Valtronic USA, a niche "mechatronics" manufacturing solutions company in Solon, Ohio, has added a 288 ft2 ISO Class 8 bioburden cleanroom. The facility is temperature-, humidity-, and contamination-controlled, allowing the company to package electronic and mechanical assemblies in a pouch ready for EtO (Ethylene Oxide) sterilization.

"The project began as a request from a new customer and we anticipate a very positive response from other implant manufacturers regarding this capability. Our new facility has provided us with the space to add this capability with room to expand it when needed," says Jim Ohneck, Global Vice President of Sales and Marketing. "We started preparing for expansion like this when we moved to our current facility last year and the right customer helped us complete it even earlier than expected. Providing this capability saves customers production time and the vertical integration also offers cost efficiencies."

Working with an independent lab for testing, the cleanroom meets ISO 8 standards of less than 3,520,000 particles greater than or equal to 0.5 micrometer per cubic meter of air according to ISO 14644-1. The qualification was led by two engineers and the company’s quality manager.

Valtronic provides electronic and mechanical products to suppliers of medical implants and devices, diagnostic imaging equipment, and sensitive aerospace and industrial assemblies. The company helps other organizations develop and produce Class II and Class III medical devices, as well as miniaturized electronic assemblies.

Velesco Expands with Center for Innovation

Velesco Pharma has expanded its drug formulation, analytical development and cGMP clinical trial manufacturing services with the opening of a new business development office in the greater Boston area. Velesco will be the first life sciences tenant of the Quincy Center for Innovation, a 12,500-sq.-ft. facility providing inexpensive and flexible office space and support services to assist start-up companies and aspiring entrepreneurs. The QCI is expected to open fully September 1.

“The growth of Velesco’s early phase CMC services has led to a need to increase our presence in this global hub for pharma and biotech companies. As we enter our sixth year of operations, we are looking forward to having a presence nearer to our existing and prospective clients,” said Gerry Cox, Velesco's co-founder and chief operating officer, who will be leading the new office. Velesco has R&D operations in Plymouth, MI and GMP operations in Kalamazoo, MI.

“One of the goals of the QCI is to provide a landing spot for those companies who are not yet located in Massachusetts, but have an interest and need to get acclimated to the region before choosing a permanent location,” said Donna Mavromates, director of the Quincy Center for Innovation.

“We will continue our focus on drug formulation, analytical method development and the supply of cGMP clinical supplies to early phase clinical trials while maintaining an evolving understanding of our clients’ needs. The Quincy Center for Innovation’s emphasis on working with young vibrant companies makes this location an excellent fit for Velesco,” added Mr. Cox.

MIT Receives $10.4 Million BioManufacturing Grant

The Biomanufacturing Research Program (BioMAN) at Massachusetts Institute of Technology (MIT) has received $10.4 Million from the Defense Advanced Research Projects Agency (DARPA) to develop new technologies and manufacturing platforms that will provide an emergency supply of medicines for front-line military medics. This project is part of DARPA’s Biologically-derived Medicines on Demand (BioMOD) program, which aims to manufacture biologic drugs on demand in a forward operations setting where resources are often limited and make these drugs available in 24 hours.

MIT will be responsible for developing innovative methodologies for engineering robust, flexible microbial strains capable of synthesizing multiple protein-based therapeutics, as well as portable device platforms for rapid manufacturing of multiple biologics with high purity, efficacy and potency at the point-of-care.

“To make and release such medications on fast timescales will require orders of magnitude improvements on today’s manufacturing practices,” commented J. Christopher Love, lead investigator and associate professor of Chemical Engineering at MIT, in a press statement. “The goal for BioMAN is to transform biologic drug manufacturing from a time-consuming, step-wise process to a tightly integrated one for small-scale production.” The implications are tremendous, according to Love. “Imagine how having rapid access to drugs in remote settings could change lives or how such new capabilities might promote better global access to these costly drugs through distributed production.”

BioMAN, part of MIT’s Center for Biomedical Innovation (CBI), seeks to develop new knowledge, science, technologies, and strategies that advance the manufacture and global delivery of high quality biopharmaceuticals. “In BioMAN, we have created a unique ecosystem, where MIT and other affiliated faculty work closely with the biomanufacturing industry, as well as government and regulatory communities, to examine key issues in biomanufacturing and see new manufacturing innovations implemented,” said BioMAN’s program director, Stacy Springs.

Nanotherapeutics to Make Biologics for U.S. military

R&D Biologics firm Nanotherapeutics has started work on a new facility that will produce biological countermeasures for the U.S. military.

The new plant - in Alachua, Florida, US - will feature single-use disposable manufacturing technologies for the production of medical countermeasures that Nanotherapeutics was contracted to make by the US Department of Defense (DoD).

The firm explained that when operational the site - called the Advanced Development and Manufacturing Center (NANO-ADM) - will be available to other third-party firms involved in the project.

"The NANO-ADM Center will integrate new biomanufacturing technologies with existing capabilities, enabling the development of both small molecule and biologic products.

While the firm did not detail the specific products that will be produced it did explain that: "The goal of the contract is to enable faster and more effective development of medical countermeasures designed to protect and treat military populations against chemical, biological, radiological and nuclear attacks and outbreaks of naturally occurring, emerging and genetically engineered infectious diseases.

The centre will include space for vector development, quality control, a development pilot plant, manufacturing core, warehouse, as well as office/administration and utilities.

The new plant - which is costing $122m to build according to Area Development Online - will be operational in mid-2015 and will provide about 200,000 sq. ft. of development and manufacturing space.

Nanotherapeutics - which expects to recruit 150 staff to work at the facility -will work with a network of firms including technology suppliers EMD Millipore Corporation and Xcellerex to fulfill the contract.

News of the new investment follows just a few weeks after Nanotherapeutics was names as one of the firms contracted by the Biomedical Advanced Research and Development Authority (BARDA) as part of its influenza pandemic preparedness and response program.

The contracts, totaling approximately $40m, were also awarded to Cook Pharmica, JHP Pharmaceuticals and DSM Pharmaceuticals.

Pharmaceutical Manufacturer Opens New Laboratory in Rocky Mount

Governor Pat McCrory congratulated Hospira, the world's leading provider of injectable drugs and infusion technologies, for unveiling a new quality and analytical testing laboratory at its Rocky Mount facility. Governor McCrory attended a ribbon-cutting ceremony where remarks were given by Hospira CEO Mike Ball and vice president of Rocky Mount operations, Marty Nealey. As a part of this latest expansion announced in 2012, Hospira is creating 200 additional jobs across the plant and investing more than $85 million. "This new facility further demonstrates that advanced manufacturing is growing in North Carolina," said Governor McCrory. "Our state's highly-skilled workforce has helped build one of strongest bioscience clusters in the nation." Hospira is the world's largest generic injectable pharmaceutical manufacturer. The company's products are used by hospitals, outpatient clinics and other healthcare sites, such as clinics and home-health facilities. The company currently has about 2,600 employees at its Rocky Mount facility.

TriLink BioTechnologies Gets Production Suite

TriLink BioTechnologies has entered into an agreement with American Cleanroom Systems (ACS) and Kelchlin Construction for the construction of a 2,000ft² pharmaceutical cGMP production suite at their San Diego facility in US.

The new facility will feature nine labs and will be equipped to manufacture and process mRNA, long RNA, aptamers, oligonucleotides, small molecules and nucleoside triphosphates.

Construction of the pharmaceutical cGMP production plant is scheduled to be completed in the first quarter of 2014. TriLink CEO Richard Hogrefe said the construction of the new pharmaceutical cGMP production facility is part of their plan to expand their quality system.

"Soon we will be able to support our customers at every stage from research to clinical trials and commercialization," Hogrefe said. "ACS offered the quality and experience we were seeking and we're confident they are the right contractor to help us meet these goals."

TriLink produces custom oligonucleotides, modified nucleoside triphosphates and CleanAmp PCR products for the diagnostic and OEM markets. Additionally, the company also provides custom chemistry, long RNA and mRNA synthesis, contract research services and ISO/QSR compliant GMP production facilities.

ACS builds ISO 4-8 Class cleanrooms for the pharmaceutical and medical device industry. The company is located in Orange County, Calif.

B. Braun Purchases Land to Build New North American Headquarters

B.Braun Medical Inc. (B.Braun) announced that it has purchased undeveloped land totaling 21.5 acres in Upper Saucon Township/Lehigh County Pennsylvania. The property was purchased from Lehigh University in Bethlehem, Pa. and will be the future home to a new state-of-the-art B.Braun headquarters campus.

"The purchase reflects the tremendous success and growth B.Braun has witnessed," said Bruce Heugel, Sr. VP & CFO. "The new headquarters campus also underscores the sustained commitment and investment B.Braun has made in the Lehigh Valley and the Commonwealth of Pennsylvania." Mr. Heugel added, "We wish to thank Lehigh University for their continued partnership and for this opportunity to grow our operations and remain one of the leading employers in the Lehigh Valley.

The current headquarters building on 12 Avenue in Bethlehem has served B.Braun for over 50 years, and will remain operational for many years to come.

B. Braun Medical Inc. (B.Braun), a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. The Company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. Guided by its "Sharing Expertise" philosophy, B.Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs.

The B.Braun Group of Companies in the U.S. includes B.Braun, B. Braun Interventional Systems, Aesculap and CAPS. B.Braun's U.S. headquarters is located in Bethlehem, Pennsylvania. The B.Braun Group of Companies employs more than 46,000 employees in more than 50 countries throughout the world.

Genzyme to Invest at Framingham Site

Genzyme, a US-based biotechnology firm acquired by French drugmaker Sanofi in 2011, is investing US$80m to expand drug manufacturing capacity at its Framingham facility in Massachusetts.

The new plant, which will be located adjacent to a new cell culture manufacturing site, will significantly expand purification capacity to support anticipated growth in global demand for Fabrazyme over the coming years, the firm said.

Fabrazyme is a treatment for Fabry disease, a life-threatening genetic disorder linked to the X chromosome, which globally affects around 5,000 people.

'As we continue to meet the global demands for Fabrazyme and build inventory, our focus also remains on the future needs of the global Fabry community,' said Genzyme President and CEO, David Meeker. 'Following last year’s regulatory approvals of our manufacturing facility in Framingham and a new vial filling line at our plant in Waterford, Ireland, we continue to execute on our global manufacturing strategy, enhancing our capabilities across the entire manufacturing process for Fabrazyme.'

Downstream processing involves the purification of material harvested from the cell culture manufacturing process. The final product, which is administered as an intravenous (IV) infusion, is formulated and fill-finished in a separate facility in Waterford, and shipped to multiple distribution centers for labeling, packaging and shipping around the world.

Genentech Plans to Expand California Biologics Manufacturing Facilities

Genentech, a member of the Roche Group announced plans to invest more than $285 million for the expansion of its biologics manufacturing facilities in Vacaville and Oceanside, California. "This investment and expansion will result in the addition of more than 250 new jobs at the Vacaville and Oceanside facilities over the next four years, bringing the total number of Genentech manufacturing jobs in California to close to 3,000," said Ian Clark, Chief Executive Officer of Genentech. The company currently employs approximately 10,000 people in the state.

These investments in Genentech's biologics manufacturing network will enable the hiring of hundreds of skilled workers, ranging from technicians to scientists and engineers. "California has always had an impressive skilled workforce that has allowed Genentech to hire diverse and talented individuals in various disciplines," Clark said. "In recent years California has made great strides toward improving the business environment for life sciences innovation and incentivizing manufacturing. We are committed to working with the state to continue this positive progress and make California an even better place to grow the industry."

Genentech's United States manufacturing network spans three locations in California—South San Francisco, Vacaville, and Oceanside—and Hillsboro, Oregon, producing medicines intended for the treatment of a wide range of diseases including cancer, rheumatoid arthritis, and asthma. When the expansion is complete, Genentech's Vacaville facility will not only be the largest producer of biologic medicines for the Roche Group but also the largest biotech manufacturing facility in the world, the company said in a press release.

Sigma-Aldrich Expands Two Facilities

Sigma-Aldrich Corp.’s manufacturing services business unit, SAFC Commercial, is expanding two of its manufacturing facilities in the U.S. to support drug manufacturers in bringing new targeted and cytotoxic therapies to market. The company is investing in commercial-scale manufacturing capacity for antibody drug conjugates in St. Louis, Mo., and expanding its high-potency active pharmaceutical ingredient manufacturing and storage at the Verona facility near Madison, Wis.

The ADC expansion at the St. Louis site is expected to be completed by mid-2015. The updated facility will feature segregated areas for high-potent solids handling, manufacturing, and aseptic bulk filling of product. Batches up to 600L/3kg can be manufactured under ISO 7 classification and the facility is suitable for HPAPI containment for SafeBridge Category 4 compounds.

“The investments at the St. Louis and Verona sites are complementary and allow SAFC to offer continuity for customers’ drug development and commercialization programs,” says Dave Bormett, Director of Operations for SAFC. “Verona’s HPAPI handling and containment standards (<0.1 microgram/M3) enable the site to manufacture the high-potency toxins and linkers that the St. Louis site uses to conjugate biological molecules and develop ADCs. It is all a part of our drive to provide customers with complete solutions based on our expertise in niche technologies.”

Online since mid-2010, and SafeBridge certified in October 2011, Verona was originally constructed as an add-on to the Madison facility for cGMP manufacture of late-phase and commercial HPAPIs requiring 200 to 4,000 liters capacity. By mid-2014, the site will have a new warehouse with storage capacity for raw materials, as well as three new cGMP manufacturing areas to support projects. Two of the areas will be designated for smaller lab-scale manufacturing in the kilo range, while the other will accommodate larger-scale manufacturing up to 800 liters. The facility expansion will also provide space for growth of SAFC’s product stability sample storage and testing service, as well as a process scale-up lab to support GMP production.

Human Milk Facility Opens Cleanrooms

Prolacta Bioscience, a provider of human milk-based nutritional products for premature infants in the neonatal intensive care unit, will open a new facility in City of Industry, Calif. The 67,000 ft2 building will be home to a pharmaceutical grade manufacturing facility for human breast milk-based products. The facility will contain a 115,560 ft3 human milk freezer, which will provide controlled frozen storage capacity for more than 29,000 gallons of breast milk. The new facility also includes two ISO 8 and one ISO 7 cleanrooms totaling over 10,000 ft2.

"The Prolacta team could not be happier about what we have achieved for preemies and hospital NICUs across the country," says Scott Elster, CEO of Prolacta. "We now have a facility that can provide human milk nutritional products for every NICU in the U.S. As hospitals continue to transition to exclusive human milk diets in their NICU, we are positioned to meet their needs by providing fortifier, pasteurized milk, and ready-to-feed products, all free of any cow milk or cow milk proteins."

Prolacta’s services include a safety combination of DNA matching of mom to milk, testing for drugs and bovine contamination, as well as HIV-1, HCV, and HBV of the final product using PCR testing, among other safety steps

California Institute of Technology, Markus Meister Lab, Pasadena, CA

Budget: $3.2 million

Size: 5,464 sq.ft.

Project team: HDR Architecture, Pasadena, Calif. (architect/lab planner)

Description: The integrated design-build team had to complete the renovation project of a 1974 science lab building within an ambitious eight-month schedule, from beginning of design to a fixed opening date. In this fully occupied science lab building, renovation required logistics planning including temporary barricades.

The lab suite was subdivided into three layers: office, research wet lab and light-controlled research and behavioral space that included: consolidating redundant prep areas for improved space utilization; co-locating related functions to improve operations and productivity; and maximizing research space within a colorful, open and light-filled suite, taking advantage of the only four windows in the space.

A significant amount of time is spent in the controlled-light research spaces. Individual experimental stations, “setups,” typically include a vibration isolation table with microscope, two moveable racks of electronics and computers and an operator’s chair. Flexible configurations of multiple setups are enabled, separated by blackout curtains.

In order to make this renovation as energy efficient as possible, the mechanical and electrical systems were designed according to industry best practices and comply with both Title 24 requirements and CALGreen (California Green Building Standards Code). The lab terminal zone controllers are programmed to operate based on occupied/non-occupied schedule after hours to help reduce energy consumption, and task lighting at lab benches is provided with occupancy sensors. For ventilation and indoor air quality, the lab side is served by a new dedicated 100% outside air unit. Supply and exhaust terminal units modulate between minimum lab ACH and maximum air volume setting to maintain room temperature.

Completion date: August 2012

District of Columbia, Consolidated Forensic Lab, Washington, DC

Budget: $145 million

Size: 351,000 sq.ft.

Project team: HOK, Washington, D.C. (architect, lab planner, interior designer, landscape architect); McKissack & McKissack, Washington, D.C. (office interior architecture); Philip S. Cooper & Associates, Washington, D.C. (production support); Vanderweil Engineers, Boston (mechanical/electrical engineer); JVP Engineers, Washington, D.C. (plumbing engineer); ReStl Designers, Washington, D.C. (structural engineer); Delon Hampton & Associates, Silver Spring, Md. (civil engineer); Whiting-Turner, Baltimore, Md. (CM); Working Buildings, Atlanta (commissioning agent)

The LEED Platinum building totals six stories above grade and two below. Owned by the D.C. Dept. of General Services, the city leadership decided to combine the District’s public safety forensic science and public health agencies into one building. The team created a plan that maintained order and a consistent zoned approach to the overall building layout. Departmental stacking was a successful effort which kept agencies within their own floor areas. This simplified security and kept cohesive units together. By separating the lab and office areas, the building responds to each section’s unique requirements. The labs on the north are compartmentalized while the offices on the south are open. The core elements (shafts, electrical/telecom rooms, stairs and elevators) are located centrally between the office and lab zone to serve both sides efficiently. A ballistics facility is incorporated into the heart of the facility, enabling forensic teams to collaborate more fully with others. Enhanced BSL-3 labs are located on an upper floor on the perimeter, allowing critical but demanding work to be performed with abundant daylight. Vehicle examination rooms operate as laminar flow cleanrooms, maintaining integrity of the evidence. All the Medical Examiner’s autopsy suites have natural light on the upper floors, bringing this critical work out of its traditional place in a basement.

Mt. Sinai School of Medicine, Leon and Norma Hess Center for Science and Medicine

Size: 422,769 sq.ft.

Project team: Skidmore, Owings & Merrill (architect); Jacobs Consultancy, Tarrytown, N.Y. (lab planner); Jaros Baum & Bolles, New York, N.Y. (MEP); Langan Engineering, New York, N.Y. (civil engineer).

Located on the edge of Spanish Harlem and the Upper East Side, the Mt. Sinai Campus is situated on the fault line between some of the poorest and wealthiest New Yorkers. Mt. Sinai sought unique financing avenues to fund the project including the sale of land and air rights for a residential tower adjacent to the project site. Although the development of the residential tower was ultimately a separate project, the master plan for the two buildings proposed the idea of locating the bulk of the Center for Science and Medicine’s (CSM) MEP systems in the residential tower and serving CSM MEP needs through a vertical umbilical connection. This strategy allows the CSM to achieve a more efficient floor plate and minimized bedrock excavation. The location of the cannon fans at the high point of the residential tower provides optimal dispersal of lab exhaust. The displacement of the mechanical support and vertical exhaust ductwork into the adjacent residential tower positively impacts indirect cost recovery.

The CSM contains six different programs. The co-location of clinical and research space within the CSM facilitates the “bench-to-bedside’ concept. The program is organized vertically into a series of two-story “neighborhoods” deep lab support zone. The dry research and interaction zone resides at the east while the building’s vertical mechanical umbilical (connected to the residential tower) is at the west. Plug-and-play casework with ceiling umbilicals provide additional flexibility in the labs. The flexible block of lab support at the center, wrapped by a U-shaped linear equipment room, allows for a range of different configurations. The most notably innovation facilitated by this organization are the “vertical” vivaria on the two Neurology floors.

The Tisch Cancer Institute occupies the third and fourth floors and includes 48 exam rooms and 54 infusion bays. Located in the subcellar, the Radiation Oncology suite houses two linear accelerator vaults and adjacent CT simulator. Imaging equipment includes two 3T human/large animal MRI, one whole body 7T human/large animal MRI, two 1.5T MRIs, one CT, one Spectral CT, a general x-ray room and a nuclear medicine suite with a PET CT, PET MRI and hot lab.

Completion date: December 2012

USTAR, James L. Sorenson Molecular Biotechnology Building, Salt Lake City, Utah

Budget: $131 million

Size: 205,000 sq.ft.

Project team: Lord, Aeck & Sargent, Atlanta (architect/lab planner); Prescott Muir Architects, Salt Lake City (assoc. architect); Van Boerum & Frank, Salt Lake City (MEP/civil engineer); Ken Garner Engineering, Salt Lake City (electrical engineer); Reaveley Engineers & Assoc., Salt Lake City (structural engineer)

The Sorenson Molecular Biotechnology Building (SMBB) is designed to support interdisciplinary biomedical and neuroscience research and promote the growth of new businesses in these fields in the State of Utah. The Utah Science Technology and Research Initiative (USTAR) recruited and co-located 24 principal research investigators and their support staff. The USTAR initiative underwrites recruiting efforts in several key areas: fossil energy and carbon engineering, nanotechnology, biosensors, diagnostic neuroimaging, biomedical deviceiInnovation, imaging technology, circuits of the brain, personalized medicine, cell therapy and regenerative medicine, micro and nano systems integration, nanoscale and biomedical photonic imaging and digital media. The SMBB may house teams recruited from any of these areas which can be combined to investigate multiple research concerns collaboratively. The SMBB contains lab space, core facilities, faculty office space, symposium and conference space, and public areas designed to encourage and support space is designed for flexibility and adaptability to accommodate existing and future occupants. Core facilities will support faculty within the SMBB as well as university-wide resources in some instances. These core facilities include microscopy, small animal imaging, vivarium and nanofabrication.

Central to the Sorenson Building is the atrium which creates a “town square” for the building. It includes the lobby, science influenced art, conference center and café. The daylit labs and spectacular views, along with climate-sensitive mechanical and other sustainable design strategies, contribute toward the LEED Gold target. Intentionally, Different programs and sciences are intentionally overlapped to create collaborative interactions.

Completion date: April 2012

Ames Laboratory to Build New Research Facility

Plans are being finalized for construction of a new Ames Laboratory research facility that will house current and next-generation sensitive instruments such as electron and scanning probe microscopes. These instruments allow for detailed description of materials at the atomic level to aid in the discovery and design of novel materials. The nearly $10 million project is being funded through the U.S. Dept. of Energy (DOE)'s Office of Science.

“This state-of-the-art facility will greatly enhance our capability to study and characterize materials at the atomic scale and in turn improve how we are able to support the DOE’s mission,” said Interim Ames Laboratory Director Tom Lograsso. “The quality and impact of Ames Laboratory scientific research has increased our visibility within the DOE and around the world. We see support for this facility as recognition of that hard work.”

The 13,300-sf facility will be a straight-forward, rectangular-shaped building, but its rather plain exterior design belies the complexity of creating interior space isolated from vibration or electrical interference. It will have six bays to house sensitive instruments, such as electron microscopes used to reveal atoms and atomic structures. Working at such a small scale, even the slightest disturbance from vibration or electro-magnetic interference will blur the image.

Planning for the Sensitive Instrument Facility (SIF) has been in the works for about three years and included an in-depth site survey of five possible locations. The SIF will be built at the Applied Science Complex northwest of the Ames Lab/Iowa State Univ. campus because this site offers "the lowest site vibration levels ever measured” by the consulting firm reviewing the sites. According to Ames Laboratory facilities engineer Steve Carter, the plans should be finalized this fall which will allow the project to be bid in early winter with construction tentatively slated to begin in April or May 2014. Construction is expected take 12 to 15 months to complete.

U of Maryland Breaks Ground on Research Building

The Univ. of Maryland is breaking ground on a 428,970-sf, 10-story, and $305.4 million School of Medicine research facility. This will be the largest building on the UMB campus. The facility will provide both the lab space and new technology for the School of Medicine to continue to advance scientific discovery and breakthroughs in addressing the most critical disease categories.

The Univ. of Maryland School of Medicine is committed to fund $65 million of the total cost of the Health Sciences Facility III. The rest of the funding will come from State Appropriations. The building, which is set to open in January 2018, is the medical school’s first new research building since the 2003 opening of the Health Sciences Facility II, a $78 million, 101,000-sf facility at the corner of Penn and Lombard streets. The first Health Sciences Facility opened in 1995, and is adjacent to the second building.

Health Sciences Facility III will be located on West Baltimore Street on the site of the old dental school building. The lot is located between the Univ. of Maryland School of Pharmacy’s new building—which opened 2010—and the Univ. of Maryland School of Dentistry’s new building, which opened 2006. The new Health Sciences Facility III will include landscaped outdoor space and a plaza for academic and social exchange among scientists, scholars and the University community.

The architecture firm working on the Health Science facility III project is HOK/Design Collective Inc., and the construction manager is Barton Malow Company. The construction crews will demolish the old dental school building in October, making way for the new facility. The project is scheduled for completion in December 2017, and occupancy in January of 2018. Though the building will be 10 stories, two of those levels—or 66,316 sq.ft.—will be shell floors for build-out sometime in the future.

Florida Tech Accepts $13.1 Million Gift

Florida Institute of Technology has accepted a donation of a facility and land from Intersil Corp. in Palm Bay valued at $13.1 million. The gift includes 100,494 ft2 of office space, manufacturing, and cleanroom facilities in a two-story complex, plus five acres of property located on Palm Bay Road. The university will use the property to create the Florida Tech Research and Development Center.

“We’re delighted to receive this important gift from Intersil, and are grateful for their support,” says Florida Tech President and Chief Executive Officer Anthony J. Catanese. “We’re now looking closely at how we may best use this donation to advance the educational and research mission of Florida Tech. Our ‘high tech with a human touch’ focus is a perfect fit for a technology facility of this nature.”

“Florida Tech is an internationally respected leader in technology education, and we are pleased that this gift is a good match for their educational needs,” says Richard Crowley, Chief Financial Officer of Intersil. “We look forward to seeing Florida Tech utilize the space in ways that will better our community.”

Catanese said the university is examining a number of uses for the property. The office space may be utilized for continuing education classes for nearby professionals. Plans call for repurposing the largest areas as lab space, supporting engineering and science student project design, automotive development, and wind tunnel research.

Formerly a wafer fabrication facility, the building was constructed by Harris Semiconductor in 1977 and had served as part of Intersil’s wafer fabrication facilities until 2009, when operations were consolidated. Known as “Fab 54,” the facility has been used to make integrated circuits for major government, defense, and aerospace programs. It was also used to make analog and mixed-signal products for consumer electronics and telecommunications equipment.

The donated complex and land, complete with almost 300 parking spaces, is located down the street from Florida Tech’s Panther Bay apartment complex that opened earlier this year.

Intersil Corp. is a provider of power management and precision analog solutions. The company's products are used within the industrial and infrastructure, mobile computing, and high-end consumer markets. Its headquarters is based in Milpitas, Calif.

Advanced Biological Marketing Facility under Construction in Geneva

Ohio-based agricultural biotechnology company Advanced Biological Marketing has started construction on a new research and development facility in Geneva, according to Empire State Development.

The state is providing $200,000 in tax credits toward the $875,000 project, which is expected to create 14 jobs and will occupy a building formerly used by International Paper.

The construction will expand on the R&D and product development work ABM already does at the Cornell University Agriculture and Food Technology Center in Geneva, according to the state agency.

According to ABM, the facility will be used for the company's work on use of microbial agents to increase crop output and improve fertilizer use. Its director will be Gary Harman, who was a professor at the state Agricultural Experiment Station until he retired from Cornell a year ago and started a job as ABM's chief science officer.

Purdue Pharma Manufacturing to Create 100 Jobs in Durham County

Purdue Pharma Manufacturing L.P. will build a new facility in Durham County. The company plans to create 100 new jobs and invest $59 million over the next three years in Durham.

"North Carolina is recognized around the world for our bioscience and cutting-edge pharmaceutical companies," said Governor McCrory. "We're committed to helping companies like Purdue Pharma grow their business and get more products to the global marketplace."

Purdue is engaged in the research, development, production, and marketing of prescription and over-the-counter medicines and health care products. Purdue is an industry leader in pain medication research, and makes several important medications used to treat pain.

The new Durham facility represents the second major investment Purdue has made in North Carolina. In 2000, Purdue opened a state-of-the-art manufacturing facility in Wilson, bringing approximately 180 new engineering, scientific and technical jobs to North Carolina. The Wilson operation pioneered the use of product tracking technology and anti-counterfeit packaging to enable authentication and traceability of products from its warehouse all the way to the pharmacy shelf.

Salaries will vary by job function, but the average annual wage for the new jobs will be $70,199 plus benefits. The Durham County average annual wage is $66,602.

"This decision underscores Purdue's commitment to the Raleigh/Durham region, and solidifies the company's footprint in North Carolina through the establishment of a manufacturing and technology hub," said President and Chief Executive Officer of Purdue John H. Stewart. "This decision also reflects Purdue's ongoing commitment to invest in high-tech jobs within the state." The project was made possible in part by a performance-based grant from the One North Carolina Fund of up to $300,000. The One NC Fund provides financial assistance, through local governments, to attract business projects that will stimulate economic activity and create new jobs in the state. Companies receive no money up front and must meet job creation and investment performance standards to qualify for grant funds. These grants also require and are contingent upon local matches.

"I am extremely pleased that Purdue has chosen to expand in Durham," said Sen. Mike Woodard. "My office fully supports the growth of businesses in our region, and I look forward to working closely with Secretary Decker on future projects." Other partners that helped with this project include: the N.C. Department of Commerce, N.C. Community Colleges, Durham Chamber of Commerce, Durham County and the City of Durham.

AROUND THE WORLD

Covidien Opens Medical Center in Korea

Dublin, Ireland-based Covidien plc has opened a new facility dubbed the Covidien Center of Innovation (CCI) Korea in Seoul. It is the company’s first research and development (R&D) and training and education center in Korea.

Covidien invested $21 million into the center over the past three years. CCI Korea is a high-tech medical training center focused on raising awareness of various disease states and bringing Covidien’s product line closer to its Korean market.

“It is our responsibility and honor to help advance physician capabilities and uncover opportunities for locally tailored solutions to increase access to the best patient care,” said Brian D. King, president of Covidien’s emerging markets business. “Korea is a key market in our global strategy, and this investment is a reflection of our commitment to partnering with Korean healthcare professionals.”

The 6,000-square-foot center has a surgical lab with 11 operating stations; an intensive care unit (ICU) lab with two ICU stations and a human patient simulator; and an auditorium with seating capacity for 112 people that has 3-D/high-definition display technology and a state-of-the-art, optimized sound system to provide an immersive and experiential training environment.

“There is an increased expectation and focus on medical technology to help improve patient outcomes,” said Peter Kim, managing director of Covidien’s Korea business. “With the opening of CCI Korea, Covidien can further advance healthcare professional capabilities and enhance collaboration activities between R&D professionals, academic institutions and healthcare professionals to create access to improved standards of care.”

Earlier this year, Covidien signed two memorandums of understanding with the Korean Surgical Society and the Korean Society for Thoracic & Cardiovascular Surgery. In accordance with these agreements, all healthcare professionals affiliated with these two societies will experience CCI Korea as part of their mandatory certification programs. According to company officials, Covidien will continue to collaborate with Korean medical societies for training programs and new product development at CCI Korea, with a focus on promoting national health and advancing medical technology in the country.

Covidien makes a range of medical and surgical devices. The company’s U.S. headquarters are in Mansfield, Mass.

Jubilant HollisterStier Completes Expansion in Montreal

Jubilant HollisterStier has completed the first phase of expansion at its Montreal facility, adding to its sterile manufacturing capacity with a new ampoule filling line utilizing a rigid barrier system. The new area will expand ampoule manufacturing capacity by almost 200%. Additionally, the sterile areas have been optimized through successful implementation of Lean and Six Sigma initiatives.

The new area is scheduled to be ready for product on September 9, 2013. A significant portion of the expanded capacity has been allocated to new customer products that will be manufactured at the site.

“We are excited to complete this phase of our optimization strategy in sterile manufacturing. Our site in Montreal will be well positioned to continue offering multiple dosage platforms for our global customers. We have been fortunate to secure several new contracts that will utilize our expanded capacity starting this year,” said Marcelo Morales, Jubilant HollisterStier’s chief executive officer.

GSK to Launch New Center in Brazil

GSK announced it has formed a new collaboration with the São Paulo Research Foundation (FAPESP) to create a new Centre of Excellence for Sustainable Chemistry in Brazil. The agreement was reached after a meeting between Rogerio Ribeiro, senior vice president, Emerging Markets & Asia Pacific, GSK; Geraldo Alckmin, governor of São Paulo State; and Celso Lafer, president of FAFESP.

"GSK has a vibrant and growing business in Brazil and, as part of our continued investment in science in Brazil, we are delighted to announce our support for the new sustainable chemistry center. This will be an important enabler towards our goal of reducing the environmental impact of both the discovery and subsequent manufacturing of drugs to help us meet our target of being carbon neutral by 2050," said Ribeiro.

The Centre of Excellence will be located in the state of São Paulo and will focus on sustainable chemistries most relevant to the discovery and development of medicines. GSK has agreed in principle to co-fund the center with FAPESP, investing approximately £400,000 per year during a ten-year collaboration which will be matched by FAPESP.

GSK is already supporting a Centre of Excellence for Sustainable Chemistry in the UK based at The University of Nottingham. Once the new center in São Paulo is established, it will form scientific links with GSK and The University of Nottingham to facilitate the sharing of knowledge and expertise between Brazilian and UK researchers.

“FAPESP has formed partnerships to create world class research centers, such as this new collaboration with GSK. By applying interdisciplinary approaches to complex scientific challenges through this collaboration with GSK, FAPESP contributes to a knowledge advance in sustainable chemistry and the development of applications in areas of common interest," said Lafer.

Professor Chris Moody, the Sir Jesse Boot Professor at the University of Nottingham, said: “We are delighted to extend our collaboration with GSK into this new venture in Brazil. The Nottingham Centre of Excellence for Sustainable Chemistry that will be housed in a unique Carbon Neutral Building now being built on our Jubilee Campus, will be ideally placed to run a wide range of collaborative projects. We are looking forward to working with Brazilian colleagues.”

This latest announcement builds on GSK’s existing partnership with FAPESP to build a sustainable, long-term scientific research presence in Brazil. Through its "Trust in Science" program, GSK aims to support outstanding scientific groups in Latin America to validate and explore compelling ideas to treat priority diseases, including those that have a substantial impact on the health of Latin America.

Sanofi Expands African Manufacturing in Algeria

Algeria is seeing a big investment from Sanofi in manufacturing.

Sanofi has begun construction of a $95m (€70m) dry and liquid pharmaceutical plant in Sidi Abdellah, Algeria. The facility, which will include a distribution center, will be Sanofi’s largest industrial site in Africa when it’s finished in about three years, said Sanofi spokesman Laurence Bollack.

“Algeria is our largest affiliate in Africa and we will pursue our investments in this country to ensure that approximately 80% of the volume distributed by Sanofi in Algeria is produced locally,” Bollack said.

The new facility is expected to create 133 skilled jobs, will cover an area of 6.6 hectares in Sidi Abdellah, which is becoming a cluster of pharmaceutical and biotech companies, and is expected to have a production and distribution capacity of 100 million units a year.

The company has had operations in Algeria for more than 20 years, with two other manufacturing sites in Ain Benian and Oued.

But Sanofi’s investments in Africa aren’t just limited to Algeria. In April, the company built a $27m (€20m) logistics hub in Morocco. That hub is slated to become the largest distribution center for Sanofi’s pharmaceutical products in Africa.

At a groundbreaking ceremony for the new plant, Sanofi and the Algerian Health Minister also signed a letter of intent announcing their intention to execute, before Dec. 31, an agreement to improve the screening and assessment of cardiovascular risk, diabetes, and hyperlipidemia and the evaluation of their common risk factors in the Algerian population together with influenza monitoring.

This latest deal from Sanofi isn’t the only sign that pharma manufacturing investments are on the upswing.

The Sanofi deal follows Hikma’s recent announcement to build a manufacturing facility in Ethiopia . Hikma in 2010 also doubled its manufacturing capacity in Algeria and took full control of a JV there.

Another encouraging sign for investments is that counterfeits are dropping as the countries’ regulators become more sophisticated and supply chains become more uniform.

In addition, earlier in 2013 regional associations set up a pan-African organization to encourage local manufacturing.

Recipham to Expand in Germany

Recipharm has announced an investment of €32 million in its Wasserburg site located near Munich. The capital will be used to create a new building that will house a fourth production area adding to the three already in operation. This development will significantly increase the company's lyophilization capacity and will result in a brand new state of the art facility equipped with the latest automatic loading and unloading technology. The building will also have the flexibility to accommodate further production lines. The number of employees will be increased from the current 282 to 320 and the new area is expected to be operational in 2016.

The Wasserburg facility has a long history of producing products in vials and ampoules for large, medium and small pharmaceutical companies and was established almost 40 years ago. It has emerged as a world leading specialist in aseptic filling and lyophilization of injectable drugs supplying Europe, the USA, Brazil and Asia Pacific.

Armin Dallüge, General Manager of Recipharm in Wasserburg said "We are absolutely delighted with this decision to significantly expand our facility. We have been operating at full capacity for several years now and we see this investment as vital to maintain and increase our leadership in this field. Demand for lyophilization is expected to increase in the coming years and we intend to be at the forefront of servicing this".

Thomas Eldered, CEO of Recipharm AB, commented "Lyophilization is a fast growing technology which we believe will become even more important. Recipharm is one of the few Contract Development and Manufacturing Organizations with the capability to make such a significant commitment to this dose form and our financial stability sets us apart from our competitors. Given the excellent track record of Wasserburg and in particular the highly skilled workforce, we are very confident that this investment will help us to consolidate our position as one of the world's leading CDMO's".

Gilead to Expand Canadian Plant

Gilead will spend $47 million (€34m) to expand a Canadian plant at which it produces biopharmaceuticals for trials, including its Ph III hep C drug candidate sofosbuvir.

The plant in Edmonton, Canada produces clinical trial supplies of Gilead's candidate antivirals - including sofosbuvir - as well as several developmental cancer treatments. The firm plans to add additional lab and production space.

Gilead currently employs 250 at the site and - when the 45,000 sq.ft. expansion is completed - plans to hire 80 additional staff according to Robin Nicol, vice-president and general manager.

“This expansion represents an important opportunity to recruit highly trained clinical and technical professionals in Alberta."

Gilead acquired sofosbuvir in 2011 when it paid $11bn for biotech firm Pharmasset. News of the investment follows just a day after the US Food and Drug Administration (FDA) released a positive assessment of the antiviral.

In the document the US regulatory said: "The currently available data support a favorable benefit-risk assessment for the use of sofosbuvir as part of a combination regimen for the treatment of chronic hepatitis C.

"In the HCV GT 2 and 3 populations, the sofosbuvir and ribavirin combination regimen provides the first all-oral, interferon-free treatment, as well as a shorter treatment duration and improved safety profile compared to the current standard of care interferon-based regimen."

Most observers suggest that an oral alternative to injection-based Hep C treatment would quickly dominate the market and the positive review indicates that sofosbuvir could be a real contender.

Pall Opens Centre of Excellence in Shanghai

Pall has opened of a Centre of Excellence (CofE) in Shanghai for both local and international customers.

“This year marks the 20th anniversary of Pall’s expansion into China. The opening of the Shanghai Life Sciences Centre of Excellence is another milestone in Pall’s development in China,” said Larry Kingsley, Chairman and CEO of Pall Corporation.

The 92,536 sq. ft. facility provides “filtration, separation and purification support and training capabilities for a growing base of life sciences customers,” said Pall Corporation spokesman Doug Novarro.

Though Pall has been in the Chinese market for over twenty years, he said “The opening of our China Life Sciences CoE reinforces our continued commitment to this region.”

The site would showcase Pall’s full range of life science equipment and disposable solutions. These include:

“MicroReactors, Bioreactors, single-use systems, depth filter systems, Stax systems, tangential flow filtration (TFF) systems, chromatography systems, process monitoring, sterile filters and others.”

Though there are differences in China regarding regulations and requirements, Pall employs “local talent in China to better understand and address local needs,” Novarro said.

“With our local team of highly qualified engineers and scientists, we will be able to cater specifically to the process development needs of the expanding base of drug manufacturers in China.”

Further benefits for Pall’s China-based customers include the ability to use the facility as a springboard to explore international markets, he added, on top of a shorter cycle time for reports due to its expanded validation services capability.

Whilst local biomanufacturing firms such as Wuxi have been leading the way for biologics in China, there have been several large Western companies looking at this region of late.

Boehringer Ingelheim commenced a joint venture with a Shanghai company in June, whilst GE Healthcare recently penned a deal with JHL Biotech to build a modular biopharma plant in Wuhan.

Boehringer Ingelheim Biopharmaceuticals Move to China

Boehringer Ingelheim has signed with Zhangjiang Biotech & Pharmaceutical Base Development Company in Pudong, Shanghai a strategic alliance agreement and contract to build a cGMP biopharmaceuticals facility. The new site will provide full range of development and clinical services to Chinese and multi-national customers. It will become the first facility established by a leading international biopharmaceuticals manufacturer in China utilizing mammalian cell culture technology.

The facility set up will include technical process development and cGMP manufacturing which will be ready for operations early 2016. Boehringer Ingelheim plans an investment of over 35 million EUR. The project will create up to 65 job opportunities with high qualification standards.

“Our partnership with ZJ Base Company is an important step in our global China strategy as it opens a further opportunity for Boehringer Ingelheim to participate in the growing demand for high quality biopharmaceuticals in China”, stated Christian Boehringer, Chairman of the Shareholders Committee.”Shanghai is our ideal partner with its advantages in investment environment, service system and talent resources.”

Lanzhong Wang, General Manager of the ZJ Base Company commented: “We are very pleased to start the partnership with a leading biopharmaceuticals company like Boehringer Ingelheim. Through the cooperation, we hope to bring here the know-how, technology and experience, all up to international standards. With a number of innovative medicines being developed by a cluster of middle to small-sized innovative companies in Zhangjiang, plus the government support, we plan to initiate the CMO manufacturing framework at this plant on a trial basis. This will provide an effective platform for middle and small-sized companies to industrialize their innovations. Thus, it will greatly prompt the development of China’s biopharmaceuticals manufacturing industry.”

Teva Subsidiary Pliva Opens Facility in Zagreb, Croatia

Teva subsidiary Pliva has opened a new $100m (€73m) oral dosage manufacturing facility in Zagreb, Croatia to increase its export of tablets and capsules to the US and EU.

The investment also covers the transfer of the existing pilot plant for tablets to the new facility and a considerable increase of production capacities for sterile forms.

Miran Denac, PhD, director of operations for Pliva in Croatia, said: “Highly qualified employees have been trained in operating new production lines, and following the gradual exploitation of production capacities, new jobs will be opened in this production facility.”

The new facility expands Teva's annual capacity by 2 billion tablets or more than 25%. Products manufactured in the new facility are mainly intended for the EU and US markets. Commercial production is expected to begin as soon as the facility is approved by the US FDA and other regulatory agencies.

Pliva also said the new facility and its upgraded tech complies with special environmental monitoring requirements.

The announcement of the new facility comes little more than a week since Teva announced $2bn (€1.48bn) in annual cuts through 2017. Those plans include the sale of plants in California and Pennsylvania.

The company’s recent activity seem to indicate a shift toward more Eastern markets, as the company earlier this year also announced plans to invest further in Japan as these markets seem more interested in generic drugs.

Biosimilar Characterization R&D Facility Opens in Austria

University of Salzburg, Sandoz and Thermo Fisher Scientific collaborate to advance protein-based pharmaceutical development, production, QA/QC.

The Christian Doppler Laboratory for Biosimilar Characterization is now open at the Paris-Lodron University of Salzburg, and scientists there have commenced developing new methods for characterizing proteins to be used in biopharmaceuticals.

The new facility, co-funded by the Austrian Federal Ministry of Economy, Family and Youth, as well as the County of Salzburg through the Christian Doppler Society, was established to develop and transfer to practice novel and more efficient methods to characterize the active ingredients in protein-based medicines. Scientists from University of Salzburg, Sandoz Pharmaceuticals and Thermo Fisher Scientific are collaborating in these efforts.

“The more physical, chemical and biological data we can obtain for protein-based drugs, the more certain we can be that they will produce the desired effects and will not produce unexpected adverse effects,” explains Prof. Christian Huber, head of the new Christian Doppler lab. “Here, we are joining expertise in protein production and characterization, structural biology and synthetic chemistry at the University of Salzburg to develop innovative characterization tools to determine the efficacy and safety of protein-based medicines.”

“As the leader in protein characterization technology, we are confident that we will make a significant technical contribution to the detailed analysis of biosimilars and their quality control,” observes Dr. Alain Guiller, vice president of global sales, life science mass spectrometry (LC-MS) at Thermo Fisher Scientific. “This is a rapidly-developing field, and this close cooperation with the University of Salzburg and Sandoz will increase our understanding and help us to serve the emerging needs of the pharmaceutical industry.

Thermo Fisher’s participation will focus on providing expertise for applying Orbitrap-based LC-MS technology, nano-UHPLC (ultra high-perfomance liquid chromatography) systems and columns, and software to future workflows for protein-based drug characterization and quality control.

“For us, the collaboration constitutes an important means to gain access to very recent technologies for industrial application, in order to make our production safer and more efficient,” adds Dr. Andreas Premstaller, head of Sandoz’ Schaftenau production site.

Rondo-Pak Opens New Facility in San Juan, Puerto Rico

Rondo-Pak, a leading provider of quality folding cartons to the pharmaceutical, biotech and medical device industries, has opened a manufacturing and distribution facility in San Juan, Puerto Rico. The new location will offer world class climate controlled manufacturing and warehousing space, and gives Rondo-Pak a foothold on an island well known for its flourishing healthcare products manufacturing industry.

The new facility immediately makes Rondo-Pak an attractive option for pharmaceutical manufacturers seeking a reliable new supplier, as well as those looking for a strong secondary supplier to help minimize risk. Rondo-Pak also will use the facility to manufacture folding cartons, and has plans to expand the plant’s production capabilities to include other printed packaging components.

The facility’s prime location is seen as a major advantage: San Juan has Puerto Rico’s

largest port, and is the convergence point for many of the island’s major highways. This

gives Rondo-Pak a logistical advantage in optimizing supply chain solutions, as well

as efficiently transporting products to customers not just in Puerto Rico but throughout the greater Caribbean region.

Puerto Rico’s stature as a prime location in the healthcare and pharmaceuticals sectors has

seen a resurgence over the past few years, thanks in part to its installed base of Biopharma

manufacturing assets, its skilled workforce talent pool and superior tax incentives.

“Our new facility in Puerto provides an on-island alternative for Rondo-Pak’s high quality

folding cartons and packaging solutions,” said Victor Dixon, President & COO of Rondo-

Pak. “Supported by Körber's Medipak Systems and Rondo AG – Rondo-Pak’s parent

company with multiple manufacturing locations worldwide – our team of pharmaceutical

packaging experts can address a wide variety of customer needs on-time and on-budget.”

Cyprotex Sets Up at Former UK AstraZeneca R&D Site

Preclinical CRO Cyprotex has set up a laboratory at a former AstraZenca R&D facility that ceased drug development operations earlier this year.

The discovery arm of the UK contract research organization (CRO) unveiled the new lab and explained that the decision to establish cell culture production, radiochemical handling capabilities and office space at the site in Alderley Park, Cheshire was motivated by an increase in client demand.

Cyprotex said: “We are observing an increase in demand across a range of offerings” from customers in the pharmaceutical, biotechnology, argichemical and cosmetics industries.

The firm added that: “We will be expanding our general screening capabilities especially in the field of drug transporters” and went on to say that the new lab will employ a six strong team of scientists.

Cyprotex also reported a 22% increase in first half revenue and operating profit of £317,000 ($514,617) citing strong performance in all of its geographic markets as the key driver.

The investment in the UK laboratory – financial terms of which were not disclosed – follows just a few weeks after Cyprotex secured additional funding of around £4m through a loan from investors including Harwood Capital.

However, while the CRO said the loan would fund expansion of its business on both sides of the Atlantic, it specified that the main focus of the spending would be the laboratory in Watertown, Massachusetts that it gained through the 2010 acquisition of Apredica .

Cyprotex is one of the first companies to lease space at the Alderley Park site since AstraZeneca revealed its intention to cease research and development (R&D) activities there in a surprise announcement in March .

Since then the Anglo-Swedish drugmaker has been relocating R&D to operations in either a new site in Cambridge, an existing unit in Macclesfield or to locations outside the UK. The firm also shifted production of the cancer drug Zoladex and packing and distribution operations formerly carried out at the site.

Cyprotex’s new lab is part of an effort by UK bioscience incubator BioCity to establish a drug R&D center – or BioHub – at the site at the behest of AstraZeneca.

BioCity spokesman Ian Webster confirmed that Cyprotex has leased laboratory space that is suitable for work involving low level radioactive isotopes as well as a cell culture suite.

The CRO is the fifth firm to lease space at the site behind discovery firm Blueberry Therapeutics, imagining analysis specialist Imagen Biotech, Redx Anti-Infectives and Gentronix, the latter of which is due to set up shop in the next few weeks.

Global Alliance Backs Insulin Plant in Bahrain

Gulf Biotech has teamed up with Merck, Helm and Linde to build a $93m (€68m) insulin facility in Bahrain.

The 16,000m2 (172,160 sq. ft.) site in the Salman Industrial City is set to commence operations by mid-2015 with capacity of 42 million units, according to a report in the built in Bahrain publication Gulf Daily News.

The project is being led by Gulf Biotech - whose shareholders include Saudi-owned Al Roaya Gulf Group Holdings - but is backed by an alliance involving the multinational firms Merck & Co., Helm and Linde.

Dr. Thomas Hagn, a spokesperson from the Germany-headquartered engineering firm Linde, confirmed its part in the project.

“Our subsidiary Linde Engineering Dresden (LED) has been awarded this contract,” he told us. However as the project is still in its early phases LED has “an initial contract only for basic engineering of the plant (formulation of compounds and filling).”

Med Tech Expands Cleanroom

Lombard Medical Technologies PLC, a specialist medical technology company focused on vascular products, will expand its facility in Didcot, Oxfordshire, U.K. The company has decided to divest its non-core OEM business based in Prestwick, Scotland until Dec. 20, 2013, the completion date of the transaction.

Lombard is expanding its facilities in Didcot by around 10,000 ft2, involving the construction of a new cleanroom and materials handling space, at a cost of around $480,000. The expansion is expected to be completed in the first quarter of 2014 and new jobs will be created at the site once the new facility is operational.

Aorfix is Lombard’s stent graft device for the treatment of abdominal aortic aneurysms with neck angulations up to 90 degrees. The R&D and process development activities for Aorfix currently undertaken at the Prestwick facility will be transferred to the expanded R&D and manufacturing facilities in Didcot. Aorfix received FDA approval from the United States earlier this year, and anticipates regulatory approval for Aorfix in Japan in H1 2014.

The OEM business, which manufactures a range of medical products for third parties, and certain assets, will be divested to Culzean Medical Devices Limited for about $959,000 in cash. Under the terms of the divestment agreement, some employees in Scotland will transfer to support the new owner’s business activities; other employees will be given the opportunity to relocate to Didcot.

Nice-Pak Products and PDI Open Innovation Center

Affiliate companies, Nice-Pak Products, Inc. and PDI, Inc., leaders in developing, manufacturing and marketing wet wipe solutions, announced the opening of their new world-class Innovation Center in Montvale, NJ. This center will deliver products for healthcare, consumer and commercial markets including surface disinfection, surface cleaning, skin antisepsis, hand hygiene and personal care.

The companies have headquarters in Orangeburg, NY and Flint, Wales, UK.

The 28,000 square foot Innovation Center is equipped with state-of-the-art lab space, and will house 60 full-time employees dedicated to the company's research and development operations, with approximately 15 additional positions to be added over the next 18 months.

"Each year our products touch consumers 150 billion times. Not only do we make a significant difference through our sustainability initiatives but we also have the opportunity to help educate families and communities on the important role they can play in promoting the health and wellness of people and the environment," says Robert Julius, CEO of Nice-Pak. "The new facility affords us the opportunity to continue providing superior products while supporting our commitment to the environment through the use of sustainable materials and packaging."

"More than 100,000 lives are lost each year in the U.S. to preventable healthcare and community acquired infections," says PDI CEO, Zachary Julius. "PDI is dedicated to developing solutions and promoting education to help fight against preventable infections. This new space is an investment in our shared, purpose-driven future."

Nice-Pak, founded in 1957, is a global leader in the design, manufacturing, marketing and distribution of premium quality branded and private label pre-moistened wipes. Headquartered in Orangeburg, NY, Nice-Pak brands include Nice 'n Clean, Grime Boss, Sani-Hands and Wet Nap.

MedPharm Opens UK GMP Facility

MedPharm opens a new facility in Guildford, Surrey, UK.

MedPharm, a UK-based topical and transdermal formulation development specialist, has opened a new £500,000 GMP facility in Guildford as it strives to double turnover and increase market share over the next five years.

The investment adds a new microbiology laboratory, cleanroom suites, a dedicated ICH stability testing area and a quality control and performance testing laboratories to support Phase I and II clinical manufacture. The facility also allows for the manufacture of highly potent compounds up to OEB 4 level with a manufacturing batch scale of up to 50kg and primary packaging, labeling and randomization services.

'The opening of the new site is a huge milestone for our business. We can now offer a true one-stop shop for formulation development, all provided in house,' said Medtech's Chief Executive Dr Andrew Muddle.

'In particular, the bespoke clinical trials supplies production facility, regulated by state-of-the-art monitoring systems, will provide clinical manufacturing capabilities designed to handle a range of non-sterile dosage forms. These include liquids, semi-solid gels, creams and ointments, as well as inhaled products, sprays and transdermal patches.'

The expansion was funded partly with assistance from Lloyds Commercial Banking.

Carbogen Amcis Invests in Manufacturing

Switzerland-based Carbogen Amcis, a division of the Indian Dishman Group, has made significant investments to enhance its antibody drug conjugate (ADC) capabilities to respond to increasing demand for ADCs in the development of cancer drugs.

Carbogen Amcis announces a series of investments aimed at enhancing its antibody drug conjugate capabilities in the development of highly targeted cancer treatments. The investments include a $4 million cleanroom clinical supply facility at the Bubendorf, Switzerland site, and a $950,000 upgrade of the sterile manufacturing area at the facility in Riom, France.

The Bubendorf facility now features a 1,076 ft2 ADC cleanroom suite dedicated to the development and production of ADC clinical material under current good manufacturing practices, and contains grade D and grade C areas to allow aseptic and safe handling of highly potent material at occupational exposure limit values (OELs) below 1 µg/m3 at 8-hour time weighted average (8h-TWA). A system of pressure cascade and air locks for material and personnel fully segregates both areas of the cleanroom from the rest of the building and ensures sterile operations within both compartments.

The grade D area of the lab is dedicated to operations such as the preparation of reagents and buffers as well as the sterilization of production equipment by dry oven or autoclave. The segregated grade C area is exclusively used for the conjugation, the purification, and the packaging of ADC material under cGMP and features an isolator for the preparation of toxin solutions, a barrier system for aseptic filtration, a walk-in fume hood for handling of organic solvents, and a bio-safety cabinet (classified grade C) for antibodies and ADCs.

The upgrades at the Riom location include the implementation of a vaporized hydrogen peroxide disinfection system and the installation of two aseptic filling isolators operating under nitrogen atmosphere and at regulated temperature, which will expand the Grade A (ISO 5) manufacturing capability at OELs below 1 µg/m3 8h-TWA, allowing a maximum batch size up to 5’000 units (2 mL vials).

“In addition to strengthening our ADC capabilities, over the past 12 months, we have built a cross-functional team with expertise in chemistry, biochemistry, and biology that is well equipped to support our customers’ cancer drug development programs,” says Mark C. Griffiths, CEO, Carbogen Amcis and the Dishman Group.

Carbogen Amcis is a service provider that offers a portfolio of drug-development and commercialization services to the pharmaceutical and biopharmaceutical industry at all stages of drug development. Carbogen is a member of the Dishman Group, an outsourcing partner for the pharmaceutical industry.

Aesica Extends Aseptic Facilities

Aesica, a UK-headquartered contract development and manufacturing organization (CDMO), has extended its aseptic capabilities at its Nottingham site with the acquisition of new equipment to manufacture pre-filled syringes that is capable of processing 5,000 units/batch. This latest addition, currently undergoing its validation through process simulation trials, will enable Aesica to work with clients across the EU and US markets.

The total investment in this specialist technology will be more than £500,000 on completion of the validation process by January 2014.

The prefilled syringes market is currently worth over £1bn and is growing rapidly. The new kit will enable Aesica to produce more innovative products, such as pen and cartridge syringes, and nasal devices.

Over the next three years, the firm says it is targeting production of 900,000 units and is already in advanced discussions with one company for the scale-up of a clinical trial product for which a joint validation is imminent.

Ian Lafferty, Site Director Nottingham, said: 'Pre-filled syringes are a natural evolution towards providing a complete product portfolio for our clients, and a reflection of the direction the wider market is heading. Demand is increasing for these products and very few other CDMOs are currently able to supply this in such quantities for clinical trials.

'Biotechnology companies are already starting to make contact with us and I would envisage a steady uptake across the US and in particular Europe where we are likely to see huge growth.'

GEA Supplies High-Containment Facility to Penn Pharma

Representatives from GEA Pharma Systems were present when Penn Pharma officially opened its new, £14m purpose-built state-of-the-art facility for the development and manufacture of high quality oncology drugs in Tredegar, South Wales at the end of September.

Penn Pharma now operates a high-containment manufacturing plant for the production of multiple active pharmaceutical ingredients (APIs) in batches of 1–120kg.

The firm identified an increase in the number of potent molecules in the market and, therefore, the opportunity to provide an outsourcing solution for the development and production of potent solid dosage products. In response, it required a totally new concept in plant design, incorporating leading technology, the latest techniques and the ability to upscale operations from R&D, through pilot-scale testing, up to full production.

Penn Pharma partnered with GEA Pharma Systems from the outset to develop an initial concept and select the technologies required, then co-operated with the engineering consultants to ensure that the plant was optimally designed for containment using a design-for-manufacture approach.

GEA’s approach was to use its containment expertise to eliminate the use of isolation suits in favor of containment interfaces (Buck MC high-containment valves and Hicoflex couplings). These would interface with GEA’s advanced granulation (FlexStream, PMA 150, PharmaConnect), containment and compression (Courtoy MODUL) technologies — all of which were incorporated into the new plant.

Compliant with the highest international standards of cGMP production, the new purpose-built 15,000ft2, three-storey site now offers a geometrically scalable dispensing, granulation and blending process from powder to capsule and has almost completely eliminated the need for isolation suits. Highly contained equipment trains were designed to minimize the need for personal protective equipment (PPE) and reduce the use of isolators to an absolute minimum.

Penn and GEA worked together to deliver an end-result on budget against a demanding timescale: the first product batch of coated tablets was delivered within 12 months of GEA receiving the initial order.

Cherwell Laboratories Expands Cleanroom Facility

Cherwell Laboratories, a supplier of microbiology media and instruments for pharmaceutical and related industries, has expanded its cleanroom facility by 750 ft2 to over 3,000 ft2. Phase II of the company’s expansion program will boost Redipor microbiological prepared media plate filling and bottle production capabilities.

Once Phase II is completed in early 2014, Cherwell's facilities will have doubled in size since July 2012. Phase I delivered new inspection and packing facilities to maintain quality requirements in media preparation prior to Phase II's increase in Redipor production facilities. Cherwell does not package Redipor products straight from the filling line but first holds them to condition, and all products then undergo inspection before final packing.

"Phase II of our cleanroom extension will provide additional manufacturing space to allow us to invest in further production equipment, such as large scale plate filling systems, media preparators, and autoclaves," says Andy Whittard, Managing Director, Cherwell Laboratories. "By carefully planning and controlling the works around our own production schedules and with our contractor, Envair Projects, we aim to minimize any impact to customers and product lead times."

Cherwell has recruited five new staff members since the completion of Phase I, with three additional new starters anticipated before the end of 2013. The company is based in Bicester, U.K.

IMCD Adds Pharmaceutical Lab in Huerth, Germany

IMCD Group, a Netherlands-based distributor of specialist chemicals, has significantly expanded its laboratory capability with the addition of a pharmaceutical laboratory in Huerth, near Cologne, Germany. This new space totals more than 120m2 (12,912 sq. ft.) of laboratory, office and conference facilities.

The IMCD Pharmaceutical Technical Centre (PTC) will focus on training and market support throughout Europe. By the end of the year it will be equipped to support activities for solid-dose development, tablet-coating and the development of suspensions and syrups.

Dr Alen Guy, Technical Director IMCD Pharma, said: 'This laboratory is a substantial investment in IMCD’s capabilities and provision of an essential service to its many customers. Strategically located in the heart of Europe, this laboratory allows us to greatly enhance our internal training and technical support for the rapidly expanding number of projects we are involved with.'

Significantly, the firm has established a true IMCD Technical Centre in Europe alongside the Coatings laboratory, QC laboratory and sampling centre already located in the same premises. IMCD says this will allow it to maximize scientific resources and create a solid technical interaction across the group.

'Heading into 2014 we will have completed 12 2–3 day training courses for IMCD account-, product- and business-unit managers from all over Europe, Africa and Asia,' Guy added.

The IMCD PTC is the 18th laboratory for IMCD, following six laboratories in Coatings, six in Personal Care and five in the firm’s Food & Nutrition Business Groups.

Vetter Expands Filling Capacity

The CDMO Vetter is investing more than $100 million across its production sites in Germany and the United States to expanding and upgrading its facilities to expand filling capacity. Two new filling lines are currently being designed for Vetter's Ravensburg South facility in Germany. The new lines will fill liquid cartridges and vials and will add to the production site’s current lines, one of which is a syringe line that was launched in the spring 2013. At Vetter’s US clinical manufacturing facility in Chicago, a third filling line for prefilled syringes is nearing completion. Expected to be operational in 2014, the new clinical line will have a maximum batch size of 30,000.

To enhance efficiency in up-and downstream processes but also to accommodate the additional capacity, Vetter is expanding its storage volume for cold-and room-temperature products as well as frozen products. In addition, two new thawing rooms in Class 100,000 environment and two more lyophilizers to add to the currently nine in operation, will be installed. Also, Vetter’s single-use isolator technology is being expanded and implemented at Vetter production facilities to lower risk of product cross-contamination with high-potent compounds, such as hormones and cancer therapeutics.

Ardmac Awarded Cleanroom Fit-Out Package for Irish Manufacturer

Ardmac has secured a cleanroom fit-out for the Helix Medical joint venture partner in Carrick-on-Shannon.

The investment, which is being supported by the government through EnterpriseIreland, will see VistaMed expand its research and development activities to ensure continued growth in export sales and Irish employment and ultimately lead to the expansion of their manufacturing facilities in Carrick on Shannon.

The 35,000 ft2 expansion of the facility includes a 12,000 ft2 cleanroom required to meet the growing need for diverse braided catheter assemblies as well as a new area dedicated to thermoplastic extrusion.

In addition to the cleanroom fit-out package, Ardmac have been awarded an 8,000 ft2 interior fit-out package.

Established in 1998, VistaMed offers design, development and manufacturing of complex Catheters and complimentary Medical Devices supported by a state of the art extrusion process manufactures complex medical tubing out of two manufacturing plants in Carrick on Shannon, Co Leitrim and Rooskey, Co. Leitrim. The company employs 93 people in Leitrim and exports to the UK, Europe, America, South America and India.

Northern Ireland to Get New Forensic Science Lab

Planning approval has been granted for a forensic science laboratory in Carrickfergus. The permission is for the development of a new laboratory at Forensic Science Northern Ireland (FSNI), which when complete will meet the highest of European standards.

The £12m capital investment will provide a state-of the-art building for DNA processing and evidence recovery facilities at the current site FSNI at Seapark, Carrickfergus.

The proposal is for a high standard laboratory accommodation and offices – a four storey building with three floors of laboratory accommodation with an enclosed plant room above.

A key feature of the new building, in addition to its ability to facilitate increased throughputs, will be the exacting standards of control of its internal cleanroom environment. It will also be a highly energy efficient building, generating more power than it consumes.

The new laboratory will meet the BREEAM excellent standard, thereby ensuring that the UK Government’s commitment to environmental and economical sustainability is met.

Fujifilm Diosynth Biotechnologies Opened Facility in the UK

The facility – in Billingham, Teeside – has been providing microbial contract manufacturing services for more than a decade. In April FujiFilm announced its intention to begin mammalian cell-based biopharmaceutical production at the site to gain a “larger slice of the market.”

The now operational manufacturing area houses two Xcellerex single-use bioreactors – one 200L capacity and one 1000L capacity – according to spokeswoman Bridget Hall who told BioPharma-Reporter.com the CMO already has experience using the systems.

“We have installed Xcellerex single-use systems at the Billingham site, as this will give us common equipment with our sister site in Research Triangle Park, NC, US.

She added that: “The build quality of the Xcellerex system is taken to be high and is an attractive feature of the system, and allows for flexibility and scale-up across the whole range, as well as ease of expansion.”

Fujifilm plans to add a 2000L capacity bioreactor sometime next year and is likely to choose an Xcellerex system Hall said, explaining that “It would make technical and operational sense to use the same system for 2000L scale-up.”

The site will also have cell line development capabilities for customers according to Hall, who added that: “The services are aimed mainly at clients starting pre-clinical development and as such we are able to offer two CHO based cell lines.”

The new facility also houses a cell banking facility, which has been operational since April this year for commercial reasons as Hall explained.

“The cell banking facility is a small section of the new Mammalian facility it was just completed and operational earlier than the rest of the facility so we could commence business.

“The manufacturing facility contains the cell growth and production suites, including downstream processing and buffer make up and hold areas.”

Bahrain to Get Insulin Factory

Construction work for a new insulin factory in Bahrain will soon get underway.

Being built by Gulf Biotech Company at an investment of $93 million, the plant will come up on a 16,000 sq.meters (172,160 sq. ft.) site in Salman Industrial City, the company's chief executive Dr Riyadh Al Ashban said in a statement.

"The plant is expected to start operations by mid-2015 with an initial production capacity of 42m units.

"We expect to create around 250 jobs for Bahrainis and Saudis," he said.

The project will be backed by an alliance involving global multinationals Merck, Helm and Linde.

The products will match American and European specifications, he said.

Gulf Biotech's shareholders include Saudi-owned Al Roaya Gulf Group Holdings and the chairman of the company's board is Saudi Prince Sultan bin Fahad bin Abdulaziz.

Canadian Feds Give Pharma a $2.9M Boost

The Hon. Gary Goodyear, Minister of State for the Federal Economic Development Agency for Southern Ontario, alongside Rick Dykstra, Member of Parliament for St. Catharines, has announced a Government of Canada investment that will allow Biolyse Pharma in St. Catharines to expand its facilities and product line of injectable chemotherapy drugs.

"Our Government's top priority remains creating high-value jobs, growth and long-term prosperity for Canadians," says Minister Goodyear. "This investment will allow Canada's only manufacturer of injectable chemotherapy drugs to expand its operations in St. Catharines, bring high-quality jobs to the local pharmaceutical industry, and help meet the global demand for affordable, life-saving cancer treatments."

"Today, our Government's commitment to investing in the development of a supportive environment for the region's pharmaceutical manufacturing cluster is being showcased," says MP Dykstra. "Getting our small- and medium-sized businesses the tools they need to stay productive and competitive is imperative."

Biolyse Pharma produces generic chemotherapy and anti-cancer drugs for Canadian and international markets. Through FedDev Ontario's Prosperity Initiative, Biolyse Pharma will receive an investment of up to $2.9 million to complete an expansion of its facilities and production capacity. This project is expected to create up to 59 new highly skilled full-time jobs, allowing the company to reach new markets and increase product diversification.

After a period of training new staff, the company will build a new 20,000 ft2 cleanroom to let it make millions of dosages every week. Among drugs to be developed are those for pain management, asthma, and antibiotics.

"The significance of this repayable contribution encourages Biolyse to move forward with its development program, which will expand its line of vital medicines made by Canadians for Canadians," says Claude Mercure, Owner of Biolyse Pharma.

Created in 2009, FedDev Ontario supports the southern Ontario economy by building on the region's strengths and creating opportunities for jobs and economic growth.

Hikma JV to Build Pharma Plant in Ethiopia

Hikma Pharmaceuticals has signed onto a joint venture with MIDROC Pharmaceuticals to establish a presence in the Ethiopian pharmaceutical market.

Hikma makes inroads into Egyptian pharma market. The JV will be called HikmaCure and London-based Hikma and MIDROC will invest in equal proportions and have committed to provide up to $22.3m each in cash.

The combined company over the next five years will establish an Ethiopian operating company, build a local manufacturing facility and begin marketing and distributing pharmaceuticals in Ethiopia. In the short term, MIDROC will work with Hikma and HikmaCure to register, market and distribute Hikma’s products in the Ethiopian market.

“We believe Ethiopia offers strong growth potential in the medium to long term and our investment at this stage will enable us to be well positioned in the market. We will continue to explore opportunities to build our presence in the sub-Saharan region,” Said Darwazah, CEO of Hikma said.

The Ethiopian pharmaceutical market is valued at over $500m and is growing at a compound annual rate of around 15% and is expected to reach approximately $1bn in 2018. Currently about 75% of the market there is based on pharma imports.

The funds for the JV will be invested to build and fit-out a local manufacturing and distribution facility in Ethiopia and to provide working capital support for the operations of HikmaCure. The facility is expected to begin commercial production in 2017.

West Opens Second China Plant

West has begun production at its second manufacturing facility in China, driven by the growing market for pharma injectable components in the Asia pacific region.

The 11,900m2 (128,044 sq. ft.) compression molding facility in Shanghai, China, was officially opened and will produce elastomer pharmaceutical components and medical devices, supporting the growth of injectables in the region.

“The plant was planned to service primarily customers in China and the Asia Pacific region,” said Warwick Bedwell - President, Asia-Pacific Region. “Customers will include Multi National Pharma companies and their CMOs as well as local Generic and Biopharmaceutical manufacturers.”

He continued to add “the market for injectable pharmaceutical components is very large and estimated at 83.5bn units per annum and growing at 12 percent.”

Furthermore, Bedwell mentioned the growing number of diabetics driving demand for pre-filled syringes and insulin components, with an estimate from WHO of 92 million patients in China alone, and a growth rate of over ten percent in SE Asia.

As for competition, he said “there are more than 60 competing manufacturers of stoppers and seals in the region,” though he expects West’s experience in China to differentiate itself by offering “consistent quality and machinability” and understanding its customers’ needs.

The facility is West’s second to be built in China and is adjacent to the injection molding facility which opened its doors in 2009. That process was deemed “very tedious” by West at the time, due to delays and setbacks put down to differences in regulations and cultural practice.

Constructing and the opening of this facility, however, was predicted to be easier due to relationships forged in the development of the original plant, and this seemed to be the case according to Bedwell.

“All new plants have their challenges, however with the help of representatives of the Chinese Government and the Shanghai Zhangjiang High-Tech Industrial Development Zone Qingpu Park [where the plants are located], the project was completed on time with very few problems.”

Furthermore, it was a much more global effort, he said, with representatives from West’s teams in China, Singapore and Germany ensuring the project ran smoothly.

West is also demonstrating the importance of the Asia Pacific market with a new packaging facility in Sri City, India which began construction last year, and will also manufacture elastometric components.

GE to Build Disposable Biopharmaceutical Factory for JHL Biotech in China

GE Healthcare Life Sciences has agreed to build a modular biopharmaceutical factory in China for JHL Biotech, which could be a model for ways to grow local manufacturing in emerging markets.

The construction of the disposables-based facility, known as KUBio, offers a new approach to biopharmaceutical manufacturing because GE can deliver a functional, ready-to-run bioprocessing facility in a shortened timespan of between 14 and 18 months when compared with the regular timeframe for building a facility.

Olivier Loeillot, general manager of enterprise solutions at GE Healthcare Life Sciences, said that the pre-designed facility is actually built in Germany under cGMP specifications, and then GE assembles it at the site in the Biolake Science Park in Wuhan, China.

The site for the new factory is expected to be fully operational by early 2015.

In addition to GE project-managing the construction, members of its Shanghai Fast Trak team will be deployed to validate the equipment and provide training for JHL Biotech staff.

After completion, the JHL Biotech facility will have a floor space of approximately 2,400m2 (25,824 sq. ft.) and will contain four 2,000L single-use bioreactors, Loeillot said.

The facility will be able to produce mAbs (monoclonal antibodies), mostly for use in cancer treatments.

The design concept of KUBio reflects in part a wider movement in China and other emerging markets such as India and Brazil, which are looking to establish local manufacturing capacity, Loeillot said, noting that GE has a “rich pipeline of projects over the next few years.”

He explained the ease with which these facilities can be set up will transform the way emerging markets can expand their local manufacturing and deal with growing cancer and diabetes rates.

“Biopharmaceutical companies are switching at a fast pace to disposables-based facilities because of the way they can entirely eliminate the prospect of contamination and cleaning, which can be more difficult with less experienced professionals.

“The advantage of being able to switch between products quickly is also one of the major benefits of disposable bioreactors,” Loeillot added.

As far as the environmental concerns of single-use, which Loeillot said he’s received a lot of questions on, there is actually more of an upside than downside, he added.

Reductions in water consumption from the elimination of cleaning as well as decreases in electricity have made disposable biopharma tech eco-friendly. But he also acknowledged that the disposable bioreactors have to be disposed of properly.

Leatherhead Brings Chemistry Facilities into One Lab

Leatherhead Food Research has brought all its chemistry facilities into one laboratory which it officially opened last week.

It was designed for flow-through of samples from receipt and preparation through to extraction and analysis.

This will allow the analytical services at Leatherhead to grow in capacity and scope, and expand research capabilities, said Leatherhead.

As ingredients enter the marketplace and consumer demand for more natural and functional product profiles increases, testing services that support and validate these changes need to evolve with them.

Leatherhead also opened the “DirtyLab” earlier this year which allows microbiological testing of foods to be done under factory-like production conditions.

Dr. Rachel Burch, chemistry research manager, said the lab provided a dedicated space for food chemistry. “It supports other parts of the business in product development, shelf life testing, changes in color and in storage, nutritional and vitamin testing – it depends on the regulations and if there are contaminant scare enquiries which come in but you can’t predict that,” she said.

“There is not a particular trend at the moment. We have many different departments which specialize in food so if there is a problem of someone comes to us with product development work we can do it.” She added that the lab had a mix of customers, mostly from the UK but some in the U.S. and had links with Australia.

The facility has retained its UKAS-accreditation for food testing, including Group 1 and Group 2 nutrition, and ELISA-based assays for allergens and meat speciation.

Dr Burch said that while they use ELISA for allergens, polymerase chain reaction (PCR) is used for meat speciation and they also have LC-MS/MS capabilities. The increased space has allowed Leatherhead to bring all of our chemistry facilities into one laboratory, with a dedicated section for allergens’ testing. “With allergens we are dealing with low levels, take cake mix for example we have flour, eggs, milk so we don’t want cross contamination in any levels as the particles can be airborne so we separate in terms of space and physical barriers,” she added.

Leatherhead said its research activity has seen significant growth in recent years and the laboratory is designed to cope with that.

Dr Derek Craston, chief scientific officer, LGC, opened the Chemistry Research Laboratory. “LGC and Leatherhead have a long association and we share a common vision to help create a vibrant industry in the UK, making sure that the products produced are of high quality.”

Boehringer Ingelheim Expanding China Plant

In the wake of recent bribery scandals, Boehringer Ingelheim (B-I) has called for stricter regulations in China, as it plans to triple production at its Shanghai manufacturing site.

The Germany-headquartered company announced it was to spend $70m (€96m) expanding its solid and liquid dose manufacturing plant and adding an R&D Centre of Competence in the Zhangjiang High-Tech Park, Shanghai.

Spokesperson Heidrun Thoma said, “The plant expansion will help establish an effective supply chain, improve product competitiveness and thus gain a bigger market share.”

The expansion will push employee numbers at the plant up to 350 and production of tablets and syrups is set to triple to over 220 million packages by 2018.

Furthermore, this will fuel the firm’s vision of making the plant “a launch site” in the company’s global operations network, Thoma added, securing “the supply of intermediates and APIs for B-I’s major products” as well as leading “innovation [with] more efficient and cleaner manufacturing processes.”

The pharma industry’s presence in the country has been undermined over the last few months, after GlaxoSmithKline was investigated over reports it had bribed officials and doctors . The scandal also led to several other firms being investigated, including AstraZeneca and Novartis.

“All the negative impact is a challenge on the psychological side, for everyone in the industry,” Thoma told us. “The majority of the employees in our industry does an ethical job, and we don't think the whole industry should be blamed for a few people acting beyond the rules.”

“All the major multinational companies operating in China have very strong compliance departments. The issue now is how to enforce the rules and make sure people don't find loopholes to go around the regulations.

“First, there has to be a set of strict regulations in the entire industry, and, second, employee training is also very important to make sure they follow the rules,” she said, stressing the importance of having a reporting mechanism within a company to ensure compliance departments remain worthwhile.

So far B-I - which has been operating in China since 1994 and recently formed a biomanufacturing joint venture with a local firm - is yet to have felt an impact from the scandals but Thoma said: “We may gradually feel it and then we'll be able to better assess the impact on the business side."

Amgen to Open China R&D Center at ShanghaiTech

Amgen and ShanghaiTech University announced the two organizations have entered into a memorandum of understanding (MOU) to form a strategic partnership for the advancement of biopharmaceutical discovery and translational research in China. This agreement includes plans for Amgen to open a China research and development (R&D) center at ShanghaiTech University.

"Amgen and ShanghaiTech University share mutual goals of scientific excellence and rigor and will benefit from each other's strength and expertise in advancing biopharmaceutical discovery in China," said Sean Harper, executive vice president of Research and Development at Amgen. "Expansion into China is a business priority for Amgen and opening this R&D center is another clear and important step forward in Amgen's commitment to the China market."

Under the terms of the MOU, Amgen will co-locate its China R&D center with ShanghaiTech University's two life science institutes: the Shanghai Institute for Advanced Immunochemical Studies (SIAIS) and the iHuman Institute.

"We are pleased to be partnering with Amgen," said Professor Mianheng Jiang, chairman of Executive Committee of ShanghaiTech University. "ShanghaiTech aims to build a research-oriented university that provides a dynamic approach to learning and ultimately solving problems facing society. This partnership is a commitment to develop more effective bio-medicine for the benefits of the patients in China and in the whole world."

"We are excited about this unique opportunity to work with ShanghaiTech University," added Mingqiang Zhang, vice president of China Research and Development at Amgen. "The combination of Amgen's industry-leading expertise in biopharmaceuticals and the world-class academic excellence of scientists at the SIAIS and iHuman institutes of ShanghaiTech will be a very powerful force in advancing drug discovery and development. We aim to address unmet medical needs that are particularly relevant for patients in China."

"We are delighted that Amgen, a key player in the global biologics sector, will be co-locating its China R&D center at ShanghaiTech University," said Professor Richard Lerner, founding director of Shanghai Institute for Advanced Immunochemical Studies, an antibody research institute of ShanghaiTech University. "We aim to become one of the world's leading antibody research institutes and the co-location of Amgen's China R&D center with us will help to steer our research to be more applicable and to ultimately help patients in the fight against serious illnesses."

Amgen expects its China R&D center will be fully operational in 2014.

Kemwell Signs Monoclonal Antibody Pact

Kemwell Biopharma has signed an agreement with a European company for the development and manufacture of monoclonal antibody therapeutics. Kemwell will provide technology transfer, process industrialization, scale-up, manufacturing of toxicology materials, cGMP manufacturing of clinical materials and commercial manufacturing for both drug substance and fill/finish in vials from Kemwell’s new facility in Bangalore, India.

Kemwell’s managing director, Anurag Bagaria, remarked, “This broad development and manufacturing agreement demonstrates our customers’ confidence in Kemwell’s biotechnical capabilities." Mr. Bagaria noted that Kemwell is expecting an inspection from a European agency for its biopharma drug substance and fill/finish facility during the second half of the year.

In 2008, Kemwell entered into a strategic collaboration with Boehringer Ingelheim, and its biopharma facilities have been designed with the engineering and operational support of BI.

Aesica Opens Diabetes Dosage Facility

Aesica has established a new high-capacity manufacturing facility following a $45 million investment at its Queenborough, Kent site. The 10,000-sq.-m. (107,600 sq. ft.) expansion has been constructed for the production of a solid dose medication used in treating one of the world’s most common lifestyle diseases: Type 2 diabetes in adults.

The facility contains a large amount of highly technical and specialist equipment including spray granulators, coaters, tablet presses, a delumper, blender and a sieve system. Commercial production at the facility will commence in November. The product manufactured at the new facility has global sales and is set for worldwide export.

Aesica will have a dedicated workforce of 55 technicians at the Queenborough, who will be recruited locally and trained on site. The design of the facility will allow the current capacity to be more than doubled in the future, which could lead to another 50 people to be recruited.

Dr. Robert Hardy, chief executive officer of Aesica Pharmaceuticals, commented, “The new investment and opening of this facility marks another key milestone for our company and a further step towards achieving our vision to be the world’s number one supplier of APIs and formulated products to the pharmaceutical industry."

Capsugel Upgrades Facilities

Capsugel’s Dosage Form Solutions (DFS) business unit has upgraded and expanded three of its manufacturing facilities in the U.S. and Europe. The multi-million dollar investments broaden the company’s global capabilities to handle hormonal as well as high-potent compounds for soft gelatin and liquid-fill hard capsules (LFHC), responding to a growing demand from its pharmaceutical and health and nutrition customers. The moves are intended to deepen the company’s finished dosage form capabilities as part of its Lipidex technology platform.

At the Ploermel facility in France, Capsugel increased containment capacity to handle hormonal as well as high-potent compounds in softgel manufacturing. Specific upgrades include a new, high precision dosing system and high-speed capsule-printing capability.

At the Livingston facility in the UK, the company added laboratory space, equipment and analytical scientists. A new CFS 1500 capsule filling and sealing machine, which incorporates proprietary Fusion technology, has been installed, and the proprietary lipid expert system has been incorporated into the team’s finished dosage form development process.

Capsugel commissioned and validated a new commercial scale liquid-fill encapsulation unit for pharmaceutical applications at its Greenwood facility in the U.S. The company has also begun the installation of commercial production capability for new solid lipid pellet (SLP) technology. SLP technology is currently being used on select customer development projects as a unique lipid-based formulation option for bioenhancement and other formulation issues.

“Investments at our soft gelatin and LFHC facilities reinforce Capsugel’s leadership in liquid-fill technologies and our commitment to offering customers a comprehensive range of services from formulation development to commercial manufacturing. Backed by decades of capsule engineering, specialized formulation know-how and global supply-chain expertise, customers can be assured of high quality encapsulated products using SGcaps and Licaps technology,” said Anthony Macci, senior vice president of Global Operations. “Our continued expansion and integration of our product development and manufacturing capabilities further ensures that customer projects find optimized solutions, fast.”

McIlvaine Company

Northfield, IL 60093-2743

Tel: 847-784-0012; Fax: 847-784-0061

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