials.
Novo Nordisk specializes in diabetes research and has 88 years of experience in diabetes care. It produces several diabetes drugs. The company is headquartered in Denmark and has research centers in Måløv (Denmark), Beijing (China) and Seattle, WA (U.S.A.).
Marine Biological Laboratory (MBL) is an internationally recognized not-for-profit research, education and training institute for environmental, biomedical and biological sciences.
The MBL institute provides research and development facilities to world renowned scientists in cell and developmental biology, ecology, aquaculture, marine biotechnology, molecular biology, reproductive biology, global infectious diseases, neurobiology and sensory physiology to improve human conditions.
The Loeb Laboratory, built in 1970, is the main research training facility of the institute. It is named after the prominent physiologist of the 20th century, Jacques Loeb.
It offers various laboratory courses in the field of life sciences including embryology, microbiology, neuroscience and cell biology, among others.
About 450 scientists and students undergo training at the Loeb lab every year. The state-of-the-art facility is a national resource for discovery and training and expands the scope of life sciences research.
"The educational campus is located on a coastal site in Woods Hole, Massachusetts, in the US. Founded in 1888, MBL is the oldest private marine laboratory in the country."The Loeb lab facility has been completely renovated with an investment of $25.2m. The three-storey, 66,000ft² laboratory facility was modernized by modifying the interior design and infrastructure.
The renovated facility incorporates modern building systems and research laboratories, a centralized microscopy facility for commercial vendors, a resource centre to allow research in to regenerative biology and medicine, as well as a computer training centre with bioinformatics, imaging and computational biology equipment.
The project integrated various training programs into the new facility with separate spaces for all the disciplines, offices and support spaces.
The interiors are designed to promote collaborations and interactions by researchers. It has also added new kitchenettes and lounge areas with laptop stations, projectors, seating and marker boards.
The facility includes the Eugene Bell Center for Regenerative Biology and Tissue Engineering, a centre aimed to develop suitable medical therapies for debilitating diseases and injuries in humans. The centre will promote multidisciplinary research on marine invertebrates and other aquatic organisms to understand and reduce the natural process of ageing and regeneration of tissues.
Groundbreaking ceremony for the gut renovation of the facility was held in September 2009. It was completed in July 2010.
"Loeb Laboratory, built in 1970, is the main research training facility of the institute. It is named after the prominent physiologist Jacques Loeb."The project created about 250 construction jobs in the Cape Cod region at the peak.
The building incorporates several sustainable features such as low consuming electrical and water installations, energy efficient HVAC and lighting systems, Tecogen 200t STx series chillers and heat recovery, envelope insulation, a reflective white roof, usage of certified wood and low emission materials for the indoors, saving about 37% energy when compared to a similar building.
About 98% of the waste materials produced from the demolition of the interiors were recycled.
Retaining the existing exterior concrete wall structure and floor plates was considered to be one of the most important green features in the renovation.
The renovated building achieved Leadership in Energy and Environmental Design (LEED) Gold certification from the US Green Building Council in January 2011.
The project is part of a ten-year master plan for the Cape Cod campus to cope with the growth of the MBL. The comprehensive master plan was prepared by Tsoi / Kobus & Associates in 2003.
Both the Woods Hole Village campus and the Oyster Pond Road campus of MBL are being developed to allow year-round research, improve research and supporting facilities, classrooms, parking and storage infrastructure.
The renovated Woods Hole lab was designed by Tsoi / Kobus & Associates. Shawmut Design and Construction was the construction manager and Odeh Engineers was the structural engineer.
AHA Consulting Engineers was the mechanical systems, electrical, plumbing and fire protection engineer.
MBL received a grant of $10m from the Massachusetts Life Sciences Center and $15m in private funds from the Howard Hughes Medical Institute (HHMI) towards project fruition.
Bioanalytical Systems, also known as BASi, is a US-based pharmaceutical research company. It offers contract laboratory services to pharmaceutical companies.
BASi opened a new discovery centre at the Purdue Research Park in West Lafayette, in the state of Indiana, in February 2012. The facility is named the BASi Discovery Center. It aims to provide research information on new compounds in the early stages of development. The target customers include pharmaceutical and biotech companies.
The discovery centre has been established with the objective of expanding the company's drug discovery capabilities to meet the increasing demand from its customers.
BASi has partnered with contract research organization XenoGesis to help pharmaceutical companies accelerate in-vitro drug discovery by eliminating fatally flawed compounds.
."The BASi Discovery Center was created by renovating an existing laboratory space. The renovations included approximately 4,800ft² of space dedicated for research activities. State-of-the-art environmental systems have been installed to maintain and monitor the lab conditions.
The facility has a number of individual study rooms, a surgical suite and an animal housing area. It utilizes an automated syringe pump called Empis to deliver compounds to animals.
Empis was developed using proprietary technology of BASi. The pump is used in tandem with BASi's automated blood sampling system called Culex.
Culex is an in-vivo sampling system. It causes less stress on animals during the collection of samples. The lower stress environment allows for collection of multiple samples from a single animal, thus reducing the number of animals needed for each experiment. It also improves the accuracy of information and enables rapid decision making.
The expansion is expected to reduce sample storage and shipping costs, and the turnaround time for the testing and analysis.
BASi's corporate headquarters is collocated within the new discovery centre at the Purdue Research Park of West Lafayette, which is located north of Purdue University's main campus. The 725-acre research park has been developed through a partnership between Purdue University, Purdue Research Foundation and the city of West Lafayette.
The facility features a quiet environment with in-house bioanalytical facilities. The air and humidity levels within the facility are maintained at a level comfortable for animals with the help of state-of-the-art handling and control systems.
Separate animal handling quarters with individually vented cages have been built. The animals are allowed to move freely so they are less stressed and provide more accurate data. They are monitored continuously to avoid any deviations in the study.
BASi has taken care to reduce the possibility of cross contamination in the facility so that the animal's health is not damaged.
The BASi Discovery Center offers automated dosing and sampling of early stage compounds. It can provide customized in-vivo evaluation of compounds in a comprehensive manner.
"The facility is named the BASi Discovery Center. It aims to provide research information on new compounds in early stages of development."It offers absorption, distribution, metabolism and excretion (ADME), neuroscience and pre-investigational new drug (Pre-IND) studies.
The ADME studies can be conducted in a variety of areas including pharmacokinetics, tissue distribution, metabolism and excretion.
Neuroscience studies that can be conducted include microdialysis, total tissue concentration and behavior studies. Pre-IND studies are often required for phase one trials.
BASi uses the Culex system to carry out these studies. The system is suitable for a variety of studies in pharmacokinetics, drug metabolism and toxicology.
It was developed for pharmacokinetic and pharmacodynamic data collection. It can collect information related to blood, bile, metabolites and dialysates from animals of various sizes, ranging from mice to swine. Samples can be collected anytime, either day or night.
The samples are sealed in chilled vials
The new Geochemsitry Lab Suite brings the latest technology to students and faculty as they work to unlock answers to everything from climate change to the Earth’s most severe known extinction event.
“We’re now able to do experiments on samples right here in this lab that we used to have to send out for analysis and wait weeks to get back,” says Geology Assistant Professor Pedro Marenco. “We’ve also consolidated a lot of equipment that was spread out throughout the building so that we can work much more efficiently.”
Construction of the new lab, which is now fully operational, began in May of 2011.
The lab is located on the third floor of the Park Science Building in a space that used to be part of the Collier Science Library. The space became available as more of the material formerly archived in Collier has become digitized.
Marenco and fellow geologists Associate Professor Don Barber and Lecturer and Laboratory Coordinator Lynne Elkins will be among the scientists making the most use of the lab. However, it’s intended as a possible resource for faculty members from a variety of departments.
“We have already discussed applications for the equipment in this space with faculty from Chemistry and Biology,” says Marenco.
The lab is a suite comprising several rooms: a sedimentology lab, a darkroom, a balance room, the geochemistry lab, and the cleanroom.
The “dirtiest” part of the lab is where researchers do sedimentology work. Here, students process and analyze sediments before moving samples to the geochemistry lab for chemical analysis.
The geochemistry lab is home to several fume hoods and work stations. Prior to entering the lab, users have to change out of their own shoes and into Croc-like slip-on shoes. In this lab, students and professors do a lot of work that involves dissolving rocks with acids, so each fume hood is equipped with “scrubbers” that neutralize the acids so as to prevent the production of harmful waste. The intermediate lab is also home to the ELTRA CS2000 carbon/sulfur determinator, which combusts powdered samples at high temperature to measure carbon and sulfur content levels.
The other major piece of equipment in the intermediate lab is the Agilent Technologies Inductively Coupled Plasma Mass Spectrometer (ICP-MS), used to determine the abundance of various elements in rock and fluid samples.
“This is a very sophisticated piece of equipment that’s rare to have at a college the size of Bryn Mawr, so we’re very happy to have this,” says Marenco.
The smallest rooms in the lab are the darkroom and balance room.
The darkroom houses the Carpenter Microsystem CM-2 microsampler for high-resolution sampling of minerals in hand samples and thin sections. The microsampler allows faculty and students to operate a microscopic joy-stick-controlled drill that’s used to extract samples.
Geology Major Hannah Gatz-Miller ’12 was recently using the setup to look for fossils of extinct eel-like organisms no larger than a grain of sand in carbonate rocks from Montana.
“The ability to do all the extraction work as well as the more delicate microscope work in what essentially amounts to the same space is really great as far as keeping things organized goes,” says Gatz-Miller. “I don’t have to worry so much about losing or misplacing my samples, and all the equipment finally has a place to go—and can actually be used.”
The balance room is a small, unventilated room in which an extremely precise balance capable of measuring one millionth of a gram sits on large marble table so as to minimize any disturbance from vibration or air currents.
“At most places this type of thing is an afterthought and they’ll take a corner of a room and build something like a tiny closet where it’s very hard to work comfortably,” says Marenco.
The ICP-MS is located directly outside of the balance room, allowing those doing research to move directly from doing a measurement of a sample to doing an analysis.
“The ICP-MS used to be located in the basement and the balance was in the lab next to my office, which was one floor and several hallways away,” says Marenco. “Obviously this is a much more efficient way to do things.”
The clean lab has an anteroom where users of the lab are required to don sterile lab suits that resemble the gear worn by hazmat crews. The lab itself is mostly free of metal and has an advanced air-filtration system.
“Anyone who wants to measure isotopes or do work that is easily contaminated will be able to use this space,” says Elkins, who will be using the lab to do trace-metal analysis in her current research.
“This new lab space allows for a much safer and more-efficient working environment for our students and faculty. We’re very excited to be part of Bryn Mawr’s commitment to offering students the latest in science research opportunities in a liberal-arts setting,” says Marenco.
Biomerics recently completed is a 10,000 square foot expansion to the Biomerics LLC, Salt Lake City, UT plant. Biomerics is a leading supplier of polymer solutions to the medical device and healthcare industries. The expansion includes an ISO Class 8 cleanroom for injection molding and device assembly, a medical device packaging cell, and a fulfillment warehouse.
The company doubled its cleanroom space according to Troy Mohr, Biomerics’ vice president of business development, and boosted the size of its overall facility to 85,000 square feet.
“We have the ability to have material polymerization and compounding in one room with full injection molding and assembly in the second room,” Mohr said in a telephone interview.
He said Biomerics also invested in machinery, including two new presses for the cleanroom. There is also a Motan automated material handling system in place, as well as new medical and pharma compounding lines.
The expansion was managed by Entelen LLC, a Salt Lake City based design and construction company that specializes in clean manufacturing facilities.
Biomerics started in 1994 as Utah Plastics Group, but has since added the new name and in the last three years has focused more on the medical device and life science area. It is able to make biomedical materials and do compounding, and later do injection molding or extrusion, as well as assembly.
Last year, the company launched a new polyimide medical tubing and coated wire production line to produce components that are used in medical devices such as cardiovascular catheters and angioplasty stent delivery devices.
Biomerics works a great deal with original equipment manufacturers as a contract manufacturer.
Overall, it has 60 employees, having added 15 jobs in the last quarter. The company plans to hire up to 20 more in the coming year.
Biomerics plans a ribbon cutting on March 23. The company said a big reason for the expansion is Utah’s focus on life sciences includes the recent passage of the state’s Technology and Life Sciences Economic Development Act.
In addition to the facility expansion, Biomerics has invested $1.5 million in new plastics manufacturing equipment. "The operations team has been focused on expanding and developing our manufacturing capabilities to support the growth," said Jeff Clark, VP of Operations for Biomerics. "In the past six months, the team has brought online new medical and Pharma compounding lines, an automated material handling system, and expanded our capabilities in injection molding, vibration welding, and device assembly."
The expansion of this ISO 13485 registered facility has resulted in the hiring of 15 employees and is expected to support the creation of an additional 20 positions over the next 12 months.
About Biomerics, LLC
Biomerics, LLC, headquartered in Salt Lake City, Utah, is a leading and innovative medical polymer solution provider to the medical device market. Biomerics specializes in biomedical materials, compounding, injection molding, extrusion, and medical device fabrication. Biomerics partners with its customers to increase their profitability via material technology, operational excellence, and customer service.
The Penn State Milton S. Hershey Medical Center and the Penn State College of Medicine have launched a new institute that will focus on personalized medicine and engage in interdisciplinary research with other institutes at the campus.
The Penn State Hershey Institute for Personalized Medicine will connect faculty, resources, and programs currently at the school to advance research areas that could translate into clinical applications, Penn State Hershey said.
The institute will collaborate with departments and institutes around the Penn State Hershey campus, including the Penn State Clinical and Translational Science Institute, to translate research findings into clinical applications.
The institute, which will move into its permanent lab space in the College of Medicine in June, will obtain blood and other biosamples from consenting patients at the Medical Center which will then be stored in a biorepository, also housed on campus.
Along with the samples, information about the patients' treatments and outcomes stored on electronic medical records will be deposited in a database for use in correlation studies, James Broach, who chairs the department of biochemistry and molecular biology at Penn State College of Medicine and who will be the inaugural director of the institute.
"This has the potential to expand to the nearly a million people who come through the hospital and the associated clinics under the umbrella of the Hershey Medical Center," he said.
Depending on the disease interest, the samples can be pulled from the repository and analyzed in any number of ways, including conducting SNP analyses using Illumina's SNP arrays, and in-house deep sequencing studies with the Illumina HiSeq and other next-generation sequencing platforms, Broach said.
The large volumes of data the institute expects to generate will be analyzed by researchers at Penn State's University Park campus using the Galaxy software package to identify relevant SNPs for each individual patient. Developed by Penn State and Emory University, Galaxy is an open source system for data integration and analysis that was developed for genomics research and now is used as a general bioinformatics workflow management system.
The institute will then seek to compare the genomic information with the outcome and treatment data found in the EMRs.
Establishing correlations between genotype and outcomes is the hard part, Broach explained, because of the large number of patients that are required to identify parts of the genome that are correlated to diseases with any statistical significance.
"Our approach will be much in the way that people are beginning to think about doing clinical trials with limited a number of patients – where you keep redirecting the cohort as the information comes in," Broach said.
The early phases of research will focus on this type of study, with the longer aim of generating knowledge linking genes and variants with outcomes in ways that could be used in treatment.
"Ultimately, the goal will be that when the patient comes in, we take their blood samples, we do the sequence, we get the SNPs, and on the basis of our previous correlations, you can make the prediction that this person would respond to one treatment versus another treatment," he said.
BASF Plant Science is relocating from its European headquarters to the US, a move prompted by the European public's hostility to genetically modified (GM) crops, its president Peter Eckes said. The German company is also cancelling the development and commercialization of all projects destined solely for the European market and in future will concentrate on markets in America and Asia. “The political and regulatory climate in Europe is unwelcoming at this moment—this is a political failure,” says Carel du Marchie Sarvaas, director of advocacy group EuropaBio in Brussels.
In 2010, the European Commission approved BASF's Amflora, a GM blight-resistant potato for industrial use. The road to approval took 13 years, during which the company had to deal with protestors and sabotage to test sites in Germany. BASF will continue the regulatory process for three breeds of potato already in the European pipeline but will halt work on a wheat variety resistant to fungal disease.
Despite moving its Limburgerhof headquarters in Germany, BASF is not pulling out of Europe completely and will retain offices in Ghent, Belgium, and in Berlin. Another GM crop developer, Bayer CropScience of Monheim, Germany, has no plans to leave Europe and will retain an active research program in Ghent. Julian Little, Bayer's UK spokesperson in Cambridge, says that Europe “remains an excellent place to do research but commercialization of such technology in Europe remains problematic.”
Kraft Foods has opened its new Global Research and Development (R&D) Centre at Bournville, as part of a £17M investment in the UK.
Kraft's R&D investment will help to develop new products and improved technologies for existing chocolate brands such as Creme Egg
The investment makes the UK home to the firm’s largest R&D base outside North America. Research will be conducted at the firm’s Global Centre of Excellence for Chocolate in Bournville, its Reading Science Centre and its facility in Banbury.
Welcoming the investment David Willetts, minister of state for universities and science, said, “It will help drive long-term, sustainable growth as well as supporting hundreds of high tech jobs in both Birmingham and Reading.”
The Centre of Excellence at Bournville includes new innovation labs, a new pilot plant facility and a ‘collaboration kitchen’ designed to facilitate experimentation with new ideas. The facilities will support the development of new products and improved technologies for the creation and packaging of chocolate brands such as Cadbury Dairy Milk, Milka, Toblerone, Côte d’Or, Terry’s, Flake, Creme Egg, Green & Black’s, Suchard, Freia, Marabou and Lacta.
The firm has also expanded its Reading Science Centre. Based on the University of Reading campus, the unit will continue to test and research new and improved products for Kraft Foods’ global markets.
The expansion includes investment in hi-tech resources and the refurbishment or expansion of four laboratories dealing with research into microbiology, physical chemistry, DNA, protein and flavour.
The investment at Banbury focuses on both coffee and chocolate categories, including new coffee processing equipment and a new cocoa pilot plant.
Jean Spence, the firm’s executive vice president, said: “Our success is driven by continued investment in R&D, which we’ve shown supports growth across our global chocolate business. This is why I am so pleased to officially open the Kraft Foods Global Centre of Excellence for Chocolate R&D in Bournville and the expanded Reading Science Centre.
“We are committed to continued investment in R&D in the UK and for the whole business across the globe, making us an increasingly nimble and dynamic organization,” she said.
Tim Cofer, president, Kraft Foods Europe, added that the firm expected to deliver “top-tier growth in 2012”. Cofer said that the R&D centers would drive transformational technologies to grow our business in Europe and around the world.
The firm claimed that investment in UK R&D facilities had boosted jobs, with the UK Research, Development & Quality workforce growing by an additional 98 – from 552 to 650 employees.
Of the total, 54 new jobs are located in Bournville and 44 in the Global Science Centre in Reading.
In December Kraft said it would cut 200 jobs at its facilities at Bournville, Birmingham, Chirk in Wrexham, north Wales, and Marlbrook in Herefordshire.
Kraft announced its intention last September to move its global chocolate centre from Germany to Cadbury’s historic home of Bournville.
Speaking at the time, a Kraft spokesman said: “The decision recognizes not only the unique heritage of the Bournville site, which has been here for 132 years, but also the knowledge and skills that already exist within the business here.
“Prior to the acquisition it was already a thriving centre of innovation and Kraft didn’t want to lose those skills.”
Kraft Foods acquired Cadbury in January 2010 for £11.5bn.
The Richard O. Jacobson Building — a $188 million proton beam treatment center that is scheduled to open in Rochester in 2015 — is part of the $3.5 billion that Mayo Clinic officials expect to spend on capital projects over the next five years.
The Mayo Clinic is almost doubling what it annually spends on capital projects, a move expected to increase construction jobs and bring other economic benefits to Minnesota in the coming years.
Mayo Clinic officials said that the Rochester, Minn.-based health provider will spend $700 million a year on new and ongoing capital projects over the next five years — nearly double the $415 million that Mayo spent on such projects last year.
They also said the Mayo will launch $600 million worth of new capital projects in 2012, though it was unclear what the projects would be. New project spending includes $300 million to invest in people and infrastructure associated with three research initiatives that the Mayo launched in recent years, through the three centers won’t have buildings constructed.
Jeff Bolton, the Mayo Clinic’s chief financial officer, said 60 percent of the capital spending will go toward replacing and renewing facilities, equipment and information technology. The rest goes toward what Bolton described as “strategic investments in new projects.”
The decision to update and build comes as the Mayo Clinic increased income and revenue. The nonprofit operator of hospitals and clinics — with hubs in Minnesota, Arizona and Florida — had operating income of $610.2 million from $8.48 billion in revenue in 2011, up from $515.3 million off of $7.94 billion in revenue in 2010.
The Mayo Clinic also had a 5.4 percent return on its $1.8 billion endowment in 2011.
“We use all the resources we generate to reinvest back into patient care,” said Shirley Weis, the clinic’s vice president and chief administrative officer.
Such reinvestments include capital projects. The $3.5 billion in capital spending Mayo officials announced included ongoing and new projects.
New spending includes $300 million in operating and capital investments into three collaborative centers started in recent years to turn medical discoveries into therapies. The Center for Regenerative Medicine is looking at ways to grow or regenerate tissues and organs from patients’ own cells; the Center for Individualized Medicine is studying methods to tailor treatments to fit specific genetic backgrounds; and the Center for the Science of Health Care Delivery is exploring health care redesign.
The spending on the three centers won’t involve constructing buildings for them but will instead focus on investments in people and infrastructure, Bolton said.
The investments send a strong message in the world of medical research, where superstars have many top-notch institutions to choose from when setting up shop, said Twin Cities-based health care analyst Allan Baumgarten.
“They’re saying, ‘We want you to come to Mayo,’” Baumgarten said. He thinks the resulting boost in Mayo Clinic-based research will benefit Minnesota through resulting spinoff companies, grants from the National Institutes of Health and high-paying research jobs.
The Mayo capital expenditures should also have a positive impact on Minnesota’s depressed construction job numbers. The state gained 200 construction jobs in 2011, a drop in the bucket compared with the roughly 50,000 construction jobs lost in the Great Recession.
Ongoing Mayo Clinic projects include a $188 million proton beam treatment center in Rochester and a similar $182 million facility at its Phoenix campus. Both facilities, which Mayo broke ground on last year, are roughly 100,000 square feet and involve an experiment of sorts into whether tiny proton beams are the best way to zap cancer tumors.
Other ongoing projects include Mayo doubling the size of its Dan Abraham Healthy Living Center in downtown Rochester; expanding and renovating the Emergency Department at St. Mary’s Hospital in Rochester; and improving Mayo Clinic Health System sites in Austin, Minn., and Barron, Wis.
Officials at the Mayo Clinic were mum about plans at the Mall of America in Bloomington. The mall has included a potential 300,000-square-foot Mayo facility arching over Lindau Lane as part of its expansion plans.
The Mayo last year launched a 2,500-square-foot Create Your Mayo Clinic Health Experience store on the first floor of the East Market Rotunda at the Mall of America, and also opened a 1,300-square-foot clinical space across the rotunda.
Dr. John Noseworthy, Mayo Clinic president and chief executive officer, said the Mayo is in a “testing phase” at the mall and will make a decision in the second half of 2012 on future investments there.
Lab21 said that it has opened a new clinical genomics center within the Greenville Hospital System Memorial Medical Campus in Greenville, SC.
Cambridge, UK-based Lab21 said the center will be located within the GHS Institute for Translational Oncology Research (ITOR) as part of an ongoing collaboration aimed at introducing complex biomarker analysis into routine cancer patient management. In addition, the firm said that Life Technologies is providing an Ion Torrent Personal Genome Machine as the key launch platform technology.
"The establishment of this center underlines our commitment to our personalized medicine strategy and to introduce state-of-the-art molecular services and products into North America," Lab21 CEO Graham Mullis said in a statement. "It also reinforces our relationship with ITOR and the potential to use this technology for clinical trial applications with a view to identifying new biomarkers which can subsequently build our proprietary companion diagnostic portfolio."
The University of South Florida (USF) Health's Center for Advanced Medical Learning and Simulation (CAMLS), which opened its 90,000 square-foot downtown Tampa facility in February, is on the fast track to becoming a national model for improving medical training, evaluation and patient safety, and creating needed healthcare solutions through cutting-edge technology, innovation and simulation. The new center is a $38 million facility that was fast-tracked and completed in less than 14 months of construction, with 350 construction workers on site. CAMLS is expected to become a job engine for Tampa Bay, bringing 30,000 or more health professionals to the region each year. CAMLS is projected to have a $5.7 million annual impact on the Tampa Bay economy going forward, with an increase of at least five percent yearly.
H. Lee Moffitt Cancer Center & Research Institute has announced the creation of a Personalized Medicine Institute aimed at making a national impact in the war on cancer by delivering on the promise of personalized cancer care. Having patented a unique clinical trial matching process, Moffitt's biotechnology subsidiary, M2Gen(TM), is partnering with Merck and other pharmaceutical and biotechnology companies to launch the first clinical trials in which patients have been recruited using the world's largest cancer-focused biorepository. This approach speeds the clinical trial process, giving cancer patients faster access to drugs that are a good match for their unique genetic characteristics.
Enzymedica Inc., a life sciences company and industry leader of therapeutic enzyme supplements, will relocate from Port Charlotte to a new, larger location in Sarasota County, allowing the company to expand its laboratory and production facilities. The company plans to add 72 employees to its staff of 50 over the next five years. Enzymedica researches, develops, manufactures and distributes targeted enzyme supplements made from plant-based enzymes.
Micronic Holding, a Netherlands-headquartered manufacturer of sample storage tubes and accessories, has launched Micronic America, a new supporting entity for the company's traceable product portfolio in the US and Canada.
Micronic America will operate in conjunction with Micronic Manufacturing USA, the firm’s US-based production facility, to produce and provide its distributor network with sample storage solutions.
Gerrit van der Gaag, chief executive at Micronic Holding, commented: ‘This expansion not only represents our investment in US operations, but is also symbolic of a larger corporate investment in manufacturing and production enhancements, including the construction of a state-of-the-art cleanroom facility and system innovations at our home office that will significantly improve productivity.’
Located in a Keystone Innovation Zone in the Philadelphia, PA region, Micronic America will support the sales and marketing of North America while working with the company’s adjacent manufacturing plant, which boasts a Class 7 cleanroom environment. Beyond ensuring quality and product consistency, Micronic uses a proprietary laser etching system to imprint barcodes directly onto sample racks and a unique 2D Data-Matrix code on the bottom of each tube for durable sample identification.
Distributors supported by Micronic America in the US and Canada include E&K Scientific, USA Scientific, Nova Biostorage Plus (formerly Micronic North America), MJS Biolynx and D-Mark Biosciences.
ThromboGenics NV, a biopharmaceutical company focused on developing innovative ophthalmic medicines, announces the opening of its new U.S headquarters. The facility which is situated in Iselin, New Jersey, is the new home to the Company's U.S. organization which is led by Dr. David Pearson, Head of U.S. Country Operations. ThromboGenics has been growing its U.S. team in recent months building its marketing, medical, commercial, market access and regulatory expertise ahead of the Company's planned launch of its lead product ocriplasmin.
ThromboGenics intends to resubmit a BLA for ocriplasmin in the U.S. before the end of April 2012 and expects the product to be granted Priority Review by the FDA. Ocriplasmin will be filed for the treatment of symptomatic vitreomacular adhesion (VMA) including macular hole.
Dr Patrik De Haes, CEO of ThromboGenics, commented: "The opening of our new U.S Headquarters is an important step as we build the first-class organization that we need to successfully launch ocriplasmin in the world's largest healthcare market. We remain on track to resubmit a BLA for ocriplasmin before the end of April for Priority Review. Our U.S. team is expecting a very exciting and highly productive period as it prepares for the anticipated approval of ocriplasmin by the end of 2012."
As a result of its decision to locate its headquarters in Iselin, ThromboGenics will benefit from a Business Employment Incentive grant from the New Jersey Economic Development Authority whose value could exceed $1.0 million over a multi-year period.
Wisconsin-based MRPC, a single-source provider of medical device components and assemblies, has completed construction of a new cleanroom for the molding of medical components. The 2,000-square-foot Class 100,000 (ISO Class 8) cleanroom will allow MRPC to add additional liquid injection molding (LIM) machines to increase their liquid silicone rubber molding capabilities.
“With this cleanroom addition, we are able to increase our LIM capabilities and remain at the forefront of molding innovation,” said Greg Riemer, MRPC president. “We’ll utilize this new cleanroom space to continue expanding our two-material overmolding capabilities using liquid silicone, a complex process that is not commonly available.”
MRPC now has a total of five cleanrooms for processes such as LSR molding, gum silicone molding, silicone extrusion, custom rubber molding, thermoplastic molding and secondary assemblies.
“As a 90-year-old company, it is exciting that we continue to evolve and expand our capabilities,” said Mark Brandstaetter, vice president of sales and marketing for MRPC. “With this expansion, we’ll be continuing to provide many of our customers with services they can’t find anywhere else.”
North Dakota State University said that it will use $1.4 million in funding from a state program and additional support from Sanford Research and the RJ Lee Group to fund the creation of a new Center of Research Excellence in life sciences.
The Center for Life Sciences Research and Applications, to be located at NDSU, Fargo, will receive the $1.4 million from the North Dakota Centers of Excellence Commission. It also will receive $2.7 million in cash and in-kind contributions from non-profit Sanford Research and the RJ Lee Group.
NDSU said it expects the center's initial research efforts will include breast cancer studies and investigation into rare diseases in children. It also will focus on spurring the growth of genomics, bioinformatics, and DNA-based forensics and identification research and applications. Other aims of the center will be to use technologies and discoveries generated by NDSU and private-sector partners and to encourage growth of the life sciences industry in North Dakota.
The center and NDSU's DNA Laboratory also will work with the RJ Lee Group, a supplier of industrial forensic capabilities, to develop next-generation DNA-based identification and forensic tests and methods.
Sanford Health's Executive VP of Development and Research Ruth Krystopolski said in a statement that Sanford and NDSU "share the belief in and enthusiasm for the application of genomic information toward novel clinical trials, next-generation therapies, and cures. … This project will allow for an even greater level of integration between scientific discovery and the doctor's office, and most importantly, improve care for the patients we serve in our region."
The German chemical company BASF announced plans to invest $33 million in an expansion in the Research Triangle Park.
The additional construction is slated to include about 80,000 square feet of office, laboratory and greenhouse space to support the company’s plant biotechnology and insect control research, according to the company.
The company has its North American crop protection division headquarters in the park, and it announced last month plans to shift its global plant science headquarters to its park facilities as well.
BASF plans to kick off construction related to the expansion in March, and to have the work done in mid-2013.
The plans include a climate-controlled greenhouse and laboratory for plant biotechnology research, and a custom environmentally-controlled insect production facility and office space.
The company hopes the larger, modernized facilities will allow for “comprehensive and faster evaluation” of its insecticide product candidates.
“It will help our speed-to-market so that our customers get new products, better products, faster than we’d be able to deliver otherwise,” said Nevin McDougall, senior vice president for BASF Crop Protection North America.
McDougall said the company’s crop protection products portfolio includes herbicides, fungicides and pest control products. He said they have a greater number of product candidates than they have had in the past.
“We have a number of new, interesting insecticide compounds that this expansion will help acceleration and development for,” he said.
McDougall added that a driver for product innovation is weed and insect resistance to products, which he said is a major issue for many growers in the country.
“There is always an evolution of diseases, weeds, current solutions don’t always effectively control (them),” he said. “There’s an inherent need, based on the biological system that we’re working in, for new chemistries, and new solutions.”
He said officials with the company do expect to add to the overall head count at the company’s park facilities, but he said they don’t have final numbers.
The company currently employs a total of about 780 people in the park, and occupies about 400,000 square feet of space.
BASF’s crop protection division at the park includes employees working in marketing, sales, supply chain, management for its North American business, as well as research and development workers, McDougall said.
The company is not the only company working in the agricultural biotechnology sector with a presence in the business park. Other companies with a park presence include St. Louis, Mo.-based Monsanto Co., Bayer CropScience, and Syngenta.
This site currently employs approximately 780 people and occupies 400,000 square feet. RTP is a major BASF location for global insecticide and plant biotechnology research. It serves as headquarters for the North American activities of BASF's Crop Protection division and soon the global headquarters for the Plant Science division. BASF established its RTP site in 1986. The last major investment in the site took place in 2006.
Perfecseal has certified its Oshkosh, WI sterile medical pouch and bag manufacturing facility to ISO 14644-1 (1999) Class 7 cleanroom standards. Though already operating the facility at a Class 7 cleanroom standard since 1997, it did not seek certification until 2011. Perfecseal’s medical, diagnostic, and pharmaceutical packaging production plant in Northern Ireland and its custom thermoforming plant in Mankato, MN have both been ISO Class 8 certified for several years. The cleanroom certification is part of an ongoing continuous improvement plan focused on risk reduction for our customers. This plan involves further cleanroom certifications for Perfecseal’s other production facilities as well as further investment in vision inspection systems for its production lines.
Perfecseal’s President, Paul Verbeten, comments that, “Our packaging products protect some of the most important and sensitive healthcare products in the world such as drug coated implantable stents and powerful pain reducing transdermal patches. Our mission continues to be focused on eliminating any packaging related risk that could negatively impact the efficacy of the products we protect that are used in various therapies, diagnostic tests, and medical procedures. We continue to invest in our facilities and capabilities using the model of our customers’ facilities and capabilities for our direction.”
Vision inspection systems have already been installed on several production lines including the large coating line that applies industry recognized heat seal coatings like Perfecseal® CR27 to medical packaging substrates like DuPont™ Tyvek® brand medical wrap. Additional vision inspection systems have been purchased and will be installed in 2012 on several more pouch and bag production lines, a blown film line, and a foil laminator. As expected, Perfecseal has found that vision inspection systems greatly reduce the number of defects shipped and have become a basic expectation of its customers in the medical device, diagnostic, and pharmaceutical markets.
A global leader in the healthcare packaging markets, Perfecseal specializes in the manufacture of co-extruded films, laminated films, flexible forming films, foil barrier laminations, pouches, bags, thermoformed trays, lids, labels, heat seal coated DuPont™ Tyvek® and heat seal coated medical grades of paper. Perfecseal, a division of the Bemis Company, has facilities in Oshkosh and New London, WI; Mankato, MN; Philadelphia, PA; San Juan, PR; Londonderry, Northern Ireland; Selangor, Malaysia; and Suzhou, China.
Westpak Inc., a Product and Package Testing Laboratory recently announced a 4000 sq. ft. expansion of its laboratory in San Diego, California.
“We are excited about the expansion of our facility and our ability to offer even more environmental testing services to our growing customer base in southern California, Mexico, and surrounding areas. This will assist us as we strive to decrease lead times while continuing to offer the same excellent test services and customer focus that has become our trademark in the industry” claims Craft.
The Westpak San Diego laboratory now occupies approximately 20,000 sq. ft. with combined 10 engineers and support staff providing Medical and Pharmaceutical Package Validation, Insulated Shipper Performance Testing and Validation, Mechanical Shock & Vibration, Product and Package Conditioning, Accelerated Aging, Package Evaluation, Pressure Differential, Tensile & Compression, DOT Hazardous Materials Package Testing and a wide variety of other testing capabilities.
H3 Biomedicine, the American subsidiary of Tokyo-based company Eisai, opened its new research facility in Cambridge, in the state of Massachusetts, US, in December 2011. The new facility is located at 300 Technology Square in Cambridge's Kendall Square. It focuses on developing new drugs to fight various types of cancer.
The Cambridge facility endeavors to gain insights into the molecular basis of cancer. It targets the genetics of cancer and develops drugs using advanced chemistry.
With the new facility, H3 Biomedicine will be able to deliver personalized drugs for oncology patients.
Eisai will provide $200m in research funding to H3 Biomedicine and access to its drug development resources. It will also support clinical development of the drugs discovered.
The location of the facility is an added advantage as it is home to the world's leading biotechnology clusters, academic and scientific institutions. The facility leverages the intellectual capital of the Greater Boston area.
"H3 Biomedicine, the American subsidiary of Tokyo-based company Eisai, opened its new research facility in Cambridge, in the state of Massachusetts, US, in December 2011."Eisai created H3 Biomedicine with the basic objective of developing drugs in oncology. Research at H3 Biomedicine starts and ends with a focus on the patient.
It starts with the genetics of a cancer patient. Therapeutic targets are identified using openly available cancer genomics data, such as Cancer Genome Atlas and International Cancer Genome Initiative.
The latest in synthetic organic chemistry is then used to develop libraries of small molecules which interact with the therapeutic targets.
The facility uses chemical synthesis technologies, such as diversity-oriented synthesis and cell-based screening methods. The diversity-oriented synthesis technology is based on high-performance liquid chromatography.
The approach used at the facility helps in generating compounds in small numbers against therapeutic targets. About 15,000 compounds are expected to be produced at the facility annually.
H3 Biomedicine's approach closes the gap between genomics and small molecule development. It is unique and more effective than the patient-based drug development approach. In the patient-based approach, a drug with known molecular targets is matched to a patient with a specific therapeutic target which is derived from large clinical trials.
According to the World Health Organization, cancer is the leading cause of deaths across the world and by 2030 it is expected to cause nearly 12 million deaths. The new facility will ensure a steady stream of anti-cancer compounds is produced to tackle this growing disease.
Drug molecules developed at the facility are expected to be highly effective in treating target population. This approach is also expected to reduce the time and cost needed to develop drugs, thereby enabling faster delivery of new therapies to patients.
The world's leading scientists, such as Stuart Schreiber and Todd Golub of the Broad Institute of Harvard and MIT, will be instrumental in the research carried out at the facility. The scientific approach used at the new facility is based on the work carried out by the two scientists.
The first phase of the Cambridge facility is spread over an area of 24,000ft². It includes labs for chemical synthesis, bacterial and tissue culture and genome analysis.
"With the new facility, H3 Biomedicine will be able to deliver personalized drugs for oncology patients."Construction of the first phase of the lab space was completed in July 2010. H3 Biomedicine plans to expand the facility up to 48,000ft².
The facility includes open office space with glass frontage, a common room / coffee break area and four modern seminar rooms. Equipment installed at the facility includes a walk-up mass spectrometer and a 400-MHz Bruker NMR machine.
Safety at the facility is maximized by splitting fume hoods into two. All evaporation equipment is enclosed in ventilation hoods. Ethylene glycol is circulated in the hoods to cool reactions.
Every researcher at the facility is provided with a laptop and access to Eisai's databases and resources.
The Richmond Group was contracted to construct the facility.
The Ossining-based biotechnology firm said that the relocation of its headquarters and laboratories to a 120,000-square-foot complex at 102 Corporate Park Drive will grow the company’s staff of 70 to 150 within two years. To accomplish its move, Histogenetics is arguing that it needs sales- and use-tax exemptions, according to its Jan. 23 application with the IDA.
The tax exemptions on the purchase of furnishings and equipment will total no more than $100,000. Histogenetics estimated its mortgage cost for the property at $9 million plus $13.2 million for furnishings, fixtures, equipment, financing and miscellaneous expenses.
The company expects to pay $117,000 in mortgage recording taxes.
The company calls itself an international leader in DNA sequence-based tissue typing and serves clients around the world. The company’s services are used to process blood stem cells that are given to patients suffering from fatal illnesses.
Histogenetics stated that it will use Antonio Velardo Inc. of Ossining as its contractor and the estimated cost of the construction will be $3 million for materials and labor.
Most of the new positions anticipated by Histogenetics will be for 25 entry-level and 20 experienced laboratory researchers, plus 15 software and computer specialists.
The IDA’s board of directors adopted a small business initiative project resolution on Feb. 2 in response to Histogenetics’ request, authorizing the IDA’s staff to negotiate terms with the company and to set a public hearing on the proposed tax breaks.
Vince and Associates Clinical Research received United States Pharmacopeia USP <797> certification of its pharmacy cleanroom. The company specializes in conducting complex, early development studies, such as First-in-Human (FIH) clinical trials. The USP <797> cleanroom allows for the preparation and compounding of a wide range of investigational compounds.
“This uniquely designed pharmacy includes an ISO 8 rated ante-room attached to an ISO 7 individual cleanroom containing a Class A2 Biological Safety Cabinet used for sterile compounding to support the ever evolving needs of our clients and safety for our research subjects,” said Scott Smiley, R.Ph., director of Pharmacy Operations at Vince and Associates Clinical Research. “This new certified cleanroom adds depth to our existing pharmacy capabilities including a negative pressure extemporaneous drug preparation room and 24 hour video surveillance monitoring.”
Florida Biologix has met European GMP requirements for aseptic fill-finish for biopharmaceutical drug products. The company can now provide aseptic fills for European clinical trials for filling Phase I/II drug products into vials or other containers.
Florida Biologix provides either manual or automated filling services of as much as 4,000 vials per lot, including formulation and filling of complex biologic products such as proteins, protein complexes, adjuvanted vaccines, oligonucleotides, liquid small molecules and other parenterals. Associated services include drug product in-process and release testing, labeling, packaging, cGMP storage, stability studies, blind labeling, and distribution to clinical study sites.
Xceleron is moving to a new custom-built facility in Germantown, MD, which is expected to be fully operational by March 31. The move follows a $2.4 million investment from Albion Ventures and Solon Ventures.
The company is relocating senior analytical staff to Germantown from York, and hiring new staff in Maryland. Xceleron will retain a study design and project management presence in the UK. The facility is capable of providing a range of studies including absolute bioavailability, metabolism and general pharmacokinetic investigations. Xceleron plans to augment its analytical capability in Germantown with the latest in highly sensitive LC-MS/MS technology, creating a lab in which all forms of microtracer and microdose investigations can be conducted in one facility.
Xceleron chief executive officer Michael Butler said, “Our customers told us that they want access to the best analytical platforms in translational science. We are providing that access with the most experienced team in the business and in one highly efficient and purpose built location. This is a first-of-a-kind combination from Xceleron that we believe will add to our customers drive for Phase II readiness.”
Almac has doubled analytical capacity in the past year at its 240,000-sq.-ft. North American headquarters in Souderton, PA. The facility provides full-service, integrated clinical packaging, drug supply management and technology solutions to pharmaceutical and biotech clients.
The facility’s analytical labs provide support for clinical packaging operations as well as standalone analytical services, and are equipped with HPLC, UPLC, GC, UV, IR, DSC, KF and others. The additional lab investment will continue to offer these services as well as polymorph and salt screening and solid form development.
The new lab will also be equipped with the latest bathless dissolution apparatus for rapid and efficient comparative dissolution studies, enhancing flexibility for developing, validating and running assay, dissolution and stability methods under the required ICH stability conditions.
Dr. Aeri Park, Almac’s operations director, said, “We always anticipated growth within our facility and are delighted that it has become necessary so quickly. This is testament to the dedication and commitment of our analytical team and we very much look forward to continued growth, coupled with superlative customer service in supporting clinical packaging operations and our stand-alone analytical and solid form businesses.”
The Aenova Group, a European manufacturer of medicines and dietary supplements, is moving its tablet production facility from Berlin to two sites in the Bavarian region of Germany.
Faced with the ending of a leasing contract for the Wallenroder Strasse site in Berlin, which has been bought by a competitor, Aenova has decided to transfer all machinery, equipment and operations from the tablet production and packaging plant to Tittmoning and Bad Aibling.
As all the facilities at the Berlin plant are being transferred, Aenova says its overall capacity for manufacturing and packaging tablets will not be affected.
The firm says the 60 permanent employees in Berlin will be given the opportunity to move to one of the two Bavarian sites, and up to 50 temporary staff in Berlin with appropriate skills will be offered permanent positions.
Aenova says the move is a continuation of the strategic development of its production network, which has included leasing a new site in Lyon, France to serve the US market, as well as taking over a development facility near Basel, Switzerland, which has increased its capacity for the contract development of medicines.
The company says it will close its production plant for effervescent tablets in Ticino, Switzerland in June and move the operation to Bad Aibling.
France-based pharmaceutical manufacturer Sanofi has announced it is to close its manufacturing facility based in Newcastle, UK, culminating in the loss of approximately 450 jobs.
The move comes as the company is forced to contend with European health spending cuts and generic competition to Plavix, the top-selling blood thinner, which is manufactured at the site.
The plant, located in Fawdon, produces drugs including Plavix for UK and European markets and is expected to close by 2015. The facility only opened three years ago, with Sanofi investing £100m at the time.
Sanofi previously announced reductions to its R&D staff numbers in September 2011, confirming that it was looking to reduce its staff allocation from 13,000 to around 10,000.
A company statement regarding the closure claimed that generic competition and other factors had resulted in a fall of demand and production volumes.
""The proposal is being considered in the context of an adverse economic climate and the challenging pharmaceutical market in Europe," the statement added.
The decision to close the plant is set to a backdrop of pharmaceutical companies expressing dejection at decisions taken by European governments to increase price pressure in an attempt to curb healthcare costs as the European economical crisis deepens.
Officials at pharmaceutical majors including Pfizer and Bayer Healthcare have been openly critical of governmental practices in Europe over recent weeks, with Pfizer chief executive Ian Read claiming that enforced price cuts are raising barriers for new medicines and severely hampering innovation.
Marken has added four additional branches in India to support clinical trial logistics. The expansion in New Delhi, Hyderabad, Pune and Bangalore will support temperature-controlled logistics of sensitive drugs and cold chain specimens.
“The expansion of our operations in India enables Marken to better support our clients’ need for regional expertise and temperature controlled supply chain services,” said Wes Wheeler, Marken’s chief executive officer. “We have seen steady growth and demand of our specimen logistics, drug distribution and API supply chain services in India.”
Marken is currently developing a new purpose-built GMP compliant depot in Bangalore scheduled for completion by the end of 2012. The Bangalore Depot will offer the full range of temperature-controlled storage capabilities including: controlled ambient, refrigerated and frozen pharmaceuticals and medical devices, as well as drug and equipment distribution solutions including: Pick & Pack, relabeling services, reverse logistics, reconciliation and certified destruction.
SCM Pharma is expanding its vial filling capabilities to support several clinical trials and commercial supply contracts. The company has invested more than £500k in new vial filling equipment for a dedicated suite at its facility. A new automated filler will allow for increased capacity and will integrate with the company’s containment isolator. The investment is geared towards companies requiring products for clinical trials and the supply of licensed drugs in niche markets, such as orphan drugs.
Neal Wesley, technical director at SCM Pharma, said, “The new kit will give us a true containment system for vial filling in that it will allow us to fill various types of potent materials in different sized vials while being totally safe for the product and operator. By having a system that isn’t compromised in anyway, we are able to handle more cytotoxic products such as oncology drugs, which we can safely fill at speed into vials under aseptic conditions to meet the demands of our clients.”
Generics and API maker Ranbaxy has opened a plant in Casablanca, Morocco in a bid to strengthen its foothold in the “increasingly important” North African drugs market.
The move is not the Indian-based company’s first foray into the region. The new plant, which will produce tablets and dry syrups, is its third on the continent with the other two being located in Nigeria and South Africa.
And with African sales up 23 per cent, hitting $189m (€144.4m) in 2011, the firm says it is staking its claim on an “under saturated” market that will only increase.
Director of corporate communications, Raghu Kochar, said the facility means direct access to the local manufacturing market, adding: “In addition to servicing the Morocco market, Ranbaxy plans to extend the supply from this manufacturing unit to other African countries, in the coming years.”
He added: “Ranbaxy already has a strong presence in Africa. In addition the three manufacturing plants, we have five subsidiaries, five representative offices and a strong workforce of nearly 1000 people, Ranbaxy’s caters to 44 of the 54 countries in this continent.”
The firm says it will largely target the local market through its new factory, with plans to make drugs in the therapeutic fields most common to African countries, including ARV (anti-retroviral) and anti-infectives. It will also make haematinics and cardiology meds.
The news follows a stream of reports of companies establishing a base in Africa.
In February there were strong rumors Swiss pharma giant Lonza had inked a deal with the South African government over a new $210m API (active pharmaceutical ingredient) plant. And last October OCIL expanded its Ugandan HIV production in a bid to boost the industry.
A Mumbai based analyst told Reuters: "The African market is not saturated and hence, generic drugmakers have good business opportunity there.
"The unit will help Ranbaxy push sales significantly over the next 24 months."
Those in the know seem to echo the sentiment that African Governments’ recent efforts to tempt more manufacturers to put down roots in the region is the key reason for the flood of developments there.
Danadams CEO Yaw Adu Gyamfi recently told us a new $1bn investment fund in a bid to produce 60 per cent of South Africa’s drugs locally is exactly the type of establishment drawing in drugsmakers.
However he said governments need to dedicate more funds to attract the business if they want to see a real success story.
Boehringer Ingelheim (BI) has announced the expansion of its biopharmaceutical manufacturing capabilities at its plants in Biberach, Germany and in Vienna, Austria.
The expansion will include cell-culture and microbial-fermentation capacity and support cell-line and process-development services for BI’s contract manufacturing business. BI has invested approximately EUR 17 million ($26.8 million) to expand cGMP cell banking, process science, cell-line development, and quality laboratories at the two sites.
BI expects to use the expanded resources for services that include monoclonal antibody development, product development using BI’s proprietary high-expression systems, and proprietary plasmid DNA platform. In addition, the facilities will support collaborations with Pfenex on Pseudomonas fluorescens bacterial expression technology and with VTU Technology on Pichia pastoris yeast expression technology.
In the company release, Dr. Dorothee Ambrosius, senior vice-president of Biopharmaceuticals Global Process Science, says, “This is another milestone within our contract manufacturing strategy securing technology leadership and towards increased flexibility and customer orientation.”
AB Sciex this week said that it has opened a new application and training center at its Singapore biomedical hub. It said the new center will serve researchers in Southeast Asia, Australia, New Zealand, Japan, and Korea, and it will complement the regional application support center the firm opened last year in Shanghai, China.
The Netherlands has pumped €13.5 million ($17.9 million) into a new proteomics research facility that will support research and foster collaboration with partners at several major Dutch life sciences institutes, according to Utrecht University.
Funded by the Netherlands Organization for Scientific Research, the Proteins@Work facility will provide technologies, equipment, and expertise for proteomics and protein interaction research throughout the country.
The large-scale proteomics facility will consist of a core hub facility at Utrecht University, with smaller labs at the Netherlands Cancer Institute, the Erasmus Medical Centre Rotterdam, and the University Medical Centre in Utrecht.
The facility, which will build upon the resources provided by the Netherlands Proteomics Centre and the Prime-XS proteomics facility, will provide open access to life scientists at universities and hospitals and in industry.
"We work with everybody who wants to understand how proteins work, for example how proteins can cause disease, but also how stem cells can develop into healthy organs," Albert Heck, scientific director of the Netherlands Proteomics Centre and initiator of Proteins@Work, said in a statement.
Concurrent with the funding announcement for the Proteins@Work facility, the University of Utrecht also said that the Netherlands Organization for Scientific Research has awarded €18.5 million for a nuclear magnetic resonance and MRI imaging facility to study Alzheimer's and Parkinson's diseases and for drug development and agricultural research that will be a partnership between Utrecht University and several other Dutch universities.
The 2012 London Olympics will be the first Olympic event to have an anti-doping laboratory sponsored by a pharmaceutical company. GlaxoSmithKline (GSK) proposed to sponsor the anti-doping program for the 2012 Olympic Games.
The proposal was accepted by the London Organizing Committee of the Olympic and Paralympic Games (LOCOG) in 2009.
GSK has made the donation as part of its £20m contribution to the Games. The sponsorship was signed under a Tier Three deal.
The company subsequently built an anti-doping laboratory at one of its R&D sites near Harlow in Essex, UK, about 22 miles from the Olympic Stadium. Spread over 4,400m² (47,361ft²), the laboratory is as big as seven tennis courts.
The 2012 London Olympics anti-doping program is aimed at eliminating doping practices by athletes participating in the Games.
GSK was announced to be the official laboratory services provider for the London 2012 Olympics and Paralympics in November 2009. The contractual scope includes the supply of equipment and provision of services for anti-dope testing for the Games.
The pharmaceutical company will supply the required equipment and facilities, while King's College London will operate the satellite laboratory in co-ordination with the Olympic Committee and International Paralympic Committee.
The facility is accredited by the World Anti-Doping Agency (WADA). It will operate on a 24x7 basis. It will analyze about 6,250 test samples during the Games, which is the highest amount ever so far at an Olympic and Paralympics event. The 2012 London Olympics is expected to attract more than 10,500 athletes worldwide.
GSK has also signed an agreement with the WADA in July 2011 to share the company's confidential research information about medicines in early stages of development that could be potentially abused by athletes.
This will help to devise more sensitive tests to detect doping in future sports events. It will also enable the discovery of a higher number of substances that could be potentially abused by athletes.
The laboratory was unveiled in January 2012 by the London Organizing Committee of the Olympic and Paralympic Games (LOCOG).
The facility will recruit more than 150 scientists to carry out the testing. It will also employ more than 1,000 LOCOG staff, mostly volunteers, for the testing process.
The laboratory is equipped with the most modern technology ever used for dope testing in the history of the Olympics. It uses a barcode identification system for the blood and urine samples collected from the participants and medal winners.
The bar code system avoids contamination and erroneous results. The system is the first-of-its-kind at an Olympics event. The facility has separate areas for sample logging, sample splitting, sample preparation, blood testing and analysis.
The anti-doping test facilities at the state-of-the-art laboratory can test about 200 illicit compounds. It also conducts combined tests for banned products.
The laboratory will provide results for most of the tests within 24 hours to 48 hours. For a few tests, such as on endurance boosting drug erythropoietin, longer time will be required (up to 72 hours) to get the results. The turnaround time of a negative result will be 24 hours.
"GSK formed an alliance with King's College London in November 2009 in order to provide the test equipment and services."The testing team will be headed by Professor David Cowan, director of drug control centre at King's College London, who will work in association with 12 anti-doping expert analysts from the drug control centre.
Each set of samples will be dispatched on an hourly basis to the GSK laboratory by a secured courier service. Each sample will be assigned with a unique number and bar code.
The urine samples will be split in two - A and B. Part of sample A will be prepared for testing and the rest securely stored. It will be screened for more than 60 prohibitive substances in just one test.
The initial result of a test (sample A) will be available in just 12 hours. In case of a suspected positive, the result will be confirmed within the next 12 hours.
Athletes have the right to get another sample (sample B) tested in presence of their legal representatives. The laboratory, therefore, will be fast, sensitive and effective in testing so the athletes will have bleak chances to challenge the result. It also guarantees the test process.
The test results will be passed to the International Olympics Committee. The B samples are mandated to be stored for eight years for retesting using any new tests and substances that may be discovered, according to the International Olympic Committee protocols.
The anti-doping laboratory is capacitated to test at least half of the athletes participating in the 2012 Olympics. Dope tests will also be conducted on all the medal winners. It will test up to 400 samples every day, including one among every two athletes participating in the Games.
Eisai Knowledge Centre is located in the Special Economic Zone at the Jawaharlal Nehru Pharma City in Visakhapatnam, Andhra Pradesh, India. It carries out research and manufacturing of new active pharmaceutical ingredients (API) and formulations. Eisai's subsidiary, Eisai Pharmatechnology and Manufacturing, operates the plant.
Ground breaking for the $50m facility took place in December 2007. The facility was officially inaugurated in December 2009. It has an annual production capacity of one billion tablets and 30t of formulations.
Eisai has been present in India since 2004. By setting up the Eisai Knowledge Centre, the company strengthened its position and integrated its development, production and sales functions in India.
In January 2012, the plant won the Facility of the Year Award (FOYA) for Project Execution.
"By setting up the Eisai Knowledge Centre, the company strengthened its position and integrated its development, production and sales functions in India."Eisai built the facility with the aim of creating a future global hub for manufacturing quality products and improving its API synthesis processes.
The facility integrates manufacturing of APIs and formulations, as well as the research and manufacture of new global products, into one site.
The plant is part of Eisai's Dramatic Leap Plan aimed at providing global flexibility for its manufacturing operations. It is also part of Eisai's corporate mission, human health care, aimed at discovering new compounds and supplying high quality products.
India was chosen for setting up the plant due to the availability of inexpensive and quality pharmaceutical products. The availability of skilled talent and lower manufacturing costs were a few other reasons for choosing India. Eisai has identified India as the main focus of its global operations due to these strategic advantages.
The Japanese market is slowly shifting towards generics although penetration is still low. Cost effectiveness is a key component to manufacturing and marketing of generics. The facility helps Eisai in achieving affordable pricing for its products and prepares it for the future growth of generic products in Japan.
The Visakhapatnam facility is Eisai's second API manufacturing site with the first one being located in Kashima, Japan. The Kashima plant supplies APIs to global markets. The Eisai Knowledge Centre is also the fourth knowledge-based centers of Eisai, the others being located in Japan, the UK and the US.
In July 2010, Eisai announced an expansion of the facility to increase manufacturing and research capabilities. Expansion of the facility will increase annual production capacity to 60t of formulations and two billion tablets by 2013. Eisai is investing $20m in the expansion project.
"Eisai's subsidiary, Eisai Pharmatechnology and Manufacturing, operates the plant."Eisai acquired 50 acres of land for constructing the facility. Currently, the facility is spread over 33 acres and the remaining 17 acres is available for expansion. The built-up area of the plant is 35,000m² (376,600 sq. ft.).
The facility comprises 14 individual buildings including an API lab, an API building, a drug substance facility, a drug product facility and a QA / QC research lab.
A hazardous material storage facility, cafeteria, administration office, energy centre, a pilot plant, a tank farm and parking facilities are also part of the plant.
Construction was completed in just 17 months. At peak construction nearly 2,000 workers were employed at the site.
JMC Projects carried out civil, structural and infrastructural works for the facility.
Eisai's primary areas of focus include neurology, gastroenterology, oncology and immunology. It plans to develop products in these four areas to deliver significant benefits to the society.
The facility is currently producing two drugs, Aricept and Myonal. In future, Eisai plans to move production of four more products including Epry, Methylcobal and Zonigran to the facility.
Nearly 95% of the production from the facility is exported to markets in Asia, Africa and Eastern Europe.
Penn Pharma has injected £14m ($22m) into its tablet and capsule manufacturing plant in South Wales, UK, in a bid to further its HP offering.
The firm says the extension – a 15,000 sq. ft. development for its site on the Tafarnaubach Industrial Estate in Tredegar – is a preparatory measure for a number of HP (highly potent) compounds in the pipeline.
CEO Richard Yarwood said the move will place Penn high in the tox producing big leagues, and will allow it to take on more large scale biz as the products come to market.
“This development puts us in a strong position globally to work with pharma companies of all sizes, “he said, adding: “We are already in talks with a number of potential clients about the use of the facility.”
The plant currently offers solid-dose production including aqueous and fluid bed drying and granulation capabilities, extrusion, film coating and encapsulation. The expansion includes the addition of latest generation contained processing equipment.
The CDMO (contract development and manufacturing organization) says, when the building is completed, it will go after more alliances with companies in the oncology and orphan drug arena.
Yarwood said that though the firm is already operating in markets all over the world, the new development will allow it to work on a bigger scale to meet the growing needs of the outsourcing industry – especially in emerging markets.
When asked why Wales was the choice for the firm’s global expansion, Yarwood attributed a large part of the firm’s success to support from the Welsh Assembly Government.
He said: “We have been based in Wales for 25 years and have enjoyed great success and received unrivalled support from the Welsh Assembly Government.”
Brecon Pharmaceuticals has opened a new storage facility for clinical trial supplies citing higher demand following its partnership with Anderson.
The Powys, Wales-based contract packaging and clinical trial services group – which is part of US group AmeriSourceBergen – opened the facility in Treforest earlier this month adding 23,000 sq. ft. of temperature controlled storage capacity.
The site – which created eight new jobs – has space for 1000 ambient pallets, 160 refrigerated pallets and 50 frozen pallets and is intended to provide distribution services for both clinical trial supplies and commercial products.
Managing director Peter Belden said the formation of Brecon’s partnership with Anderson Packaging – which is also owned by AmerisourceBergen and part of ABCS – prompted the expansion and had created opportunities in the UK and beyond.
“Since the creation of Anderson Brecon Clinical Services (ABCS) in the UK, there has been much greater demand for clinical trial support services.
“The new site will enable Brecon Pharmaceuticals to meet the growing needs of its customers and as a result, will create more opportunities for the industry across the UK and the rest of Europe.”
Brecon and Anderson became part of AmbersourceBegren’s consulting services (ABCS) segment - which ships trial supplies and approved drugs - last year when the US services firm decided to rearranged its contract packaging and distribution services division.
The opening of the new Brecon facility took place just a few days before Catalent completed its acquisition of Aptuit’s trial supplies business, which added two UK distribution centers to the New Jersey contractor’s global network.
And, the Brecon opening followed a few weeks after Northern Ireland, UK-based contractor Almac opened a new clinical supply services facility in Craigavon.
All of which suggests that the UK is likely to maintain its position as a key trial supply distribution hub and that competition among service providers will increase.
Frontage Laboratories says it is focusing on improving regulatory and GMP compliance in China after signing a $10 million (€7.5m) collaboration with drugs maker Fanghui Pharma.
Under the deal, the contract research organization (CRO) will provide consultancy services to the Henan Province based firm, which plans to expand with new facilities in the region.
Growth plans include a solid dosage manufacturing platform for generic and new products that is compliant with current good manufacturing practices (GMP).
Frontage’s input includes equipment selection and process validation for the product pipeline, coordination of third party engineering and architectural contractors, and regulatory guidance.
“This agreement furthers our own plans to provide more infrastructure development, GMP and regulatory guidance, and facility construction consultation to Chinese pharmaceutical companies,” said Song Li, founder and CEO of Frontage.
Fanghui Chairman Xiyuan Zhao added: “We selected Frontage based on its success in helping many Chinese pharmaceutical companies develop products for international markets.”
The deal is the latest in a number of developments at Frontage over the last few months.
In December it announced it had upgraded its clinical centre at Jilin University Hospital in a bid to “accommodate the growing need for early phase oncology research studies.”
And in September the services firm teamed up with Spaulding Clinical Research.
CMO Asymchem Laboratories will invest $12 million (€9m) in its new China manufacturing facility to add downstream capabilities.
So far Asymchem has invested $20 million in the Dunhua, China commercial-scale ingredients facility and is preparing to spend more to expand capabilities. The second two phases of the project are due to end later this year and will equip the site to manufacture APIs (active pharmaceutical ingredients).
“We believe that [investing in facilities] is the primary path forward in maintaining competitiveness as the global market evens out across the international and domestic Chinese intermediates and API markets”, Hao Hong, CEO of Asymchem, said.
The 36-story, 126-m. (414-ft.) Prime Tower office building in Zurich is currently Switzerland’s tallest building.
That will soon change as construction is commencing on the shell of Roche's Building 1 in Basel, which, when completed in 2015, will be Switzerland's tallest building at 178 meters (584 ft.).
The 41-story tower, which will rule Basel's skyline, will be the city's tallest by a wide margin. Basel currently has just one building taller than 20 stories, the 32-story Basler Messeturm office building. For the pharmaceutical giant Roche, the new tower is about consolidating offices currently scattered around the city.
"Roche needs a new office building in Basel," Roche CEO Severin Schwan said when the project was announced in late 2009. "We are convinced that having all the company's departments — research, development, production, marketing and corporate — close to each other will be crucial in ensuring that they work together successfully."
Roche is investing CHF 550 million (US$604 million) in Building 1, which will be home to 2,000 Roche employees. Excavation work on the foundation pit began last spring. Shell construction will begin in March and continue through the end of 2014. Interior fit-out work will take place simultaneously, starting in 2013. Roche plans to move into the building at the end of 2015.
Building 1, sometimes referred to as the Roche Tower, is being designed by the renowned Basel architectural firm Herzog & de Meuron, whose most famous project is Bird's Nest stadium, built for the 2008 Beijing Olympics. The Roche building, which will have 71,900 sq. m. (774,363 sq. ft.) of gross floor space will feature earthquake-resistant construction and will be built to strict Swiss Minergie energy standards.
"Building 1 is a clear commitment of Roche to the Basel site as its corporate headquarters," said Matthias M. Baltisberger, head of Roche's Basel site. "We will create attractive workplaces that are conducive to dialogue and exchange, and offer a top-quality infrastructure to our employees."
Herzog & de Meuron describe the structure as having a "distinctive wedge-shaped form," slanting down towards the west and almost vertical to the east. The building is vertically structured by superimposed floor slabs of varying sizes, which are sculpturally expressed on the exterior by horizontal white parapet bands, according to the architects. Because of its geometry, Building 1 looks entirely different depending on the angle of view, making it a recognizable landmark for each part of the city from which it is seen.
Building 1 will include a 500-seat auditorium. Offices and meeting rooms are located from the fifth floor upward. The top floor features a cafeteria with views of Basel and the surrounding area.
The tower is just the latest Basel expansion for Roche. In November, the company inaugurated its new CHF 250-million (US$275-million) R&D building. The facility focuses on investigation and development of pharmaceutical formulations for new active ingredients, as well as manufacturing supplies for global clinical trials.
"Finding the safest and most efficient formulation for an active ingredient is a key part of the drug development process," said Roche CEO Schwan. "Functions from the entire pharmaceutical value chain are located in Basel. This investment further strengthens the role of Basel headquarters and as a global center for research and development."
In June 2011, Roche opened its new administrative center in Rotkreuz in the canton of Zug. It is the sixth new building to be constructed at the site in the past five years. The new 16-story, CHF 90-million (US$99-million) building will be home to 600 employees, and will bring together all the administrative departments attached to the various diagnostics business units at the site.
A Chinese company that offers drug development services using a network of 99 third-party vendors has filed an $80m IPO.
Shanghai-based Newsummit hopes to raise up to $80m (€60m) in its IPO (initial public offering) to fund expansion efforts. The company formed in 2001 as a CRO (contract research organization) but switched models in 2008 to become an intermediary linking clients to a network of vendors.
Newsummit has ‘strategic framework agreements’ with two-thirds of its vendors. These deals give the company “favorable service fees, priority in scheduling, and the availability of test resources”. Even with these favorable terms Newsummit spent 69 per cent of total sales on outsourcing fees.
Some of the currently outsourced work could be insourced after the IPO. Newsummit leases five sites and plans to raise GMP (good manufacturing practice) standards, add pilot-scale production capacity, and build laboratory testing capabilities at its facilities using the expected influx of cash.
There are also plans to expand into life science parks in Guangzhou, Chengdu, and Xiamen. Adding sites in other areas of China is intended to expand service capacity and give Newsummit access to new potential clients.
IPO cash will also fund an expansion into Phase IV to benefit from the Chinese government’s five-year plan to improve drug safety through greater post-approval activity. To offer Phase IV services Newsummit expects to add a presence in Shanghai and Wuhan.
Opening these sites will add to headcount at Newsummit, which as of December 31 2011 was 415, up from 200 a year before. More than one-quarter of staff work on marketing and Newsummit plans to expand its sales team in the US and Europe soon.
By expanding overseas Newsummit hopes to add to the 80 foreign biopharma companies and research bodies with which it is collaborating, and in doing so “acquire advanced technologies and higher industrial standards”.
However, expanding overseas creates new problems. Newsummit admits it has “limited experience” dealing with the US Food and Drug Administration (FDA) and European Medicines Agency (EMA). As such it “may face significant challenges in complying with the relevant regulations”
Backlog at the end of 2011 totaled $377m, divided roughly equally between small molecules, biologics, medical devices and diagnostics, and traditional Chinese medicines. More than half of the 327 deals are for compounds in preclinical development.
Preclinical dominated sales last year too. Work on INDs (investigational new drug) generated four-fifths of total sales in the first six months of 2011, but Newsummit expects its NDA (new drug application) work to become more important in the future.
Stung by constant criticism of delayed handling of food and drug safety scandals in China, the country’s State Food and Drug Administration (SFDA) has decided to talk directly to the end user.
On February 26, the SFDA announced the establishment of a centre to deal with complaints directly with consumers.
The centre went live the same day, with the watchdog setting up a new website (www.12331.org.cn ) and a hotline (12331) for customers to call in directly with complaints.
The SFDA says the centre will investigate wrongdoing in research, development, production, distribution and utilization of foods, cosmetics and drugs.
It will be the sole authority in charge of coordination of efforts during the outbreak of a food (or other product) safety scandal, carrying out inspections, analysis, and investigations.
It will interface with the general public and national media during outbreaks, said a spokesman for the administration.
“The center will reduce the response time of the reaction towards safety issues with these products. What we are also looking at is preempting the outbreaks by connecting directly with the users,” he said.
Chinese authorities have been caught off guard by major food scandals such as the melamine milk scandal of 2008.
More recently, China was hit by a ‘gutter oil’ scandal where oil scooped up from sewage drains and restaurant back doors was being repackaged and sold across the country.
More than 100 oil manufacturers have been implicated in the scandal, in which the Supreme People’s Court said in a recent note that the death penalty is a firm possibility for offenders.
The Swedish life sciences research center SciLifeLab will use SEK 177 million ($26.8 million) in funding from Uppsala University and the Swedish academic real estate company Akademiska Hus to expand its labs at Uppsala Biomedical Center.
SciLifeLab is a collaboration between Stockholm University, the Karolinksa Institute, the Royal Institute of Technology, and Uppsala University that is focused on creating a center for high-throughput research, including genomics, comparative genetics, proteomics, bioimaging, and other biomedicine and environmental science projects.
A central aim of SciLifeLab is to identify genetic risk factors, biomarkers, and molecular mechanisms in human diseases for use in early diagnosis, personalized therapies, and identification of novel drug targets.
The new construction will create "a more coherent base" for SciLifeLab's operations, which currently are spread over a number of sites at Uppsala University, and to create a "stimulating, creative environment" for scientists from different labs to work together, the university said this week. The spirit of the expansion and consolidation was modeled on the Broad Institute of Harvard and MIT.
The SciLifeLab additions will include the planned five-story Navet (Hub) building and space in existing areas of BMC that will total 118,400 square feet and will be completed in the fall of 2013. The Navet building will include a central meeting space and room for guest researchers from other institutes in Sweden and abroad.
Kerstin Lindblad-Toh, a professor of comparative genomics at Uppsala and leader of the Uppsala SciLifeLab node, said that bringing researchers closer together to share technologies, platforms, and methodologies is beneficial for research.
"It's a matter of drawing together researchers from different departments, faculties and higher education institutions around joint methods," she said in a statement. "When people with different backgrounds meet in a workaday context, novel opportunities for attacking difficult problems arise."
The SciLifeLab labs currently house 15 next-generation DNA sequencers, mass spectrometry and imaging facilities, and two labs for a range of high-throughput genomics projects.
Clinical Reference Laboratory (CRL) has fully integrated its lab partner Phoenix Pharma Central Services in Singapore. The integration of Phoenix’s testing platforms into CRL’s Global LIMSystem enhances CRL’s support of clinical trials in Asia, adding efficiencies, increased quality, reduced costs and full global project oversight, as well as extensive knowledge of the Asian market and clinical trials.
Tim Sotos, chief executive officer of CRL, said, “We have a trusted relationship with Phoenix, having worked together for over a decade supporting a large number of clinical trials globally. “By incorporating Phoenix’s data into our centralized Global LIMSystem it allows for both sites and clinical teams to access their data throughout the world using CRL’s proprietary web-based ‘OASIS’ systems. This provides drug development companies with direct oversight on the status of their trial and allows them to evaluate drug safety on a real-time basis.”
Dr. Yan Lee, chief executive officer at Phoenix Pharma Central Services, said, “We have enjoyed a successful business relationship with CRL for a number of years and for the company to integrate us into their IT system shows a real commitment to both Phoenix and the industry. Together we are well positioned to provide support to pharmaceutical and biotechnological industries in the development of drugs and medical devices.”
Eli Lilly says plans for a new €330m ($444m) manufacturing facility in Ireland are in preparation for the launch of a range of its pipeline molecules.
The big biopharma business will build its new 24,000 sq. ft. plant in Kinsale, Ireland, where it has existing API (active pharmaceutical ingredient) production activities. When complete Lilly expects to employ 200 people at the plant.
A spokesperson said the new factory is now vying for a list of products discussed on a recent investor conference call, which are all under development in the US.
The plant – which is expected to reach completion in three years – will work in conjunction with the pre-established facility, which makes oncology drug Alimta (pemetrexed dosdium), antipsychotic Zyprexa (olanzapine), and Evista (raloxifene) to name but a few.
“The facility has a complex build time of around three years,” the spokesperson said.
“Molecules that may end up being produced in Kinsale are still under testing, which fits quite well because the plant should be ready just in time for Lilly rolling-out the list of pipeline products.”
He added the firm is still not sure exactly which products will be produced there, and a lot relies on the compounds passing through the regulatory process smoothly.
The spokesperson added: “Almost 50 per cent of the pipeline molecules are produced from a biotech platform and the new facility will be designed to support this platform.”
Lilly said it is still too early to speculate exactly what type of equipment will be installed in the new building.
However, the spokesperson did nod towards possible high potency production plans when he said: “The site's existing small molecule manufacturing facilities have extensive experience in producing high potency products.”
The news is the latest in a stream of pharma investments in the South West of Ireland – most recently for Abbott, which announced plans to inject €85m into a new plant in Sligo.
Haselmeier, a leading designer and manufacturer of pen injection systems, is to establish a new manufacturing facility in Bangalore, India, to produce and supply high quality, competitively priced pen injectors for the pharmaceutical industry in India. The reusable and easy-to-use pen is based on the i-pen technology and designed to allow accurate and reliable dosing.
Haselmeier’s new facility will cover approximately 1,100m2 (11,836 sq. ft.), including a cleanroom suite for the assembly of reusable pens. The manufacturing capacity can be swiftly adapted to changing market needs.
'The incidence of diabetes is increasing significantly in India and other developing countries and with it the demand for injection pens will also increase,' said Jochen Gabriel, chairman of Haselmeier. 'Device manufacturers will be faced with supplying high quality and affordable pen injectors in those countries. By establishing production in India, we will be well prepared for this challenge.'
Haselmeier India Pvt Ltd was incorporated in August 2011. In the meantime, the company has acquired a suitable location and hired key personnel to prepare for production readiness within the shortest possible time.
The new facility will expand Haselmeier's manufacturing capacity, which currently consists of facilities in Germany and the Czech Republic. Haselmeier plans to build its own facility in India within the next years which will open the way for vertical integration of crucial manufacturing steps, such as injection molding and printing.
Sterling Instrument, an ISO 9001:2008 and AS9100C certified manufacturer of precision electromechanical components and assemblies, has received certification of its ISO 7/Class 10000 cleanroom. Located in New Hyde Park, New York, this new production area will meet customers’ most critical manufacturing requirements, the firm said.
The new area will be used for testing, assembly and packaging.
The environment of the cleanroom is maintained through an HEPA filtration system with strict humidity and temperature controls. Employees are required to wear lab coats, booties and gloves.
A priority at Sterling Instrument is to provide customers with a quality component or assembly in compliance to their specifications.
Sterling Instrument is a partner to Stock Drive Products, known as SDP/SI, which has been providing precision components and system solutions for industrial, medical, defense, and aerospace applications for 50 years.
Having identified a business need in the US for a flexible and high quality commercial packaging service provider, the Pharma Services business unit of Almac is proud to expand its established commercial packaging operations with a $10m investment in a new state-of-the-art 100,000ft2 commercial facility in Audubon, PA.
Bringing more than 30 years commercial packaging experience from its MHRA/FDA approved UK facilities and having established a reputation for delivering high quality, reliable and cost-effective commercial packaging solutions, clients can now leverage this expertise from a local US based operation.
David Downey, VP Commercial Operations, said "addressing the needs of our clients, we have taken the strategic step of establishing a US based operation for commercial packaging services. For many years Almac has been bulk manufacturing and packaging US products from our UK facility. With the addition of the Audubon facility, we will now be able to offer these packaging services local to the U.S. market place, providing cost saving and mitigating supply risks".
Following completion of the evaluation and feasibility design work, refurbishment of the facility has commenced and systems handover is scheduled for Fall 2012.
Upon FDA approval, Almac will offer commercial primary and secondary packaging of tablets and capsules into bottles, blisters, wallets and hospital unit dose formats along with secondary labeling and packaging of biopharmaceutical presentations such as vials and ampoules.
Complementing these services are dedicated teams in pack design & artwork management and in-house tooling fabrication. Significant warehousing in ambient, refrigerated and controlled drug storage completes the services offering.
Graeme McBurney, President & Managing Director, Almac Pharma Services, said "we are delighted to be able to invest in new facilities and establish operations in the US. With the alignment of our packaging processes at both our UK and US sites, we offer the highest levels of customer service and continuity of supply, through a flexible and quality lead operation".
Samsung Biologics and Biogen Idec announced that the companies have established their joint venture, Samsung Bioepis Co., Ltd., to develop, manufacture and market biosimilars in keeping with their agreement announced in December.
Christopher Hansung Ko, previously Senior Vice President of Samsung Strategic Business Development, has been named the CEO of Samsung Bioepis. The joint venture’s Board of Directors will consist of five directors and one auditor.
The strategic collaboration between Samsung Biologics and Biogen Idec will enable Samsung Bioepis to build the capabilities needed to develop high-quality biosimilars.
Construction of Samsung Bioepis’ research and development center, located at Samsung Biologics’ site in Song-do Incheon, Korea, has started and will be completed by the end of the year.
Quintiles is driving its clinical development services in the Russian Federation through a new alliance with Russian Venture Company (RVC).
The firm says the move is a bid to plug the gaps in the “under-presented” Russian R&D (research and development) sector, touting it as the next big emerging market for pharmaceuticals.
Ben Cons, global VP of Quintiles corporate development, said: “With a population of 143m, Russia ranks among the largest emerging markets for clinical research worldwide, and is the world’s ninth most populous country.
“The Russian biopharmaceutical market is predicted to expand rapidly over the next few years, and Quintiles is well poised to help its biopharma customers navigate it.”
Russia’s unmet medical needs were highlighted in 2009, when the government launched the 2020 Pharma Health Plan; an effort to improve quality and affordability of healthcare for citizens by establishing more activities locally.
RVC is a result of said plans, which include ambitions to get more than 50 per cent of drugs on the Russian market produced domestically.
Both firms have kept plans to establish ventures in the region fairly close to their chests. However, Cons did tell us: “While details aren’t being disclosed at this time, these JV (joint venture) companies, when fully operational, will be part of Quintiles’ global family of services provided to customers, ensuring that they will operate to global standards for performance and quality.”
Quintiles said it is well placed to operate within Russia, since it has had clinical services and solutions there since 1997. The firm has offices in Moscow, St Petersburg and Novosibirsk, with a team of almost 280 professionals, and opened a new commercial solutions facility in 2011.
Furthermore, earlier this year the CRO (contract research organization) also set up a regulatory hub in the region.
The “hub” consists of a team of market authorization experts who will serve the Russian Federation and Commonwealth of Independent States (CIS), and will act as Quintiles’ regulatory base for all of Eastern Europe.
But the company insists the move was not in preparation for the RVC partnership. Peter Lassoff, VP of regulatory affairs, said: “The timing of these two announcements is entirely coincidental.”
He did however say the timing was fortunate: “With our expanded regulatory footprint in Russia, we can now provide customers with a one-stop-shop for the registration and commercialization of new products both locally and beyond.”
AKW, a UK contract packaging company, has invested £35,000 in a 1,500 sq. ft. cleanroom facility at its Trafford Park headquarters.
The addition of the BRC accredited facility comes just two months after the company invested £150,000 in high-specification steam sleeving machinery.
The cleanroom, which was converted by the AKW in-house team, features full air extraction and purification technology, supplied by Stulz GmbH, an air lock and shower room. When used with AKW’s stringent operational processes, the firm says it delivers complete contamination control, protection against external sources and product integrity from the start of a project to its completion.
The air filtration unit has an EU4 grade pre-filter and a HEPA main filter.
AKW, which is traditionally known for its transport solutions, has invested heavily in its contract packing business over the last five years and now offers contract packing services that include gift set assembly, steam sleeving, shelf ready packing, shrink wrapping, product labeling and the building of retail pallet displays.
AKW’s facilities also include 500,000ft2 of warehouse space, more than 100 vehicles and access to a further 1,500 through Partnerlink offering UK wide distribution. The company currently works with a number of FMCG companies including L’Oréal, P&G, Diageo, Unilever, Kellogg’s and Heinz.
Abbott Laboratories will pump €85m ($113m) into the expansion of its API production plant in Sligo, Ireland, in preparation of the launch of its pipeline products.
Plans for the extension include the upgrade of a 1,000 sq. meter (10,760 sq. ft.) warehouse space, as well as an additional 1,400 sq. meter (15,064 sq. ft.) dedicated to furthering production capabilities. Abbott will also hire 175 new skilled workers.
Though the firm declined to reveal exactly what will be made at the facility, it told in-PharmaTechnologist the expansion means it can produce APIs (active pharmaceutical ingredients) for drugs used to treat high blood pressure, viral infections and kidney disease.
Carmel Mulroy, head of public affairs for Abbott in Ireland, added: “We now have somewhere for our new pipeline [products] to be manufactured.”
The Sligo plant currently makes drugs for cancer, as well as for thyroid complaints and blood pressure, including Xinlay (atrasentan) the prostate cancer treatment and the hyperparathyroidism treatment Zemplar (paricalcitol).
Mulroy told us the plant's track record of regulatory compliance made it an obvious choice for expansion.
“I think a key factor in the decision to expand is the site’s history in meeting manufacturing standards, and the fact it is brilliant with compliance. It’s already FDA and EMA approved so it will help us to bring our APIs to the global market quickly and efficiently.”
The work is expected to be completed by 2014. Abbott would not specify how far along in the development spectrum its up-and-coming products are.
However Mulroy did tell us the products are, for the most part, in clinical trial phases, and that: “They are now at a stage where we need to ramp up our manufacturing capabilities at Sligo.”
Abbott has also received an unspecified investment grant from the IDA (Industrial Development Agency) in Ireland for the expansion.
The agency said the move is the latest in a string of pharmaceutical investments in the area, which currently plays home to a “cluster” of life sciences organizations.
An IDA spokeswoman told in-PharmaTechologist: “I suppose one reason for the amount of firms investing in Sligo is the amount of skilled labor available. The Irish education takes a big part on this.
The spokesperson added that the IDA works closely with academic institutions to form relationships with industry.
Contract manufacturer Asymchem Laboratories has brought on stream a new large scale manufacturing facility located in Dunhua, China. The new facility, located in the Jilin province, will operate under the name Jilin Asymchem Laboratories Co. Ltd.
It was built to meet an annual demand for commercial projects in excess of 5 million tons and will serve to expand Asymchem's capabilities in high volume processing and back-end ingredient and intermediate production.
Asymchem has invested approximately US$20m in the construction of the Dunhua facility between 2009 and 2011. A further $12m investment is planned at the 35 acre site between over the next two years in preparation for additional downstream commercial projects.
The new facility will be able to accommodate high volume processes as a standalone service, as well as back-end integration for starting materials or intermediates that will then be further processed in the existing Tianjin and Fuxin Asymchem facilities.
Phase 1 completion of the Dunhua manufacturing facility included the addition of 5,000-20,000L vessels for the limited cGMP manufacture of raw materials to intermediates. The completion of Phase 2 in July 2012 will see the installation of a second module that will allow for a total capacity of 532m3. The facility will be completed by a Phase 3 construction, scheduled for October 2012, which will increase capability through GMP manufacturing of APIs and API intermediates.
The increased capacity provided by the Dunhua facility will allow new commercial projects to be undertaken, as well as allowing for more efficient housing of large scale projects. Furthermore, the new facility will create an expansion of capacity at the existing Asymchem sites as they will now be able to relocate portions of large volume projects that were previously absorbing the available resources.
“Asymchem will continually look towards investing in world-class facilities and new technology developments as a strategy for success. We believe that this is the primary path forward in maintaining competitiveness as the global market evens out across the international and domestic Chinese intermediates and API markets,” said Dr Hao Hong, CEO of Asymchem.
“Due to exceptional customer demand, we found that we had exhausted the resources at our other locations. As a result, we realized that we needed to have larger scale cGMP capabilities at this new site. Based on our plans, the facility will support both existing and new contract manufacturing business as well as working to establish Asymchem as a top tier player in the global custom development and manufacturing markets.”
DuPont’s Pioneer Hi-Bred will build a seed technology hub in Beijing, China, this year to match its expansion in Johnston, the company said.
The Beijing hub will use molecular breeding to develop high-yield corn hybrids, focusing on plants that are disease resistant and that use water efficiently. Disease and chronic water shortages are two factors limiting yields in China.
The globe’s second-largest economy is also the world’s second-largest corn producer, but the country cannot keep up with demand as the Chinese eat more meat. Farmers there produce about 86 bushels per acre, compared with 172 last year in Iowa. As a result, China is a growing importer of corn from the United States.
“For China to meet demand, it cannot afford to leave any technology off the table,” said William Niebur, who runs Pioneer’s operations in China.
DuPont’s announcement coincides with an Iowa visit by Chinese officials seeking greater economic ties to the state. Vice President Xi Jinping is scheduled to arrive, and other officials are visiting Pioneer headquarters.
Niebur said it was too early to estimate the cost of the Beijing hub. But he said the proposal would be similar to a $40 million research center that will open on Pioneer’s Johnston campus in April. The centers in Johnston and Beijing would be linked to another new research site in Hyderabad, India, to share research data.
Pioneer’s rival, Monsanto, also has a biotech research center in Beijing, as do other seed companies. But Niebur said no other company will have as large or as advanced a research hub as the one Pioneer plans.
The hub will use molecular breeding techniques to identify and select optimal traits without using genetic modification. China has not approved transgenetic corn for commercial cultivation.
DuPont said it signed a multiyear lease with the Beijing International Flower Port, a state-owned enterprise that includes an agricultural science and technology park. The DuPont hub will employ nearly 50 researchers.
Pioneer has seven other research locations in China and a research joint venture established in 2007 with SinoBioway Group Co. Ltd., a Peking University bio-agriculture company.
Saif Bader Al Qubaisi, Chairman of Abu Dhabi Health Services (SEHA), has unveiled plans for the new three-million-square-foot, 838-bed Sheikh Khalifa Medical City. The new complex, designed by Skidmore, Owings & Merrill LLP (SOM) in a joint venture with ICME and Tilke, will replace the existing Sheikh Khalifa Medical City and provide expanded medical, pediatric, and trauma care for the residents of Abu Dhabi.
With construction scheduled to start in 2013, Sheikh Khalifa Medical City will combine a general hospital with a level-one trauma center and women’s and pediatric hospitals. Given the massive scale of this project, creating a hospitable sense of character and overall unity for the entire facility – while conveying a sense of identity for each individual hospital – is one of the primary design challenges.
Envisioned as a “city within a city,” the design endeavors to create a new paradigm for a medical center, one that is more like a bustling campus, with vibrant public spaces and a sense of community. Informed by historical regional precedents, the design seeks to strike a balance as a state-of-the-art vision rooted in local heritage. The design responds to, and is respectful of, the unique culture of the UAE and its demanding desert climate.
The primary architectural challenge of the project was to balance the client’s desire to create distinct identities for each of the three hospitals, while maintaining an overall unified expression for the medical city. This was achieved by developing a series of unifying and differentiating components. The medical city’s heavy stone plinth – a reference to the ancient architecture of the region – serves as a common pedestrian-scaled expression, within which the most intense medical functions will be found along with shared amenity spaces and light-filled courtyards. The roof of the plinth is home to a network of gardens that also serves to unify the bed towers that rise above. The architecture of the bed towers communicates the identity of each hospital within a common vocabulary. The exterior sun screens, which characterize the bed tower facades, will vary from the simple rhythm of the general hospital to playful colors and patterns of the children’s hospital to the intricate mashrabiya-inspired geometries of the women’s hospital.
SOM created a centralized, orthogonal plan that establishes a clearly defined sense of place. The facility’s base – a two-story plinth – houses a comprehensive array of medical functions, shared among the three hospitals. The ground floor will hold the adult and pediatric emergency departments, the women´s urgent care center, and all outpatient departments. At the heart of this floor, the diagnostic and treatment center serves all departments in the complex. The second floor houses inpatient and day surgery, intensive care units and related functions. On the main garden level above, the LDR, NICU and C-section ORs are located along with rehab and infusion. Rising above this shared plinth, the nursing areas give identity to the individual hospitals and address the specific needs of each patient population. Below grade, an extensive network of spaces is vertically integrated to support the medical functions above. Staff and visitor parking are located in a sub-cellar.
Embedded in the plinth and at the heart of the medical campus is a vibrant “town center” comprised of lobbies cafes, retail and education spaces. This lively and interactive multi-level space connects to a network of open spaces above the plinth. Located at the convergence of the two entry drives that connect the campus to the city, this town center perhaps best exemplifies how this project re-visions the building type and serves to define and distinguish this medical campus as a true center within the urban fabric.
The design of the medical city is based on the belief that patients are guests and everything about the facility supports that notion of hospitality. The patient and visitor experience is carefully controlled to minimize exposure to the back-of-house components of the facility. Lobbies and other public spaces convey a sense of serenity through spaciousness, natural materials and diffused natural light, while courtyards and terraces engage building interiors with the outdoors.
Like the exterior architecture, which expresses distinct identities developed from a common language, the interiors will be unified yet uniquely branded. The shared public spaces within the plinth will serve as connective tissue, while the lobbies and bed tower interiors of General, Women’s and Pediatric hospitals will express their own similar yet distinct identities. As a whole, the interiors will be comfortable, tranquil and reassuring – creating a sense of calm for patients while instilling confidence that they are within the confines of a world-class health care institution.
From the landscaped entry drives to the main garden level and the light-filled courtyards that perforate the plinth, the medical city’s gardens will create a calm and healing environment. The diverse network of open spaces is considered essential in establishing a tranquil atmosphere and in crafting the campus-like environment that will help to distinguish this medical campus.
The green space strategy begins with the two tree-lined entry boulevards which transition into a grand garden oasis at the center of medical city. This shaded garden, on the roof of the building’s plinth, is accessed from below by gracious interior and exterior stairs and activated by adjacent cafes, conference areas, and family waiting areas. Within the plinth, itself, a series of courtyards serves to bring light and nature into these large floorplates, thereby mitigating the sense of distance, assisting in way-finding and creating a more tranquil atmosphere in this medically intense setting. Above the plinth, the bed towers will be woven with a series of sunlit terraces, hanging gardens and adjacent family lounges.
The medical city will utilize state-of-art, high-efficiency systems as well as age-old regional concepts to mitigate the extreme desert climate of Abu Dhabi. From roof-top solar collectors to the simple fabric scrims that will shade the main garden level, a comprehensive climate strategy is designed to achieve a certified sustainability rating within the local Estidama guidelines (Abu Dhabi’s equivalent of LEED). The medical city will embrace the future sustainable growth by incorporating systems that harness, amplify and support the natural environment.
SOM’s Health + Science practice combines design excellence and technical expertise while promoting sustainable solutions and enhancing the human experience. Notable healthcare projects include the Northshore LIJ Katz Women’s Hospital in New Hyde Park, New York; the 1.8-million square foot Denver VA Medical Center in Aurora, Colorado; the Cincinnati Children’s Hospital Master Plan in Cincinnati, Ohio; and the LEED silver-certified Memorial Sloan-Kettering Zuckerman Research Building in New York, New York. BD+C
Austrian firms Vela Laboratories and Anagnostics Bioanalysis are teaming up to offer Anagnostics’ hybcell DNA and protein microarray technology to the pharma and biotech industries for applications in clinical diagnostics and drug development.
Anagnostics claims the hybcell platform is the world’s first microarray technology based on the use of cylinders rather than slides. The platform combines DNA- or protein-based hybcell tests for drug development and clinical diagnostic applications with the fully automated, hyborg instrument that carries out all hybcell test processing, from hybridization to liquid exchange, cycling, and scanning.
The partnership between Vela and Anagnostics will initially offer the hybcell technology for use in companion diagnostics in clinical studies, and also position the technology as an alternative to surface plasmon resonance methods used in affinity and immunogenicity drug testing applications.
The firms’ deal follows an announcement by Anagnostics that it had signed up Danish firm Ramcon as distributor for its hybcell tests in the Nordic countries. Ramcon will market and distribute Anagnostics’ existing hybcell DoA urine and hybcell DoA saliva drug screening tests, and its hybcell Oncogenesis Tissues pharmacogenomic tests.
Vela is GMP-certified contract laboratory specialized in offering analytical protein characterization services for protein-based biopharmaceuticals and biosimilars. The firm’s expertise spans a full range of bioanalytics services for drug development and preclinical/clinical trials.
Gulf Pharmaceutical Industries, known popularly as Julphar, is set to inaugurate the first ever insulin production facility in the Middle East.
The plant is nearing completion in the city of Ras Al Khaima, UAE, where the company's headquarters is also located. The plant requires an investment of $136m.
Julphar broke ground for the insulin production plant in January 2008. The construction is almost complete as of January 2012 and the company expects to inaugurate the plant in just a few weeks.
The insulin products will be sold in the Middle East and exported to 40 countries worldwide, including but not limited to those in North Africa and Asia. The plant will conform to the latest European Medicines Agency (EMEA) regulations in order to comply with international quality standards. Upon approval by the EMEA, the insulin will be exported to European Union (EU).
"The plant is nearing completion in the city of Ras Al Khaima, UAE, where the company's headquarters is located. The plant requires an investment of $136m."The UAE stands second worldwide, after Narushima Island, in the number of diabetics, with an estimated 32.6 million. The World Health Organization (WHO) estimates that nearly one-fifth of the region's population are diabetic. The demand for insulin has, therefore, been high in the region.
Julphar saw significant opportunity in insulin production as the Middle East region has no domestic insulin producer and is totally dependent on imports. It has partnered with the International Diabetes Federation (IDF) to execute the project. The IDF estimates the number of diabetics in the UAE will increase by 80% by 2030.
Local production of insulin will reduce the dependency on imports and bring down the cost of insulin for patients.
The new insulin production facility has a floor space of 20,000m² (215,200 sq. ft.). It is an independent complex with separate buildings for production and auxiliary operations. It has 5,000m² (53,800 sq. ft.) cleanrooms and 15,000m of clean piping.
The sub plants are connected through central corridors, shafts and underground tunnels. The central corridor also connects the main building to main production area, other areas and the central control room.
Insulin will be produced in six operational suites which include a media preparation area, buffer preparation area, buffer storage suite, fermentation suite, recovery area and two purification suites.
Julphar's Projects and Engineering Department has designed the plant in collaboration with Linde-KCA, a European engineering consultant.
GEA Diesel installed the process piping and plant equipment. Belgium-based Isocap installed the cleanrooms. Plant automation, control systems and instrument validation services were provided by Siemens.
The process equipment was supplied by GE Healthcare (chromatography purification systems), Pall (Tangential Flow Filtration systems), GEA Westfalia (cell separators), Abec (fermentors and process vessels), Martin Christ (lyophilisation), Fedegari (Autoclaves) and Veolia (RO system, WFI Distiller & Clean Steam Generator).
The plant will produce Julphar's recombinant human insulin, branded as Jusline. Julphar has been producing Jusline for eight years using insulin crystals imported from the EU. The product is registered in more than 14 countries and is available in three variants, namely Jusline 30/70, Jusline n and Jusline r.
The Ras Al Khaima insulin production plant has a capacity of 50 million vials of insulin and 1,500kg of insulin crystals.
Insulin in the plant is produced by cell based fermentation using recombinant DNA (rDNA) technology. The production process encompasses fermentation, recovery, purification and crystallisation.
"The insulin products will be sold in the Middle East and exported to 40 countries worldwide, including but not limited to those in North Africa and Asia."The biotechnology production process begins with the insertion of the insulin gene into a suitable vector, usually a non-pathogenic weakened strain of the E. coli bacterium. The genetically modified host cells are stored to frozen state.
The host cells are thawed and transferred to a flask containing growth medium. Upon attaining a specific cell density that is sufficient for cell culture inoculation, the cells are transferred into a production scale fermentor. The rapid growth of cells in the fermentor is further intensified by continuous stirring and the addition of air and nutrients. The cells mature to produce insulin.
Pro-insulin from the inclusion bodies, after the cells are broken, is extracted by a folding reaction through incubation.
Purification is done by flowing the cell culture fluid and impurities through a number of chromatography columns. The desired protein from the growth medium and other proteins are separated from the impurities through different modes of selectivity in the columns.
The purified insulin is filtered and concentrated to the required level by ultra filtration / diafiltration (UF / DF) process before final crystallisation. The resultant insulin is treated in Class C cleanroom conditions to obtain the dried insulin in crystal form.
The entire production process is monitored and controlled using a process control system with a capacity of about 10,000 items of input and output information.
High quality of the end product is ensured by using deionized, purified water in all stages of production.
Excella GmbH has met the SafeBridge Certification criteria for Potent Compound Safety and has been deemed competent and proficient in the safe handling of potent APIs at its chemical plant located in Feucht, Germany. Excella previously achieved this SafeBridge certification at its oral solid dosage (OSD) form facility, making it the first company worldwide to achieve SafeBridge Certification in both OSD product and API synthesis.
SafeBridge conducted a 60-element review of programs, procedures, containment and control over the production of APIs at the company's site. The results certify that Excella meets current industry standards for the safe handling of potent APIs in the identified areas.
Since the program began in 1999, 11 organizations have achieved the Potent Compound Safety Certification. The Excella API facility joins nine other facilities actively involved in the SafeBridge Potent Compound Safety Certified program.
Catalent Pharma Solutions has completed the expansion of its facility in Aprilia, Italy, which was successfully inspected by the Italian Medicines Agency, Agenzia Italiana del Farmaco (AIFA) last month. This expansion offers services from product conceptualization to formulation, development, production and packaging for prescription and OTC products. It also enhances European quality and analytical capabilities that include services such as market registration, analytical testing and market release by qualified persons.
“Expanding our drug delivery capabilities and expertise reinforces Catalent Aprilia’s position as a leading integrated development and delivery facility in Southern Europe,” said Stefano Arena, general manager of Catalent’s Aprilia site.
Catalent provides services for solubility, stability and bioavailability challenges for a wide range of liquid and semi-solid formulations.
Norwich Clinical Services (NCS) is expanding its clinical research capabilities with a new clinical facility in Bangalore, India to conduct all aspects of Phase I-III trials including pharmacokinetics in healthy volunteers, bioavailability and bioequivalence studies, drug metabolism studies, dose proportionality studies and multiple dose studies.
“Utilizing proven technologies and this new, modern clinical facility, NCS is now able to offer functional expertise and therapeutic experience with reliability that will create cost and time efficiency for customers,” said Dr. Saral Thangam, M.D., Ph.D., managing director of Norwich Clinical Services. “We are proud to be opening this new clinical trial facility with full regulatory approval from the Drugs Controller General of India as an indication of our unequivocal adherence to GCP, GLP, CFR part 11 and other applicable regulatory requirements.”
The 72-bed, 16,500-sq.-ft. facility has been successfully audited by the Drugs Controller General of India and contains separate areas for subject screening and blood draws, an on-site pharmacy, and a fully equipped intensive care unit. NCS is also conducting additional clinical programs in a separate FDA- and EMA-approved research facility. Studies conducted at this 86-bed facility have been submitted to health agencies including FDA, EMA, TPD, MHRA and DCGI.
“Our customers’ needs are rapidly evolving for contract pharmaceutical services and we understand that Norwich capabilities must also evolve to include one comprehensive solution for all stages of the product lifecycle,” said Terry Novak, president of Norwich Pharmaceuticals, the parent company for NCS. “Combining the clinical trial capabilities of these two research facilities will meet a specific need for Norwich customers seeking budget efficiency and schedule adherence from the early stages of development through study-end reconciliation.”
The Klöckner Pentaplast Group announced that it broke ground on January 18, 2012, for construction of its first manufacturing facility in China. Located 80 km west of Shanghai in the Suzhou Industrial Park in Suzhou, China, the new site will produce packaging films for the growing domestic Chinese market. The first phase of production capacity will focus on transverse-direction oriented shrink-label films, used primarily for full- or partial-body shrink-sleeve applications. Klöckner Pentaplast is the only producer of shrink-label films with global manufacturing in the Americas, Asia, and Europe.
The new 12,000-square-meter (129,120 sq. ft.) manufacturing site will house state-of-the-art production equipment, high-tech production control systems, and a research and development laboratory. The site will increase Klöckner Pentaplast’s global shrink-films capacity by 6,000 metric tons. The CNY 185.7 mio ($29.5 mio USD/€22.5 mio) investment is targeted for completion in first quarter 2013 and is expected to employ 100 people.
Canadian biotechnology company Medicago is investing approximately CA$4m (€3m; £2.5m) and creating about 20 new jobs as it expands its pilot production facility in Quebec City.
The company said the investment includes capital expenditure and labor costs, as well as preclinical studies for a rabies vaccine and other drugs.
‘Investing in our Quebec City facility is an important step for Medicago as we look towards expanding our product candidate pipeline,’ said Andrew Sheldon, president and CEO of Medicago.
‘We are happy to invest in our local community with the addition of approximately 20 new employees in 2012.’
Medicago is a clinical-stage biotechnology company developing novel vaccines and therapeutic proteins to treat infectious diseases.
The company uses proprietary VLP and manufacturing technologies that it says will speed up and lower the cost of developing vaccines.
Medicago has benefited from support from the Quebec Consortium for Drug Discovery, which in 2009 awarded the firm CA$1.77m in funding to support the development of VLPExpress, an automated high-throughput technology enabling the rapid expression, purification and testing of VLPs to identify the best antigens for a disease-causing agent within ten weeks.
GlaxoSmithKline (GSK) will invest A$60 million (US$64m; €49m) to expand its manufacturing and new drug development activities in Victoria, Australia, creating 58 new jobs by 2017.
The UK-headquartered pharmaceutical firm has had a base in Australia for nearly 130 years and is a significant contributor to the local economy, spending on average more than A$30m a year on R&D in Victoria and exporting more than A$300m a year in pharmaceutical products from the state.
GSK’s Boronia site, east of Melbourne, manufactures medicines for migraine, herpes, epilepsy, smoking cessation, hypertension, asthma, pain relief and anti-virals. The site is also the company's largest site globally for the production of sterile and non-sterile liquid products using ‘blow-fill-seal’ (BFS) technology.
The new investment will allow GSK potentially to double its current BFS manufacturing capacity by installing new production technology at the plant. It will also support the creation of a pilot scale facility for the development of new powder and sterile liquid pharmaceutical products, enabling GSK to continue its successful R&D collaboration with the Monash Institute of Pharmaceutical Sciences in Melbourne developing next-generation pharmaceutical products.
GSK also plans to make this new facility accessible to local companies for contract manufacturing.
GSK Boronia site director Troy Webb said the investment would ‘build a sustainable manufacturing capability within the local community while driving manufacturing technology’.
The Victorian government has recently released its A$55m Technology Plan for the Future – Biotechnology to promote biotechnology-enabled innovation and support the growth of Victoria’s life sciences sector.
South Africa will set up a R1.6-billion plant to manufacture active pharmaceutical ingredients (APIs) for antiretroviral medicines (ARVs) in a joint venture with Swiss group Lonza, Science and Technology Minister Naledi Pandor announced.
The project, dubbed Ketlaphela, would be jointly funded by Lonza and a number of State institutions, including the Industrial Development Corporation and Necsa subsidiary Pelchem.
The project is a joint initiative by the departments of Science and Technology, Trade and Industry (DTI), Health and Economic Development. Pandor said its initial focus would be on HIV/Aids, tuberculosis and malaria, while noncommunicable diseases such as diabetes, hypertension and cancer would later be added.
“The project is in line with government’s goal of addressing HIV/Aids through the local and cost effective-production of ARVs,” she noted.
The facility, which will be 50% State-owned, will be constructed at Pelchem's Pelindaba site, near Atteridgeville, outside Pretoria, and is expected to create 2,200 direct and indirect jobs in the formal and informal sector.
Construction is expected to start in early 2013.
"Ketlaphela will reduce the country's dependence on imported drugs and will provide security of supply of priority drugs, stable pricing with less sensitivity to exchange rates," Pandor said.
Trade and Industry Minister Rob Davies said South Africa consumed R25-billion worth of drugs a year, the majority of which are imported from the US and Europe.
“If South Africa were to continue to import ARVs at the current rate, in 2016, we would have to import 1 430 t of AIPs at a cost of R4.7-billion at current exchange rates. The new facility was expected to manufacture 40% of this in its first phase, a possible second phase would increase this percentage,” Davies stated, adding that the initiative was a big step forward in terms of South Africa’s manufacturing capacity.
The plant would also be in line with the DTI’s Industrial Policy Action Plan’s objectives, which encompass diversifying the South African economy towards higher value-added manufacturing, creating jobs and thus controlling the trade balance.
Economic Development Minister Ebrahim Patel said it was anticipated that about 60% of the capital expenditure of the project would go toward local sourcing. He referred to the local procurement accord signed by government last year in which an agreement was struck with the private sector to seek opportunities to purchase locally produced goods.
“There will be an active attempt to secure as much support as possible by buying local supplies,” he noted.
Further, Pandor enthused that Ketlaphela would leapfrog South Africa in terms of local pharmaceutical manufacturing and that it would provide opportunities for South African scientists and pharmaceutical companies.
She stated that the consortium had entered negotiations with the South African government with the aim of delivering the first locally manufactured ARVs from 2016.
BGI launched a new genomics research center in Copenhagen, marking its first such center in Europe.
The 13,000 square-foot European Genome Research Center, situated in the Copenhagen Bio Science Park at the University of Copenhagen, will focus on establishing collaborations to advance genomics in healthcare, bioenergy, agriculture, and other research areas.
BGI had announced the establishment of a European office in the Danish capital, as well as a US office in Cambridge, Mass., in May 2010. But this announcement marks the official opening of the new genome research center.
The center is stocked with 10 Illumina HiSeq 2000 sequencers, said BGI, and will house two integrated projects including an effort to identify cancer pathogens for research into cancer vaccines and another to establish a catalog of genetic variations among Danish people.
"Our primary mission of this research center is to provide BGI´s world-class expertise and infrastructure for the European researchers in genomics, proteomics, bioinformatics and other related areas," BGI Europe Director Ning Li said in a statement. "I believe this center also will strive to cultivate joint collaborations between China and Europe."
"The vision is to create the best facilities in the fields of genomics and bioinformatics, so that we have an opportunity to utilize knowledge on genomics and better Denmark's possibilities of preventing and curing diseases. We hope that it will be possible, for example, to develop a vaccine against cancer," University of Copenhagen Vice Chancellor Thomas Bjørnholm added.
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