London-based drug giant AstraZeneca unveiled progress on its new $200 million, 40,000-square-foot facility in Frederick, MD recently. It plans to add about 300 jobs in the manufacturing, lab and administrative space.

When it came to deciding where drug giant AstraZeneca would expand its work making biologic medicines, there was no question the project would happen in Maryland, the company's top U.S. official said.

"I don't know where else we would go in terms of innovation," said Paul Hudson, AstraZeneca's U.S. president as the company unveiled progress on its $200 million expansion in Frederick.

The local and regional ecosystem for healthcare research, and its proximity to research at institutions including the National Cancer Institute and Johns Hopkins University, made it a prime location for the company, he said.

"We plan to make this a world center for biologic medicine," Hudson said. "This is for the medicines of tomorrow."

Biologics are therapies that are made from natural sources using biotechnology methods, whereas a drug is typically manufactured through chemical synthesis.

Hudson was showing the 40,000-square-foot facility to Maryland Gov. Larry Hogan and local officials. There, the London-based pharmaceutical will expand manufacturing, lab and administrative space. It plans to add about 300 jobs to increase production of biologics.

MedImmune, AstraZeneca's biologics research and development arm, has more than 120 drugs in its research pipeline, including more than 30 in clinical development. AstraZeneca says the expansion will support its research.

AstraZeneca acquired Gaithersburg-based MedImmune in 2007 for $15.6 billion. AstraZeneca's Frederick manufacturing center is its largest biologics facility in the world. The site currently produces a commercialized pediatric medication, as well as other investigational biologic products.

Frontage Expands Clinical Ops in NJ

Frontage has opened a new facility in Secaucus, NJ, expanding its clinical research services. The new 36,000-sq.-ft., 160-bed clinical research center complements the company’s existing center in nearby Hackensack.

The Secaucus facility has the capabilities to conduct a wider range of clinical studies including multiple concurrent studies and Phase II-IV studies involving patient populations. This expansion will nearly triple the company’s clinical capacity in the U.S.

“We are excited to operate a second facility in New Jersey as it has been an ideal location for our clinical research due to the immediate access to the medical communities as well as subject and patient populations,” said Eileen McAuley, senior vice president of Clinical Services.

“Frontage’s ability to provide comprehensive support to our clients and their needs in the early drug development stage is greatly enhanced by our investment in facility expansion and clinical services infrastructure,” said Dr. Song Li, chief executive officer of Frontage.

SAFC Expands Carlsbad Production Capabilities

Sigma-Aldrich Corp.'s custom manufacturing business unit, SAFC Commercial is expanding its facility in Carlsbad, CA to further enhance clinical and commercial bulk drug production capabilities, as well as fill/finish of viral products for its gene therapy, viral vaccine and immunotherapy customers.

"Gene therapy is an emerging technology, and our SAFC and BioReliance sites in Carlsbad, Rockville, MD and Glasgow, Scotland, have supported this growing industry for years," said Gilles Cottier, president of SAFC. "This investment is pivotal to our customers and reflects SAFC's continued dedication to providing the infrastructure customers need to bring their drugs to market."

The investment was driven by continued interest in targeted gene therapies for indications such as hemophilia and cancer immunotherapies (CAR-T cells). Utilizing the biosafety testing expertise of BioReliance, the Carlsbad facility provides a full range of GMP manufacturing and testing services.

SAFC Completes St. Louis Facility Manufacturing Expansion

SAFC Commercial, the custom manufacturing services business unit of Sigma-Aldrich Corp., has completed the expansion of its St. Louis, MO facility to support commercial-scale antibody drug conjugate (ADC) manufacturing. The facility is in final validation and expected to go online in 3Q15.

The St. Louis expansion, designed to meet SafeBridge category 4 compound handling to safely accommodate usage of highly-active compounds, creates commercial-scale manufacturing capacity for ADCs and other targeted therapies. The expanded capabilities in St. Louis further the company’s commercial capacity for highly-active manufacturing and storage at its Madison, WI facility.

"The ADC market is a growing market, and is expected to expand over the next few years. This strategic expansion is the latest in a series of enhancements in our ADC offering designed to support this important therapeutic area and to help our customers to seamlessly scale ADC production from preclinical to commercial phases," said Gilles Cottier, president of SAFC. "Our offer can bring customers' molecules to the clinic faster, with the ease of working with one supplier from start to finish. With the added support of our recently launched ADC Express service, we believe SAFC presents the most comprehensive offer in the contract manufacturing market."

California Site for SAFC

In a second investment, SAFC expanded its facility in Carlsbad, California for finished biologics manufacturing, testing, and filling.

The facility will produce bulk drugs for clinical and commercial uses, as well as performing fill-finish services for gene therapy, viral vaccine and immunotherapy customers.

“Gene therapy is an emerging technology, and our SAFC and BioReliance sites in Carlsbad, Rockville, and Glasgow have supported this growing industry for years,” said Gilles Cottier. “This investment is pivotal to our customers and reflects SAFC’s continued dedication to providing the infrastructure customers need to bring their drugs to market.”

The investment was driven by demand for targeted gene therapies, such as cancer immunotherapies (CAR-T cells) and those for hemophilia, the firm said.

SAFC’s other biopharma GMP capabilities include a cell banking facility in Rockville, Maryland, and biomanufacturing near Glasgow, Scotland.

Patheon Expands Stability Testing Capabilities in Greenville, North Carolina

Patheon is investing more than $3 million to expand its Greenville, North Carolina site's stability testing capabilities.

The expansion includes the most advanced automated systems and assembly of a highly experienced scientific team to enhance its centralized stability lab offerings.

Since 2011, more than 1,000 stability studies with 110 different products have been initiated at Patheon's stability lab in Greenville.

With this expansion, the facility offers more than 30,000 cubic feet of state-of-the-art stability storage, and the capabilities to support the largest, most complex projects.

These projects will be on small molecule APIs, large molecule biologics, drug substances, solid oral dose drugs, sterile liquid or lyophilized drugs, controlled substances and highly potent compounds.

Patheon executive director and global head of analytical sciences Bill Weiser, PhD said: "Our complete suite of advanced analytical tools dedicated to stability testing delivers accelerated results for customers' late-stage development and commercial projects, providing high-quality data in 30 days or less.

"An additional benefit is that the stability lab's high-tech chromatography system will be fully integrated with the data reporting system, which allows customers to access their data anytime, anywhere allowing for quicker access to submission ready reports."

Patheon is a recognized leader in quality, and the investment in its Greenville facility demonstrates the company's commitment to continued growth and customer needs.

Companies facing costly upgrades to in-house stability capabilities will benefit greatly from the use of Patheon's efficient and cost-effective centralized stability services.

Hemispherx Biopharma Completes New Commercial Production Facility

Hemispherx Biopharma, Inc. announced that its manufacturing site located in New Brunswick, New Jersey, presently configured at over 43,000 square feet, has completed its $8 million of upgrades. These upgrades will provide for a higher capacity, more cost effective manufacturing process for the production of Alferon N Injection^®, the only FDA-approved natural alpha interferon. The added efficiency of the process has been accomplished by integrating continuous flow manufacturing technology throughout the process. This has led to improved cost efficiency, enhanced yields, real-time process monitoring, flexibility to tailor batch size for lean manufacturing, and improved operational safety as seen in other cutting edge pharmaceutical companies.

The upgraded facility is installed with a 600- liter bioreactor instead of a labor intensivelabor-intensive method using 100 x 6 liter flasks for the same size batch. Scaling up to the automated 600- liter bioreactor has eliminated ~ 80% of the manpower previously needed for this part of the process.

In March 2008, the company halted the manufacturing and marketing of Alferon N Injection^® due to the high labor cost for manufacturing Alferon^® and the low capacity significantly limiting the commercialization potential of Alferon N Injection^®. The original process, producing the Alferon® in hundreds of small flasks, was extremely labor intensive. The upgraded manufacturing facility which uses a 600-liter bioreactor will provide a cost effective process and provide the capacity to supply both the US and South American market. The FDA will need to re-affirm the amended Biological License Application (BLA) for the facility before the commercial sales of Alferon N Injection^® are recommenced. The company is anticipating having commercial product available for distribution by Armada Healthcare by late 2015.

According to industry sources, global sales of interferon (from multiple manufacturers) was approximately $7.8 billion in year 2013, with about two-thirds of global sales generated in the U.S.

Charles River to Save with New Efficiency Initiatives

As competition and pricing get fiercer for CRO Charles River Laboratories, the company is looking to save about $35m from new efficiencies in its RMS (Research Models and Services) business, Jim Foster, chairman, president and CEO of CRL, told investors at the Baird 2015 Growth Stock Conference.

A portion of that $35m, or about $3m, came from the consolidation of “a couple of discovery service sites into larger sites in Japan – so that work is done,” Foster said, noting that the company will begin to see the benefits of that consolidation in Q2 and for the balance of the year.

“This business is about 70 years old and yet it’s still quite manual. Embarrassingly manual,” Foster said, noting that the company is working through “a lot of IT initiatives right now that will enhance efficiency, productivity, inventory management, headcount, and facility footprint,” all of which have the aim of continuing to improve operating margins.

“The $35m is in multiple places in procurement, facility utilization, better headcount, [and] IT initiatives,” Foster added, also offering the example of how the company re-engineered its safety assessment business over the last five years and made it “extremely efficient as evidenced by the 600 basis point pop in margin in Q1,” he said.

And as far as the discrepancy between RMS sales in North America and those in Europe and Japan, Foster said that Europe and Japan tend to follow North America, so as the American business strengthens, the others should follow suit.

Tom Ackerman, CFO of Charles River noted that the company is seeing “great growth” for some of its research models in the Chinese market.

Foster also said that the company’s genetically engineered research model business grew at a slower rate than anticipated, “principally because of one large client, though we’re also in the beginnings of a technological change in how the models are made. These multi-genetic knockouts are becoming powerful tools for new compounds with much better translational information.”

“I think we really have significant opportunities in the research models business which is still a big business, but in some ways is unsophisticated with lots of manual processes, to drive efficiency to add people more slowly or utilize people differently to drive margin,” Foster added.

CRO QPS Holdings Opened Research Laboratory in Fargo, ND

This new physical extension of QPS’ Dermal and Transdermal Research Services portfolio will further strengthen the company’s ability to assist clients in moving their dermal and transdermal products from preclinical evaluations through to late stage clinical development.

“With QPS’ increasing early phase clinical presence in topical and transdermal pharmacokinetics and bioequivalence, this is a logical step in the evolution of our Dermal and Transdermal Research Services Division,” said Ben Chien, QPS President and CEO.

The laboratory will be directed by Paul Lehman, VP and Head of QPS Dermal and Transdermal Research Services, and backed by 36 years of topical pharmacokinetics experience with the Franz Diffusion Cell. This model and associated methodologies support dermal drug development testing in the preclinical, clinical, and post-approval phases, including the in vitro rate-of-release assay based on the FDA SUPAC-SS Guidance.

The facility now offers its services to clients conducting in vitro Research & Development (non-GLP) topical pharmacokinetics and in vitro release rate studies using the Franz Diffusion Cell. The laboratory will also be offering augmenting services for studies intended for regulatory submission (with full GLP compliance).

Oncobiologics Builds Commercial Manufacturing Facility in New Jersey

mAb biosimilar developer builds commercial manufacturing facility in New Jersey

Oncobiologics, a biotherapeutics company focused on developing and commercializing monoclonal antibody (mAb) biosimilars, has completed the construction of its GMP commercial manufacturing facility at its headquarters in Cranbury, New Jersey.

The new facility employs single-use technologies, while the company says that its footprint and associated capital investment is significantly lower than a conventional facility of equivalent capacity.

The new commercial 2000-L facility has already been deployed to manufacture ONS-3010, a Humira (adalimumab) biosimilar candidate, for use in an upcoming Phase III clinical trial. Two of Oncobiologics' eleven mAb biosimilar candidates have entered the clinic within the past year.

The design and construction of the facility was completed in less than one year, which is less than half the time required for typical stainless steel-based commercial facilities. The new Cranbury facility also can be rapidly replicated in the future, the company said, which provides it with added flexibility in meeting demand for its biosimilar portfolio.

"By fully-integrating our CMC development and manufacturing operations at a single site, we are able to expedite technology transfer, resulting in a streamlined path to commercialization," Scott Gangloff, Oncobiologics' Senior Vice President of Development and Manufacturing, said.

Oncobiologics Founder & CEO, Pankaj Mohan, added, “This project is another demonstration of the capital efficiency and speed that we embrace as critical success factors in the emerging mAb biosimilars marketplace.”

Eli Lilly is Building an Innovation Centre in Cambridge, MA

The announcement comes at a time when Lilly’s drug pipeline is shifting towards injectables, accompanying an industry-wide boom in biologics. The company says it expects its revenues from device-enabled products to double by 2020.

The Lilly Cambridge Innovation Center will employ about 30 scientists and engineers over the next two years, the company said. Construction will begin immediately, and the site will open by the end of the year.

Lilly said it expects the facility to increased drug delivery and medical device R&D by almost 50%, with a 25% increase in staff.

CEO John Lechleiter said the company chose Kendall Square in Cambridge, MA, for its location in an engineering and life sciences hotbed.

"The Lilly Cambridge Innovation Center complements a deliberate push by the company to be an industry leader in providing convenient, reliable drug delivery and device innovation," he said.

"Locating in Cambridge is an important strategic move for achieving this goal, as it provides us access to a concentration of high-caliber academic institutions, cutting-edge life science and technology companies, and some of the world's leading talent."

The Centre will be used as a hub for external partnerships, and for collaboration with Lilly’s research facilities in San Diego, New York City and Indianapolis. The company said the site will also improve its business development presence locally.

The investment "underscores Lilly's commitment to providing meaningful innovation in this arena," said Jan Lundberg, Executive Vice President of Science and Technology and President of Lilly Research Laboratories.

"New drug delivery and device innovation is critically important to Lilly's growing portfolio of potential medicines, particularly in our focus areas of diabetes, neurodegeneration, immunology and pain,” said Lundberg.

“The best therapies of the future will marry breakthrough scientific discovery with customer-friendly devices. That's what will make life better for people who need our medicines and give Lilly a true competitive edge."

WuXi PharmaTech Plans New Cell Therapy Manufacturing Facility

WuXi PharmaTech will soon begin construction of a new, 145,000-ft2 cGMP facility in Philadelphia, Pennsylvania for the manufacture of cell therapy products, the company announced on Mar. 12, 2015. This facility is designed for cell therapy products that contain viral vectors, such as chimeric antigen receptor T-cell (CAR T-cell) therapies, and will become WuXi's third cell-therapy manufacturing facility when it becomes operational by mid-2016.

The new facility will provide single-source contract development and cGMP manufacturing capabilities to support the rapidly growing cellular therapeutic industry's unique requirements, particularly the rapidly expanding demand for clinical studies and commercial supply, said the company in a press release. In the US, the new facility will expand upon WuXi's existing 16,000- ft2 cGMP cell therapy manufacturing facility and a 45,000- ft2 facility for the manufacturing of allogeneic and autologous cell-based therapeutics that is expected to be completed by mid-2015. These facilities will complement the company's current fully integrated facility for biological safety and lot-release testing in Philadelphia.

GSK to Establish Global Vaccines R&D Centre in the U.S.

GSK announced it is further strengthening and expanding its vaccines presence in the U.S. by establishing a new global Centre for vaccines research and development (R&D) in Rockville, Maryland. The site will become one of three global vaccines R&D centers for GSK, complementing the company’s existing global R&D centers in Rixensart, Belgium and in Siena, Italy, a site which GSK recently acquired from Novartis in March 2015.

The new U.S. vaccines R&D Centre will expand GSK’s efforts to discover and develop novel vaccines across a range of pressing public health threats, including those relevant to the U.S. It will consolidate vaccines R&D activities currently conducted at other GSK sites including in Philadelphia, PA and Cambridge, MA, into one centralized location. Key late stage development programs, as well as vaccine discovery and new platform technology development will be led from Rockville.

The Rockville site, which was acquired by GSK in 2012, offers proximity to vaccines collaborators and key public health stakeholders. GSK anticipates site operations for vaccines to begin in Rockville as early as September 2015.

Luc Debruyne, President, GSK Vaccines, said: “As the global vaccines leader, GSK is on the cutting edge of vaccine development. Following the acquisition of Novartis’s global vaccines business and in recognition of the vaccines knowledge and expertise in the United States, we are pleased to expand our U.S. presence with the creation of a world-class vaccines R&D Centre. This will drive innovation, and enhance our capabilities for new vaccine discoveries that protect the US and public health around the world.”

Maryland Governor Larry Hogan said: “I am proud that a world-class pharmaceutical company like GSK has chosen to grow its U.S. operations in Maryland. With key federal labs like the Food and Drug Administration and the National Institutes of Health in our backyard, a highly-educated workforce and a critical mass of life sciences companies, Maryland offers GSK an excellent environment in which to grow and thrive.”

This move follows GSK’s acquisition of Novartis’ vaccines business as part of the companies’ major three-part transaction that closed in March 2015. GSK and Novartis’s vaccines R&D organizations are highly complementary, bringing together respective expertise in virology and bacterial infection.

GSK – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com.

Wexford Science + Technology and the University City Science Center Expands

Wexford Science + Technology, a BioMed Realty company, and the University City Science Center in Philadelphia announced that Penn Medicine University City has agreed to expand into an additional 56,000 sq. ft. at the recently opened LEED-Gold-certified 3737 Science Center Building. With this lease expansion, anchor tenant Penn Medicine University City will occupy 267,800 sq. ft. in the 13-story laboratory and office building in West Philadelphia. “3737 Market’s rapid lease up exemplifies the attractiveness of the Science Center as a location of choice for organizations in the innovation ecosystem,” said Science Center President and CEO Stephen S. Tang, Ph.D., MBA.

REST OF WORLD

Porvair opens New Facility in Hampshire, UK

Member of Parliament, Desmond Swayne, will officially open the 42,000-square-foot facility on March 20, 2015.

Porvair Filtration Group has opened a new facility in New Milton, Hampshire, United Kingdom, creating approximately 20 jobs. Member of Parliament, Desmond Swayne, will officially open 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.

As well as integrating Porvair’s industrial process operations, the new facility will provide further capacity at Head Office in Segensworth, to support the company’s growth plans in the Energy and Aerospace markets.

The company currently employs 60 staff in New Milton across separate units, and the new building will see staff numbers increase to 80 when Porvair moves its microfiltration business from Segensworth to the new facility in Hampshire.

Porvair has spent £3.5m on purchasing and fitting out the building, including an investment of £300,000 in an ISO Class 8 rated cleanroom.

The group manufactures in both the UK and U.S. and has a network of sales offices and distribution channels throughout the world. It has been working to increase its presence in the pharmaceutical sector and recently set up a Product Validation Service, designed to provide a cost-effective, in-process, product validation service for its range of polymeric cartridge filters for use within the pharmaceutical industry.

Process validation of cartridge filters, specific to a product is mandatory within the pharmaceutical industry to ensure compliance with standards set by regulatory authorities including the US FDA, European Pharmacopeia and ISO 13408-2.

In collaboration with leading FDA approved laboratories, Porvair Filtration is offering to undertake independent testing for chemical compatibility, extractables, leachables, and bacterial retention at a lower cost than other filtration companies.

Hughes said: 'It is our intention to remove the cost barrier validation has historically presented, to allow customers the freedom to select our products for their process. We believe that our product- and process-specific validation service provides considerable peace of mind, going above and beyond standardized tests, and promoting new levels of assurance.'

The company, which is currently experiencing double-digit growth in its pharma sector business, is also looking to increase its presence in the single-use sector and expects to launch new products relevant to this market sector in the near future.

Theorem to Open New Clinical Supplies Facility

Theorem Clinical Research will open a new clinical supplies facility in Frankfurt, Germany, in June. The cGMP-compliant facility will triple the company’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 facility will also serve as a clinical supplies hub near the Frankfurt Airport.

“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 chief executive officer. “The new facility will enhance speed and scalability while preserving the versatility of our supply solutions.”

The new facility enhances current practices, such as its 24/7/365 storage, continuous monitoring and backup, and provides space for future expansion.

Körber Medipak Systems Opens New Location in Sao Paulo

Körber Medipak Systems has expanded its Latin American footprint with a new site in Sao Paulo, Brazil. The company says due to the growing populations in Latin America, with current figures at over 600 million people, the pharmaceutical industry is recording strong growth in the region, particularly in Brazil. The services of the new location cater to meeting the increasing need for solutions for the pharmaceutical and biotech industry in Latin America, from Mexico to Argentina.

The company’s complete portfolio of solutions and services will be offered at the new site. In addition to two managing directors, there are IT consultants from Werum IT Solutions, as well as sales and project managers for the inspection and packaging technology business, all of whom are based directly in situ. Specially trained service technicians for the installation and maintenance of the lines complete the team, which is set to grow further over the coming weeks and months.

Until now the regional and multinational customers of the Medipak Systems companies have been supported from bases in other countries. Now they can benefit from the advantages of having local experts with an international network.

“Personal contact with our customers has proven to be the key to success in every country in which I have worked so far,” said Borja Guerra, managing director, Körber Medipak América Latina. “With our office in Brazil, we are now able to give our customers even better support with a bigger team right on spot.”

Medicago Plans New Vaccine Facility

Medicago, Inc.'s $245 Million Facility Will Create 200 New Jobs, 40 Million New Vaccine Doses.

Booming Canadian biotech Medicago, Inc. will shell out $245 million for a new production complex in Quebec City, as demand for vaccines grows and the company puts 200 people to work at the new site by 2019.

Medicago attracted attention in late 2014 when it was awarded a contract by the U.S. government to manufacture Ebola antibodies in its Quebec City pilot production plant. Now it needs room to grow, said company executives.

Its new 44,000 square meter (473,440 sq. ft.) complex will be located near its head office and laboratories and will include research and corporate facilities. The new complex will be built in Quebec City's Espace d'innovation D'Estimauville (Estimauville Innovation Park) and finished by 2019.

When completed, Medicago says the new site will be able to crank out 40 million to 50 million doses of seasonal flu vaccines annually, generating more than $461 million in direct and indirect economic benefits over the next five years.

"We're pleased that Medicago will take this next major step in Quebec City, where we have already developed our innovative technology," said Andy Sheldon, Medicago's chief executive, in a statement. "We will export most of our vaccines to foreign markets, but we also believe our new production complex will help Canada meet its needs for seasonal and pandemic flu vaccines, in addition to strengthening the country's response to emerging diseases around the world."

The Canadian government has high hopes for the project as well, investing via a $60 million loan from Quebec province and an $8 million loan from Ottawa.

Medicago is a clinical-stage biopharmaceutical company developing novel vaccines and therapeutic proteins used to treat infectious diseases. It uses its proprietary Virus-Like Particles (VLPs) and manufacturing technologies that use plants “like miniature factories” to rapidly produce large quantities of vaccines or treatments.

“This technology demonstrated its potential for responding to global pandemics when it produced candidate vaccines for H1N1 in 2009 and H7N9 in 2013 in just 19 days, compared to the several months required to produce vaccines using eggs,” said the company in a statement.

Nisso Opens Expanded HPC Plant

Recent US FDA approval of products containing the excipient HPC has driven demand, according to Nippon Soda (Nisso) which has expanded its production facility in Japan.

Hydroxypropyl Cellulose (HPC) is used in many roles in the drugmaking industry: it is a high efficiency tablet binder which can provide the necessary hardness at lower addition rates than other binders, for example, as well being used in solid dispersions – through spray drying or hot melt extrusion - to increase drug solubility, and can be added to film coatings to increase adhesion.

“Demand has been steadily increasing for HPC as the global solid oral pharma market expands. We are in a few products that were recently approved by FDA and other global bodies, so that is driving our demand in particular”, said Wade Tanev, company spokesman.

This was a driving force in the recent expansion of Nisso’s HPC facility in Nihongi, Japan, which saw the addition of a completely independent production line, pushing the total number of production lines to four.

The expansion was first announced in 2012 but was completed in March. The site will support manufacture of Nisso’s latest HPC product, SSL-SFP, which the firm says has a lower molecular weight and is of a finer excipient grade to other HPCs on the market.

“Customers have been receptive to this expansion as the HPC market has been tight till now. Our expanded capacity allows us to reduce lead times and develop new grades, like the Nisso SSL-SFP grade mentioned.” Tanev said. “We have some other grades in development that will be announced later this year.”

In August 2014, rival Ashland announced plans to expand its own HPC plant in Hopewell, Virginia, also citing increased demand. The plant will open its doors in 2016.

Alexion Pharmaceuticals Announces Expansion in Dublin

Alexion Pharmaceuticals will expand its Irish operations in a €450m four-year project that will see the company construct a 2,000m2 (21,520 sq. ft.) biologics manufacturing facility – it's first outside the US. The project will create around 200 jobs at its College Park site in Blanchardstown, Dublin, bringing the company's total workforce in Ireland to almost 500 employees.

Since first entering Ireland in 2013, Alexion has invested €130m in two facilities – a vial fill-finish facility in Athlone and a global supply chain facility at College Park. Phase 1 of the College Park facility, comprising the company's global supply chain headquarters, laboratories, packaging and warehousing operations is expected to be operational by the end of this year.

Approximately 560 construction workers are involved in the development of the current Athlone and College Park projects, and the planned expansion of College Park will also create more than 800 construction jobs. This project further underscores our commitment to Ireland Alexion has worked closely with the Department of Jobs and IDA Ireland on the development of its operations in Ireland.

Julie O'Neill, Alexion's EVP Global Operations, said: 'This project further underscores our commitment to Ireland and is enabled by our ability to recruit highly competent and professional personnel to support the production and distribution of our medicine, Soliris, and our strong pipeline of biologics medicines.' She added: 'Alexion has a unique mission to develop life-transforming therapies for patients with severe and life-threatening ultra-rare disorders. We are already serving the very few patients in Ireland suffering from two very rare and devastating diseases; with this major expansion, our Irish operations, comprising biologics manufacturing, vial fill-finish and global supply chain, will be at the forefront of this vital work globally.'

Martin Shanahan, CEO, IDA Ireland, added: 'This is one of the largest investments in healthcare in the history of the Irish state – putting an additional €450m into a site is a real statement of intent from Alexion. Alexion has rapidly grown its headcount and functional responsibility over the last year.'

Sandoz Opens New Packaging Center in Stryków, Poland

Sandoz Poland has completed a new packaging center Sandoz, the generics division of Swiss pharmaceutical company Novartis, has opened a new PLN171m (€42m; US$47m) packaging center in Stryków, Poland, in one of the largest investment projects in the region's pharmaceutical sector completed in recent years. The plant is expected to reach full production by the end of this year. The expansion has already led to the creation of 90 new jobs, soon to be followed by at least 40 more. Sandoz's workforce in Poland is currently around 1,200, of which about 450 people work in Stryków.

The Stryków plant is one of the biggest Sandoz facilities, producing five billion tablets a year which are exported to nearly 60 countries worldwide, including Poland. Among others, the plant produces painkillers, anti-inflammatory medicines (ketoprofen), diabetes medicines (metformin, glimepiride), as well as medications for vascular hypertension (ramipril, torasemide).

As part of the enlargement of the production and logistics site in Stryków, a modern packaging and warehousing center has been added to the facility. The ribbon-cutting ceremony was led by Poland's Deputy Prime Minister Janusz Piechociński, who underlined the importance of the Sandoz investment for the development of the Polish economy. We will be able to pack around four billion manufactured tablets.

The construction of the Sandoz Packaging Centre has taken nearly two years – it started in June 2013 and ended in the second quarter of this year. Previously, the majority of the tablets produced in Stryków were transported to other Sandoz facilities for packing. At the first stages of the construction project, eight state-of-the-art packaging lines and a fully automated warehousing system have been installed in the new building, which will enable the packaging process to be carried out directly at the manufacturing site.

Ard van der Meij, President of the Board of Sandoz Poland, said: 'This investment will greatly facilitate the manufacturing and packaging process, as we will be able to pack around four billion manufactured tablets, without the need to send them to external packaging facilities.' Van der Meij added: 'Poland plays a vital role in our company’s growth strategy. This investment will increase the capacity of the plant and, simultaneously, reduce costs. Our decision to expand the Stryków site was motivated by two key considerations: the excellent location of the site, right at the heart of Europe, and the accessibility to highly qualified personnel.' -

AstraZeneca plans New Biologics Manufacturing Facility in Södertälje, Sweden

AstraZeneca has announced plans to invest approximately $285 million in a new high-tech facility for manufacturing of biological medicines in Södertälje, Sweden. The new plant will be focused on filling and packaging of protein therapeutics. It is anticipated that the new facility will supply medicines for clinical trial programs of AstraZeneca and MedImmune, the company’s global biologics research and development arm, from the end of 2018, and will deliver finished products for commercial use once fully operational by 2019.

Södertälje is currently home to AstraZeneca’s largest global tablets and capsules manufacturing facility and is also a launch platform site for the company, with specialist capabilities on-site that allow large-scale production of new medicines, working closely with the research and development organization. By locating the new manufacturing plant in Södertälje, the company will combine its expertise in biologics with the well-established culture of operational excellence that exists within the Sweden Operations unit.

The planned investment will, subject to relevant approvals by the local authorities, create between 150 and 250 highly skilled new roles at AstraZeneca by 2019.

Pascal Soriot, Chief Executive Officer, said: “This is a strategically important investment for AstraZeneca to support the accelerating development of biotech medicines, which now make up around half of our pipeline. We expect to bring a significantly increased number of new specialty care medicines to patients in the coming years, driven in large part by biologics. This new plant will give us greater capacity and flexibility to handle clinical trials, and will also play an important role in our future commercial production."

The $285 million planned investment is the first phase of a potential three-part programme to expand AstraZeneca’s biologics manufacturing capabilities. Further investment decisions are expected to be made in the coming years.

Jan-Olof Jacke, President, AstraZeneca AB, said: “Building what will be a world-class facility in this area is not only important to AstraZeneca but we believe it will also add value to the Swedish and Nordic life sciences sector by enhancing the skills base. Södertälje will also be considered as the location for the next phases of our programme to expand our global biologics manufacturing capacity. In addition to our strong internal capabilities and the access to a highly skilled workforce within the life science sector, we are encouraged by signals from the Swedish Government regarding a competitive and supportive environment for business investment."

The new manufacturing facility in Sweden will support the progression of drug candidates across the main therapy areas and be aligned with investments being made in the current biologics manufacturing centers, such as the expansion in Frederick, Maryland, announced in November

West invests in Global Site Expansions

West Pharmaceutical Services, Inc. has made a multi-year investment to add capabilities to all of its global Packaging Systems R&D facilities and develop two new R&D Centers of Excellence (CoE) in the Asia Pacific and in Europe, to leverage regional capabilities in parenteral drug packaging.

The facility in Europe will serve as the company’s CoE for drug vial and cartridge seals, plastic technology and packaging component materials development, and will be on line by the end of 2016. The location in the Asia Pacific region will serve as a CoE for innovation across all technologies specific to the emerging markets, and is expected to be operational by the end of 2015.

“For more than 90 years, West’s focus on innovation, science and service has made us a trusted partner for pharmaceutical and biopharmaceutical companies worldwide,” said Karen Flynn, president, Pharmaceutical Packaging Systems, West. “Our enhanced R&D Development Centers—in all regions of the globe—will further our commitment to our customers by providing world-class, science-based process and product development that enables us to quickly and efficiently anticipate and respond to changing market needs with new, innovative solutions.”

Additionally, a significant investment is being made in North America to expand the current R&D center at the Exton, PA headquarters, and to upgrade the St. Petersburg, FL facility.

Nikon and Lonza Form Collaboration on Manufacturing in Japan

Lonza and Nikon Corporation have announced an exclusive collaboration in the field of cell and gene therapy manufacturing in Japan.

Nikon will have access to Lonza's quality and operating systems, facility design and ongoing consulting services for the establishment of a wholly owned Nikon cell and gene therapy contract manufacturing business.

The Tokyo/Yokohama area of Japan is currently under consideration for the site location of Nikon's new facility.

Japan has become an attractive location for the future of regenerative medicine since the induction of the Revised Pharmaceutical Affairs Act, which became effective in November 2014.

The act states conditional product approval may be granted in Japan at the time when clinical safety and an indication of efficacy of a regenerative medicine product are demonstrated.

For this reason, Japan is expected to be a promising location for the expedited clinical application of cell and gene therapy products.

The use of somatic stem cells (hematopoietic stem cells and mesenchymal stem cells) already gained traction in the US and European biotechnology and pharmaceutical markets, with the use of induced pluripotent stem cells (iPSCs) following quickly behind. Virally modified gene therapy has demonstrated promising clinical results in multiple disease indications, including cancer.

Using viral vectors, immune and stem cells can be genetically modified and reintroduced to the patient as a targeted therapy.

The global reach of the regenerative medicine market and advancement of stem cell manufacturing have driven this collaboration in Japan.

With this collaboration, Nikon will benefit from Lonza's extensive track record in global cell manufacturing, while expanding its entry into the contract manufacturing market.

Nikon will acquire technical knowledge to differentiate and manufacture cells, including somatic stem cells, as well as Lonza's quality and safety evaluation standards and operational procedures in the manufacturing process.

The collaboration will accelerate Nikon's efforts to realize future practical applications of iPSCs in the field of regenerative medicine.

Lonza Pharma and Biotech head of Emerging Technologies Andreas Weiler said: "This collaboration will contribute greatly to the growth of the global cell and gene therapy market.

"We are utilizing our expertise built over the last decade to work together with Nikon in bringing high-quality, innovative development and manufacturing to Japan. "Because of its work in iPSC technology, we believe Nikon is an ideal partner for this collaboration in regenerative medicine."

Nikon's newly formed subsidiary, Nikon CeLL innovation Co will actively contribute to the early realization of Japan's regenerative medicine market and over time will expand its business domain into adjacent technology areas.

Nikon will also develop equipment and disposables needed to optimize the manufacture of high-quality cells, along with hardware and software from Japan to the international market.

Quintiles opens New Bioanalytical Lab in the Netherlands

Wasting no time in furthering its lab-based JV with Quest Diagnostics the world’s largest CRO Quintiles has opened a GLP-compliant bioanalytical liquid chromatography-mass spectrometry (LC-MS) laboratory in Oss, the Netherlands.

The facility – which will be led by Dr. Benno Ingelse, an industry expert with more than 15 years of (bio) analytical experience -- will have bioanalytical testing capabilities and will provide a European facility for Quintiles customers looking to conduct pharmacokinetics studies.

As part of Quintiles’ bioanalytical and ADME laboratory services group, the Oss lab has been fully integrated with Quintiles’ other lab in Ithaca, New York, which allows for the transfer of assays back and forth between the labs. In addition, the new EU facility will become part of the JV with Quest once that transaction closes, which is expected to occur in Q3 of 2015.

Costa Panagos, SVP and global head of Global Central Laboratories at Quintiles, who will also serve as the new JV’s CEO, said that the opening of the lab comes after a series of conversations with sponsors who were looking for a high-quality lab in the EU, particularly for those clients looking to keep their samples in the region.

“The Oss laboratory will further enhance the scale, clinical trial expertise and diverse therapeutic experience that will be a cornerstone of the proposed joint venture with Quest Diagnostics,” Panagos said, adding that the lab will also work in tandem with Quintiles’ Phase I unit in London when bioanalytical testing services are needed.

Currently, Quintiles’ bioanalytical and ADME (absorption, distribution, metabolism and excretion) capabilities and work are managed out of three lab sites in the US.

Merck Serono’s Pharmaceutical Manufacturing Facility, Nantong, China

Merck Serono, the biopharmaceutical division of Merck Group, broke ground on a new pharmaceutical manufacturing facility in Nantong, China, in August 2014.

It will be Merck's second biggest pharmaceutical manufacturing plant worldwide and will produce and package Merck Serono's leading brands of drugs including Glucophage, Concor and Euthyrox, which are used for the treatment of diabetes, cardiovascular diseases and thyroid disorders respectively.

The large-scale greenfield investment will not only strengthen Merck's presence in China, but also localize research and development (R&D) to further enhance its portfolio of medicines in general and specialized segments.

It will also make Merck the first and only multinational company (MNC) in China to produce drugs listed in China's Essential Drug List (EDL), which contains therapies meant to satisfy public healthcare needs and must be made available at all times.

The plant's construction is expected to be completed in 2016 and commercial production is scheduled to begin in 2017.

Merck announced its plans to build a €80m ($86.8m) pharmaceutical manufacturing facility in China in November 2013.

During the signing ceremony of the project, Merck announced a total investment of $170m for the pharmaceutical and healthcare industry of the country, making it the first MNC to establish manufacturing plants in China's domestic production of essential medicines list drugs.

The new plant is being constructed in the BioSpark zone of Nantong Economical Technological Development Area (NETDA) located in the Greater Shanghai region, approximately 100km north in the city of Nantong, Jiangsu Province, China.

BioSpark is a high-tech industrial park in NETDA that is designed to attract multinational and small and medium-sized companies to establish pharmaceutical manufacturing, R&D and related supply chain activities in China.

Nantong, the eastern coastal city of China, offers unique advantages in terms of geography, resource allocation, supply and other factors.

The new pharmaceutical facility is being constructed in an area of 40,000m² (430,400 sq. ft.), with a provision for further extension by up to 20,000m²(215,200 sq. ft.). It will have a total built-up area of 38,000m² (408,880 sq. ft.), with the production building occupying 23,000m², (247,480 sq. ft.) the warehouse and logistics building occupying 9,000m² (96,840 sq. ft.) and the remaining by support facilities.

Both production and warehouse facilities are dedicated to high-level current good manufacturing practice (cGMP) activities. The support buildings will feature central utilities, fire fighting pump station, canteen and offices.

The plant is designed in accordance with the highest international standards in terms of quality, environment and health and safety to ensure the availability of high-quality medicines for patients. Sustainable measures are being implemented during the plant's construction in order to maximize resource efficiency and minimize waste generation during manufacturing.

The new biopharma facility in China will be dedicated to the bulk production of multiple types of dry forms of oral solid dosage (OSD) and their final packaging.

Focus will be, however, more on the company's leading brands of pharmaceutical preparations for the treatment of diabetes, cardiovascular disease, thyroid disorders and other diseases.

Merck awarded the construction contract of the new facility to German high-tech engineering and construction company M+W Group in October 2014. The contractual scope includes engineering design, procurement, construction management and validation.

Merck has been operating in China, which is one of its eight strategic countries, for more than eight decades and is constantly expanding its presence. The company is a leading brand in the pharmaceutical, chemical and life science sectors of the rapidly growing Chinese market.

Besides the new manufacturing site in Nantong, the recent investments of Merck in China include a pharmaceutical research center in Beijing, a biopharmaceutical technical and training center in Shanghai, and a liquid crystals production unit in Shanghai.

Charles River has New Efficiency Initiatives

Tom Ackerman, CFO of Charles River, also remarked at the Deutsche Bank 40th Annual Health Care Conference on Wednesday and noted that the company is seeing “great growth” for some of its research models in the Chinese market.

And as far as the employees that CRL is looking to scoop up, Foster was his most candid, noting, “I think the clients viewed the CROs as second-rate – that was the perception… the reality is that if you’re in most of the Big Pharma companies, you’re at risk, and I think people are tired of that, and biotech is a fun, sexy place to work, but there are dozens of places that go bankrupt every year.”

WuXi Biologics begins Construction of World's Largest Mammalian Cell Culture Manufacturing Facility Asia

WuXi Biologics has begun construction of a new US$150m biologics manufacturing facility in Wuxi city, China. When complete by January 2017, the facility will be the largest mammalian cell culture manufacturing facility using disposable bioreactors in the world, the company said. It will also be the largest biologics manufacturing facility of any kind in China. WuXi said this added capacity will support its strong biologics manufacturing pipeline in the near term and enable it to maintain its position as the premier biologics manufacturer in China, as well as a leading player worldwide.

The new facility will house 14 disposable bioreactors of 2000L for fed-batch cell culture and two 1000L bioreactors for perfusion runs. It will be able to run advanced continuous or semi-continuous manufacturing processes in addition to traditional fed-batch and perfusion modes.

This facility further expands WuXi's already extensive biologics manufacturing capabilities. In August 2012, the company completed state-of-the-art biologics clinical drug substance and drug product manufacturing facilities in Wuxi city, the first in China that met cGMP standards of the US, EU, and China. Since then, the facilities have ramped up quickly to produce clinical supplies for these and other markets. In March 2014, the drug substance facility received an honorable mention in the Facility of the Year Awards organized by the International Society for Professional Engineering (ISPE), a first for China.

Ge Li, Chairman and CEO of WuXi PharmaTech, said this project 'continues to strengthen WuXi's capabilities in integrated biologics discovery, development, and manufacturing services'.

Novo Nordisk Building Danish Plant

Novo Nordisk has broken ground on a new DKK 1.5bn ($225m) facility to manufacture the firm's hemophilia products.

The groundbreaking ceremony took place yesterday at the site in Kalundborg, Denmark where Novo Nordisk already has operations, with this new 7,500 m2 (80,700 sq. ft.) facility expected to be approved and fully operational by 2020.

"The primary product for this investment will be recombinant factor VII, the active ingredient in NovoSeven," said Jan Hoff, Senior Vice President of Biopharmaceuticals.

NovoSeven is the Danish pharma company's recombinant treatment for patients with congenital hemophilia. The product contains the active substance eptacog alfa (activated) which is almost identical in action to the human protein factor VII, which helps enable the blood clotting process.

The Factor VII product was first approved by the US FDA in 1999 and is currently being produced from the site in Kalundborg, but the new facility will also support Novo Nordisk's hemostasis pipeline that includes N8-GP and N9-GP, glycoPEGylated long-acting recombinant coagulation factors VIII and IX respectively, both in Phase III trials.

"[The new plant] will be stainless steel in line with our current Factor VII production." Hoff said, and around 100 new production jobs will be created, adding to the current workforce of more than 2,800 people.

Hoff added the firm believes a new plant was preferential to using a contract manufacturer as "production of factor VII is a core competence for Novo Nordisk."

Novo Nordisk has been active about keeping the manufacturing of its nearly all its products in-house, with CEO Jesper Brandgaard telling investors in February the firm is set to invest up to DKK 5bn into its infrastructure.

Last year $100m was pumped into an insulin plant in Denmark, while the company acquired a biologics facility in New Hampshire from Olympus Biotech to support its hemophilia products. And just last month the company opened a new insulin formulation and filling plant in Kaluga, Russia.

West Pharmaceuticals' has New Manufacturing Plant in India

West Pharmaceutical Services Inc. dedicated its manufacturing plant in India’s Sri City Special Economic Zone, where the company is expanding its primary packaging for injectable medicines business.

Construction of the 164,700-square-foot facility began in August 2012. The plant will produce seals used in primary packaging of injectable medicines manufactured by West’s pharmaceutical and biopharmaceutical customers in India and the Asia Pacific region.

“With more and more pharmaceutical customers establishing operations in India, our new plant will help West meet market demand and further establishes the company’s presence in this growing market,” said Donald E. Morel, Jr., West’s chairman and CEO.

West, a pharmaceutical packaging and delivery system manufacturer that had worldwide sales of $1.4 billion last year, signed a 99-year lease for the Sri City land during the summer of 2012.

Future plans for the plant include expanding production to include West’s elastomer component business.

Hospira acquires Orchid's API Manufacturing and R&D Facilities

Hospira reported it has completed the acquisition of an API manufacturing facility and an associated R&D facility from Orchid Chemicals & Pharmaceuticals, an Indian pharmaceuticals company, for approximately $218 million, after settling prior advances of approximately $30 million.

The acquisition enables Hospira to vertically integrate into the beta-lactam antibiotic APIs (penems and penicillins) and is also expected to improve Hospira's cost position in this therapeutic space. In addition, backward integration into these beta-lactam APIs will improve the company's security of supply.

The API manufacturing facility, located in Aurangabad, India has capabilities for manufacturing sterile APIs and employs approximately 665 employees including chemists, engineers, and technicians. The associated R&D facility is based in Chennai, India, and will be directed primarily to beta-lactam and other API developments with approximately 110 scientific personnel.

Post deal, Orchid retains its cephalosporin API business and facilities and certain non-antibiotic, non-sterile businesses, and facilities it owns. Orchid will continue to supply Hospira with cephalosporin APIs.

PPD Expands GMP Laboratory in Athlone, Ireland

Pharmaceutical Product Development, LLC (PPD) has expanded its good manufacturing practices (GMP) operations in Athlone, Ireland, by adding a new, state-of-the-art laboratory for cell-based assays to its existing portfolio of services at the facility. The new laboratory provides GMP bioassay testing with dedicated areas to support cell culture activities with multiple assay endpoint expertise.

This expanded capability enhances the company’s ability to deliver global scientific and technical expertise with expanded laboratory capacity to meet growing client demand for these services in Europe, the Middle East and Africa, and the Asia-Pacific region. By adding these services to its Athlone operation, PPD is able to provide clients in these locations with the same services already available in the U.S. through its Middleton, Wisconsin, GMP lab.

In addition to the new cell laboratory, the facility continues to provide fully integrated solutions for product development and analytical development, including analytical testing services in method development, validation, stability, and release and quality control testing. The facility also provides regulatory services, product licensing and marketed product support, including qualified person (QP) services for all drug dosage forms, with particular emphasis on inhalation and biopharmaceutical products.

“The expansion of our GMP laboratory represents PPD’s ongoing investment toward continued growth of our operations in Ireland in order to offer enhanced service capabilities to our growing client base in this region and throughout the world,” said David Johnston, Ph.D., executive vice president of global laboratory services at PPD. “In addition, Ireland offers a business-friendly climate, highly skilled work force through its close proximity to the Athlone Institute of Technology and strong support from the Irish Government, particularly IDA Ireland.”

The GMP laboratory conducts testing for clinical programs and marketed programs spanning all phases of drug development, and supports PPD’s 30 years of global laboratory expertise. It is part of the company’s exceptional scientific expertise, broad therapeutic experience, and state-of-the-art facilities and instrumentation that deliver best-in-class laboratory services for its clients.

PPD opened its Athlone laboratory in 2010 and, once the expansion is complete, will employ nearly 150 people at the facility, including Ph.D.-level scientists, analytical laboratory staff and other clinical development professionals. In total, PPD employs more than 1,000 people in its global GMP operations.

This development is supported by the Department of Jobs, Enterprise and Innovation through IDA Ireland.

The Irish life sciences sector has experienced significant growth in recent years, with more than $3 billion of investments committed across a broad scientific and regional spread during the last two years alone,” said Barry Heavey, Ph.D., IDA Ireland’s head of life sciences. “PPD’s expansion of its Athlone operations is an extremely welcome part of the renewed growth in the life sciences cluster in the Midlands, and supports IDA Ireland’s efforts to bring more high-quality, cutting-edge life sciences companies to our country.”

PPD also recently established a link with the National Institute for Bioprocessing Research and Training (NIBRT) and IDA Ireland to create targeted training and retraining for industry-experienced people in the biotech field to help them obtain the skills necessary to be considered for positions at the Athlone facility. The program is open to people at all levels from new science graduates to Ph.D.-level professionals who want to gain the necessary scientific and/or technical experience.

The Health Products Regulatory Authority (HPRA) has performed a full inspection of the new lab and has authorized PPD to perform cell-based assay services in Athlone. PPD already had been licensed by the HPRA to support both investigational medicinal products and marketed products and laboratory certifications for quality control of medicinal products.

PPD’s Athlone campus also includes a dedicated global clinical supplies facility, which offers packaging, labeling and storage to support clinical trials.

In addition to the GMP labs in Athlone and Middleton, PPD’s global laboratory services include: central labs in Beijing, China; Brussels, Belgium; Highland Heights, Kentucky; and Singapore; bioanalytical labs in Middleton and Richmond, Virginia; and vaccines and biologics labs in Richmond and Wayne, Pennsylvania.

Rentschler Biotechnologie Expands European Manufacturing Capabilities

GE Healthcare Life Sciences a provider of tools, technologies and services to the biopharmaceutical manufacturing industry and Rentschler Biotechnologie GmbH, a leading contract manufacturing and development organization (CDMO) for biopharmaceuticals, announced a joint celebration to mark the handover of GE Healthcare’s 1000th ÄKTAprocess^™ and the expansion of Rentschler’s biopharmaceutical manufacturing capabilities in Laupheim, Germany. ÄKTAprocess, GE’s automated process and manufacturing-scale chromatography system, has gone into operation as part of Rentschler’s recently expanded single-use manufacturing suite. GE biomanufacturing technologies such as the XDR 2000L bioreactor, the associated seed trains of 50, 200 and 500 L as well as the new ÄKTAprocess play a key role in Rentschler’s new single-use manufacturing line.

Peter Rogge, VP USP Production, Rentschler, commented, “This line will further enhance our ability to deliver high quality projects for companies around the globe and is providing increased capacity in Europe of next-generation manufacturing capabilities. GE continues to have the innovative tools and expertise to deliver the high quality products and services demanded by companies like us.”

Emmanuel Ligner, GM Global Commercial, BioProcess, added, “Rentschler has the depth of experience and high-quality infrastructure to support the manufacture of the most challenging complex biotherapeutics. I am delighted to formally hand over the 1000th ÄKTAprocess and to see the new single use line featuring the GE XDR 2000L. Our relationship with Rentschler began almost 20 years ago and we are proud to have been able to support their growth over so many years. We look forward to supporting them as they adapt and expand to meet the future needs of the industry.”

Kemwell’s Bangalore Facility Completes Successful FDA Inspection

FDA has concluded that Kemwell’s facility, systems, and practices comply with FDA’s requirements and no observations were reported on Form 483.

CDMO, Kemwell, announced that its oral solid dosage manufacturing facility in Bangalore, India has successfully completed a second FDA inspection. The facility was audited following an abbreviated new drug application (ANDA) filing for a customer. The FDA inspector has concluded that Kemwell’s facility, systems, and practices comply with FDA’s requirements and no observations were reported on Form 483.

Production in the state-of-the-art oral solid dosage facility commenced in 2008. The facility, which is equipped to manage batch sizes ranging from 10–1000 kg, manufactures five billion tablets and capsules annually according to Kemwell. The company has been shipping products from this facility to Europe, US, Canada, and Australia.

SGS completes Mumbai Expansion

SGS Life Science Services has completed 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 is planned for May 20, 2015.

The expansion has seen the previous 1,393 square meter (14,998 sq. ft.) laboratory space more than double in size, to 3,400 square meters (36,380 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,” said 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.”

Onyx Scientific to Expand GMP Capability

UK-based Onyx Scientific is to invest in growing its GMP space following an increase in demand for its small scale API manufacturing services.

The move will see the installation of a new Class 100,000, ISO Class 8, suite at its facility in North East England aimed at satisfying an upsurge in Phase I/II GMP campaigns from clients in Europe and the U.S.

Onyx Scientific specializes in pre-clinical/clinical development projects and expansion plans were given the go ahead at the contract research organization (CRO) following another successful audit by the MHRA in February.

Celebrating its 15th birthday this year, the CRO provides clients with the production of API up to 50l-100l under current GMP regulations, which dovetails its earlier stage custom synthesis, lead optimization, solid state and analytical services.

Denise Bowser, commercial director at Onyx Scientific, said: “This latest investment will bring the total capacity at our UK site up to four dedicated GMP suites, which represents a steady but significant growth in this area over the past few years.

“We have worked with hundreds of clients at the small scale non-GMP stage and have been able to provide rapid scale up to GMP for many of them with the same technical team, all under one roof.”

“So by having an additional GMP suite at our disposal, it gives us even greater flexibility to assist our clients that are under increasing timeline pressure to deliver against their development programs.”

This latest venture by the chemistry specialist follows a significant investment into continuous flow manufacturing last year. This has allowed its clients to explore alternatives during product research and development programs, while overcoming the often time-consuming and costly process of batch manufacturing.

Onyx Scientific has achieved preferred partner status and undertaken GMP projects for some of the world’s largest pharmaceutical companies and major institutions such as Cancer Research UK.

The company also works with many specialty drug development firms and biotech organizations across the globe, helping accelerate candidates from discovery to production.

The CRO’s team has built a strong reputation for dealing with some of the most complex early stage chemistry challenges for companies developing new compounds.

The IPCA Laboratories-owned CRO assists companies with medicinal chemistry through Phase I-III. The UK site is then able to scale-up, tech transfer and increase efficiency using its parent company’s large scale API manufacturing sites in India.

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