Unicep Packaging Inc., a provider of specialized liquid and gel contract manufacturing and packaging, has relocated its shipping, receiving and administrative offices from Liberty Lake, Wash., to a larger facility in Spokane.

The new facility has administrative space, multiple loading docks, and warehouse and production space. The facility is strategically located near the interstate and approximately 5 miles from the Spokane International Airport.

"With combined space between the Sandpoint, Idaho, facility and the new Spokane location, we will greatly expand our manufacturing and packaging capacity, allowing us to support current and future business growth," company officials said in a statement.

Founded in 1992, Unicep provides new product development, custom blending and manufacturing, contract filling, and unique blow-fill-seal single use packaging for the cosmetic and personal care, oral healthcare, over-the-counter, animal health, and medical device and diagnostic markets.

Abiomed Plans Expansion

Heart pump maker Abiomed Inc. is planning a massive expansion thanks to recent FDA approvals, adding employees and space to increase its manufacturing.

The Danvers, Mass.-based firm plans to add 100 employees in the next two years; it currently has approximately 600 employees. The company will lease an additional 85,000 square feet of space in a building next to its Danvers headquarters, bringing total square footage to 160,000 square feet.

Management expects the expansion will cost more than $5 million over the next 5-10 years.

In March, Abiomed received U.S. Food and Drug Administration (FDA) premarket approval for Impella 2.5 heart pump for elective and urgent high -isk percutaneous coronary intervention (PCI) procedures. Impella 2.5, which the company claims is the world's smallest heart pump, is the first hemodynamic support device to receive such a nod from the agency. About 100,000 patients suffering from cardiac problems in the United States are declared unfit for heart surgery due to extreme risks associated with the procedures. The Impella 2.5 pump changes care options for those patients.

Delivered through a catheter requiring only a small hole in the leg, the Impella RP is FDA indicated for providing circulatory assistance for up to 14 days in pediatric or adult patients who develop acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery. These patients lack blood flow from the right side of their hearts. The Impella RP is designed to provide the flow and pressure needed to compensate for right heart failure. The device does not require a surgical procedure for insertion, and it provides up to four liters per minute of hemodynamic support.

Abiomed expects already robust demand for Impella to increase substantially following the recent approval.

Lonza Will Build Viral Therapy Production Site

Lonza will build a viral therapy production site in Houston, Texas in a bid to capture a share of the growing gene therapy market.

The Swiss life sciences supplier said it would build a 100,000 sq.ft. facility for the development of viral therapy and immunotherapy products that will house modular cleanrooms, 2000 liter-scale production bioreactors and a separate fill-finish suite.

Andreas Weiler, who heads up Lonza’s emerging technologies team, said the investment was prompted by increasing pharmaceutical industry interest in gene therapies, particularly for the treatment of cancer and heart disease.

"This investment will allow Lonza to be well positioned to meet the demands of this growing market and to remain at the forefront of the viral gene therapy industry” Weiler explained.

He added that: “Our viral team has more than 20 years of experience in viral vector gene therapy that, when combined with our newly constructed leading edge facility, will provide a key advantage to our customers and ultimately to their patients.”

The Houston site is expected to be operational in the first half of 2017.

The investment comes after three years of manufacturing capacity reduction at Lonza, which has been trying to reduce costs and increase efficiency.

News of the new plant also follows Lonza’s deal with Japanese conglomerate Nikon , which will see it share its facility design expertise to help set up a cell and gene therapy production facility.

The collaboration comes as the Japanese Government works to encourage the country's regenerative medicines industry and build cell therapy production capacity.

New Biomedical Research Centre at Northwestern University

The construction of Louis A Simpson and Kimberly K Querrey Biomedical Research Centre at Northwestern University Feinberg School of Medicine in Chicago, Illinois, US, began in May 2015. The research center is named after Louis A Simpson and his spouse Kimberly K Querrey, who are the Northwestern University's trustees and alumni.

The new facility, expected to be opened for operations in late 2018, will enable new centers for research excellence, create venture space, and generate new startup companies and scientific discoveries that will save lives and improve health.

The research center will be situated in a 12-storey building having a total floor space of 600,000ft². It will have nine floors of laboratory space containing sophisticated lab equipment. Each laboratory floor will have a 40,000ft² space, which can be used for accelerating the pace of discovery and heighten the collaborative nature of advanced research.

The laboratory floors will include flexible laboratory blocks known as neighborhoods, which will accommodate teams of six to nine researchers. The neighborhoods will also include offices for principal investigators, and formal and informal meeting spaces.

The new facility is being constructed as replacement to the Prentice Women's Hospital in Chicago. The building will be connected to the adjacent Robert H Lurie Medical Research Centre. It will offer new research opportunities for high-quality research faculty, PhD students, and postdoctoral fellows as well as medical students, residents and clinical fellows. It will also lead the Northwestern University's research facilities and will be a hub for the world-class research and development enterprises that attract innovation and entrepreneurship.

The facility will create employment opportunities for more than 2,000 people during construction phase and more than 2,500 permanent and full-time jobs after the completion of construction. It will also generate approximately $3.9bn in future economic activity in Chicago.

Perkins + Will Architects were selected to design the new biomedical research center building in December 2013. The designs were provided by Ralph Johnson, global design director of Perkins + Will.

The total estimated investment for the construction of the biomedical research facility is $117.8m. The couple Louis A Simpson and his spouse Kimberly K Querrey through the Querrey Simpson Charitable Foundation contributed a $25m gift towards the construction of the facility in March 2014 and an additional $92m gift in March 2015.

The new biomedical research facility will be constructed with the aim of achieving LEED Silver rating from the US Green Building Council. The building will feature a curved glass exterior, and a sunny winter garden area that will allow natural light into the building.

Coquí RadioPharmaceuticals Plan Medical Isotope Production Facility

The construction license application of the facility will be submitted to the Nuclear Regulatory Commission by the fourth quarter of 2015.

Coquí RadioPharmaceuticals (Coquí) completed the schematic design for a new medical isotope production facility (MIPF) in Alachua County, Florida, US, in April 2015 and has initiated the detailed design.

The facility will be the first commercial supplier of the radioisotope Molybdenum-99 (Mo-99) that is used in 20 million procedures a year in the US. It will use low-enriched uranium (LEU) fuel to produce the radioisotope.

Medical diagnostic and therapeutic radioisotopes used in the US are currently imported from a Canadian production facility that is expected to be closed in 2016, while no other company produces Tc-99m in the Western Hemisphere.

Coquí expects to submit a license application to the Nuclear Regulatory Commission for the construction of the facility by the end of 2015, following a critical design review in August and submission of an environmental report two months prior to the submission of the application.

Ground breaking for construction of the plant is expected in 2017. The project is estimated to involve an investment of $330m and create up to 164 jobs.

Details of the first commercial medical isotope facility in the US

The medical isotope production facility will have a total floor space of 250,000ft². It will be built on 25 acres of land donated by the University of Florida Foundation in January 2015. It will be constructed using open pool reactor technology, which was used for the construction of an OPAL reactor in Australia.

The facility will include two pool-type MTR reactors, a radio isotope processing plant, a waste conditioning plant and administrative and support services offices.

It is planned to have a capacity of 7,000 six-day curies a week and is expected to fully comply with the Global Threat Reduction Initiative that aims to facilitate quick disposition of high-risk, vulnerable nuclear and radiological materials.

Medical isotopes are used in medical tests to detect a wide range of diseases, including cancer and cardiovascular diseases. Technetium-99m, which is derived from Mo-99, is the most widely used medical isotope in the world.

The site was chosen for a number of reasons, including its location 106ft above mean sea level, slightly sloped topography and availability of skilled workforce owing to its proximity to the university.

In addition, the University of Florida Training Reactor (UFTR) ensures availability of knowledgeable local emergency responders.

The state of Florida also has an emergency plan in place because of existing power reactors.

The facility will be installed with sophisticated equipment including hot cells with an enclosure ventilation system to keep cells at less than atmospheric pressure, and shielded containers to transport the targets, radioactive material and waste.

It will feature thermal baths, heat exchangers, hydrogen recombiner, dissolver, vacuum pumps and tanks for liquid and gaseous waste collection.

Other equipment will include reactor coolant systems, engineered safety features, as well as instrumentation and control systems.

Buildings at the MIP facility will be constructed to operate on a minimum energy consumption rate with limited carbon dioxide emissions.

The building will be designed to mitigate solar exposure and enhance daylight control. Its design will also ensure the most effective use of water inside the facility, as well as for the landscaping outside.

Argentinian nuclear engineering firm INVAP was contracted to provide design and construction services for the MIP facility in November 2014. INVAP was also involved in the design of the OPAL reactor and has 30 years of experience in nuclear development.

Gresham, Smith and Partners were selected as the consultant for siting, environmental data collection and environmental report (ER) preparation. ENERCON was appointed as the consultant to assist in preparation of the construction and permit application.

MPR Associates was selected to serve as the owner's engineer and consultant to Coquí. Hogan Lovells was appointed to act as nuclear regulatory and environmental attorneys for the project.

Based in Coral Gables, Coquí RadioPharmaceuticals is a Puerto Rican medical isotope company dedicated to the production of Mo-99. It was founded in 2009 with the aim of establishing a reliable and commercially-scalable medical diagnostic and therapeutic radioisotopes supply base in the US.

Argos Therapeutics Biomanufacturing Facility, Research Triangle Park, Durham, NC

Argos Therapeutics initiated the construction of a biomanufacturing facility at Research Triangle Park in Durham, North Carolina (NC), US, in October 2014. The facility will be used for manufacturing personalized immunotherapy product candidates that are used for the treatment of cancer, HIV and other serious illnesses. The facility is expected to be operational by the end of 2018.

The new biomanufacturing facility will have a total floor space of 100,000ft². It will include sophisticated equipment for automated manufacturing of Arcelis-based products. It will initially produce Argos' lead oncology product candidate AGS-003, which is being evaluated in the ADAPT Phase III clinical trials for the treatment of metastatic renal cell carcinoma (mRCC).

The facility is expected to be operational by the end of 2018. The project has created 100 construction jobs, while an additional 230 jobs are will be created in future.

The new facility will use Arcelis® technology platform for automated manufacturing of personalized immunotherapy product candidates. The technology captures altered and different antigens that are specific to each patient's disease. It can help to get rid of tumor- and disease-induced immunosuppression in cancer and HIV by extracting a durable memory T-cell response without using toxic adjuvants.

The process uses a small tumor or blood sample along with the patient's dendritic cells, which can be collected and optimized after a single leukapheresis procedure. It then uses RNA isolated from the patient´s disease sample to programme dendritic cells to target disease antigens. The antigen-loaded dendritic cells are formulated into the patient´s plasma and injected intradermally.

The new biomanufacturing facility construction contract was awarded to Keith Corporation. Invetech was contracted to develop and supply manufacturing systems to support production needs for fully personalized immunotherapies in November 2014. The contractual scope includes offering services, technology and equipment to support the design, development, supply and maintenance of customized manufacturing systems.

The total estimated investment for the construction of the biomanufacturing facility is $57m. The state of North Carolina, Durham County, the City of Durham, and the North Carolina Biotechnology Center contributed a total of $9.5m incentives for the project.

The incentive package offered by North Carolina department of commerce is $7.1m, which includes a job development investment grant of $4.5m, education and on-the-job training assistance of $600,000, sales tax exemption on qualifying equipment of $1.8m, and a $200,000 Economic Development Award from the North Carolina Biotechnology Center.

The NC Commerce, the City of Durham and Durham County contributed the rest of the $2.35m incentives package, which includes a cash grant of $1.85m and $500,000 in on-the-job training assistance.

Argos Therapeutics is a biopharmaceutical company focused on the development of fully personalized immunotherapies based on Arcelis technology platform for treating cancer and infectious diseases. The most advanced product candidates of the company include AGS-003 for the treatment of metastatic renal cell carcinoma (mRCC), and AGS-004 for the treatment of HIV.

New Academic Building, Davidson College, Davidson, NC

The New Academic Building gives Davidson a collaborative environment for teaching and transdisciplinary research, and a facility that will flex to accommodate new disciplines that will emerge in the years ahead. The building will be home to the departments of biology, chemistry, psychology and environmental studies, with two wings of teaching and research space and a 400-seat forum at its heart. The forum will be a convening space where the sciences and wider campus community meet, with informal activities and a wide-ranging program of events. The atrium, in which it sits, is a circulation hub for the complex, connecting the teaching and research spaces in the new facility to faculty offices in the renovated chemistry building.

Each of the 35 wet research labs can be reconfigured easily to keep pace with the changing nature of research, with write-up space, infrastructure for fume hoods and lab gases, flexible storage and reconfigurable lab benches. Support spaces are located in front of labs rather than between them to connect without interrupting collaboration between labs. The 21 teaching labs are active learning environments, with moveable partitions or direct connections that allow the creation of a unified teaching space that accommodates a variety of teaching styles, from lecture-based to team-based learning.

Direct access to equipment in the robust prep and support spaces means the labs can be less intensive. Not being hard-wired for one particular discipline allows labs to be easily reconfigured as the demands of disciplines change. Flexibility extends to seating arrangements: rather than the fixed seating of the departments’ earlier facilities, reconfigurable benches can accommodate different group sizes and dynamics.

Completion date: August 2017

Budget: $60 million

Size: 158,000 sq. ft.

Project team: Davidson College (owner); Shepley Bulfinch (architect/lab design); Simpson Gumpertz & Heger (structural engineer); Vanderweil Engineers Inc. (MEP/FP engineer); Surface678 Landscape Architects (landscape architect); Rodgers Builders (CM).

New England Biolabs to Build New Cleanroom Facility

New England Biolabs (NEB) has made plans to build capacity for manufacturing enzymes and other reagents. The plans include the construction of a new 30,000 sq. ft., state-of-the-art, GMP-compliant cleanroom facility, to be located near NEB’s Ipswich, MA headquarters. Construction is scheduled to begin in 2015, and the site is expected to be commissioned, validated and fully operational by early 2017.

“Our customers are evolving, and we’re continually improving our manufacturing processes to help these customers achieve their goals. By moving towards GMP compliance, we are giving our customers the confidence that they will be able to continue to rely on our products for their molecular diagnostics materials needs, as they prepare for the future,” said Jim Ellard, chief executive officer, New England Biolabs.

NEB’s OEM business unit, NEBsolutions, has been delivering customized manufacturing and packaging solutions to customers for over 25 years. Relying on this extensive experience, the GMP-compliant manufacturing facility will offer a complete solution for biological reagent manufacturing, including fermentation, purification, formulation, filling and final packaging.

“Since the late 90s, NEB has proudly served molecular diagnostics customers, and met their needs for supply of critical reagents. Our core enzymes, specialized reagents and full next-generation sequencing (NGS) workflow solutions continue to be leveraged in novel ways by our customers. We believe our increased commitment to the regulatory compliance needs of our customers will enhance these partnerships, while bringing NEB closer to the clinic,” said John Pelletier, director, NEBsolutions.

NEB currently holds ISO13845 and ISO9001 Quality Management Systems certifications at its headquarters in Ipswich and will continue to maintain these standards for its research-use products.

GSK to Open Independent Research Institute for Medicine Development

GlaxoSmithKline (GSK) has unveiled plans to open an independent and non-profit research institute, Altius Institute for Biomedical Sciences, in Seattle, Washington, US.

Altius will initiate new technologies and approaches for decoding how genes are controlled and how a cell's operating system functions in health and disease.

Headed by Dr. John A Stamatoyannopoulos, Altius will be wholly independent from GSK with its own management, board of directors and external advisors.

Dr Stamatoyannopoulos said: "Innovative technologies are needed to gain a deeper understanding of how cells' 'operating systems' work."

GSK has signed ten-year collaboration agreement with Altius, with the institute providing long-term support for innovative and high-impact research.

"Innovative technologies are needed to gain a deeper understanding of how cells' 'operating systems' work."

The research work from the institute will be used by GSK to understand gene control to select and validate better drug targets, in addition to accelerating multiple key aspects of developing new medicines.

GSK will provide around $95m in cash and other resources during the first five years for the institute to advance the basic research and technology efforts. The institute will also gather funding from public and other sources.

Additional funding will be provided by GSK to use the institute's technologies and discoveries in a wide range of drug discovery and development projects, including specific projects identified by the firm.

GSK alternative discovery and development senior vice-president Lon Cardon said: "Dramatic breakthroughs in understanding how the human genome functions are still in their infancy in terms of how they can be applied to drug discovery, but we can see their potential to transform the process."

Sartorius Opens New York Demonstration Lab

Sartorius has opened its first North American demonstration laboratory in Bohemia, NY to provide customers with access to the company’s upstream and downstream processing systems and laboratory products. The laboratory, part of the company’s new 40,000-sq-ft facility, features hands-on demonstration stations, as well as classroom learning space.

The Long Island-based Sartorius Application Center is modeled after similar application centers in China and Germany. In the FlexLab, customer can view FlexAct systems, Sartocheck bag testers, and TAP Biosystems equipment. Laboratory products on display include scales, balances, and liquid handling systems. In addition, an R&D section showed developments in bioreactors and freeze/thaw equipment.

BioPharmaSpec Opens Analytical Lab

BioPharmaSpec Inc., an analytical research laboratory, has opened a new lab facility in Malvern, PA to provide characterization services for the U.S. biopharmaceutical market.

“The Eastern seaboard of the U.S., including the tri-state area of Pennsylvania, New Jersey and Delaware, is home to a good proportion of the U.S. pharmaceutical industry. The demand for our characterization services from North and South America has also been strong, due to the technical biochemical and instrumentation expertise we have built up over 40 years in analytical areas such as De Novo Protein Sequencing, Peptide Mapping, Disulfide Bridge and Carbohydrate Analysis. We look forward to using this expertise in our new lab to assist our American clients more readily with a full range of cost-effective services,” said BioPharmaSpec founder and president, Howard R. Morris. “Our new facility in Malvern is a fully-equipped, modern laboratory, capable of a broad range of biopharmaceutical characterization services, with the quick turnaround for our North and South American client base that would only be possible with a domestic facility.”

Allele Biotech Purchases cGMP Cell Production Facility

Allele Biotechnology & Pharmaceuticals, Inc. has purchased a new facility for the cGMP production of clinical-grade cells for cell therapy applications. Cells will be produced by Allele for industrial and academic partnerships, as well as its own efforts in the area of cellular therapeutics.

The 18,000 sq.-ft. facility, located near its headquarters in San Diego, CA, will be the center of production of human induced pluripotent stem cells (hiPSCs) using its synthetic mRNA platform technology.

Allelle’s mRNA platform eliminates some of the drawbacks that are common to other technologies for making hiPSCs. For example, cells are produced with neither the random integration of foreign DNA nor the use of whole virus or virus-based elements. hiPSCs, as cells that have the potential to become any cell in the human body, holding great potential for therapies.

Allele recently made a number of advances regarding the differentiation of hiPSCs towards cells, such as neural progenitor cells, neurons, astrocytes, mesenchymal stem cells, cardiomyocytes, skeletal muscle cells, hepatocytes, and adipocytes. These cells would also be produced in the cGMP facility when intended for specific therapies.

“This dedicated facility will help us to realize a number of our visions in bringing the benefits of pluripotent stem cells to society,” said Jiwu Wang, Ph.D., president and chief executive officer of Allele. “The first step in helping people in need with all the stem cell technologies developed in labs is to clear a path to move them from bench to bedside, which requires high-quality, controlled production that can be monitored by the FDA. Together with our licensees, drug development partners, investors, and individuals who would like to participate in banking hiPSCs for research and therapy, we anticipate even faster pace in our business development in this area.”

LSNE Completes PAI Inspection

Lyophilization Services of New England, Inc. (LSNE) has completed a successful Pre-Approval Inspection (PAI) and GMP inspection, clearing the way for the company to manufacture commercial drug product for U.S. distribution. This is the second PAI at the Bedford, NH facility. The first inspection was for a bulk drug intermediate lyophilized in LSNE's 260 sq.-ft. lyophilizer.

Shawn Cain, chief operating officer of LSNE said, "The completion of this inspection is a critical milestone for LSNE as it is the first PAI for a sterile product at the 25 Commerce Road facility. This is also our second site to now be successfully inspected by the FDA to produce commercial products in the past few months. This demonstrates LSNE's commitment to meeting all applicable regulatory standards for the production of commercial medical devices, bulk intermediates and sterile injectable drugs. It is only through the talent and dedication of our staff that we have been able to achieve and maintain this level of compliance."

Additionally, LSNE is adding capabilities across three sites including the expansion of QC analytical testing capabilities, ICH stability chambers, additional complex formulation capabilities, as well as increased manufacturing capacity.

Vetter Development Service Chicago Completes On-Site Expansion Activities

Vetter, a contract development and manufacturing organization (CDMO) that specializes in aseptic filling, has announced that a number of activities undertaken at its Skokie facility to satisfy existing and ever-increasing future customer demands have been completed. The initiatives include an additional staff shift for daily clinical manufacturing operations, as well as the doubling of capacities for performing visual inspection and In-Process Control (IPC). The facility also expanded its on-site offerings by giving customers the option to obtain secondary packaging services for small batches of frozen drug products such as vial labeling, cartoning, and carton labeling. Furthermore, the long-term collaboration with Sentry BioPharma Services, a provider of cGMP clinical packaging solutions and supply chain management, supports a streamlined path from filling to clinic.

“We are extremely pleased with our past years performance at the Skokie facility, as well as our overall success to date,” said Peter Soelkner, managing director, Vetter.

The site, located at the Illinois Science + Technology Park in suburban Chicago has passed audits and qualifications by as many as 30 companies, including 9 of the top 20 leading (bio-) pharmaceutical companies. This performance has resulted in a wide-ranging customer base that includes not only those in the U.S., but also European companies based for example in the UK and Denmark, as well as Asian headquartered companies such as in South Korea.

“Many of our customers have already returned for development work for a second, third, or even fourth molecule,” said Susanne Resatz, president, Vetter Development Services USA, Inc., who is responsible for heading up the operation. “Furthermore, our outlook for future performance is very positive as demonstrated by a pipeline filled with high quality customer projects for biologics.”

Drugs under development by Vetter’s customers include treatments for blood cancer, muscular dystrophy, wound healing, and dwarfism.

GW Plastics Completes Multiple Expansions

Bethel, Vt.-based GW Plastics, a provider of injection molding and contract manufacturing to the healthcare market, has completed the recent expansions at their Tucson, Ariz., and Dongguan, China, facilities for the firm’s medical device assembly business. GW Plastics specializes in complex injection molded thermoplastic and silicone solutions, including close-tolerance mold building, precision injection molding, and contract assembly. Core competencies include product development, in-house precision tooling, scientific injection molding, and automated assembly.

GW Plastics’ Tucson facility has recently completed a 30,000-square-foot expansion including clean-room molding, contract assembly, warehousing, and regulatory office space. Tucson’s medical device contract manufacturing capabilities now include clean- and white-room precision molding, automated and manual assembly, and finished packaging capabilities encompassing pouching, tray-lidding, rigid and flexible form, fill, seal, order fulfillment warehousing and contract sterilization.

“GW Tucson has transformed its facilities during the last 24 months into a world-class medical device contract manufacturing operation. I could not be more proud of our team,” said James Ford, GW Tucson general manager.

At the same time, GW Dongguan is in the final stages of completing a new 125,000-square-foot facility more than doubling the size of the existing China plant. GW’s new China facility will permit the company to streamline their tooling, molding, and medical device assembly operations while leaving significant room for future contract manufacturing growth, company leadership said.

The facility is expected to be fully operational in late 2015 and will feature product development services, in-house tooling, precision molding and clean-room contract assembly.

“Both Ed Boyden, GW Dongguan general manager, and I are very excited about our new facility in China,” said Ben Bouchard, GW Plastics vice president of international business development and managing director, China. “GW Dongguan will truly be one of the most advanced medical device injection molding and contract manufacturing operations in Asia”.

Of the international expansion, GW Plastics President and CEO Brenan Riehl said: “This has allowed GW Plastics to become a natural extension of our customers’ production capabilities by providing them with a reliable and proven partner to confidently develop and manufacture their finished medical devices across the globe,”

CRO Veristat Moves Headquarters

Full-service CRO (contract research organization) Veristat will move its corporate headquarters from Holliston, Massachusetts, to Southborough, Massachusetts, this summer as the company has outgrown its old space.

The company says the growth is tied to a shifting demand for full-service clinical research offerings from pharma and biotech clients that previously partnered with the company for a single service.

Patrick Flanagan, CEO of Veristat, told Outsourcing-Pharma.com that the company has “literally” outgrown its space, with headcount increasing 300% in the last two years. He also said the new space is strategically closer to the CRO’s clients.

“The bulk of our new deals are more strategic partnerships covering multiple services,” Flanagan added, noting two recent preferred provider agreements with Karyopharm and Molecular Templates, as well as “many others which have not been publicly announced as well as a number in the works.”

The shift comes as clients are moving away from engaging Veristat for single services to “more integrated full-service and strategic functional roles in addition to awarding us multiple programs in their development portfolio. We’ve responded to this shift by expanding our services and maturing a full-fledged Clinical Operations team,” he added.

The new space in Southborough, MA, will add to the company’s additional offices in Cambridge, MA, and Montreal, Canada. Veristat also says it has plans to expand its current operations in the San Francisco Bay Area with the opening of a new office.

“Historically, clients came to Veristat for our Data Management, Biostatistics, Medical Writing and Regulatory Submissions services. More and more clients now engage us to manage their entire trials, so we are getting involved earlier with program design, regulatory agency engagement, and study start-up activities,” Flanagan said. “We are managing entire studies with full clinical operations, biometrics, and regulatory submission support.”

Accuratus Expands

Accuratus Lab Services and its principal owner, Ampersand Capital Partners, have announced the acquisition of the chemistry, manufacturing and controls (CMC) operation of Array BioPharma. Accuratus was formed in July 2014 when ATS Labs acquired Microtest Labs. The company provides GMP and GLP analytical and microbial testing services to the medical device and biopharmaceutical industries, as well as manufacturers of EPA-regulated consumer products.

The addition of Array's CMC operation sets the course for Accuratus to become a leading contract development and manufacturing organization (CDMO) in the pharmaceutical industry.

The Array CMC operation will be known as Avista Pharma Solutions and housed in a state-of-the-art, 50,000ft2 laboratory facility in Longmont, CO, US. Existing Accuratus locations will continue to deliver services to clients while leveraging the expanded capabilities of the Longmont team and facility.

‘The addition of Avista solidifies the commercial development strategy of Accuratus and brings a strong scientific team with demonstrated expertise in process chemistry and new drug manufacturing,' said Dr Tom Burnell, Chairman of Accuratus Board of Directors. ‘The entire Accuratus organization is excited to welcome the Avista team to the organization.’ Under Accuratus’ ownership, Avista will continue to support the CMC services requirements of its former parent Array BioPharma while expanding its business with other clients. ‘We are pleased to complete the sale of our CMC operation, which we believe has tremendous growth potential as part of a high quality, independent CDMO business such as Accuratus,’ said Ron Squarer, CEO, Array BioPharma. ‘Array looks forward to continuing to work with the Avista team in support of our clinical development programs, which are critical to our future success as a company.’

Janssen and Rutgers Expand R&D

Despite pharma being “highly regulated and slow to change,” continuous manufacturing will soon be realized, says Rutgers University which has received an R&D grant from J&J.

The $6m (€5m) investment from Johnson & Johnson will be used to support research efforts and help implement a specially designed manufacturing line at a Janssen facility in Puerto Rico, as part of its ongoing collaboration with the Rutgers University School of Engineering to help bring continuous processing techniques to the pharma industry.

“While our group and others have been working at this for almost a decade adoption of the technology has just begun in the last year or so,” said Douglas Hausner, Associate Director for Industrial Relations and Business Development at Rutgers. “FDA approval for the first adopters are just beginning to happen now.”

He told us how the research efforts had originally comprised of a few industry scientists and that most outside of that group thought this would never get the US Food and Drug Administration (FDA) to accept a continuous processing approach.

“That changed a few years ago when the FDA began to actively promote the technology and encourage adoption. Then engineering and manufacturing people at companies got involved and interested. Now as this is making its way to market, regulatory people within the companies are joining in.”

Hausner continued: “All in all, this is a highly regulated industry that is slow to change, at least with respect to manufacturing technology,” but recent dialogue seems to suggest industry and regulators are now on board.

Earlier this month, the FDA’s Janet Woodcock called on drugmakers to begin the switch from batch manufacturing, offering grants to innovation and pushing for legislation and guidance, stating continuous processing “is the future.” As part of ongoing R&D, Rutgers designed and built “the first continuous direct compression line and demonstrated that a large number of products that currently require more complicated batch manufacturing methods can be made using this approach,” Hausner said.

This was the model for the continuous processing line at Janssen’s Puerto Rico plant, but that design has also been implemented at other large pharmaceutical company R&D facilities including Bristol-Myers Squibb and Eli Lilly.

“Those companies are now all going to market with this technology,” Hausner added.

Tim Jamison, an MIT Professor and founder of continuous flow chemistry solutions firm Snapdragon Chemistry, said that while industry and regulators have begun embracing such techniques, a lack of talent could temporarily hamper a shift from batch production.

Hausner agreed, but added this problem is being addressed: “This technology requires a different way of thinking and training. This is needed for current as well as new personnel.

“We have developed training for the FDA and we are working on developing an international institute which will be a coalition of research groups like ours worldwide. This will work on standardizing curriculum and other aspects related to training.”

Poseida Therapeutics Expands Into JLABS

Poseida Therapeutics, a privately held human therapeutics spinout of Transposagen Biopharmaceuticals, has begun drug development operations at its new location at JLABS in San Diego, CA.

The drug development and license agreement between Transposagen and Janssen, which was announced in November of 2014, has been transferred to Poseida. The three-year drug development partnership and license agreement will focus on developing at least two allogeneic CAR-T product candidates. Poseida will receive milestone payments of up to $292 million per product candidate and tiered royalty payments. Both companies will work together on preclinical development and Janssen will be responsible for manufacturing and commercialization.

The 40,000 square foot San Diego JLABS facility features core research labs hosting specialized capital equipment, shared administrative areas and individual bench, wet lab and office modules.

Takeda to Consolidate U.S. Vaccines Operations in Cambridge

Cambridge, MA, will get a little more crowded after Takeda's announcement that it plans to close multiple U.S. facilities and expand its presence there into a U.S. vaccines headquarters.

The company will leave its Bozeman, MT, Madison, WI, and Fort Collins, CO, vaccines sites and shift its U.S. vaccines headquarters from Deerfield, IL, to the Boston area over the next two years as it moves all U.S. nonmanufacturing vaccines activity to the new hub. In total, about 150 jobs will be impacted through the closures; Takeda spokesperson Julia Ellwanger said that as the transition will take two years, it's too soon to say how many employees will make the move to Cambridge.

Along with Zurich, Switzerland, the new U.S. post will serve as Takeda's global vaccines headquarters outside of Japan. Regionally, the company plans to maintain sites in Singapore and Brazil with manufacturing plants in Hikari, Japan, Durham, NC, and Singen, Germany.

The location will "significantly enhance communication and collaboration across [vaccines business unit] divisions, and will allow VBU to leverage Takeda's significant R&D presence in Cambridge. It will also provide access to the area's remarkable biotech/pharmaceutical ecosystem and talent base," Takeda's statement said.

Despite the decision to close several of the R&D outposts, Takeda's vaccines president, Rajeev Venkayya, said in a statement they were "instrumental" in bringing the company's norovirus and dengue programs to late clinical stages. The consolidation will help the company "to achieve the efficiency and operational excellence needed to execute the Phase III clinical programs and set the stage for global commercialization of these vaccines," he added.

Takeda's move follows GlaxoSmithKline's ($GSK) announcement in April that it's closing a vaccines R&D facility in Cambridge inherited in its multibillion-dollar asset swap with Novartis ($NVS), instead opening a global vaccines R&D headquarters in Rockville, MD. Takeda, for its part, announced the new Singapore location in February as it continues its own global vaccines push.

And the company isn't alone in focusing on Cambridge, as multinational pharmas Eli Lilly ($LLY), Novartis, Pfizer ($PFE), Sanofi ($SNY) and others have moved into the neighborhood in the last couple of years, ditching remote R&D outposts for the talent hotbed.

As he engineers a turnaround for the company, CEO Christophe Weber has said that Takeda has an increased focus on vaccines. The company last month inked a deal with Japan's Kaketsuken to distribute a flu vaccine in that country, and, in January, said it's eyeing vaccine-makers in India as a possible entry point there

The National Institutes of Health’s (NIH) Pharmaceutical Development Section (PDS), Stops Operations

The National Institutes of Health’s (NIH) Pharmaceutical Development Section (PDS), which manufactures products for clinical trials, has suspended operations due to the discovery of serious manufacturing problems and contamination by US FDA inspectors.

Following an inspection of the PDS between May 19 and May 29, FDA officials uncovered a series of deficiencies that will require the NIH Clinical Center to take a number of corrective actions.

The FDA found that in April, two vials of albumin, used for the administration of the drug interleukin in experimental studies, were found to have fungal contamination. Vials made from the same batch were administered to six patients, although the NIH says it is unknown whether those or other vials were contaminated. The six patients are being followed closely for any signs of infection, though the NIH says that at present, none has developed signs of infection or illness.

The inspectors also revealed that some chemotherapies produced by PDS were made in an area that is not negatively pressured for containment.

“This is a distressing and unacceptable situation,” NIH Director Francis Collins said in a statement. “The fact that patients may have been put in harm’s way because of a failure to follow standard operating procedures in the NIH Clinical Center’s Pharmaceutical Development Section is deeply troubling. I will personally oversee the steps to protect the safety of patients and remedy the situation as swiftly as possible.”

Among the problems the FDA identified in their inspection and unveiled in the Form 483 , were deficiencies in the physical facility, including flaws in the air handling system, and issues with inadequate quality control, insufficient employee training, and lack of compliance with standard operating procedures.

The NIH said it’s taking a number of steps to protect patients, including through the creation of an external group of microbiology and sterile manufacturing experts that will review the operating procedures of PDS, as well as working to secure alternative ways to manufacture products for about 250 patients scheduled to receive drugs made from the center.

In addition, NIH will provide an interim corrective action plan to the FDA by June 19.

Coastal Life Technologies Adds Cleanroom

Coastal Life Technologies a San Antonio-based contract manufacturing outsource provider focused on delivering turn-key services for medical devices, is adding a second ISO Class 8 Cleanroom to its manufacturing facilities. The company expects the expansion to be complete within 12 months.

The new controlled environment production area will be built to align raw materials between the two clean rooms to maximize efficiency. The additional room will raise the total controlled production areas to approximately 20,000 square feet. "Our growth over the last few years and our projections for the coming years necessitate that we expand our headquarters at this time. In so doing we can continue to provide capacity for outsourcing solutions for our current and future clients," said Coastal Life Technologies Chief Operating Officer David Huff.

University of Tennessee Health Science Center (UTHSC) Expand Cleanroom Facilities

G-CON Manufacturing has been selected to build a multi-POD ISO Class 7 formulation and filling suite for the University of Tennessee Health Science Center (UTHSC).

The new facility in Memphis, Tennessee, will expand capabilities of the UTHSC Plough Center for sterile drug delivery, which is currently used for process development, analytical and stability studies, as well as hands-on training in aseptic processing and sterilization techniques.

UTHSC executive vice-chancellor Dr Kennard Brown said: "UTHSC's primary goal was to build a facility that enabled them to offer assurances to the pharmaceutical industry and the general public that any products produced in the facility were done so at the highest cGMP quality standards.

"The university's focus with the new facility will be the development and manufacture of unique drug products with innovative drug delivery systems.

"The Plough Center hopes to become recognized for its ability to formulate and manufacture difficult to produce new drug products for clinical trials and for paving the way for manufacturing medicines of the future such as antibody-drug conjugates, nanoparticles and bio-similars."

The PODs will provide approximately 1,800ft² of cleanroom space and incorporate areas for component preparation, compounding, formulation, filling and lyophilisation for use in the manufacturing of clinical and small-scale products.

An additional POD will provide approximately 760ft² of cleanroom space for the manufacturing and development of semi-solids products.

G-CON Manufacturing Sales Engineering director Dennis Powers said: "UTHSC's selection is a reflection of the market's increased interest in combining aseptic filling processes within our cleanroom POD technology.

"Integrated designs like these can be replicated or re-deployed anywhere in the world as needed."

G-CON was selected as part of a project team that includes brg3s Architects, ETFC Architects, DPS Consulting and DPS Engineering.

DPS Consulting is providing pharmaceutical consulting and guidance. DPS Engineering is providing process architecture and design for the PODs.

Akron, Cognate Partner to Offer More Complete Services

The strategic partnership between Baltimore-based CMO Cognate BioServices and Florida-based Akron Biotechnology will offer clients a more complete package of cGMP manufacturing services and regulatory support to develop regenerative medicines and cell-based products and therapies.

The companies will continue to operate as separate entities, with both companies further developing their core competencies to advance new cell therapy-based treatments from workbench to the clinic.

For Cognate, these competencies include cGMP manufacturing, scale up, validation and process development through specialized infrastructure and expertise to support clients through all aspects of cell-based drug development up to and including commercialization. Akron’s specialties include the production and distribution of validated raw materials and solutions to cell therapy clients, as well as innovating new products and technologies for the regenerative medicine space.

Akron Biotech founder and CEO Claudia Zylberberg, said, “This partnership is a unique opportunity to integrate the offerings of our two companies to meet the growing needs of the industry by strategically reducing the cost of goods through enabling solutions and procurement of raw materials in a cost-efficient manner for our customers and Cognate clients.”

Northwest Biotherapeutics previously agreed with Cognate to begin a large-scale expansion of the manufacturing, storage, handling and distribution of its personalized immuno-therapies for solid tumors.

J. Kelly Ganjei, CEO of Cognate BioServices, added, “We believe that offering a more full service integration with specific key supply chain demands provides us and our clients a competitive advantage in this field.”

Sequenom to Consolidate Lab Facilities

Sequenom will move its laboratory operations in Grand Rapids, Michigan to its facility in Raleigh-Durham, North Carolina, the company said.

Sequenom's cystic fibrosis carrier screen test, which previously ran out of its Grand Rapids lab, will now be performed in the North Carolina location. In addition, as part of the consolidation, the firm said it would discontinue its SensiGene Fetal RHD test.

"The expansion of our North Carolina laboratory operations to include our HerediT CF carrier screen test will enable us to continue to provide high-quality and meaningful test offerings to physicians and their patients while continuing to build value for our shareholders," Sequenom President and CEO William Welch said in a statement.

The company decided to discontinue the SensiGene Fetal RHD test, which it began offering in 2010, because it has not contributed substantially to its revenues. Sequenom said it would reintroduce the test if medical committees issued guidelines in support of broader use and reimbursement.

Sequenom said it would provide transition services and outplacement assistance to affected employees.

Gilead is Opening New Labs

Flush with a new, multibillion-dollar drug franchise, a booming Gilead is now hiring investigators for its fast-growing operations in Canada. The biotech is doubling down on its $100 million R&D investment in Alberta, Canada, with plans to expand on the new lab that opened this week at its Edmonton campus as it hires up to 170 more scientists for its R&D work.

The ribbon-cutting ceremony today comes as construction is underway on Gilead's second lab, due to open now in the spring of 2016. Gilead ($GILD) says that this second $100 million project will add a new process tower for API manufacturing as well as a maintenance facility and upgrades. "The process tower will expand the capabilities of the operations in Edmonton to allow for the handling of more potent compounds," the company said in a statement. The Edmonton facility provided clinical trial quantities for Gilead's research operations, including clinical trial supplies for HCV, HIV and new cancer therapies.

Gilead has enjoyed huge and rapid growth as its hep C drugs have set a new standard of care for that disease. Sovaldi registered a jaw-dropping $10.3 billion in sales last year, and its combo therapy has continued to rack up big numbers in the first quarter of this year. Building on its blockbuster HIV franchise with an ambitious pipeline of new drugs in the clinic, the big biotech has been investing heavily in new facilities and a growing number of staffers in all areas of the business.

At its HQ campus in Foster City, CA, Gilead has been working on a complete makeover that includes razing a dozen buildings while building 17 more. Gilead reported in its latest 10-K that it had 7,000 fulltime employees at the end of January, up from 6,100 the year before.

Gilead's Robin Nicol "The state-of-the-art research and development facility that opens today marks an important milestone for Gilead as it further increases its contribution to Alberta's growing life-sciences industry," said Dr. Robin Nicol, the GM of Gilead Alberta ULC. "As Gilead expands into new therapeutic areas, the additional laboratory space enables our process and analytical chemistry teams in Edmonton to make an even greater contribution to the development of life-saving therapies for patients."

NWI Ready to Break Ground on New Center

The nonwovens program at North Carolina State Univeristy is about to get a whole lot bigger. The Nonwovens Institute, which is the U.S.’s only accredited academic program in the field of engineered fabrics, will soon be housed in a state-of-the-art building and testing facility located right on the university’s Centennial Campus.

To be known as the Nonwovens Innovation and Technology Center, the new building will house a Reifenhäuser Reicofil RF4 bicomponent spunbond line as well as hydroentanglement technology, a calendar as well as drying and winding capabilities provided by Andritz Perfojet. This new set-up will allow the Nonwovens Institute to run trials and develop technology in a wide application range.

The center, which will also offer leased office space, should be through the construction phase in early to mid 2016 and be fully operational by October 2016.

According to Behnam Pourdeyhimi, executive director of the institute, the value of the equipment scheduled to go into the new center is around $20 million. In addition to supporting student research, the lab will be outsourced to member companies to do pilot research.

The new line, which will be one of only a few of its kind in the world, will be able to produce lightweight and heavyweight fabrics both in existing nonwovens categories as well as in emerging markets, says Pourdeyhimi.

“We are excited about what this new line will bring to our research capabilities,” he says. “Not only for our school but for the nonwovens industry. We could not have done this without our partners.”

According to its website, the Nonwovens Institute at NC State is an academic program for the interdisciplinary field of engineered fabrics. Described as an innovative global partnership between industry, government and academia, NWI receives several million dollars per year in memberships, private research and product development services. At any given time, the program supports about 70 graduate students and graduates about 10 per year.

“We are the only U.S.-based university program dedicated to nonwovens,” says Pourdeyhimi. “Other (university) programs were so closely tied to textile programs that when textile programs disintegrated so did the (nonwovens) programs.”

NWI was launched in 2007 but traces its roots back to 1991 when the Nonwovens Cooperative Research Center (NCRC) was established through a collaboration of matching grants from the National Science Foundation, the State of North Carolina and several industry partners. NSF grant funding ended in 1998 but the NCRC continued to enhance its technology and research capabilities while growing its membership to become North America’s largest state-industry-university cooperative research center.

Currently, several nonwovens-related companies, including Mann + Hummel and Eastman Chemical Company have offices at the institute and many others use the equipment to run trials of new technologies. Pourdeyhimi says he expects more companies to follow suit as the new state-of-the-art equipment comes onstream.

Prior to the new investment, the NWI already housed Reicofil meltblown technology as well as drying, spinning and other nonwovens equipment.

Rochester has Plans to be Biotech Hub

Rochester, Minn., home to the famed Mayo Clinic, is about to embark on what would be the largest economic development initiative in this state’s history.

The state government, the Mayo Clinic, and private investment partners are prepared to spend $6.5 billion on a 20-year plan whose goal is to elevate Rochester into a global biotech hub. The plan is also intended to rejuvenate Rochester’s downtown, promote open transit, and reconnect the city with its waterfront.

On April 23, the Board of Directors of the Destination Medical Center Corporation formally adopted the development plan for Destination Medical Center (DMC), which would be comprised of six districts spread across 550 acres. The vertical construction would support a diverse mixed-use environment that complements Mayo’s existing facilities, which already provide care for one million patients annually.

The six districts identified in the development plan include:

• The Heart of the City: The plan would convert the downtown area into a place of “connected urban experiences” that build off of the city’s existing walkable attributes, with enhanced areas and mixed-use buildings;

• Discovery Square: Steps from Mayo Medical School, this would be the address for the expansion of science, research, tech, and entrepreneurism;

• Downtown Waterfront: This would be located where the Zumbro River and Second Street intersect. It would be a cultural and historical center, and provide live-work opportunities;

• Central Station: A nexus of transportation for the downtown area, with an intermodal transit station that is incorporated into mixed-use development;

• UMR and Recreation Area: On the south edge of downtown, this location would encompass the University of Minnesota-Rochester campus and Soldier’s Memorial Field; and

• St. Mary’s Place: A new public space in the downtown’s western corner.

Peter Cavaluzzi, FAIA, Principal and Board Member for Perkins Eastman, this project’s lead designer, thinks The Heart of the City will be the most critical component, and have the biggest impact, early on. “The first phase of every large-scale project has to be bold enough to have an impact, but at the same time be small enough that it can be achieved.”

Perkins Eastman says the initial phase will start at the city’s 1st Street and 1st Avenue, in the middle of Peace Plaza, where a grand dining terrace will span the Avenue and connect to the historic Chateau Theater.

A breakdown of Destination Medical Center shows that it would have 6.8 million sf of healthcare facilities, 1.02 million sf of biotech, 310,000 sf of offices, a 1,380-room hotel, 2,850 units of residential, 354,000 sf of educational space, and 117,000 sf of transit, which would include 22,850 new parking spaces. Fast Company reports that there is also a possibility of a rail link between Rochester and Minneapolis, 90 miles away.

Rochester officials see this project as a way for their city to get out from under the shadow cast by the Minneapolis-St. Paul metroplex. DMC could also give Mayo Clinic a leg up on other healthcase hubs like Cleveland Clinic and Johns Hopkins that are all vying for what’s known as medical “tourists,” affluent foreign patients seeking the best treatment available.

Lisa Clarke, DMC’s executive director, estimates that this development would create between 25,000 and 40,000 jobs over 20 years, plus significantly more tax revenue.

Fast Company reports that $6 billion of the project’s cost would be raised from the private sector, and state and local taxpayers would contribute $585 million. Foreign companies, many with ties with Mayo Clinic, are expected to provide much of the private funding.

The Destination Medical Center, though, is controversial. For one thing, the plan calls for the downtown area to be “winterized” with skywalks, heated sidewalks, and underground passageways. There’s nothing in the plan that stipulates construction of affordable housing (which could be a real problem if, as estimated, this urban development project causes Rochester’s population to double from its current 111,000 people). And some residents fear that local cultural structures, like the public library and downtown theater, could ultimately be destined for the wrecking ball.

REST OF WORLD

GW Dongguan Expanding China Facility

GW Dongguan is in the final stages of completing a new 125,000-square-foot facility more than doubling the size of the existing China plant. GW’s new China facility will permit the company to streamline their tooling, molding, and medical device assembly operations while leaving significant room for future contract manufacturing growth, company leadership said.

The facility is expected to be fully operational in late 2015 and will feature product development services, in-house tooling, precision molding and clean-room contract assembly.

Theorem Opens New State-of-the-Art Clinical Supplies Facility

The current good manufacturing practice (cGMP)-compliant facility will triple Theorem’s current clinical supplies capacity, with space for 2,700 square meters (29,052 sq. ft.) of ambient (15 to 25°C) and refrigerated (2 to 8°C) space. The opening also positions Theorem’s clinical supplies hub near the Frankfurt Airport, Germany, a major transportation hub.

“We’re excited to have the additional manufacturing and warehousing space and, more importantly, an infrastructure to deliver the flexibility our clients rely on,” said John Potthoff, Theorem president and CEO. “The new facility will enhance speed and scalability while preserving the versatility of our supply solutions.”

Theorem packages, labels, stores and distributes study drugs and medical devices for studies worldwide. Theorem also provides qualified person services, as well as a range of temperature-controlled transport and logistics solutions, to facilitate the supply of global clinical trials. The launch of the new facility will strengthen current practices — such as its 24/7/365 storage, continuous monitoring and backup — and provides space for future service expansion.

ISO 3 Cleanroom and BSL3 Laboratory at Mintek, South Africa

The successful installation of a R13-million ISO 3 cleanroom and BSL3 laboratory at national mineral research organization Mintek was proof that the Department of Science and Technology’s (DST’s) ongoing investment in national research projects was bearing fruit, said Science and Technology Minister Naledi Pandor at the facility’s unveiling, which took place in April at Mintek’s Nanotechnology Innovation Centre (NIC).

The facilities were installed by international consulting and engineering company Royal HaskoningDHV, after they were commissioned by the DST in December last year.

“Such facilities play an important role, in not only helping us solve pertinent social issues but also developing young minds and helping [to equip] our researchers with the skills they need for their work,” said Pandor.

The facility was designed to enable the DST, the NIC and South Africa’s researchers to develop and fabricate nanotechnology-based diagnostic devices and tools for application in the health sector, and for the containment of biological reagents.

The center will also produce nanotechnology-based devices and systems that meet the standards of International Organization for Standardization diagnostic kits. This makes it possible for the NIC to follow good manufacturing practice guidelines and to comply with pharmaceutical inspection conventions and cooperation schemes.

The facility will also allow for the rapid development and production of diagnostic devices that can diagnose illnesses, such as malaria, in their early stages.

“Early diagnosis and subsequent treatment is a crucial lifesaver for those afflicted, [which is why this] is a major step forward in disease control for the country,” says Royal HaskoningDHV specialized cleanrooms division project manager and mechanical engineer Walter van der Linde.

He explains that the contract entailed the design and site supervision of the ISO 3 cleanroom, the BSL 3 laboratory and the manufacturing lab for rapid diagnostic devices, including all mechanical, electrical, lab-layout and structural services.

The electrical services portion of the contract included the provision of lighting, electrical reticulation to support the mechanical equipment, switched socket outlets and power supply to general lab equipment.

The mechanical services included the provision of an environmental control system, unidirectional airflow, an autoclave, an effluent system, a fumigation pass-through hatch, wet and gas services, and biosafety cabinets.

Royal HaskoningDHV’s cleanrooms team was also responsible for the lab layout, and specifying the partitioning type and shell of the cleanrooms and biosafety laboratory, says Van der Linde.

Pandor emphasized government’s commitment to continue supporting research in the public and private sectors.

She said projects, such as the Square Kilometer Array – a radio telescope project cohosted by South Africa and Australia, with a total collecting area of 1 km2 – had been positive for South Africa, as there was growing interest from international research organizations.

Pandor added that government was also pleased with the work being done by the Human Sciences Research Council to promote research and development across all sectors and to help develop and support researchers.

“I like the blue-sky researcher who occupies [his/her] mind with making discoveries and solving problems that ordinary people never think about. “I support such people, but the end result must enable us to solve our social problems,” said Pandor.

Illumina Plans New Euro HQ/Science Center in Cambridge

The gene-sequencing pioneers at Illumina ($ILMN) are planning to build a major new science center and European headquarters in the U.K.'s growing biotech hub in Cambridge. Illumina signed a lease on a 155,000-square-foot facility, designed to grow another 70,000 square feet as needed for future expansion.

Illumina struck a deal to build the new HQ with BioMed Realty, which is developing a campus next door to Cambridge University. Cambridge is also slated to become home to AstraZeneca's new complex, a passion project for CEO Pascal Soriot, who's determined to turn around the one-time pharma laggard.

"This new state-of-the-art European Headquarters will provide enhanced collaboration opportunities for our growing employee base, which is so foundational to Illumina's innovation and success," says Marc Stapley, the CFO for Illumina.

Illumina knows the area well. The company's Solexa deal added operations in Cambridge and Illumina later added BlueGnome's arrays for genetic screening a few years ago.

"Illumina and BioMed Realty's commitment to building a new state-of-the art facility in Cambridge is great news for our area," said George Freeman, the undersecretary of state for life sciences. "This is a strong endorsement of the UK's Life Science Industrial Strategy and leadership in driving forward better treatments for people with cancers and rare diseases."

Expansion of Boehringer Ingelheim Research Institute of Molecular Pathology (IMP), Austria

The construction of a new research premises for the Research Institute of Molecular Pathology (IMP) began in March 2015 at the Vienna Biocenter in the third district of Vienna, Austria's capital city.

The project is fully sponsored by Boehringer Ingelheim, which will invest €50m ($54.53m) for the construction. The new building, which will be completed by the end of 2016, is expected to be a leading research institute in molecular biology on a global scale.

The IMP building will have a total floor space of 15,000ft². It will have gross built area of 14,945m² and gross built volume of 66,854m³. It will accommodate 250 researchers from 35 nations and be provided with sophisticated laboratories and office space.

The building will include a five-story atrium under which the office and laboratory areas will be arranged. It will house a spacious lecture hall, server room, a workshop and a cafeteria.

A smooth glass façade will stretch up the atrium from the ground to the fourth floor. The façade will be transparent in the open areas. A bridge will be used to connect it with the neighboring building, so that the entire infrastructure will be used.

The facility will open up new possibilities to further develop Vienna Biocenter in future. It will bring about improvements in infrastructure, flexibility and new communication opportunities to achieve scientific results.

The facility will be used to carry out research in cell and molecular biology, neurobiology, disease mechanisms and computational biology. It will be used for the discovery of fundamental molecular and cellular mechanisms underlying complex biological phenomena.

It will focus on carrying out research on neural circuits in drosophila auditory perception and memory in the neocortex, spatio-temporal specificity of miRNA function, and stem cell commitment in haematopoiesis circuit mechanics of emotions in the limbic system.

The research topics will include symmetry breaking during cell polarization, learning and memory in drosophila, in addition to the molecular basis of migration, and molecular machines and mechanisms of protein quality control and antibody diversification.

Other areas of research focus will include systems biology of regulatory motifs and networks, molecular mechanisms of kinetochore function, mitosis and chromosome biology, and finding and probing cancer drug targets using advanced in-vivo RNAi.

The contract to design the new IMP building was awarded to ATP architects engineers, an Austrian-based company. The building construction contract was awarded to PORR, which is also an Austrian company.

The IMP building will be constructed using building information modelling (BIM) and will comply with environmentally friendly methods. It will have a resource-saving energy concept, which will facilitate the recycling of most of the energy used in the building.

SGS Opens New French Laboratory

SGS Life Science Services is set to open its new bio/pharmaceutical quality control laboratory at Villeneuve La Garenne, a Paris suburb, replacing an existing facility in Clichy.

The new state-of-the-art laboratory, opening June 29, 2015 will incorporate best-in-class infrastructure and equipment to meet the current and future demands of its bio/pharmaceutical clients. This multi-million euro investment will serve the French market, support biologics development, and will operate under good manufacturing practice (GMP) protocols.

The 2,100 square meter (22,596 sq. ft.) facility is strategically located near the main logistics hubs and has been designed and built specifically for the needs of the pharmaceutical industry, targeting the reduction of sample processing times through increased operational efficiency. All services currently available in Clichy will be transferred to Villeneuve La Garenne, with a special emphasis on safety equipment (fume hoods) to treat organic products and classified carcinogenic, mutagenic, reprotoxic (CMR) substances. At the new site, SGS will introduce services to address the growing biopharmaceutical pipeline with capabilities for mycoplasma tests and amino acid analysis.

The contamination of cell cultures by mycoplasma is a major risk for the biopharmaceutical industry. By their diversity, their small size and lack of bacterial wall, these microorganisms are not detectable visually, are very difficult to remove and can compromise the quality of biologic medicines. To meet the needs of its customers, SGS has created a new Mycoplasma detection department.

"By recruiting an expert project manager, Ms. Aude Sanchez, engineer in biotechnologies (ENSTBB) and in close collaboration with Thermo Fisher Scientific, SGS has the means to provide innovative solutions, performance, and reliability to its customers", said Paul Beyou, laboratory director for life science services Villeneuve La Garenne. “In addition to fluorescence detection methods and automated DNA extraction combined with qPCR, SGS can detect over 90 species of mycoplasmas and achieve results in 48-72 hours.”

The creation of this new laboratory confirms the SGS Group’s commitment to increase its capacity and expand its service offering in France. Additionally, this development complements the bioanalytical capabilities of its other French laboratory based in Poitiers.

Catalent Expands Packaging Capabilities in Singapore

Catalent has expanded its Singapore facility, which recently received GMP approval from the Health Science Authority, to provide secondary packaging and labeling capabilities. The site is now fully approved for GMP across all its activities, including secondary packaging, label printing, storage, distribution, returns and destruction management.

“Our Singapore facility is a strategic hub for Catalent’s Asia Pacific clinical supply network, with expertise in storage and distribution of clinical supplies,” said Gerry Hepburn, chief operating officer, vice president and general manager, Catalent’s Clinical Supply Services business. “Introducing new packaging capabilities, as well as obtaining GMP certification for the facility complements the services provided by our Shanghai site, and allows us to provide more integrated and flexible solutions for customers conducting trials throughout Asia Pacific.”

With uniform systems and facilities in the U.S., UK, Germany, Singapore and China, and an extended network of over 60 audited depots, Catalent’s clinical supply capacity enables the company to handle a broad range of international compliance and distribution requirements, ultimately reducing customer turnaround time.

West Breaks Ground for Waterford, Ireland Manufacturing Facility

West Pharmaceutical Services recently hosted a groundbreaking ceremony in Waterford, Ireland to mark the start of construction for the company's new pharmaceutical component manufacturing facility.

The Waterford facility will manufacture packaging components for insulin injector cartridges and other high-value packaging components for injectable drugs, to meet increasing customer demand. The company intends to employ approximately 150 people in engineering, production and other positions by the commencement of operations in late 2018.

"West's presence in Ireland is of great importance to us for meeting customer demand for high-quality packaging components," said Eric Green, Chief Executive Officer at West. "Packaging systems play an important role in ensuring the purity, long-term stability and efficacy of injectable drug products. The advanced components that will be produced at our state-of-the-art Waterford plant will help our pharmaceutical and biotechnology customers deliver their products to patients."

Green continued, "We are very fortunate to have found an ideal location in Waterford, Ireland, with a highly skilled life sciences workforce and local government officials and agencies who are true partners, working together with our team to help us fulfill our vision to create a healthier world. We'd like to thank Mayor Tobin, Waterford City & County Council and IDA Ireland for their continued support."

The 95,000 square foot (approximately 8,800 square meter) facility will be situated at a 44-acre site at Knockhouse on Old Kilmeaden Road in Waterford. The site has been cleared for construction and activity will commence with civil work in mid-July.

The new facility will function as a center of excellence for West's proprietary elastomeric sheeting, which is used to package insulin for use in pen injectors. Additionally, the facility will include manufacturing capacity for additional proprietary injectable component product lines, which are integral to the packaging of many injectable medicines. Two key product lines include Westar® RU components, which are delivered sterile and ready-to-use to customers for their aseptic filling operations; as well as NovaPure® components, West's highest quality packaging component line.

West has had a presence in Ireland since 2005. Its Mulhuddart, Dublin manufacturing and development center, where the company recently completed a multimillion Euro expansion, is home to Tech Group Europe Limited, West's global contract manufacturing solutions provider that specializes in providing device design, development and manufacturing services for pharmaceutical, biotechnology and medical device manufacturers.

Harper Government Announces Support for Life Sciences Manufacturer in Mississauga

Contract Pharmaceuticals Limited Canada will expand its contract manufacturing capabilities and generate business growth in the life sciences sector, with the aid of up to $8,992,672 by a member of parliament for Mississauga, Streetsville Brad Butt, on behalf of FedDev Ontario minister Gary Goodyear.

The Harper government's investment is through FedDev Ontario's Investing in Business Growth and Productivity initiative, which is aimed at helping established businesses to expand their operations, invest in productivity improvements and compete globally.

Mr. Brad Butt said: "The life sciences sector in Mississauga and the greater Toronto area, will greatly benefit from this investment to grow contract manufacturing services and products."

The company's project will include purchasing new equipment to establish more automated systems and services.

This will allow the company to work more efficiently, reduce waste costs and produce at a greater volume, to better meet the needs of its growing client base.

Contract Pharmaceuticals Limited Canada's strategic investment will allow the company to increase its manufacturing capabilities and introduce new technologies that will increase capacity to further diversify in global markets.

This project is expected to create up to 155 full-time jobs by 2018 and an additional 20 jobs within two years of project completion. It will also leverage $26,978,016 in additional funding for the project.

Facts about the company:

• Contract Pharmaceuticals Limited Canada was established in 1991 and operated initially as a third-party packaging contractor for pharmaceutical products.

• Contract Pharmaceuticals Limited Canada has grown significantly over the last 24 years, expanding its operational capacity from a 59,000ft² plant in Mississauga to a 140,000ft².

• Investing in Business Growth and Productivity funding is currently available for eligible small and medium-sized enterprises and not-for-profit industry associations or regional economic development organizations.

• Since 2009, FedDev Ontario has committed nearly $350 million to an expected 2,100 direct and indirect manufacturing projects.

• The Economic Action Plan (EAP) 2015 will support manufacturers with the aid of a ten-year tax incentive, which will boost productivity, enhance investments and support business growth. EAP 2015 will also invest in growing trade and expanding markets, which will boost job-creating opportunities for Canadian businesses.

Pfizer Building New Consumer Products Production Facility in China

Pfizer has started construction on a new consumer products production facility in Suzhou, China, which will involve an investment of around $95m.

The new facility is being developed to increase production capacity to meet the growing demand for its healthcare brands in China and the Asia-Pacific region.

Pfizer Consumer Healthcare Asia-Pacific and Europe, Middle East and Africa regional president Andy Schmeltz said: "Asia-Pacific is a large and rapidly growing region for Pfizer Consumer Healthcare and our new plant in Suzhou will give us the production capacity we need to meet increasing demand for our brands, particularly in China."

"Our new plant in Suzhou will give us the production capacity we need to meet increasing demand for our brands, particularly in China."

The new facility will be mainly used for the production of Caltrate dietary supplements and Centrum multivitamins and will also support production of additional products in the future.

In addition, the company intends to house a research and development facility on the new site to support innovation in the region.

Pfizer Consumer Healthcare North Asia regional general manager Keith Choy said: "We are pleased to build on the strong foundation we have in Suzhou, where we have produced consumer healthcare and prescription products for more than 20 years."

Having begun production in 1994, Pfizer Suzhou facility produces Centrum multivitamins, Caltrate dietary supplements, Robitussin cough and cold products, antibiotics, as well as other prescription and over-the-counter products.

Products produced in the facility will be distributed to multiple countries in the Asia Pacific region, including China.

Ex-Sanofi Site Offering Manufacturing Space for Pharma in London

An ex-Sanofi site in the UK has been redeveloped to offer start-up and small pharma access to manufacturing space.

The facilities in Dagenham, London had historically made pharmaceuticals - employing at one point over 4,500 people - but former owners, French Pharma Giant Sanofi, announced plans to shutter the site in 2009, and production ended in 2013.

The site, which was sold to regeneration specialists Site Operations Group (SOG) last year, Dagenham, has now reopened to offer access to manufacturing space “that money can’t buy,” said former Government Minister Steven Norris.

“What you have at Londoneast-UK are scientific facilities; for example production facilities for pharmaceuticals which are temperature controlled, dust controlled, humidity controlled,” he added. “These facilities would probably cost you, if you were going to build them from new, upwards of £50m [$76m] – and that’s just the build costs.”

Paul Smith, said there pharma are able to rent some of the 17 acres of specialist buildings on short or long-term licenses, depending on their requirements, and existing labs can be remodeled to suit client’s requirements.

“Naturally Sanofi has taken their drug production equipment away,” he said, “but the clean room/sterile facilities all have extensive behind-the-scenes, very high-tech filtration systems, fume extraction systems to ensure a clean air environment in some of these of the buildings.”

While he told us SOG is speaking to several science-based companies, details for now remain confidential.

In 2011, Pfizer closed its R&D facilities in Sandwich, Kent and the site was redeveloped as a ‘discovery-park,’ with over 40 pharma, biotech and life sciences companies leasing lab space.

Similarly, AstraZeneca’s Biocity in Alderley Park, near Manchester, offers emerging pharma firms the opportunity to use state-of-the-art facilities independent of the Pharma giant.

NBMC Darlington Biotechnology Gets Ardmac Cleanrooms

Ardmac is now live on site delivering cleanrooms at the National Biologics Manufacturing Centre in Darlington in the UK. Following an extensive design phase, which included contemporary architectural design of exhibition spaces and live R&D environments by Archial Norr, works are now underway at the facility.

With all labs and cleanrooms requiring flexibility for a number of different processes, project delivery of this kind is not without its challenges. The lack of roof space means that there has not been sufficient head height to accommodate a walk-on ceiling, so M&E services must be installed from below.

Ardmac has provided a flexible approach to its construction methodology to allow for walls to be installed initially, followed by the ceiling. This will give provision for the M&E first fix installation to overlap with the architectural fit out of the walling. 'Projects like this are always interesting for our team. They allow us to draw on our extensive knowledge of high GMP architectural practice and combine it with more contemporary layouts and architectural features that a modern building like this commands,' said Ardmac Senior Engineer Lee Harvey. 'As a Centre for Process Innovation, the cleanrooms need process flexibility, so it is very highly serviced. We have worked extremely closely with both the architect and Interserve’s M&E team to create a fully integrated BIM model to ensure that all project functions are working towards the same goal – an amazing, high quality, high GMP center of process excellence.'

cGMP Certification for Phage Therapy Plant

AmpliPhi Biosciences’ phage-based antibacterial therapies plant in Ljubljana has been deemed to meet manufacturing standards by Slovenian regulators.

The certification that phage therapies made at the site are produced in compliance with current good manufacturing practices (cGMP) allows AmpliPhi to move forward with its clinical development programme according to CEO, Scott Salka.

“This clearance is a pivotal regulatory milestone that further supports AmpliPhi’s leadership in the field of bacteriophage with the only cGMP-certified manufacturing facility in the world dedicated to producing bacteriophage products for human use.”

AmpliPhi’s candidate products are bacterial viruses – bacteriophages – that infect and kill bacteria.

The Ljubljana site produces phage therapies that target Staphylococcus aureus and Pseudomonas aeruginosa, which are being prepared for clinical trials.

The 600sq. meter (6,456 sq. ft.) facility, which was commissioned last year, houses cell banks and storage areas for the viral ‘seeds’ that are used to produce the phage. It also has libraries holding various species of pathogenic bacteria used in product development.

Phage therapy was used extensively in the Soviet Union as access to antibiotics developed in the West was limited.

While the approach is still used in Russia and other former eastern bloc countries, it has never caught on elsewhere. Quite why this is unclear, although researchers like Mzia Kutateladze from the Eliava Institute in Tbilisi, Georgia have suggested that (unfounded) concerns about using viruses to treat disease were a factor. For others it is because, unlike their Soviet counterparts, Western doctors have always had access to antibiotics.

What impact the antibiotics cliff – a combination of increasing resistance to antibiotics and the falling drug industry interest in developing replacements – will have on interest in phage therapy is unclear.

AmpliPhi reported: "The rise of multi-drug resistant bacteria has led to a renewed interest in exploring bacteriophage-based therapies to treat infection and modern scientists have a deeper understanding of how phage work and are making positive strides to introduce new therapies into mainstream medical use."

What is clear is that the EMA is interested in phage therapy.

Later this month the agency will hold a workshop on the therapeutic use of bacteriophages citing the “emergence of bacteria that are resistant to most, if not all, currently available antibiotics” as a driver for the meeting.

Cobra Biologics has made phage under GMP certification for several years.

Phillips-Medisize Opens Design and Development Center in China

Phillips-Medisize Corporation has opened its new design and development center in Suzhou, China to support its customers’ needs for patient-administered biologics and pharmaceutical drug delivery and diagnostics device design and development services.

As part of the company’s network of design and development centers, the Suzhou facility has multiple capabilities including device design, injection molding simulation, developmental tooling and assembly equipment, along with on-site program management. This design and development group is working on multiple projects, including biologics drug delivery devices intended specifically for Asian markets.

“This is a very exciting time for our customers and our company. The new Suzhou design and development center, as part of our network, will support our customers’ need for outsourced design and develop of new market appropriate products for the Asian market,” said Matt Jennings, chairman and chief executive officer, Phillips-Medisize.

The company’s network of four design centers located in North America, Europe and now Asia, employ approximately 200 engineering professionals, while the global program management and new product introduction teams of 275 engineering professionals successfully drove the launch of 81 new products in 2014. Traditionally, over 80% of the new drug delivery, diagnostic, and med-tech products the company launches have their roots within the Phillips-Medisize design and development organization.

Varian Medical Systems Establishes Saudi Arabia Facility

Palo Alto, Calif.-based Varian Medical Systems (VMS), which makes radiotherapy systems and software for the treatment of cancer, is expanding in the Middle East with the creation of a strategic operating entity in Saudi Arabia. Varian Medical Systems Arabia, the result of a joint venture with El Seif Development Group, was officially launched on June 3 at a ceremony attended by local dignitaries and Varian’s CEO Dow Wilson.

“This move represents the next step in our commitment both to cancer patients and the medical community in Saudi Arabia,” said Dow Wilson. “Radiotherapy plays a vital and cost effective role in treating cancer and we are committed to making more advanced treatment systems available to more patients across the region.”

Varian Medical Systems Arabia will be home to 35 sales, service and administrative employees supporting Varian’s three business segments: oncology systems, imaging components and particle therapy. Varian has also established a spare parts depot in Riyadh, Saudi Arabia’s capital.

“We look forward to supporting the ministry of health in Saudi Arabia as well as with the other healthcare service providers in the military sector, independent organizations and private hospitals,” said Mazyad Al Utaibi, managing director of VMS Arabia. “Our expertise, experience, strengths and capabilities ensure we are well placed to continue offering our partners the latest technology and local service to fight cancer and help save lives.”

The first Varian linear accelerator radiotherapy system was installed in Saudi Arabia over 30 years ago and the company now has 22 systems operating across the country. Varian was also selected to equip the Middle East’s first proton therapy center, which is under construction at King Fahad Medical City in Riyadh.

New Harmac Facility in Tijuana, Mexico.

Harmac Medical Products Inc. has opened a 57,000-square-foot facility in Tijuana, Mexico.

The Tijuana facility sits on a four-acre, standalone site located 10 minutes south of the Otay Mesa border in San Diego, Calif. Consistent with Harmac sites, the Mexican operation is approved and registered with the U.S. Food and Drug Administration and the International Organization for Standardization (ISO 13485:2012 and ISO 9001:2008).

With a “seasoned executive leadership team on location,” Harmac officials are confident that this new manufacturing site will “continue to provide quality innovation for current and future customers,” company leadership noted.

“Collectively, our team in Tijuana has over 75 years of experience in the medical technology industry and is committed to providing only the highest levels of service to our customers,” said John Somers, president and CEO. “Our strong commitment to quality ensures compliance to all specifications and our manufacturing team uses the latest in lean manufacturing techniques to ensure ongoing reliability.”

Founded in 1981, Buffalo, N.Y.-based Harmac Medical Products is a contract manufacturer of single-use medical devices. In addition to Tijuana and Buffalo, Harmac also has a facility in Castlerea, Ireland.

Quotient Clinical to Double Manufacturing Capacity

Service provider and CMO Quotient Clinical is upping its investment in cGMP manufacturing with the addition of a new site in Nottingham, UK.

The new facility follows on the company’s recent growth, with more than 30 new pharma and biotech clients adopting its translational pharmaceutics platform. The increase in adoption of the platform has driven a year-on-year increase in revenue of 24%, with similar growth levels anticipated over the next 12 months.

Quotient CEO Mark Egerton said, “The bulk of our investment program is focused on an expansion of our pharmaceutical sciences capacity. Specifically, we will be bringing a second GMP manufacturing facility on line in the autumn of this year – which will double our manufacturing capacity. This will also include a range of investments in manufacturing equipment.”

The company also plans to double the footprint of its formulation development and pharmaceutical analysis laboratories by the end 2015, Egerton said.

In addition, the company saw a significant proportion of studies begun in 2015 that were from repeat customers whilst completing successful routine GMP and GCP (good clinical practice) MHRA (Medicines and Healthcare products Regulatory Agency) inspections and more than 50 client audits.

Egerton added: “We have made significant progress over the past 12 months surpassing all expectations, with growth rates well above industry norms. Our growing customer base, coupled with the positive dynamics of the pharma R&D outsourcing market, have been the key drivers behind our decision to increase our operating capacity.”

He added that clients are increasingly interested in coming back to Quotient for repeat work, with just over half of its business in the last year classified as repeat business.

WuXi, Fudan University Partner for Human Genomics

WuXi NextCODE and Fudan University have partnered to bring WuXi’s population human genomics database system and integrated research and clinical tools to the Fudan-led Collaborative Innovation Center of Genetics and Development (CICGD).

The partnership will help CICGD scientists perform gene sequencing and bioinformatics analysis with the intent to accelerate research, clinical diagnosis, and the treatment of rare inherited diseases and malignant tumors.

WuXi NextCODE's technology is being used to analyze and manage whole-genome data on 350,000 people, which the company says is more than any other system worldwide.

Fudan led the establishment of CICGD in 2012 under the auspices of the Higher Education Institution Innovation Improvement Plan implemented by China's Ministry of Education and Ministry of Finance. The CICGD brings together several other Chinese research institutions, including Shanghai Jiaotong University, Nanjing University, Zhongshan University, Central South University, the Shanghai Institutes for Biological Sciences, the Institute of Genetics and Developmental Biology, and the Beijing Institute of Genomics.

Li Jin, Director of CICGD and VP of Fudan University, said: "Fudan's partnership with WuXi will turn Shanghai into a premier global innovation center for human genomics."

In other news for WuXi NextCODE, the company said that after two rounds of head-to-head evaluation against leading sequence analysis providers, it was the only system selected by GeL (Genomics England) to provide clinical interpretation of the whole genome sequences of both rare disease and cancer patients as part of the first phase of the 100,000 Genomes Project (UK100K) of the UK National Health Service (NHS).

WuXi NextCODE will deploy its database model and clinical and tumor-normal analysis and reporting systems at GeL, enabling NHS clinicians to begin to efficiently analyze patient sequence data and to identify causative variants in rare diseases and driver mutations in tumors.

GeL plans to sequence and interpret the genomes of 8,000 patients in the initial phase of the project and to test the systems prior to contracting with four companies.

Established by the UK Department of Health with the aim of sequencing 100,000 whole genomes from about 75,000 volunteer participants by 2017, GeL's will look to recruit NHS patients with common cancers, as well as NHS patients with rare diseases and their families.

AstraZeneca Signs JV to Build Manufacturing Facility in Algeria

AstraZeneca has partnered with two Algerian companies, AHT Health and Hasnaoui Finance, to create a joint venture with the aim of building a new $125m manufacturing facility in Algeria.

The plan is for the new facility to formulate AstraZeneca medicines from multiple therapeutic indications, including those covering cardiovascular diseases, gastroenterology, oncology, and diabetes.

AZ will control 49% of the JV, as required by Algerian law, with the long term goal of building a facility that can produce a “significant portfolio of innovative medicines," according to Said Habib Bennaceur, AstraZeneca North West Africa President.

AstraZeneca initially set up operations in Algeria in 2007 and now has almost 180 employees there. This latest project is expected to create about 104 direct jobs and 231 indirect jobs, according to the companies.

Other major drugmakers, such as Sanofi, have also set up manufacturing operations in Algeria.

Green Cross Constructing Canadian Immunoglobulin and Albumin Plant

Green Cross Biotherapeutics has begun constructing a facility in Canada it says will produce up to five tons of injectable antibodies and 25,000kg of albumin annually.

The firm - a subsidiary of Korean-based drugmaker Green Cross - is investing CA$315 (US$255m) in the 225,000 sq. ft. plant located on the Montreal Technoparc's Saint-Laurent Campus, in order to produce plasma protein products for the domestic, US and international market.

“The facility will have the capacity to fractionate one million liters of plasma per year, yielding up to five tons of immunoglobulin (IVIG), depending on the source of plasma, and approximately 25,000 kg of albumin,” said Joon Han, Managing Director at Green Cross Biotherapeutics.

IVIG is used to treat immune deficiencies, autoimmune diseases and acute infections, and is sold by firms including Baxter (as Gammagard) and CSL Behring (as Privigen). Albumin is used as a blood-volumizing agent and to treat burns.

These are sterile injectable products essential to the health of Canadian and American patients, Han explained, and North America accounts for more than 40% of the total global market. Furthermore, “Canada is currently relying solely on imports [and so] it will greatly benefit from having a domestic manufacturer.”

Commercial production is expected to begin in 2019 and more than 200 scientists, engineers, microbiologists, chemical engineers and other professionals will be employed at the site.

Once operational, the site will manufacture IVIG and albumin using the Cohn-Ethanol fractionation method which is a series of purification steps based on the different physical properties of the plasma proteins, used to extract immunoglobulin and albumin.

“Using innovative technology transferred from Korea, the immunoglobulin and albumin are processed through a series of purification and virus inactivation/removal steps, yielding to purified bulk products,” we were told.

Following this, “bulk immunoglobulin and albumin are aseptically filled into vials and then packaged into finished products.”

The facility will be equipped with some single-use technologies “in certain areas of the process where it is economically and technically feasible to do so,” Han added.

Gilead Sciences Has Opened a New Laboratory

The site in Edmonton, Alberta employs over 300 people, but the additional R&D unit has opened plus a second laboratory set to be completed next year - will add an additional 170 scientists working on Gilead’s growing pipeline.

“As Gilead expands into new therapeutic areas, the additional laboratory space enables our process and analytical chemistry teams in Edmonton to make an even greater contribution to the development of life-saving therapies for patients,” Robin Nicol, VP of Chemical Operations and General Manager of the plant said.

Furthermore, the firm is investing an extra $100m at the site in order to construct a process tower for the manufacture of active pharmaceutical ingredients (APIs), and will allow the plant to handle more potent compounds.

The investment in its own network comes a week after senior management explained how the Gilead’s reliance on third-party research organizations and manufacturers has given the firm “a lot of flexibility over the years,” and begs the question whether the ‘virtual’ pharma company is now looking to increase its own capabilities.

Along with the Edmonton site, Gilead has its three facilities in California, and a plant in Cork, Ireland, where certain APIs and fully formulated products are manufactured for clinical and commercial uses.

However, Gilead’s lead product Sovaldi (sofosbuvir) - an orally formulated nucleotide analog which costs patients with HCV up to $84,000 for a course of treatment (or $1,000 per pill) – was developed and is fully manufactured by third parties.

Launched in December 2013, the drug clocked in sales of over $10bn last year.

Intertek Opens Drug Testing Facility

Intertek has opened a new stability facility citing demand for bespoke drug and device services like abuse potential assessments and stress testing.

The facility in Royston near Cambridge, UK houses capacity for stability testing for small molecule and biopharmaceutical drugs and medical devices. The site will operate as part of Intertek’s network, which includes sites in Manchester, New Jersey in the US and Melbourne, Australia.

Intertek said “The drive for the new GMP stability facility is primarily client demand for both stability storage and stability programs that include testing” adding that it will provide capacity for bespoke tests like risk management and use/misuse studies.

The firm added that “The sheer volume of the new expansion allows us to store bulkier or larger products such as some medical devices. These can take up a lot or room in a stability chamber.”

The Cambridge site – which Intertek acquired along with Melbourn in 2013 – has provided stability testing services to the pharmaceutical and medical devices sectors for more than 20 years for drugs for a range of conditions according to Intertek.

“Our expertise for drug stability includes areas of specialism such as inhaled products behind treatments for Asthma, Cystic Fibrosis, Diabetes, and Chronic Obstructive Pulmonary disease and biologics such as monoclonal antibodies, proteins and antibody drug conjugates.”

In addition to regulated pharmaceuticals and biologics, the new stability site will also house testing services for ‘nutraceuticals,’ which include things like vitamins, nutritional supplements, herbal remedies and so called functional foods.

The firm told us that demand for such products was also a factor, explaining that “There is also a demand for stability testing for nutraceuticals and functional foods and the increased capacity will allow a much wider service provision than before.”

Three-way Collaboration for Packaging Serialization Ahead of EU Directive

Schott, Heuft and GEA have teamed up to offer drugmakers a serialization service for primary packaging to help with EU anti-counterfeiting requirements.

The EU Falsified Medicine Directive (EUFMD) will require bar codes on even the smallest saleable drug units, and with some experts saying drugmakers are already behind on preparations for the 2018 deadline, three firms have teamed up to offer a new serialization service.

Glassmaker Schott, quality assurance company Heuft and processing equipment firm GEA have developed a joint solution for the clear traceability of primary packaging, based on a 'glass-coding' principle which marks and traces vials throughout the process chain.

"The primary packaging, meaning the glass vial, is coded by the glass manufacturer [Schott]," explained Stephan Bachmeier, Product Manager at Heuft Systemtechnik. "Each vial is unique and has a unique serial number. For each batch of empty glass vials there is a list of numbers."

He continued, telling us that these vials are inspected within GEA's equipment for freeze-drying within the pharmaceutical production line using Heuft's code-reading technology.

"As the dimensions of the GEA machine are defined, the Heuft system knows in detail which vial is on which position within the freeze-drying machine."

A second inspection occurs following the lyophilisation process:

"All the vials are counted to make sure that really every vial that has entered the process also leaves the machines again. But much more important is, that predefined vials can be rejected from the line for further quality analysis."

The approach is focused on the primary packaging, and not secondary packaging and as such fulfils just one part of the upcoming EU directive.

None of the three firms are 'leading' this project, but rather the service can only work with all parties involved. Bachmeier was unable to divulge any financial details of the collaboration.

Janssen and Rutgers Expand R&D

Early adopter of continuous processing Janssen has installed a manufacturing line at its plant in Puerto Rico.

Despite pharma being “highly regulated and slow to change,” continuous manufacturing will soon be realized, says Rutgers University which has received an R&D grant from J&J.

“While our group and others have been working at this for almost a decade adoption of the technology has just begun in the last year or so,” Douglas Hausner, Associate Director for Industrial Relations and Business Development at Rutgers said, “FDA approval for the first adopters are just beginning to happen now.”

He related how the research efforts had originally comprised of a few industry scientists and that most outside of that group thought this would never get the US Food and Drug Administration (FDA) to accept a continuous processing approach.

FDA’s Janet Woodcock called on drugmakers to begin the switch from batch manufacturing, offering grants to innovation and pushing for legislation and guidance, stating continuous processing “is the future.”

As part of ongoing R&D, Rutgers designed and built “the first continuous direct compression line and demonstrated that a large number of products that currently require more complicated batch manufacturing methods can be made using this approach,” Hausner said.

“Those companies are now all going to market with this technology,” Hausner added.

Hausner agreed, but added this problem is being addressed: “This technology requires a different way of thinking and training. This is needed for current as well as new personnel.

Novo Nordisk Invest in New Plant

Danish pharmaceutical company Novo Nordisk has begun construction of a large manufacturing plant that will focus on producing products in the hemophilia market, alongside active pharmaceutical ingredients for NovoSeven. Although Novo is best known for their diabetes drugs the organization is preparing for an expected increase in demand for hemophilia products. The US$225mn production facility will be based at its site in Kalundborg, Denmark.

"The investment in Kalundborg underscores our long-term ambition to create and maintain jobs in Denmark. This year alone we expect Novo Nordisk will create about 250 new jobs in Kalundborg, and we are always on the lookout for capable and highly skilled employees” according to Henrik Wulff, executive vice president, Product Supply, Novo Nordisk.

"The investment is estimated to create 100 new production and engineering jobs in Kalundborg, where Novo Nordisk currently employs more than 2,800 people."

The 7,500-square-meter (80,700 sq. ft.) Kalundborg facility in the hemophilia market is expected to be fully operational by 2020 and has been in the pipeline since 2011. NovoSeven was Novo's first ever product specifically designed for treating hemophilia, but this drugs sales have levelled at around US$1.5bn in 2014, so the company has decided to look to other products for growth. Novoeight, Novo's latest hemophilia A product received regulatory approval in many countries last year and is on course to be launched in the United States with the next few months.

Researchers at Novo are currently working on a new product with the aim of limiting how often treatments are required. However, Novo will be entering a heavily competitive market for next-generation medication, although it is extremely lucrative.

The hemophilia market globally is led by the United States, with Baxter International, Novo Nordisk and Pfizer working in a very competitive environment. Although it is relatively rare to diagnose hemophilia, with around one in 10,000 people being born with the illness, there are still close to 420,000 individuals living with hemophilia in the United States alone.

The hemophilia market is expected to be driven by an increasing incidence of hemophilia globally and therefore more treatments. However, this industry is forecast to be hampered by a high cost for treatment of hemophilia and an often prohibitive cost to research and develop new drugs in this market. The rFVIII sector of the hemophilia industry will be the most competitive in the future, due to a range of new products entering this segment.

SGS Completes Expansion in Mumbai, India

SGS Life Science Services, the leading pharmaceutical clinical and bioanalytical contract solutions provider, announced the completion of a major expansion at its Mumbai, India, facility with validation of new equipment currently underway. An official opening of this state-of-the-art laboratory was planned for May 20, 2015.

The expansion has seen the previous 1,393 square meter (14,988 sq. ft.) laboratory space more than double in size, to 3,400 square meters (36,584 sq. ft.), and, once validation is completed, the laboratory will act as a dedicated cGMP pharmaceutical testing site. The workforce has increased from 65 to 115, with the potential for up to another 40 employees in the additional facilities.

Investment at the laboratory has been focused on increasing stability chamber capacity, and in supporting chromatography equipment, including new UPLC capabilities. The Mumbai facility now has the largest stability testing facility in the SGS Life Science Services’ global network, with the expansion driven by the increased demand from both local and international customers.

Three new 100 cubic meter capacity stability chambers have been installed for 21 CFR part 11-compliant short term, long term and accelerated studies, and covers all the International Conference of Harmonisation (ICH) conditions, as well as flexibility for specific client conditions. The Mumbai expansion follows SGS’s renovation of its Chennai, India, laboratory in 2014, increasing laboratory space within the facility. The number of employees increased from 60 to 75, with the flexibility to further accommodate up to 90.

“India is strategically very important for SGS Life Science Services, and the investments we have made in both Mumbai and Chennai have been based on customer demand for dedicated Full Time Equivalent-based models,” commented Paul House, Managing Director of SGS India Ltd. “These two facilities, coupled with our facility in Singapore, work very much as a harmonized unit, supporting not only local clients, but those across South East Asia and beyond.”

With 19 laboratories offering contract analytical and bioanalytical services, SGS leverages its wholly-owned global network, present in North America, Europe, and Asia, to deliver harmonized solutions to large pharmaceutical and biotechnology firms. In addition to testing services for the bio/pharmaceutical market, SGS also provides Phase I to IV clinical trial management and services encompassing data management and statistics, PK/PD modeling and simulation, pharmacovigilance and regulatory consultancy.

Porvair Opens New Facility in Hampshire, UK

Porvair Filtration Group has opened a new facility in New Milton, Hampshire, United Kingdom, creating approximately 20 jobs. Member of Parliament, Desmond Swayne, officially opened the 42,000-square-foot premises on March 20, 2015.

The company, a supplier of filtration equipment to the process industry, including the pharmaceutical sector, has invested £3.5 million into the new facility, which includes cleanroom technology.

According to Mike Hughes, general manager of Porvair, this expansion represents a significant milestone for the company’s business and will strengthen its capability to meet growing market demands. “It will increase overall capacity within the group, facilitate growth across the business, and provide a platform for further expansion,” commented Hughes in a press statement.

Porvair Filtration Group’s managing director, Tom Liddell added that the investment is a strategic step forward to increase the company’s capability to design and manufacture products that meet customer expectations.

Sigma-Aldrich Opens Cell Culture Technical Center in Singapore

Sigma Aldrich announced on Apr. 17, 2015 that the company is opening a new technical center to service its biopharmaceutical clients looking to develop their research and production capacities.

"The development and manufacturing of biologics, whether innovative new products or generic versions of existing drugs (biosimilars), continues to be an attractive area of growth as our customers continue pushing the boundaries of science and advancing their ability to treat and cure disease," said Jason Apter, vice-president and managing director, Asia Pacific for Sigma-Aldrich.

The center will specifically provide cell culture media and optimization service, as well as preclinical media manufacturing for customized production of non-cGMP batches of materials.

Sigma-Aldrich also said it also has plans in the works to open its own cGMP distribution center in Tuas, Singapore, and this facility is expected to open at the end of 2015.

Pluristem Therapeutics to Set Up Manufacturing Sites

The Haifa, Israel-based drugmaker uses stromal cells extracted from donated placenta to make therapies for a range of conditions, including inflammation, ischemia, hematological disorders, and radiation damage.

Production involves a variety of manufacturing techniques and Pluristem’s strategy is to seek patent protection “in projected future markets and manufacturing centers” according to Karine Kleinhaus, divisional VP for North American.

The patents secured recently cover separate manufacturing, culturing and media methods as well as various applications of cell therapy, however, as Kleinhaus explained, there is some overlap.

“The most similar of the recently granted patents are the Israeli and the South Korean patents, which relate to very similar subject matter although the claims of even these two patents are not identical. “Otherwise, the recently granted patents cover various aspects of Pluristem’s core technology and methodology, the cells produced thereby, and particular therapeutic uses of the cells” she added.

According to Kleinhaus, Pluristem intends to “build our own manufacturing facilities in different territories and we may partner with a third party to establish joint ventures in certain territories.”

While working to secure its intellectual property, Pluristem is also seeking regulatory approval for its cell therapies.

Kleinhaus said, “we are simultaneously pursuing regulatory approval of our cells in multiple markets, any of which might ultimately be the first to grant marketing approval” citing the firm's admission to the European Union's Adaptive Pathways project pilot as an example.

“The EU [programme offers] the possibility of conditional approval for therapies targeting certain indications and with a successful Phase II trial there we could potentially receive conditional marketing authorization as early as 2018.”

Pluristem has also used the recently introduced regenerative medicines pathway in Japan according to Kleinhaus, who explained that the quality of cell therapies made at its plant in plant have met with PDMA requirements meaning they could be used in a local trial.

Quintiles Opens Chinese R&D Hub

Quintiles ($Q) has opened up a new, up-sized headquarters in China, toasting the country's growth as a global biopharma power and angling to play a bigger role in its continued evolution.

The outpost, situated in Shanghai's Feng Lin Science Park, is a 43,000-square-foot building that employs about 300 workers with room for 450, Quintiles said. Its opening comes 17 years after the CRO first made its way into Shanghai, giving Quintiles a front-row seat to China's rapid rise to become the world's second-largest market for drug development, founder Dennis Gillings said.

"Today we celebrate not only Quintiles' growth, but also Greater China's emergence as a global player in biopharma R&D," Gillings said in a statement. "Two decades ago we opened in Shanghai with 20 employees across Greater China--now we have more than 1,000."

Quintiles, which has outposts around the world, has increasingly turned its focus to Asia, last month launching a new service specifically catered to small and mid-size biotech companies in the region.

Meanwhile, Quintiles is shooting for between 7% and 8% annual revenue growth in 2015, expecting about $4.5 billion in sales on the year. The CRO dialed back its projections last quarter to account for a strong dollar and an unforeseen jump in cancellations, but the company is counting on its sizable backlog to balance things out as the year goes on.

Quotient Clinical Expands cGMP Manufacturing with New Site in Nottingham, UK.

The company also plans to double the footprint of its formulation development and pharmaceutical analysis laboratories by the end 2015, Egerton said.

He added that clients are increasingly interested in coming back to Quotient for repeat work, with just over half of its business in the last year classified as repeat business.

Opko Health acquires Bio-Reference Labs

Drug and diagnostics company Opko Health will acquire the third largest US-based clinical lab Bio-Reference Laboratories for $1.47bn.

Opko said it plans to leverage Bio-Reference’s national marketing, sales, and distribution resources to enhance sales of its 4Kscore test, a blood test that provides a patient’s specific personalized risk score for aggressive prostate cancer, as well as other diagnostic products under development.

Opko will also look to enhance the drug discovery and clinical programs of industry and academic scientists with Bio-Reference Laboratories’ genetic sequencing laboratory and its oncology and women’s health business units.

Phillip Frost, Opko’s Chairman and CEO, said Bio-Reference Laboratories has “the first commercial laboratory to offer next generation sequencing for rare disorders and almost a quarter of a million patients have benefited from these services including almost 20,000 patients who have undergone exome analysis. Their newly introduced sequencing services for use in oncology are both innovative and impressive.”

The diagnostic services of Opko will be merged with the Bio-Reference operations across the US, and Opko said it anticipates that Bio-Reference’s presence there will add distribution capabilities for Opko’s diagnostic services.

Marc Grodman, Bio-Reference Laboratories’ Chairman, CEO and President, added: “Bio-Reference Laboratories has accumulated a plethora of genetic and genomics data that will be invaluable to the drug discovery programs at OPKO and other drug developers. The Bio-Reference Laboratories data is diagnostic, or disease-related, and therefore provides an important connection between disease, treatment and cure.”

Under the terms of the acquisition, which has been approved by the Boards of Directors of both companies, holders of Bio-Reference stock will receive 2.75 shares of Opko stock for each share of Bio-Reference stock. The companies expect the transaction to be completed during the second half of this year.

J.P. Morgan acted as the financial advisor to Opko, while Allen & Company acted as financial advisor to Bio-Reference.

Intertek to Open an Immunochemistry Lab in Manchester, UK

The laboratory – which will be based at Intertek’s existing site at Blackley in the north of the city - will provide bioanalytical services to support the preclinical and clinical development of large molecule pharmaceuticals.

A spokeswoman said, “The expansion gives clients access to bioanalytical support for biologic medicines such as monoclonal antibodies, proteins and biosimilars in both Europe and the US.”

She added that: “The new facility mirrors our existing San Diego immunochemistry facility, which was expanded last year, and will provide global clients access to specific methods operated from both facilities, requiring no further local validation.”

News of the new lab comes just a few weeks after Intertek opened a stability testing facility in Cambridge to cater for firms developing small molecule drugs, biopharmaceuticals and medical devices.

Immunochemistry is concerned with the molecules and mechanisms of the immune system - notably antibodies and antigens – which have the potential to be turned into more effective treatments for a wide range of diseases.

This potential has already been recognized by the drug industry with virtually all of the major firms – Pfizer, BMS , AstraZeneca , Eli Lilly and Novartis – announcing Immunochemistry-focused deals and investments in the past two years.

And growing drug industry interest has been cited as an investment driver by a number of other contract services firms in recent years.

For example, last month LabCorp said its acquisition of Covance had been driven in part by resurgent pharma interest in the immunochemistry.

In May last year US contract research organization (CRO) PRA invested in a new immunochemistry lab for its facility in Kansas and Harlan partnered with France’s Bertin Pharma to ramp-up large molecule bioanalysis capabilities.

Intertek opens GMP Pharmaceutical Stability Storage Facilities

Intertek, a leading quality solutions provider to industries worldwide, has opened a new 8,000ft2, 190,000-litre pharmaceutical stability storage facility in Royston, UK, in response to increased client demand; it will enable the company to broaden the range of solutions it can offer to the global pharmaceutical industry.

Based in Cambridge, the heartland of the UK's pharma and biotech industry, the new pharmaceutical stability storage facility is part of a wider investment programme in Intertek’s global pharmaceutical capabilities. It also complements the company’s existing product development services for pharmaceuticals, consumer healthcare, biologics, medical devices and nutraceuticals both in Melbourn and globally. This new facility will enable clients globally to establish recommended and bespoke storage conditions with a state-of-the-art environmental monitoring system.

With the opening of this new Good Manufacturing Practice (GMP) compliant facility, Intertek, as a leading provider of analytical and formulation support for the pharmaceutical, biotechnology and drug delivery industries, has increased its stability storage capacity significantly, enabling it to meet the growing demands for bespoke storage conditions, risk management/contingency storage programs and ‘storage-only’ projects.

'This new facility, integrated with our scientists’ experience and knowledge of pharmaceutical testing, will bring a range of storage solutions with options for client bespoke conditions and risk management storage to meet the increased demands from our global clients,' said Mark Hammond, Laboratory Director.

Chetan Parmar, Senior Vice President of Intertek Life Sciences, added: 'With more than 20 years of experience in the design and management of pharmaceutical stability studies, Intertek’s new facility will benefit our clients through a truly flexible stability outsourcing partnership.'

GMP stability testing forms a key part of Intertek’s pharmaceutical development services. Intertek’s global International Conference on Harmonisation (ICH) stability storage and testing locations also include Manchester (UK), Whitehouse, (New Jersey, USA) and Melbourne, (Australia).

McIlvaine Company

Northfield, IL 60093-2743

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

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