Snapdragon Chemistry is pleased to make several significant announcements. First, Snapdragon has moved to new lab facilities at 85 Bolton Street in Cambridge, Massachusetts.

Snapdragon’s corporate partner, Zaiput Flow Technologies, has also moved to the 85 Bolton Street site. This co-location will enhance the collaboration of these strategic partners and accelerate the development of advanced continuous chemical manufacturing technologies and solutions.

Snapdragon also announces completion of an investment round that enables both the significant expansion of its capabilities and technologies and the recruitment of additional top scientists in order to keep pace with the high demand for Snapdragon’s services. Snapdragon is expanding its reaction profiling and analytical capabilities to include additional in-line process analytical technologies (PAT), including real-time and automated feedback control of process parameters. Snapdragon is also expanding its computational modeling capabilities, using reaction-profiling data in order to deliver “right-first-time” reactor design.

As part of the expansion, Snapdragon has hired Dr. Eric Fang as Director of Chemistry and added both PhD and BS level chemists. Snapdragon also plans to hire additional scientists and engineers in the near future.

Finally, in recognition of his contributions to the expansion of the company and the successful fundraising round, Snapdragon is pleased to announce the election of Dr. Matthew Bio to President and CEO, succeeding the current President/CEO and Co-Founder Tim Jamison. Jamison will continue as Chairman and as scientific and technical advisor to Snapdragon. Co-founder Aaron Beeler will also continue to serve on the board of directors and as scientific and technical advisor.

Bristol-Myers Expands Hub

Bristol-Myers Squibb is once again growing its footprint in the fast-growing immuno-oncology R&D world. The biopharma company inked a lease on the third and final facility BioMed Realty owns at Woodside Technology Park in Redwood City, CA, opening the door to an expansion of its biologics discovery team, set to grow from the 250 now employed at the hub to as many as 400 with the add-on.

Bristol-Myers’ deal nabbed the last 62,000 square feet of space at the park, which brings its total in the Bay Area Peninsula biotech area to 256,000 square feet--a clean sweep of the campus it first moved into close to three years ago. A spokesperson for the company says that the expansion could add up to 150 staffers on site.

The campus is devoted primarily to the company’s big R&D efforts in immuno-oncology, a field that Bristol-Myers now dominates with its pioneering drug Opdivo.

The leases for Bristol-Myers started back in 2013, when the company inked a contract for the first big building on the site. The second facility was taken in 2014.

During the past three years Bristol-Myers has been steadily upping its game in I/O. Opdivo--a pioneering drug designed to unleash an immune system assault on cancer cells--has been quickly penetrating the vast oncology market, nabbing label expansions and competing head-to-head with Merck’s Keytruda.

"The expansion of our facilities in Redwood City is evidence of the value that Bristol-Myers Squibb sees in the Bay Area scientific community and our relationship with BioMed Realty," said Nils Lonberg, head of oncology biology discovery at Bristol-Myers Squibb.

Raumedic to Open U.S. Facility

German company Raumedic AG, a development partner and system supplier of polymer-based components and systems for the medical and pharmaceutical industry is opening its new headquarters in Mills River, N.C. A modern, full-service development and production center allows Raumedic to provide its customers in North America high-quality polymer extrusion, injection molding and assembled products on site.

The decision to open new headquarters in Mills River, North Carolina, was made at the end of 2014. The company broke ground in March last year, and just nine months later was were able to move into the new building. A two-story production and administration building with a total area of 60,000 square feet serves as a production and development center for customer-specific polymer components and systems, including 13,000 square feet of cleanroom production according to ISO Class 7.

Raumedic in Mills River started production in January 2016 with 56 employees. Specialists in the fields of engineering, research and development, clean room production, quality management, logistics, marketing and sales, as well as management have settled into their new workplace. The order books have filled up nicely and the number of new employees will increase in the coming months.

Not only is the architecture reminiscent of the German headquarters, but also the technology, quality and services as a polymer specialist for the medical engineering and pharmaceutical industry. High-quality polymer products will be custom developed, produced and packaged at both locations, the German plant and the new U.S. location.

“This is an important step for Raumedic,” said CEO Martin Bayer. “We will now offer our customers the same quality and service they have come to expect from us as a development partner and system supplier at the Mills River location in the USA.”

This includes multi-component injection molding with hard-hard and hard-soft connections, micro injection molding, insert molding, fully automated assembly systems, micro extrusion with an internal diameter of 0.1 mm and multiple layers in the tubing wall including X-ray tubing or film blowing. These are advanced technologies that will be introduced gradually at the new Mills River plant.

Based on decades of expertise in chemistry and raw materials, Raumedic processes all current medical-grade thermoplastics, silicones and high-temperature polymers such as PEEK, FEP or PTFE. The ability to do our own compounding for customized material formulas rounds off our portfolio.

Until now, medical products manufactured in Germany were sold in the United States by Raumedic Inc.

“With our new development and production center, we are able to combine the strengths of both German and American engineering,” said Rudi Gall, Managing Director of Raumedic Inc. “The advantages are obvious: short routes and a more comprehensive as well as timely service for our North American customers.”

Raumedic has invested approximately $11 million into the construction of the modern building. A total investment of approximately $27 million will be reached by 2022.

The official dedication of the building will take place on April 22, 2016.

Rock River has New Laboratory

Rock River Laboratory has opened the doors to a new feed and forage analysis laboratory in Binghamton, N.Y.

This addition to the Rock River Laboratory family creates a new option for northeastern animal nutrition consultants, nutritionists, and industry partners to access accurate analysis with exceptional customer service at a convenient location.

Utilizing wet chemistry and Near Infrared Spectroscopy (NIR), Rock River Laboratory-Northeast will offer key feed and forage testing analyses, including manure, Kernel Processing Score (KPS), Total Mixed Ration digestibility (TMRD), Neutral Detergent Fiber (NDF) digestibility, and Total-Tract Neutral Detergent Fiber Digestibility(1)(TTNDFD ), among others.

Rock River Laboratory-Northeast is now accepting feedstuffs samples for analysis. Samples can be dropped off at: 21 Kattelville Road, Binghamton, NY, or shipped, for free with a Rock River Laboratory shipping label, to: PO Box 34, Chenango Bridge, NY, 13745.

Emulate has New Headquarters and Laboratory

Emulate inaugurated a new headquarters and laboratory at Drydock Avenue in Seaport District, Boston, in February 2016. The new facility has a total floor space of 20,000ft².

The new facility, located in the existing innovation and design building, will be used as headquarters and for support of commercial activities, product development, and collaborative research programs for the company's proprietary organs-on-chips technology.

The proprietary technology helps to predict the potential efficacy and safety of drug candidates, and improves the drug development process.

The facility will accommodate 40 employees and can be expanded for 85 employees in the future. Facility construction began in 2014 and was completed within 18 months. It was opened for commercial operations in February 2016.

The headquarters, located in an eight-story building, has more than 20,000ft² of total floor space. It is expected to provide the next stage of evolution as Emulate moves towards the industry launch of its proprietary organ-chips within an automated human emulation system.

It is equipped with laboratories to carry out support commercial activities, product development, and collaborative research programs for the organs-on-chips technology.

The headquarters will facilitate collaboration in Boston's biotechnology hub of pharmaceutical and biotech companies by offering organs-on-chips technology.

It can be used to establish strategic collaborations to use organs-on-chips technology to develop more effective and safer drugs, consumer products and foods, as well as improve patient wellbeing through new precision medicine and personal health applications.

Organs-on-chips technology, developed by Emulate, is a new automated living human emulation system that knows the inner workings of human biology by providing researchers ways to assess human responses with greater precision and detail.

An organ-chip the size of a USB memory stick made for the lung, liver, brain or kidney, contains tiny hollow channels lined with numerous living human cells and tissues.

It is a living, micro-engineered environment that recreates the natural physiology and mechanical forces that cells experience within the human body.

The lab-ready organic chips, instrumentation and software developed by Emulate will offer a system that supports effective innovation, design and safety of products across a range of industries, including pharmaceuticals, agriculture, cosmetics, chemical-based consumer products and precision medicine.

The company produces a range of products based on the organs-on-chips technology, including lung chip, liver chip, intestine chip, kidney chip and brain chip. The chips are comprised of micro-engineered environments lined with living human cells and tissues.

Local industry collaborators for Emulate include Johnson & Johnson Innovation Centre, Merck and academic researchers at the Wyss Institute for Biologically Inspired Engineering at Harvard University.

Based in Boston, Emulate creates living products to understand how diseases, medicines, chemicals and foods affect human health.

The company's human emulation system sets a new standard for recreating true-to-life human biology, which is being used to advance product innovation, design and safety across various applications, including drug development, agriculture, cosmetics, chemical-based consumer products and personalized health.

Emulate holds an exclusive license from Harvard University to a broad intellectual property portfolio for the organ-chips technology and related systems worldwide.

Athenex to Build Manufacturing Facility

Athenex, in partnership with SUNY Polytechnic Institute, plans to build the high pharmacy oncology manufacturing facility in Dunkirk, New York, to manufacture sterile high-potency oncology drugs.

Construction on the project is expected to begin in the second quarter of 2017 and production is expected to begin in the fourth quarter of 2018.

The facility will be located off Lake Shore Drive East (Rte 5), northeast of the Dunkirk city line, in Chautauqua County. The state-of-the-art facility will occupy an area of approximately 300,000ft².

The plant will manufacture sterile high-potency oncology drugs in a specialized and controlled environment. Oncology pharmaceutical products, which are often listed in the FDA's drug shortage list, will be manufactured for sales worldwide.

The project is expected to generate 900 jobs in areas such as high-tech manufacturing, product formulation, regulatory and pharmacovigilance.

Athenex's partnership with New York State and SUNY Polytechnic Institute supports its presence and growth in the state and also contributes to the generation of high-paying jobs in different locations in western New York.

The oncology drug manufacturing facility is the first of its kind to be built in North America in the last 15 years.

Athenex will invest $1.52bn in the project, of which $200m will be invested by the New York state government, through the SUNY Polytechnic Institute.

The state government will contribute to the project as part of the Buffalo Billion Investment Development Plan, to support the regional economic development and create jobs in the western New York region.

Athenex, a specialty oncology drug manufacturing company based in the US, is mainly engaged in the development and production of next-generation therapies for cancer diseases.

The company's headquarters in North America has a formulation product development center and a pilot plant, which mainly deals with the refinement of oncology drugs before the technology is further transferred to a new manufacturing facility in Dunkirk for large-scale production.

Athenex is committed to produce innovative oncology drugs that deliver a life-changing impact on cancer patients. It is currently involved in the development of ten innovative and proprietary products.

The company operates multiple offices in China and the US, and has regional development collaborators in Dunedin, New Zealand, Hong Kong, Guangzhou, China, Seoul, South Korea, Taipei, Taiwan, Buenos Aires, Argentina and Guatemala City, Guatemala.

GSK Consumer Healthcare Inaugurates New Facility in US

GSK Consumer Healthcare has inaugurated a new facility in Warren, New Jersey, US, which will employ nearly 900 people.

The facility has been opened as part of a joint venture between GSK and Novartis, which was finalized in March last year.

Spread over an area of around 109,000ft², the Warren facility houses three lab suites comprised of a shopper science lab, consumer sensory lab and a R&D Lab. These facilities are scheduled to open later this month.

The shopper science lab has been designed to optimize collaboration between GSK, the retailer and the consumer.

GSK Consumer Healthcare North America general manager Colin Mackenzie said: "The opening of GSK Warren provides a tremendous opportunity for our US-based team to come together under one roof, to foster collaboration and build a great place to work.

"That collaboration and the SMART working design promise to give our teams every advantage to produce best-in-class work that will get us closer to our consumers and retail customers."

The new site will house a cross-functional mix of employees, including marketing and sales, research and development, quality, and supply chain team.

The interior design of the plant is modelled after GSK's global approach to SMART working, which provides an open floor plan as well as flexible workspace and hours to better accommodate the individual needs of employees while fostering collaboration.

GSK Consumer Healthcare North America integration director Michael McClaine said: "GSK has a unique opportunity to create the first and best Fast Moving Consumer Healthcare (FMCH), the new GSK Consumer Healthcare, that drives growth, outperforms the competition and reaches more consumers around the world so that they can do more, feel better and live longer."

GSK Consumer Healthcare is said to be one of the world's largest consumer healthcare companies.

The company's healthcare brands include Sensodyne, Theraflu, Excedrin, Nicorette and NicoDerm CQ, Flonase, and TUMS.

Gilead Plans Expansion at Foster City

Armed with tens of billions of dollars from the overnight success of its two new hep C pills, Gilead ($GILD) is looking to expand its reach into its 71-acre corporate campus in its native city with new labs also being proffered.

The Foster City, CA-headquartered company is planning to knock down an existing single-story building and construct a six-story lab and office building, according to a city Planning Commission as quoted by The Daily Journal.

“They’ve done a really nice job with the campus and Gilead is a great partner with Foster City,” Community Development Director Curtis Banks told the newspaper. “It’s nice to see those buildings modernized and that Gilead is really committed to making Foster City their home.”

This comes after Gilead spent around $120 million to purchase the nearby 12-acre Chess-Hatch office complex, which could eventually be redeveloped into nearly 800,000 square feet of building space. The company has yet to submit plans to redevelop the site.

Gilead has nearly 7,500 employees across the world but said that the Foster City campus could “host up to 5,000 new employees”.

The company's fortunes were built around its blockbuster suite of HIV drugs, but the approval of its Harvoni and Sovaldi for hepatitis C--which have revolutionized the way hep C is cured--has added much more to the bottom line. Its full year 2015 sales were $32.6 billion--up from $24.9 billion in 2014, with a current market cap of $130.8 billion.

Analyst have been asking the company who it will buy with its cash piles--it did just last week snatch up an early-stage NASH from the MA-based biotech Nimbus Therapeutics for $1.2 billion, but is yet to confirm any major M&A deals, currently content with internal expansion rather than a major external add-on.

“The Bay Area has long served as a center of excellence for the biopharmaceutical industry, and we remain committed to maintaining our presence in Foster City,” said a Gilead spokeswoman.

“As Gilead’s business continues to grow, we are always evaluating needs to expand the Foster City campus with regard to both laboratory and office space to assist in our mission of delivering life-saving medicines to patients worldwide.”

Gilead’s not the only life science firm looking to gain deeper inroads into the Bay Area as BioMed Realty Trust and California’s gene-sequencing company Illumina ($ILMN) have also received city approvals to proceed with a $149 million biotech campus on a more than 20-acre site.

Novo Nordisk Builds Manufacturing Facility in North Carolina

Novo Nordisk broke ground on its new $1.8 billion diabetes medicine production facility in Clayton, NC, the company announced in a March 28, 2016 press release. The facility will produce APIs for a range of Novo Nordisk's current and future GLP-1 and insulin medicines. The Clayton facility is expected to be fully operational by 2020.

The new facility will measure 833,000 ft2 and have a footprint of 417,639 ft2. This expansion is expected to create close to 700 new jobs, as well as have up to 2500 people working on the project at peak construction.

"As the prevalence of diabetes has grown in the US, so too has the demand for effective treatments," said Lars Rebien Sørensen, president and CEO of Novo Nordisk. "It gives me great pride to break ground on our new facility site in Clayton where we have an existing, strong organization. This site will play a vital role in enabling us to meet the needs of people living with diabetes in the US for years to come."

The new site is situated adjacent to Novo Nordisk's 457,000-ft2 Clayton, NC facility. Expanded several times since it was inaugurated in 1996, Novo Nordisk's current plant in Clayton, NC is one of the company's strategic production sites responsible for formulation, filling, and packaging of diabetes medicines. The plant also assembles and packages the company's FlexPen and FlexTouch prefilled insulin devices for the US market.

Once the new site becomes operational, the diabetes API production organization in Clayton will be named DAPI-US (Diabetes Active Pharmaceutical Ingredients-US). It will be part of the Danish diabetes API production organization in Kalundborg, which will be named DAPI-Denmark. The company is also investing in its manufacturing facilities in Denmark.

Toppan Opening Barrier Films Plant

Toppan USA Inc. is opening its new $100 million barrier films plant in Griffin, GA.

The subsidiary of Tokyo-based Toppan Printing Co. Ltd. said the new site will produce transparent barrier films and is the first such location for the company outside of its home country.

The 103,771-square-foot plant, the company said, is a “significant enhancement in capacity to supply transparent barrier films to North, Central and South America and Europe.”

Toppan USA said it will predominately make its GL Film brand in Georgia. Markets include food, drinks, medical care, pharmaceuticals and industrial materials.

Addition of Veterinary Isolation Facility at University of Minnesota

The University of Minnesota is planning to build a veterinary isolation facility, which will be located on the school's Minneapolis. MN campus. The single-story, 38,500 sq. ft. building will include biocontainment laboratories, large animal isolation space and a small animal vivarium. Architectural Alliance is the designer. The project value has been estimated at $27 million.

Velesco Pharma Expands

Velesco Pharma has boosted its cGMP analytical testing capabilities with an expansion of its analytical laboratory in Plymouth, MI. The addition of a new cGMP analytical testing laboratory increases the breadth of services to more fully meet the needs of its broad client base.

The main activity supported in the new cGMP-compliant laboratory is the testing of clients’ stability samples. Specific testing activity includes: • Assay and related substances by HPLC (UV and RI) and UPLC-UV; • Assay by titration; water content (Karl Fisher); pH; viscosity; osmolality; density/specific gravity; disintegration; dissolution and UV; and • Hardness and friability for tablets.

In addition to executing clients’ cGMP stability programs, the laboratory is ideal for the testing of samples for cleaning validation studies, in vitro equivalency determination and test article characterization.

“Our new cGMP analytical laboratory is impressively designed, equipped and staffed so that we can meet our clients’ growing demand for analytical services,” said Dave Barnes, chief executive officer, Velesco. “We look forward to collaborating with our clients to ensure strong cGMP testing programs. Our clients can be confident their testing will exceed FDA compliance requirements.”

AAIPharma and Cambridge Major Laboratories Expand

AAIPharma Services Corp/Cambridge Major Laboratories, Inc. (AAI/CML), a leading provider of custom manufacturing and development services for the pharmaceutical and biotechnology industries, has announced expanded sterile fill-finish capabilities and capacity in its Charleston, SC site. Substantial growth in demand has driven several recent investments.

When AAI/CML acquired the Charleston facility in 2001 it had one filling line with small-scale lyophilization. The site has invested in significant upgrades to equipment and staff since, including a small scale lyophilizer for cycle development studies conducted by an expert formulation development (FDL) team on site. Customers requiring lyophilization receive the benefits of quick turnaround times from an experienced staff that also supports sterile filling and GMP manufacturing.

A second line for GMP batches was qualified in 2015 to support continued growth in demand for sterile manufacturing, more than doubling the filling capacity for the site. This has been used for multiple regulatory submissions and is expected to produce its first commercial product in 2016. A new, mid-scale lyophilization unit has been recently installed and will be qualified by May, doubling the site's lyophilization capacity. To complement the additional equipment capacity, a third manufacturing shift has been added, increasing capacity and scheduling flexibility.

"These upgrades to our manufacturing facility in Charleston support the overall progress of our growth as a company to meet the needs of our customers. We are excited to offer increased sterile manufacturing capacity to the market and added capabilities for specialized areas of drug product development and manufacturing," stated Ted Dolan, Chief Operating Officer.

The sterile manufacturing facility has an excellent track record of compliance and has been referenced in 15 regulatory filings. The additional lyophilization unit extends AAI/CML's integrated service offerings, which include formulation development, fill/finish, packaging and testing for batch sizes up to 400L.

AAIPharma Services Corp./Cambridge Major Laboratories Plans Investment

AAIPharma Services Corp./Cambridge Major Laboratories Inc. (AAI/CML), a leading provider of custom manufacturing and development services for the pharmaceutical and biotechnology industries, announced today the planned investment of at least $10.7 Million to relocate its St. Louis, MO analytical testing facility to the Cortex Innovation Center.

AAI/CML provides innovative analytical testing solutions for manufacturers' new drug entities, generic drugs, animal health products, medicated consumer health products, chemicals and biopharmaceuticals. Its analytical testing business is comprised of three centers of excellence in St. Louis, MO; Wilmington, NC; and Edison, NJ to serve its regional, national and global customers.

Its current St. Louis, MO facility employs approximately 80 full time staff and specializes in chemical and microbiological analytical testing including raw material testing, drug product release, stability, and environmental monitoring for both sterile and non-sterile drugs.

The new facility is a response to increased customer demand and the growing trend of analytical testing outsourcing within the pharmaceutical and biotechnology industries. It will house state-of-the-art equipment in addition to its existing service offerings, and will provide new testing capabilities to meet industry and changing regulatory requirements, such as glass and plastic containers testing for pharmaceutical use, elemental impurities, disinfectant qualification and efficacy studies.

The structural completion and build-out are due to be finished in the fourth quarter of 2016 and transition from the existing location will occur in the first quarter of 2017. The new facility will be operational concurrently to ensure no interruption of customer commitments in testing during the transition period until the new site is fully operational. AAI/CML's additional sites in Edison, NJ and Wilmington, NC will serve as testing support if appropriate. Each existing project will be discussed in detail with customers to ensure a seamless transition.

Stability chambers at the new facility will be operational prior to removing this capability from the existing site so as not to interrupt any studies. Transfer of stability samples to the new facility will occur using temperature controlled equipment and will be monitored to ensure no deviations from specified conditions. The two facilities are within close proximity, with a travel time of less than 30 minutes from each other. Clients will be notified prior to shipment of stability samples.

The new facility will have a new FDA registration number and clients will be notified in advance when their studies are planned to be relocated. AAI/CML will absorb the cost of method transfer exercises, re-verifications or method suitabilities related to the site move, ensuring relevant regulatory requirements continue to be met. In early 2017, clients will be notified by AAI/CML with details of relocation activities and a new shipping address for sample submissions.

"This expansion comes at a critical time in our company's growth," said Stephan Kutzer, CEO, President and Chairman of AAI/CML. "Analytical testing is an instrumental pillar of our company and we are excited to provide our customers and the market with innovative testing solutions as part of our overall service offering including our other pillars in API, Drug Product and Development Services."

Pfizer Planning Andover Facility

Pfizer is planning to build a clinical manufacturing facility in Andover, MA. The five-story, 178,680 sq. ft. facility will be located at One Burtt Rd. Construction managers are being discussed. The project is valued at $15-$25 million.

Ely Lilly Starts New Facility in Indianapolis, IN

Messer Construction has started building a research and development facility for Ely Lilly in Indianapolis. The four-story, 130,000 sq. ft. building will be located at 1555 S. Harding St. Flad & Associates is the designer. The project is valued between $25 million and $50 million.

Hovione Opens facility in East Windsor, New Jersey

Hovione and Vertex Pharma have teamed up to set up a continuous manufacturing facility at the former’s site in New Jersey, US.

The project – which is scheduled to be completed before the end of 2017 – is designed to support production of Vertex’s approved medicines.

Vertex’s approved products are the cystic fibrosis dugs Kalydeco (ivacaftor) and Orkambi (ivacaftor/ lumacaftor).

The firm's former product, the hepatitis drug Incivek (telaprevir) was discontinued in 2014. Vertex cited falling demand for the drug caused by competition from newer hepatitis C treatments.

The new manufacturing facility in East Windsor, New Jersey will house continuous blending capacity, wet and dry granulation systems, fluid bed drying platforms and tableting and coating technologies.

Filipe Gaspar, VP R&D at Hovione, described continuous manufacturing as “as an important scientific advance and an important advance for patients, as the technology will allow us to run manufacturing and process development in parallel with clinical studies.”

News of the collaboration follows a few months after Hovione said it would spend $24m (€22m) to expand production capacity and enhance the New Jersey facility’s potent active pharmaceutical ingredient (API) handling capabilities.

The expansion – which is due to be completed early next year – is expected to create 60 jobs.

Air Techniques Acquires DOP Solutions and the Academy for Cleanroom Testing

Air Techniques International (ATI) has acquired DOP Solutions and the Academy for Cleanroom Testing in Letchworth, Hertfordshire, UK as part of an initiative to expand its global brand.

DOP Solutions manufactures aerosol photometers and generators, while the Academy for Cleanroom Testing (ACT) provides training and education services.

Since 1988, DOP Solutions has been a leader in clean air testing, offering aerosol detection and generation instruments and accessories including positive injection pumping systems, aerosol injection ports, sparge pipes, and smoke generators. The Academy for Cleanroom Testing grew from a heritage of providing theory and practical training for cleanroom testing, based on proven techniques and industry standards such as ISO 14644 and EN12469/NSF49.

Tim Triggs, Co-owner and Director of DOP Solutions and ACT, will lead ATI's business operations in the geographic region from Europe to India. 'By combining with ATI we gain the support and experience of a highly-respected global company, reinforcing our growth initiatives in our core business. We also look forward to helping our customers benefit from ATI's product range in new applications including filter testing and ChemBio defense,' he said. Ron Adkins, President of ATI, added: 'ATI has begun an exciting period of new growth and expansion. We will bring innovative new products and services to our global customers and expand our application expertise to better serve their needs. We believe there is a strong cultural fit, and our combined capabilities will create significant value for our customers.'

REST OF WORLD

LabCorp Doubles Testing Capacity of Covance Laboratory in Geneva

LabCorp announced that Covance has completed an expansion of its now approximately 48,000 square foot central laboratory in Geneva, Switzerland, the largest of its kind in Europe. Through this investment Covance doubled its testing capacity in Geneva by increasing the degree of automation and improving workflow efficiency. The Covance Central Laboratory in Geneva provides services for global clinical trials in Europe and Africa and plays a key role in LabCorp’s strategic vision to improve health and improve lives.

“For the last 24 years, Covance has provided laboratory testing services in Geneva. This expansion enables us to better meet our customers’ growing demand for high quality central laboratory services in support of clinical trials,” said Deborah Keller, chief executive officer, Covance. “The expanded and renovated lab continues to bring solutions to our clients in rapidly developing areas such as pathology, genomics and companion diagnostics, helping pharmaceutical companies bring innovative medicines to patients faster and more efficiently.”

Jean-Marc Leroux, general manager for Central Laboratory Europe and Covance’s chief innovation officer commented, “With continued investment and our local R&D relationships we demonstrate our commitment to the Geneva region which was acknowledged by the Chamber of Commerce and the Canton of Geneva with the ’Prix de l’Economie’ in 2014.”

GE Healthcare Life Sciences Expands Production

GE Healthcare Life Sciences announced on April 12, 2016 that its European manufacturing and distribution site in Pasching, Austria for sterile liquids has expanded its capabilities to include production of large volumes of buffers, process liquids, and cell-culture media. The company has also launched a rapid production service for prototype cell culture media and buffers, according to a press announcement.

According to GE Healthcare Life Sciences, the Pasching facility works with biopharmaceutical companies in more than 40 countries across Europe, Africa, and the Middle East. The facility now offers rapid response production services, which enable production of small volumes of prototype cell-culture media and buffers within five days of ordering.

GE’s additional production capacity at Pasching has been developed over two years, with an investment of $4.3 million. The site is also a production and distribution center for Europe, with more than 300,000 individual product items shipped through the site per year.

GSK Opens Medicines Production Plant in UK

GlaxoSmithKline (GSK) has expanded its respiratory medicines production capacity with the opening of a new £56m manufacturing facility in Ware, UK.

More than £100m was invested in the new facility over the past five years, which has been built to cater to the demand of GSK's respiratory medicines delivered by Ellipta inhaler.

The Ellipta inhaler is a multi-dose dry powder inhaler (DPI) developed to deliver GSK's once-daily respiratory medicines.

GSK CEO Sir Andrew Witty said: "This new facility demonstrates our commitment to manufacturing in the UK, which continues to be a very positive environment for life sciences investment.

"We currently export Ellipta inhalers from Ware to more than 74 countries and the new facility opened today will increase capacity to meet growing demand for our new portfolio of respiratory medicines worldwide."

The 48,420 sq. ft. (4500m²) facility is expected to nearly double production of Ellipta inhalers in the region to at least 37 million per year by 2017, of which 95% will be exported.

Life Sciences Minister George Freeman said: "This £56m investment by GSK is fantastic news for Ware and the UK's thriving life sciences industry.

"As well as driving growth and creating 150 new jobs, this expansion of GSK's medicines manufacturing facility in Ware is a strong endorsement of the UK's leadership in manufacturing and respiratory medicine."

Since 2013, more than 400 additional roles will have been created at the manufacturing site in Ware, bringing staff numbers to more than 1200, the company said.

In a separate development, GSK has begun a Phase II study to evaluate an anti GM-CSF antibody for inflammatory hand osteoarthritis.

Osteoarthritis causes damage to the surface of joints in the body, leading to joint pain and stiffness.

Air Techniques Acquires DOP Solutions and Academy for Cleanroom Testing

Air Techniques International (ATI) has acquired DOP Solutions and the Academy for Cleanroom Testing in Letchworth, Hertfordshire, UK as part of an initiative to expand its global brand. DOP Solutions manufactures aerosol photometers and generators, while the Academy for Cleanroom Testing (ACT) provides training and education services.

ATI, located in Maryland, US, has not revealed any financial details but says the acquisitions expand the breadth of its cleanroom-testing products and services and strengthens its position in Europe to support customers and partners in the region. Since 1988, DOP Solutions has been a leader in clean air testing, offering aerosol detection and generation instruments and accessories including positive injection pumping systems, aerosol injection ports, sparge pipes, and smoke generators.

The Academy for Cleanroom Testing grew from a heritage of providing theory and practical training for cleanroom testing, based on proven techniques and industry standards such as ISO 14644 and EN12469/NSF49.

Ron Adkins, President of ATI, added: 'ATI has begun an exciting period of new growth and expansion. We will bring innovative new products and services to our global customers and expand our application expertise to better serve their needs. We believe there is a strong cultural fit, and our combined capabilities will create significant value for our customers.'

Sanofi Expands Belgian Plant

Sanofi will invest €300m ($340m) and create over 100 jobs at a biomanufacturing site in Belgium intended to support its monoclonal antibody pipeline.

The facility in Geel, Belgium is the sole manufacturing site for Sanofi/Genzyme’s Myozyme (alglucosidase alfa), a protein therapy used to treat Pompe disease, but the expansion will add 86,000 sq. ft. (8000m2) of manufacturing space to up capacity and bring in production of other biological products.

“The Geel site is designed to be a multi-product site,” said Sanofi spokesperson Nicolas Kressmann. “It manufactures one key product at the moment [but] systems and infrastructure are in place to support a multi-product portfolio.”

The expansion will be dedicated to the production of monoclonal antibodies, he continued, specifically one of the mAbs currently in Sanofi’s clinical development.

“Geel is one of our centers of expertise for the production of biopharmaceuticals. The site was acquired by Sanofi Genzyme in 2001. The existing infrastructure allowed us to reactive and construct additional production lines for monoclonal.”

Additional capacity will come from mainly stainless steel systems, Kressmann added as “this is still the current platform for large scale monoclonal antibody production.”

Geel will also gain new laboratories focused on quality control and manufacturing sciences and a range of highly-skilled biotechnology jobs will be created.

The investment supports the French pharma giant’s strategy of growing its biologics network. In November last year , the firm pledged to continue investing in its biologics sites despite rolling out a €1.5bn cost-saving plan across its manufacturing network, which comprises of over 100 sites.

Over 70% of Sanofi’s pipeline is in biologics, and around 40% are monoclonal antibodies, said Sanofi spokesperson Flore Larger in January 2015.

Sanofi’s strategy involves “investing in [its] own resources, partnering with Regeneron and building an agile internal and external manufacturing network,” she said, after the firm signed a Master Service Agreement (MSA) for commercial contract manufacturing of mAbs with Boehringer Ingelheim.

Redx Pharma Set for New HQ at Alderley Park, Cheshire

Drug discovery firm Redx Pharma is to establish new headquarters at Alderley Park, Cheshire.

The move will see the company create a 74,000ft2 (approximately 7,000m2) state-of-the-art drug development facility that brings together its three subsidiary businesses onto one site.

The company has reached an agreement with Manchester Science Partnerships that will see Alderley Park become the new home for Redx Oncology, a developer of anti-cancer drugs currently based within the Royal Liverpool Hospital’s Duncan Building, which is due to be demolished in 2017.

The Redx group already has two other subsidiaries, Redx Anti-Infectives and Redx Immunology based at Alderley Park in 37,000ft2 (3,500m2) of laboratory and office space.

Alderley Park, formerly home to ICI and recently vacated by AstraZeneca, which is building a new headquarters in Cambridge, is now an open-innovation community for life science businesses. Current developments will see the creation of up to 7,000 jobs there over the next decade.

The Redx Pharma move will be completed by the end of the year and will see all 193 Redx staff operate on the same site for the first time, including the relocation of all 88 staff from Liverpool.

Neil Murray, Chief Executive of Redx Pharma, said: 'Bringing our three teams together will support our ambitious growth plans and give the business some valuable human, scientific and logistical synergies.

'Alderley Park’s high specification laboratories and superlative facilities present a commercially attractive solution as we seek to provide the best infrastructure and environment for our staff. The £30m capital investment that has been committed to the site over the next three years is impressive indeed. It will create one of the most important multi-occupier sites for life science in Europe.

Murray added: 'Alderley Park is also one of the key assets in the Northern Powerhouse proposals outlined by UK Chancellor George Osborne and, separately, by the leaders of Northern cities. They share a vision of the North of England as one city of 15 million people that, by working well together, can achieve more in terms of attracting talent, investment and competing in global markets.

'The site has a great history as a global leader in cancer research and we look forward to adding Redx drugs to the roll call of successful cancer therapies that ICI and AstraZeneca produced over the years.'

API Manufacturing Facility Expansion, Hanko, Finland

2018 will mark the start of a new era in Fermion’s history as Fermion’s plant in the south of Finland, Hanko, starts operating new API manufacturing facilities including 76 m3 reactor space, incremental to Fermion’s current total reactor volume of 320 m3. With best-in-class automated systems, controlled material flows, isolators and smart infrastructure the new facilities can process not only standard but also potent APIs. There will be a reactor space of 25 m3 for OEB5 compounds (containment level down to 0,1 µg/m3) and the rest of the new capacity is equipped for compounds requiring a containment level of 1 - 10 µg/m3.

With the new, modern facilities Fermion will be prepared to meet tightening regulatory requirements and better positioned to support both current and new business. Fermion’s President Arto Toivonen said: “The expansion lifts Fermion to a new level in the global arena of API and especially HAPI manufacturing, improving Fermion’s capability to meet increasing demand. Fermion will continue to ensure high quality and delivery reliability of its products. The new unit alone will be able to produce 100 metric tons HPAPI per year increasing the total production capacity of Fermion to over 400 metric tons API/year. Fermion’s scale of HPAPI development and production will now be complete with capabilities from grams to tons.”

Fermion’s investment of EUR 30 million in Hanko is the largest in the history of the company since 1970 and also turns a new page in the history of the Finnish pharmaceutical industry.

The Hanko plant is Fermion’s largest production facility with an annual API capacity of approximately 300 metric tons. The Hanko plant supports the full scale of commercial API manufacturing, both generic and custom APIs. The plant consists of three operational units, two dedicated for intermediate production and the third, fully automated unit inaugurated in 2001 produces APIs. The plant is well equipped with dryers and mills for API micronization and has a Buss loop reactor for hydrogenations as well as an on-site incinerator of VOC gases and a biological waste water treatment facility.

The expansion project already has a building permit and the planning is well underway. The actual construction will start in the summer of 2016 and the inauguration will be celebrated in Q2 2018. Times beyond 2018 may hold even more exciting news for Fermion as upon inauguration, the new facility will host empty, flexible space enabling the installation of a total of 25 m3 additional reactor space for special process technologies.

Shire to Expand Biotechnology Manufacturing Capacity in Ireland

Investment to help meet growing demand for rare disease treatments; expected to create 400 jobs in Ireland at new state-of-the-art facility in Co. Meath.

Dublin, Ireland — Shire plc announces that it plans to expand its global biotechnology manufacturing capacity over the next four years by investing $400 million in Ireland to meet the rapidly growing demand for its highly innovative products and robust pipeline.

Shire will create a new, state of the art biologics manufacturing campus, which it expects will lead to the creation of approximately 400 permanent jobs on a 120-acre site at Piercetown, County Meath. Construction of the new site will begin in mid-2016 with the site expected to be operational by mid-2019.

“Increasing our biologics manufacturing capability is fundamental to achieving our ambition of becoming the world’s leading biotechnology company focused on rare diseases and other specialty conditions,” said Shire’s Chief Executive Officer, Flemming Ornskov, MD, MPH. “The expansion will enable us to meet increasing product demands, support our pipeline and, ultimately, help more patients. We are delighted to be expanding our operations in Ireland, where we have strong, existing relationships. The new campus in County Meath will provide necessary geographic diversification and will help us serve our growing international business.”

Employing the latest bioprocessing techniques, the facility will employ flexible production strategies enabling it to supply both clinical and commercial scale products. The roles at Shire’s new campus in County Meath will consist of highly skilled, full time jobs in the areas of R&D, operations, technical staff, engineering and construction.

Shire’s Senior Vice President of Technical Operations, Tim Kelly, commented: “The expansion supports our manufacturing strategy to develop and provide innovative specialty medicines for patients. Ireland is a strategically important location for Shire, providing both excellence in life science R&D and manufacturing. We already have a strong team on the ground in Ireland and believe that it is the right location for us to build a new state of the art facility which will complement our existing manufacturing operations in the U.S.”

Mr. Richard Bruton TD, Irish Minister for Jobs, Enterprise and Innovation, said: “Today’s announcement is a huge boost for the Irish economy and for County Meath. The scale of the global investment being made by Shire and the creation of 400 full-time positions in Ireland, as well as over 700 additional jobs during construction, will have a major impact, and further validates Ireland’s position as a leading global location for biotechnology manufacturing and R&D. Biotechnology is a key sector which we have targeted as part of our jobs plans, and Shire's decision to build on its very capable team already in Ireland with a $400-million investment is a very welcome step-up in its presence here.”

Mr. Martin Shanahan, CEO, IDA Ireland, said: “Ireland is an attractive location for many industries, but for the life sciences and biotechnology sectors in particular. These are sectors in which we excel and we are very pleased that Shire is building on its existing presence here with the development of a new campus at Piercetown, County Meath. This investment by Shire demonstrates not only IDA’s strategy of attracting biotechnology investment to Ireland but also our focus on supporting balanced regional economic development. It is also worth noting that this is the second significant investment for Meath in the past six months. The scale of this investment will have a substantial economic impact on Co Meath and the wider Mid-East Region.”

WellSpring Invests in Facility

WellSpring Pharma Services has completed a $3 million capital investment in new equipment and has entered a strategic partnership with IDT Australia Ltd. to manufacture drugs for the U.S. market.

The investment adds capabilities in smaller development-scale equipment, expanded manufacturing for specialized dosage forms, such as bilayer tablets, and improved support for high-potency compound manufacturing. New equipment includes: an Alexanderwerk Roller Compactor; an IMA Precisa capsule weight checker; a 400 kg O’Hara Tray Drying oven; a Korsch XL 400 Tablet Press with bilayer module; a Glatt GPCG 2/5 Fluid Bed Processor; an O’Hara Aqueous Film Coater with 18” and 30” interchangeable pans; and a 5L Becomix Counter sweep vessel.

Additionally, WellSpring signed a manufacturing and supply agreement to produce several products for IDT Australia at its facility near Toronto, including Pindolol, a cardiac drug with an estimated U.S. market value of $10 million.

“Our expanded capabilities include new expertise in process development and manufacturing for earlier phased clinical trials as well as future expansion of our large-scale manufacturing capabilities,” said David Mayers, president, WellSpring Pharma Services. “We’re now better equipped to offer our clients services from small-scale development and scale-up to large-scale manufacturing, packaging and distribution.”

Aesica Opening of New Purpose Built Facility

Aesica Pharmaceuticals has announced the doubling of its development capacity - manufacturing multiple drug products up to Phase III clinical trials at Queenborough.

With the addition of the new capabilities, Aesica can now develop and manufacture a customer product from early formulation development through clinical manufacture and into commercialization - covering all aspects of product life cycle on the one site. This process will now be a seamless end-to-end service offering for the customer.

The company’s high potent and controlled drugs service offering has been significantly expanded at Queenborough as a result of the new center. Whilst previously the company only provided commercials scale manufacturing capabilities for these drug classifications, it now offers full formulation and development capabilities in these specialist fields. The site handles high potent drugs for any active up to SafeBridge Category 3, together with controlled drugs, with licenses for both Schedules 2 to 4. Moreover, the facility is therefore experienced in handling drugs that are both highly potent and at the same time controlled.

Ian Muir, Managing Director of Aesica Pharmaceuticals commented; “In response to growing customer demand, and as part of our on-going strategy to meet the needs of the market to simplify the supply chain with reliable, highly efficient, single source solutions, we have taken the strategic initiative to ensure that our high capacity Queenborough Development Centre, which doubles our development capacity, combined with our commercial manufacturing capabilities at the facility, provides a complete service offering for formulation, development and product manufacturing for multiple customers.”

He continued: ‘High potency is a key contract services market, with strong growth potential, requiring a mix of highly specialized and advanced technological skills and capabilities. We have set these resources in place and have now taken the strategic initiative to combine them with full clinical and commercial scale manufacturing capacity in this highly complex field from a single site location – further enhancing our offering to customers.”

Eli Lilly Plans New API Facility in Ireland

The new plant in Kinsale, County Cork is expected to open early next year and will become Lilly’s worldwide center of excellence for continuous manufacturing of Active Pharmaceutical Ingredients (API) through this investment.

“The team is highly motivated to undertake this project as it offers a significant new opportunity for the site,” said Chris Langan, general manager at the site. “The company is amongst the industry leaders in the development of this technology, and it is an exciting project for everyone involved here at the site.”

This is the latest investment at Kinsale, hot off the back of Lilly’s new commercial scale biologics facility, a 240,000 sq. ft. plant which opened last year at a cost of €330m.

The pharmaceutical industry has been slow to adopt to continuous manufacturing as companies remain averse to switching to new processes and equipment, while lacking the talent and clear regulatory guidelines to do so.

But over the past few years, industry has taken a number of strides in shifting to more continuous methods for both small and large molecule.

A ten-year collaboration between Rutgers University and J&J’s Janssen to implement has produced a continuous manufacturing line at the pharma firm’s facility in Puerto Rico, while GSK, Pfizer and Novartis have also invested in developing such technologies.

And in a White House report on the state of US manufacturing published by the Subcommittee for Advanced Manufacturing of the National Science and Technology Council, continuous manufacturing was high-lighted as a way of improving “the agility, flexibility, and robustness in the manufacture of pharmaceuticals.”

However, while the report says such technology is promising at the laboratory scale, it adds the technologies and equipment enabling continuous manufacturing at the commercial scale are not widely available or accessible.

“Consequently, continuous manufacturing technology is currently in need of further interest and resources from industry, government, and regulatory authorities to translate proofs-of-concept to widespread commercial adoption.”

The report also notes the US Food and Drug Administration (FDA) will be essential in bringing about the shift from batch to continuous manufacturing, “using scientific and data-driven methodologies to facilitate future approvals, thereby encouraging commercial adoption of continuous manufacturing.”

GSK Antibiotic Plant Expansion, Irvine, Scotland

GSK’s antibiotic facility is located in i3, Irvine’s life sciences enterprise area.

GlaxoSmithKline (GSK) opened its expanded antibiotics facility in Irvine in February 2016. The Irvine plant produces GSK's antibiotic drugs, including potassium clavulanate that is sold under the brand name Augmentin.

Construction on the facility's expansion began in 2013, with the aim to expand the antibiotics production capacity to serve 100 million more patients a year.

The expansion generated 55 new jobs in Irvine and involved an investment of approximately £70m ($98.8m).

GSK has invested more than $280m to further develop its sites in Irvine and Montrose since 2013. The Irvine expansion project was awarded a Scottish Enterprise Regional Selective Assistance (RSA) grant of $1.5m.

GSK antibiotic facility is located in i3, Irvine's life sciences enterprise area. Established in 1973, it is the biggest enterprise area in Scotland.

The strategic location of i3 offers world-class infrastructure and utilities, including development-ready sites, high-speed broadband, electricity, gas and water.

The Irvine site accommodates a major proportion of GSK's secondary global production operations. It produces a wide range of chemicals and antibiotics such as penicillin G and clavulanate acid, serving specific clinical trials and commercial production.

The expansion increased the production capacity for antibiotics to meet growing demand in emerging markets. The plant primarily produces Augmentin, which is used in the treatment of pneumonia, bronchitis and skin infections.

The expanded facility is equipped with chillers, tankage, a 24m-high solvent tower, crystallizers, dryers, and centrifuges. The control room within the facility accommodates various manufacturing devices and monitors and manages each stage of the production process.

A contract worth $13.8m was awarded to Kirby Engineering and Construction to provide mechanical, electrical and plumbing (MEP) services, including fabrication and installation of piping, duct work services, as well as electrical and instrumentation services.

Luddon Construction was awarded a $4.86m contract to provide civil and building construction services for the project. It included the construction of seven new separate structures and asphalt road, as well as the installation of barriers and fencing.

GSK is engaged in the research and development (R&D) of innovative products in the areas of vaccines, medicines and consumer healthcare products. It has offices in more than 115 countries and produces biopharmaceutical and prescription products.

The company develops a range of products for the treatment of respiratory, oncology, cardiovascular, metabolic, urology, immune-inflammatory and HIV diseases.

Zayed Centre for Research into Rare Disease in Children, London, United Kingdom

Construction of the Zayed Centre for Research into Rare Disease in Children in London, UK, is expected to begin in March 2016. The research center will be located near Great Ormond Street Hospital (GOSH) and the University College London (UCL) Institute of Child Health (ICH).

The new research center will have the facilities for clinicians and researchers to work together to understand rare diseases, identify new and better treatments and manufacture innovative medical devices.

The facility is named in the honor of Sheikh Zayed bin Sultan Al Nahyan and being developed as a partnership between GOSH and UCL. The plans for the construction of the facility were approved by councilors at Camden Town Hall in March 2015. The construction is expected to be completed by 2018.

The research facility is located adjacent to Great Ormond Street Hospital, which treats approximately 1,300 children from more than 80 countries.

The new research facility will have a six-story building with a total floor space of more than 139,880 sq. ft. (13,000m²). It will have two set-back levels and be equipped with sophisticated laboratory facilities and a large out-patient facility spread across two floors.

The facility will include a variety of laboratories, specialist equipment rooms, and workspaces for experts to develop diagnostic procedures, manufacture gene and cell therapies, as well as create personalized medical devices. Two large laboratories will be located on the lower ground floor.

Cardiology and flow cytometry suites for the counting, storing and analysis of cells with laser technology will be included. Freezers and liquid nitrogen stores will also be part of the facility.

A good manufacturing practice (GMP) facility will be located on the fourth floor, which will carry out research on 6,000 known conditions, including cancers, cystic fibrosis and muscular dystrophy. It will manufacture specialist products for novel therapies, which will help develop regenerative medicine programme for children with absent or damaged tissues.

It will accommodate roughly 400 academics and clinical staff, as well as 150 laboratory bench positions. It will also house more than 200 patients and accompanying family members.

The facility will be constructed to achieve Building Research Establishment Environmental Assessment Methodology (BREEAM) certification. It will be equipped with a high-performance building envelope, which preserves heat and prevents damp.

Other sustainability measures include low-energy and motion-responsive lighting, water conservation systems and rainwater recycling, combined heat and power (CHP) plant, use of recycled materials for construction, solar panels at roof level to supplement the energy needs, and a green roof.

The £42m ($60.27m) design contract was awarded to Stanton William Architects. Other contractors associated with the project include Gardiner & Theobald as cost consultant and project manager, BHSLA as landscape architects, and Pell Frischman as structural engineer.

Hoare Lee is the services, environmental and BREEAM engineer, Turner & Townsend is the CDM coordinator, DP9 is the planning consultant, and Eckersley O'Callaghan is the façade consultant.

The total cost for the construction of the Zayed Centre for Research into Rare Disease is estimated to be £90m ($129.04m).

The project was initiated by the chairwoman of the UAE General Women's Union, Her Highness Sheikha Fatima bint Mubarak, the wife of the late Sheikh Zayed bin Sultan Al Nahyan, who donated £60m ($86.10m) for the project in July 2014.

Great Ormond Street Hospital Children's Charity will raise £20m ($28.70m) of funds, while a £10m ($14.35m) grant will come from the Higher Education Funding Council for England's Research Partnership Investment Fund.

Pharmachem Technologies Expanding in Grand Bahama

Pharmachem Technologies has started expanding its API facility in Grand Bahama just days after its main customer Gilead Sciences won US FDA approval for a new HIV drug.

The expansion of the Freeport facility began on March 31. The project will cost $120m, take two years and increase active pharmaceutical ingredient (API) manufacturing capacity and capability according to an announcement on the Bahamas Government website.

Pharmachem has made tenofovir disoproxil - the active pharmaceutical ingredient (API) in Viread and one of the active pharmaceutical ingredients in Atripla and Truvada – for Gilead for more than a decade.

A Gilead spokesman told us: "The new API facility is for the exclusive production of Gilead product. The facility will be built next to the existing manufacturing plant on Grand Bahama, with the additional capacity and operational capability enabling the manufacturing of more structurally complex APIs."

The new facility – which is expected to be operational in 2019 – will supply APIs for Gilead’s new HIV treatment Descovy, which was approved by the US Food and Drug Administration (FDA) on Monday.

The drug combines emtricitabine and a new tenofovir prodrug - tenofovir alafenamide – which has demonstrated equivalent antiviral efficacy to Viread at a tenth of the dosage.

The Freeport facility was set up by Mexican drug firm Laboratorios Syntex SA in the 1960s to make the API for Naproxen, a non-steroidal anti-inflammatory drug (NSAID). In 1994, Roche bought the facility along with Syntex.

Two years later the plant was acquired by Pietro Stefanutti, then president of Italian API firm Pharmaceutical Fine Chemicals. In 1998 it was sold to manufacturing conglomerate Allied Signal, however, it was later mothballed when that firm merged with Honeywell.

Stefanutti reacquired the Freeport facility in 2003 in partnership with the Bahamian Port Authority, bringing with him a supply contract from Gilead.

Under Pharmachem, the facility has supplied Gilead with tenofovir disoproxil since 2004, including during the seven year period the firm was owned by France-based contract manufacturing organization (CMO) Novasep.

Canada Building a Centre for Advanced Therapeutic Cell Technologies in Toronto

GE Healthcare, the Federal Economic Development Agency for Southern Ontario (FedDev Ontario), and the Centre for Commercialization of Regenerative Medicine (CCRM) are building a center for advanced therapeutic cell technologies in Toronto with an investment of CAD $40M from GE and FedDev Ontario. The center is being established to accelerate the development and adoption of cell manufacturing technologies that improve patient access to novel regenerative medicine-based therapies. CCRM and GE will welcome partners from pharma, biotech and cell therapy companies to bring this initiative to life.

The wide-scale deployment of cell-based therapies brings enormous economic and social potential for transforming the course of incurable diseases. The global market for cell-based therapies is expected to surpass the $20 billion USD mark by 2025, with an annual growth rate of 21%(i). The main targets for cell-based therapies are high impact disease areas with significant unmet need, including cancer, heart disease, neurodegenerative diseases, musculoskeletal disorder and autoimmune diseases.

The Honorable Justin Trudeau, Prime Minister of Canada, commented: "The health of Canadians is a priority. We believe that supporting this new, world-class facility will have significant benefits for innovative health-related technology in Canada and around the world. It will also generate new jobs and make Ontario an even stronger competitor in the bio-tech industry."

Cell therapy's pace of development and clinical outcomes have, in many cases, exceeded expectations. Industrialization, technological innovation, and systemic support are now required to maintain this momentum. The center will provide cell therapy companies with facilities and expertise to help establish manufacturing processes that can produce the large cell numbers required for clinical and commercial use. Located in Toronto's hub of stem cell science, bioengineering, and clinical trials activities, the center will work with its industry partners to introduce new technologies to solve emerging technical challenges and bridge gaps in current and future workflows.

Kieran Murphy, CEO of GE Healthcare's Life Sciences business, commented: "It is increasingly clear that cell therapies and regenerative medicine will transform healthcare globally, but successful industrialization is now crucial to widespread adoption. This new center will enable us to work with cell therapy companies to push beyond existing technical limits and problem-solve. Toronto's concentrated and collaborative clinical infrastructure, combined with the strong guidance of the internationally-renowned CCRM, make it an ideal location for the center."

Michael May, President and CEO, CCRM, added: "We have built a strong industry consortium of nearly 50 companies to help drive a collaborative approach to realizing the potential of regenerative medicine. GE Healthcare already plays a leading role in that consortium and the company's deep knowledge of the bioprocessing industry, combined with its global scale and health care insights, makes it the ideal anchor partner for the new center. We greatly appreciate FedDev Ontario's support in making this crucial initiative happen. Both partners are essential to the center’s success."

Clariant to Invest in Healthcare Packaging

Clariant, a world leader in specialty chemicals, announced plans to invest CHF 10 million in a new Healthcare Packaging manufacturing plant in Cuddalore in Tamil Nadu State, located about 25 km from the city of Puducherry. The plant will manufacture Clariant's market-leading moisture control products to support the growing pharmaceutical packaging market in India.

"India is the largest provider of generic drugs globally," says Ketan Premani, Head of Clariant Healthcare Packaging Sales in India, "making it a key market for Clariant's desiccant products. We want to ensure that we serve our customers here as directly and efficiently as possible. When the plant is complete, they will now have the ability to procure Clariant's global-standard products directly produced in India."

Clariant Healthcare Packaging, a member of Business Unit Masterbatches, manufactures a full range of controlled atmosphere packaging solutions including pharmaceutical desiccants, equilibrium sorbents, adsorbent polymers, oxygen scavengers and pharmaceutical closures and containers.

The new plant in Cuddalore will initially produce desiccant canisters and packets, which are inserted into pharmaceutical packaging to control moisture and protect the stability of the medicine during shelf life. The desiccant production area will be Cleanroom Class 100,000 and certified ISO 8. It will be compliant with all relevant cGMP and US FDA standards.

Dr. Deepak Parikh, Region President – India, Clariant, said, "We are happy to announce our plans to invest in a new state-of-the-art manufacturing plant in India. This new manufacturing facility is in alignment with our overall growth strategy in the country. The new facility will enable us to enhance our medical specialties business and offer end-to-end solutions to our existing as well as potential customers. Clariant in India is accelerating change and continues to fulfil our commitments to all our stakeholders, as the Indian market stays at the core of Clariant's global focus."

The new plant will primarily serve globally active generic and branded pharmaceutical companies operating in India, as well as the domestic Indian pharmaceutical market. According to Markets and Markets, a major global market-research firm, India's pharmaceutical packaging market is projected to grow at a compounded annual growth rate (CAGR) of 10.2 percent from 2015 to 2020. India Ratings & Research, another research company with six offices across India, recently reported that Indian drug makers accounted for 40 percent of U.S. generic drug imports. It forecasts a 20 percent CAGR for the overall pharmaceutical market through 2020.

The new Healthcare Packaging plant in Cuddalore—together with its plant in Changshu, China and the recent acquisition of healthcare packaging specialist VitaPac, located in Dongguan, China—positions Clariant to play a major role in the expanding healthcare sector across Asia.

Creating another base for desiccant canister and packet production also supports Clariant's rigorous business-continuity goals. "More and more global pharmaceutical companies are instituting business-continuity plans, or BCP, to deal with possible market disruptions, both natural and man-made," explains Matthias Brommer, Vice President and Head of Clariant Healthcare Packaging. "This new plant will support our ability to provide the same products from multiple plants in Asia and around the world."

"The significant investment in Cuddalore of our new Healthcare Packaging plant further strengthens our commitment to capture the growth opportunities that exist in emerging markets and specifically in the highly attractive market in India," stated Marco Cenisio, Senior Vice President and General Manager of Business Unit Masterbatches. "It also highlights the commitment of our Business Unit to devote a large portion of the capital budget to our Healthcare Packaging business to continue to fund its growth."

Amec Foster Wheeler Awarded Pfizer Saudi Arabian Contract

Amec Foster Wheeler announces that it has been awarded a contract for the commissioning and qualification management for Pfizer Saudi’s Greenfield pharmaceutical manufacturing facility in King Abdullah Economic City (KAEC), in Rabigh, in the Kingdom of Saudi Arabia.

Amec Foster Wheeler’s services will include commissioning management and coordination, and facilitation of the operational qualification protocols.

The award follows Amec Foster Wheeler’s successful completion of engineering services for the facility in partnership with Egyptian engineering company EGEC, which included site master plan, conceptual and basic design, detailed engineering, and support for the selection of a general contractor for the execution of the construction works.

Roberto Penno, Group President of Amec Foster Wheeler’s Asia Pacific, Middle East, Africa and Southern Europe business said, “ I’m proud to say that we have been involved in providing services for Pfizer’s pharmaceutical facility in Saudi Arabia since its inception in 2010 and that this contract extension further enhances our partnership.

The value of the contract has not been disclosed.

Amec Foster Wheeler designs, delivers and maintains strategic and complex assets for its customers across the global energy and related sectors.

With pro-forma 2014 annualized scope revenues of £5.5 billion and over 40,000 people in more than 55 countries, the company operates across the whole of the oil and gas industry – from production through to refining, processing and distribution of derivative products – and in the mining, clean energy, power generation, pharma, environment and infrastructure markets.

Amec Foster Wheeler shares are publicly traded on the London Stock Exchange and its American Depositary Shares are traded on the New York Stock Exchange. Both trade under the ticker AMFW.

Pfizer Saudi’s Greenfield Pharmaceutical Manufacturing Facility,

The new facility, occupying a 344,320 sq. ft. (32,000 m2) plot, will be dedicated to solid dosage forms, and includes production functions (manufacturing, primary and secondary packaging) as well as support areas (quality control laboratories, warehouse, services, staff support areas).

The new plant in King Abdullah Economic City is expected to become operational in 2016. Once complete, the facility will produce 18 million pharmaceutical packs per year and a broad range of Pfizer’s medicines currently supplied to the Kingdom of Saudi Arabia.

IBM Plans Watson Health European Centre of Excellence in Italy

IBM has announced plans to launch its first Watson Health European Centre of Excellence in Milan, supporting the government of Italy's initiative to establish an international hub for the advancement of genomics, big data, ageing and nutrition.

The Center is part of a long-term collaboration between IBM and the government of Italy. IBM plans to invest up to US$150m (€135m) during the next several years and bring together Watson Health data scientists, engineers, researchers and designers to develop a new generation of data-driven healthcare applications and solutions.

Further, the formation of the Centre is intended to encourage the development of a pan-European ecosystem for healthcare reform, research and health-tech start-ups. IBM data scientists, engineers and programmers are expected to work in collaboration with organizations across Europe to create a new class of cloud-based connected solutions at the intersection of cognitive computing, life sciences and healthcare.

The Centre is expected to provide access to resources and technology designed to accelerate research into new treatment options, promote personalized medicine and encourage discoveries aimed at improving overall public health management while advancing sustainable health systems.

‘Italy is important to IBM, not only because of the creativity, skills and talent of the country's workforce, but also because of the government's efforts to digitize Italy's economy,’ said Erich Clementi, Senior Vice President, IBM Europe. ‘That is why we are excited to announce our new Watson Health European Centre of Excellence near Milan, which will support the Italian government's healthcare reform and research agenda by bringing together Watson developers and IBM research scientists to apply remarkable cognitive computing capabilities to modern healthcare problems.’

IBM anticipates that the Centre will tap into the Watson Health Cloud and other offerings, which are designed to help enable individualized insights and a more complete picture of the many factors that can affect people's health. The Watson Health cloud platform allows this information to be anonymized, shared and combined with an aggregated view of other health data to, for example, improve the ability of doctors and medical researchers to identify unexpected new drug targets or enable doctors to personalize treatment options for cancer patients.

‘Healthcare is undergoing tremendous change, driven by data. The volume and variation of health data is growing exponentially with each passing day and our ability to monitor new measurements of health — such as social data and weather data — are making global health an even more complex equation to solve,’ said Deborah DiSanzo, General Manager for IBM Watson Health. ‘This new era in health will not be achieved through solitary efforts. It will require the work of countless experts together in an ecosystem in which ideas are easily shared to improve and save lives around the world.’

GE Healthcare launches New Research Plan in Turkey

GE Healthcare’s Life Sciences business has launched a new research plan to help foster Turkish bioprocessing development and manufacturing through the launch of its latest Fast Trak Bioprocessing Technology and Training Laboratory in Istanbul, according to a March 29, 2016 press announcement. Based in GE’s Turkey Innovation Center, the R&D laboratory will help support the region’s rapidly growing biopharmaceutical and biotech industry.

According to a report from Deloitte, Turkey has Europe’s sixth largest pharmaceutical industry and is poised to become a significant player in the global biopharmaceutical market. The country’s vision for its healthcare industry includes a strategy by Turkey’s Scientific and Technological Research Council to support R&D and address skill shortages through a range of grant schemes and industry-academia collaborations. GE notes its research scheme, which was launched on March 24, 2016, sits within this framework by offering support for academic collaborations through access to its new technology and training facility.

The Laboratory is equipped with GE’s bioprocessing and research technologies and supported by a team of local GE bioprocessing experts. The facility is already available to customers in the region for training and process development through GE’s Fast Trak training program, and will now be made available to applicants from universities and research institutions to support their research projects.

“The share of high-tech products in our exports is around 3-4 percent. We should increase this ratio to the level of 15 percent. For this purpose, we should focus on increasing the added value work in the well-established sectors and we need to take serious steps in new-generation sectors,” said Professor Hasan Ali Çelik, deputy minister of science, industry and technology, at the inauguration of the facility. “In this respect, the pharmaceutical industry stands out here as a critical sector.”

Bristol-Myers Squibb Collaborates with Bioprocessing Institute in Ireland

A team of Bristol-Myers Squibb scientists will work in a new laboratory at the National Institute of Bioprocessing Research and Training facility in Dublin, Ireland.

Bristol-Myers Squibb will collaborate with the National Institute of Bioprocessing Research and Training (NIBRT) in Dublin to establish a process science and technology laboratory that will strengthen productivity of biological manufacturing processes, according to a March 29, 2016 announcement.

The laboratory will house a team of twelve Bristol-Myers Squibb scientists who will advance complex bioprocesses used to produce BMS's biologics products and who will benefit from close collaboration with the scientific staff at the NIBRT. The laboratory is expected to be operational by June 2016.

The collaboration comes ahead of Bristol-Myers Squibb's plans to open a new, large-scale biologics manufacturing facility in Cruiserath, County Dublin, near Blanchardstown, Ireland that will produce multiple therapies for the company's growing immuno-oncology portfolio. The manufacturing facility is estimated to be operational in 2019.

In addition to establishing a laboratory, the Bristol-Myers Squibb–NIBRT collaboration will include additional training programs for Bristol-Myers Squibb employees and programs to develop skills for potential new biopharma employees.

The Cruiserath facility, which will employ up to 400 skilled science, professional, and technical staff, will produce multiple therapies for the company's growing biologics and diversified specialty medicines portfolio. Bristol-Myers Squibb employs 25,000 people worldwide, including 550 in Ireland.

"We are delighted to expand our partnership with Bristol-Myers Squibb," said Dominic Carolan, CEO, NIBRT, in the press release. "As the national bioprocessing training and research facility, NIBRT is committed to supporting international and domestic biologics investment to Ireland. Working with companies to develop innovative, tailored programs to complement recruitment, training, and research needs is core to our mission."

WHP completes Bio-Manufacturing Facility for Oxford Biomedica

UK cleanroom design and construction firm WH Partnership (WHP) has completed Oxford Biomedica’s new cleanroom production facility in Yarnton, Oxford, which manufactures gene-based medicines for some of the world’s largest pharmaceutical companies.

Constructed to comply with stringent UK Good Manufacturing Practice (GMP) regulations, the additional 60,256 sq. ft. (560m2) of cleanroom space took less than a year from concept to completion and creates extra capacity.

WHP’s Managing Director, Nigel Hall, said: 'We have gained a strong reputation for our cleanroom design and construction in the biotechnology industry and the number and quality of projects that we have in the pipeline continue to grow. We are delighted to have brought our wealth of expertise in stringently-regulated sectors to OXB’s facility and look forward to supporting them in any future expansion plans.'

The Yarnton facility has also recently been approved by the Medicines Healthcare Products Regulatory Agency (MHRA) to manufacture bulk drug material for Investigational Medicinal Products (IMPs).

The additional capacity will support Oxford BioMedica’s proprietary programs in development as well as consolidating key current and potential new relationships such as the well-established CAR-T focused partnership with Novartis for CTL-019.

Purposely designed around the Group’s current and future LentiVector based platform processes, the extra cleanroom space bolsters the Group’s manufacturing capabilities, and increases total operational capacity across its two sites to 10,222 sq. ft. (950m2).

Further capacity expansion at the Group’s existing Harrow House facility (also based in Oxford) is scheduled for completion in the first half this year and will provide a third independent suite to house Oxford BioMedica’s next generation of serum free, suspension cell line based processes.

The firm says continued investment in its specialist biomanufacturing facilities and capabilities will help it address the industry’s challenges of bridging clinical and commercial supply, one of the main hurdles associated with the rapid progression of gene and cell therapies through Phase II and Phase III clinical trials, and then ultimately to market.

James Miskin, Chief Technical Officer of Oxford BioMedica, said: 'OXB is delighted with the recent completion of its new GMP cleanroom production facility in Yarnton. The WHP team worked closely and collaboratively with a small team of OXB in-house experts throughout the project, and WHP’s specific expertise, from detailed design to engineering solutions, was absolutely critical in completing this high quality facility in such a short period of time.'

John Dawson, Chief Executive of Oxford BioMedica, added: 'We are world leaders in the development of lentiviral vector-based products and the successful commissioning of our second manufacturing facility is a landmark achievement for Oxford BioMedica.

'This investment brings significant potential not only to support our own current and future pipeline of gene and cell therapy products in development but also to support our key collaboration with Novartis.

'Our IP, know-how, manufacturing operations and capacity now position Oxford BioMedica very strongly for securing further new partnerships and alliances.'

Synaffix New High Potency Lab Is Fully Operational

Synaffix BV, a biotechnology company exclusively focused on the development of an industry-leading antibody-drug conjugate (ADC) technology, announced that its newly constructed high potency laboratory is now fully operational.

The high potency laboratory is designed to facilitate the synthetic modification and safe handling of the most potent anti-cancer payloads and their site-specific attachment to antibodies. This recent advancement enables Synaffix to generate gram-scale batches of ADCs for preclinical use.

“The installation of our high potency laboratory marks an important event in the evolution of our R&D capabilities here at Synaffix. Coupled with the preexisting speed of our GlycoConnect™ technology to generate ADC material as fast as couple of weeks, the increased scale and ongoing commitment to safety will further enhance our ability to support the growing number of collaborations with biotech and pharma companies”, said Floris van Delft, Chief Scientific Officer of Synaffix.

GSK invests in Two New Irish API Plants

GSK has invested €12m ($14m) into a site in Ireland to develop and manufacture ingredients for its future portfolio.

The site in Currabinny, Cork has been in operation since 1975 and currently manufactures nine active pharmaceutical ingredients (APIs) for GlaxoSmithKline’s pharma portfolio. Since then it has seen over €700m of investment from the firm.

But with this latest investment, GSK is looking at its future product range across diseases such as cancer, HIV and depression, the firm said, adding a €9.5m kilo-scale manufacturing facility and a €2.5m technical development laboratory.

“Our new Kilo Scale Facility represents an important new opportunity for GSK in Cork,” said the firm’s Head of Engineering Kevin O’Keefe. “The plant will expand our operating scale to allow us introduce new targeted medicines that require highly specialised manufacturing equipment.”

The Site Director, Joe Power, added the investment “demonstrates GSK’s strong commitment” to Cork and Ireland. “It’s a wonderful endorsement of the world-class technical capability we have here and will work to attract new business for the operation.”

The Currabinny site has seen a fair amount of drama over the past few years. In 2010 , GSK axed 121 jobs due to “changing market situations.”

And in 2014 , the site was hit with a US Food and Drug Administration (FDA) Warning Letter after inspectors found a number of GMP violations including equipment used to make API batches to be “contaminated with material from [its] pharmaceutical waste tank .”

This led to GSK issuing a recall of its antidepressant drug Paxil made at the site.

The FDA issued a close-out letter last August.

Vetter Groundbreaking of a New Production Building

German contract development and manufacturing organization (CDMO) Vetter held a ground-breaking ceremony at its Ravensburg Schuetzenstrasse site to announce the construction of a new building.

Scheduled for completion in the first quarter of 2018, the €70m (US$79m) building is expected to begin operations in early 2019.

The construction is part of an investment strategy announced by the company in September 2015, and will constitute an important element in the rebuilding, modernization and expansion of the Schuetzenstrasse facility.

Upon completion, the seven-story building will cover 86,080 sq. ft. (8,000m2), and include a cleanroom with supportive media systems.

The applied technology of the cleanroom will be dedicated to the filling of bulk syringes and will be able to handle sensitive drugs such as biologics and ophthalmics. Syringes prepared in the bulk process offer a number of customization options that are tailored to substance and primary packaging material components, and offer customizable low silicone levels and thus, process flexibility.

The cleanroom will also include an improved restricted access barrier system (RABS) concept to combine the advantages of isolator and RABS technology. The core of the approach is the uniquely fast, by today's standards, three-hour cycle and fully automated decontamination of the cleanroom using hydrogen peroxide (H2O2), resulting from a high level of process innovation.

'This addition to our Schuetzenstrasse site is an exciting chapter in our company’s history and will again support Vetter’s target to offer its customers high manufacturing quality for their high value drugs,' said Vetter Managing Director Thomas Otto.

Omya Opens New Lab

Officially opened on 15 March 2016, Omya’s new pharmaceutical and nutraceutical laboratory is now operational. The innovative facility at the company’s Swiss headquarters in Oftringen comprises a wet lab for product development, a dry lab for granulation, tabletting and performance analysis, as well as storage and office space.

Cutting-edge equipment – including fluid-bed technology, a roller compactor and a rotary tablet press – allows for high-quality mineral research, development and technical customer support.

Until now, Omya has done pharmaceutical and nutraceutical product development with external partners through third-party agreements. However, securing intellectual property rights in collaborations such as these can be challenging. With its own lab, Omya can react to market needs much faster now and ensure legal certainty for both itself and its customers, which is a prerequisite for the company to be able to sell its products without restrictions.

Of paramount importance for the new laboratory will be developing innovative applications and maintaining ongoing natural minerals research projects. These include the award-winning Omyapharm, a Functionalized Calcium Carbonate excipient that allows granules and tablets with high levels of mechanical strength and fast disintegration times to be produced.

Owing to its outstanding properties, Omyapharm was recently selected from 20 shortlisted substances and presented with the 2015 CPhI Pharma Award for most innovative excipient.

‘With the new laboratory, we are able to protect intellectual properties and further extend our specialist calcium carbonate expertise. This includes developing new structured minerals that are tailor-made for specific applications or optimizing existing products to meet the changing needs of the industry. Moreover, our experienced team of scientists and technicians is available to support customers regarding product development and ensure shorter times-to-market for pharmaceutical and nutraceutical products,’ explains Stefan Lander, Vice President Consumer Goods at Omya.

Novo Nordisk’s New Production Facility

Novo Nordisk has broken ground on a new diabetes medicine production facility in North Carolina, US, which will be built at a cost of $1.8bn.

The investment is part of the company's plans to invest nearly $2bn in production facilities in Clayton, US and Malov and Kalundborg, Denmark.

When operational in 2020, the facility will produce active pharmaceutical ingredients (API) for a range of Novo Nordisk's current and future GLP-1 and insulin medicines.

North Carolina governor Pat McCrory said: "Novo Nordisk's billion dollar decision to bring this landmark manufacturing facility to North Carolina underscores its commitment to our state and confidence in our state's talent."

The proposed facility is being built adjacent to Novo Nordisk's existing plant in Clayton, which is involved in the formulation, filling and packaging of diabetes medicines.

The plant also assembles and packages the company's FlexPen and FlexTouch prefilled insulin devices for the US market.

McCrory added: "This expansion of the current site and workforce highlights our ability to be a leader in biomanufacturing at the global level."

The production expansion will create 700 new jobs with another 2,500 jobs to be created during the construction phase of the new plant.

Novo Nordisk president Lars Rebien Sørensen said: "As the prevalence of diabetes has grown in the US, so too has the demand for effective treatments. It gives me great pride to break ground on our new facility site in Clayton where we have an existing, strong organization. This site will play a vital role in enabling us to meet the needs of people living with diabetes in the US for years to come."

With nearly 39,700 employees in 75 countries, Novo Nordisk markets its products in more than 180 countries.

WuXi AppTec Launches South Korean Branch

WuXi AppTec an open-access R&D capability and technology platform company serving the global pharmaceutical, biotechnology and medical device industries, has announced the opening of its branch office in Seoul, South Korea, one of the most dynamic life science innovation hubs in the Asia Pacific region.

Located at an industrial park in the Pangyo Techno Valley, WuXi AppTec Korea branch will help bring WuXi's comprehensive platform of integrated enabling capabilities closer to the life science community in South Korea. It will also help accelerate the development and commercialization of innovative healthcare products from the region for China and the rest of the world through WuXi's global expertise and global resources. It is the latest addition to WuXi's global footprint of 5 million square feet of facility space across 23 sites and offices worldwide.

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