PHARMACEUTICAL & BIOTECHNOLOGY

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UNITED STATES

Texas Biomed Steps Closer To New High Containment Lab in US

San Antonio City is supporting Texas Biomedical Research Institute’s efforts to design a new high containment research lab.

The San Antonio City Council has authorized a loan of $250,000 to Texas Biomedical Research Institute (Texas Biomed), an independent, not-for-profit biomedical research institution, to help fund a biosafety level 4 (BSL-4) facility on its campus.

In June 2017, Texas Biomed announced that its Board of Trustees had approved moving forward with the construction of its second BSL-4 lab, expanding the organization’s capabilities in developing vaccines and therapies for the world’s deadliest infections (including infectious pathogens with a growing resistance to current treatments).

Texas Biomed’s current BSL-4 laboratory is the only privately owned BSL-4 laboratory in the US.

“Texas Biomed has been a tremendous asset to our City and our nation, working to advance scientific and medical breakthroughs that keep our communities safer and healthier,” said Mayor Ron Nirenberg. “The expansion of the biosafety level 4 lab is crucial to ensuring that this institution, an anchor in our local economy, continues to receive the resources it needs to be a world leader in biomedical research.”

Under the Loan Agreement, Texas Biomed must retain 43 current BSL-4 jobs and create at least nine additional full-time jobs in the new expanded facility.

City Manager Sheryl Sculley said, “Expanding the BSL-4 laboratory and its capabilities will allow Texas Biomed to retain and recruit some of the world’s top scientists in the area of infectious diseases, while also significantly increasing the amount of bioscience research dollars flowing into San Antonio.”

Expansion of the BSL-4 laboratory is part of a larger strategic plan for the Institute under the leadership of recently-hired Texas Biomed President and CEO, Dr Larry Schlesinger.

“The Institute’s current biocontainment facilities (BSL-3 and BSL-4) must expand if we are to meet the growing demands for discovering more effective diagnostics, therapies and vaccines for these infections,” said Dr Schlesinger. “We are excited to get started so that we may bring greater innovation, new discoveries and added hope for a safer, healthier future.”

In the past decade, Texas Biomed has contributed significantly to the understanding of infectious diseases. For example, the team has:

demonstrated efficacy of a live vaccine for Lassa Hemorrhagic Fever virus

identified new inhibitors of Ebola virus disease in systematic screenings of FDA-approved drugs

identified a viral component that is important for Ebola virus replication and could serve as a potential target for antiviral therapy. This finding was selected by the National Institutes of Health as a top discovery in 2015.

The Institute is also making major advances in new therapies and vaccines for HIV, malaria and tuberculosis, which combined accounts for the majority of human suffering and death due to infections worldwide.

ACF Bioanalytical Plant Opens

ACF Bioservices has completed the construction of its Exton, Pennsylvania, US-based facility for cell and gene product testing.

Parent company Absorption System’s Chris Bode told us the 2,400 sq. ft. site will also offer biological testing capabilities.

“We anticipate that a good portion of the site will be utilized solely for gene and cell therapies. But our core business is expanding into the emerging category of GMP biological testing, which also includes the area of non-clinical equivalence testing for small molecules.”

“We will use the facility to continue to expand our in vitro expertise to replace certain types of clinical equivalence testing for small and large molecules,” he stated.

According to Bode, the GMP-compliant facility was built in anticipation of client demand.

“We had conducted studies in the gene and cell therapy space for existing clients, and in order to stay in touch with these projects as they progressed further into clinical trials we needed a cGMP facility,” he said.

“As we explored our options, we came to the realization that gene and cell therapies had reached a tipping point and were coming of commercial age, so to speak. Our competitive intelligence provided further evidence of commercial need for such a facility,” he added.

Bode said the facility – which cost ACF Bioservices $2m (€1.7) – will attract new business.

“The complex nature of these new therapeutics (cells and genes) is pushing the limits of our historical approaches to understanding product performance,” he explained.

The company the opening of the facility will create 15 jobs in the next 12-18 months.

Ventria Bioscience Plans to Double Biomanufacturing Capacity

Ventria Bioscience will double biomanufacturing capacity for therapeutic proteins, reagents and cell culture products.

Ventria Bioscience Inc. announced an expansion of biomanufacturing and laboratory facilities to roughly double Ventria’s capacity for production of recombinant proteins. The company broke ground on the expansion of its molecular biology lab, greenhouses, process development and analytical lab, and processing capacity in Junction City, Kansas. Ventria’s proprietary ExpressTec platform for biomanufacturing produces biological products known for purity, safety and cost-effectiveness.

Ventria is developing a promising pipeline of novel therapeutic proteins for potential treatment of human diseases. In addition, Ventria manufactures high-quality, defined, animal-free reagents and cell culture products, marketed globally by its InVitria division and leading laboratory supply distributors. Partnering with pharmaceutical and biotech companies, Ventria also supplies a variety of recombinant proteins for development as potential new drugs.

"We are very pleased to announce this expansion. As Ventria's business continues to grow, we are excited about serving our customers and partners globally, as well as contributing to the vibrant economy of Junction City and central Kansas," said Scott E. Deeter, president and chief executive officer of Ventria. "The proven effectiveness of Ventria's unique technology for biomanufacturing is gaining recognition in our industry, and Ventria's pipeline of therapeutic proteins has the potential to make a real difference in people's health in the future."

Ventria's therapeutic development effort focuses on an unmet need for safer and more effective treatments for inflammatory bowel disease (IBD), characterized by chronic inflammation in the digestive tract, generally as ulcerative colitis or Crohn's disease. Both can cause debilitating diarrhea, pain, fatigue, weight loss and sometimes life-threatening complications. An estimated 1.6 million people in the United States and 2.2 million in Europe suffer from IBD, according to the Crohn's & Colitis Foundation of America, and the European Crohn's and Colitis Organization.

Construction on the 3,000-square-foot addition to Ventria’s facilities, representing an investment of more than $1.5 million, will begin immediately. Ventria expects its local workforce to grow by more than 50 percent, with several new employees already on board for the expansion.

The general contractor for the project is KBS Constructors, Inc., based in Topeka and leading this project from its Manhattan, Kansas, office; the architect-engineer is BG Consultants, Manhattan; and the greenhouse contractor is Stuppy Greenhouse, North Kansas City, Missouri.

Maxxam Analytics Opens First US Food Testing Lab

Maxxam Analytics (Maxxam) has opened a 3,000-square foot food testing laboratory in Kansas.

The provider of food, environmental, industrial hygiene and DNA analytical testing said it is its first US food testing lab, building on the ones it has in Canada.

The ISO 17025 accredited lab is in the Kansas City Animal Health Corridor at Kansas State University Olathe.

Ralph Richardson, dean and CEO of K-State Olathe, said: "[The] company has created new jobs in Olathe and is helping usher in a more skilled workforce for the region by giving K-State Olathe's graduate students the opportunity to learn Good Laboratory Practice operating standards and industry-based lab operations before graduation."

Donna Garbutt, Maxxam’s CEO, said it was excited to work with the university and the relationship would bring mutual benefit.

“Food testing is a big part of our testing in the food space, for the overall organization it is the largest percentage of what we do,” she said.

“Our focus in Kansas is on the pet food market to begin with before we expand into human food. We have existing customers of ours for a number of years that have existing production plants in the area.

“We are focused on making sure we assist customers to meet the regulatory environment but there is also a big interest in the food industry. Everything is reviewed and that goes from the microbiology and chemistry perspective and if a product makes claims with regards to allergens etc. that must be validated by an independent source.”

The testing lab will ensure food meets safety and regulatory requirements through its microbiology, chemistry and residue testing.

The Maxxam lab at K-State Olathe has 10 employees including researchers, a lab manager and a number of analysts, but plans to grow to 15 staff.

Garbutt said being aligned with the university was a good opportunity to access the latest research while providing opportunities to graduate students to get experience in a production environment.

“We have the general standard suite of equipment for microbiology and chemistry testing including GC-HPLC, incubators and a lab space. We are there to be local – turnaround time is 24 hours but we can do faster, it depends on the need and of course some tests take longer,” she said.

“We have clients and experience in Canada but the food industry is global. We have customers here in Canada that also have facilities in the US and when we looked at expansion it made sense that it was Kansas City. If we need to deal with a large uptick in a short time we don’t need to run couriers long distance.

“There are regulatory differences in the US and Canada but a lot is consistent and there are more similarities than differences. How we operate the lab is the same and we can use our experience in the space but different customers are available in the US versus Canada.”

Maxxam is part of the group of companies under Bureau Veritas.

The food division is specialized in microbiology, chemistry and residue testing of samples.

It has 2,200 employees in 45 facilities across North America processing over 2.5 million samples a year.

Bureau Veritas is in lab testing, inspection and certification services. The group has more than 70,000 employees in 1,330 offices and labs in 140 countries.

Juno Opens HQ & Cancer Research Site

Juno Therapeutics has opened its new headquarters and research facility in South Lake Union, Seattle, US.

The development consolidates Juno’s Seattle team – previously spread across three locations – under one roof in South Lake Union.

The facility houses 65,000 sq. ft. of biosafety level one and two (BSL-1 & BSL-2) laboratory space over five floors. The focus will be the development of cell-based immunotherapies based on chimeric antigen, and high-affinity T cell receptors.

Spokesperson Chris Williams said the site is strategically placed near Washington’s largest city.

“Our headquarters and research building is about 20 miles south of our manufacturing facility, which is located in Bothell, Washington, which his north of Seattle. The new HQ is in the same neighborhood as our previous HQ,”said Williams.

“For a variety of reasons, including attracting talent, we wanted to make sure our new building was in or near downtown Seattle,”he added.

Juno has premises across Washington, US, and Göttingen and Munich, Germany.

Avara Acquires GSK Facility

Avara Pharmaceutical Services has signed an agreement with GSK to acquire a GSK consumer healthcare manufacturing facility in Aiken, SC.

"This acquisition is an important component of our strategic plan and expands our services by adding additional solid dose capability in the U.S., which is in very high demand," said Timothy Tyson, chairman and chief executive officer, Avara. The transaction is expected to complete on or before June 1, 2018.

Avara Pharmaceutical Services is a state-of-the-art contract manufacturing and technical services organization providing both API formulation and manufacturing, along with secondary formulation, manufacturing and packaging of small molecule drugs, including highly potent compounds. Avara has secondary manufacturing technologies including granulation, coating, blending, encapsulation, compression and drying of tablets and capsules. Avara also has sterile manufacturing capability.

Following completion of the transaction with GSK, Avara Pharmaceutical Services will have seven sites. Three in the U.S., including the corporate HQs; one in Puerto Rico, one in the UK, one in Ireland, and one in Italy.

"As we celebrate another important milestone, we continue with great confidence to add pharmaceutical services and capabilities with complementary offerings in key regions in this rapidly growing market,” said Mr. Tyson.

Fresenius Kabi Acquires Akorn

Fresenius Kabi broke ground recently on a $250 million manufacturing campus. The development in Chicago's near west suburbs will transform the current plant into a state-of-the-art pharmaceutical manufacturing campus. It comes following an extensive intergovernmental agreement worked out last year that provided for tax incentives and land use controls.

Fresenius Kabi is a global pharmaceutical company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition. The company's global headquarters is in Bad Homburg, Germany. Today, the company employs more than 1,700 people in Illinois.

The current Melrose Park site manufactures generic, sterile injectable pharmaceuticals used in hospitals and clinics for chronically and critically ill patients throughout the U.S. The expansion will create multiple new buildings connected to the existing manufacturing site and will feature fully automated aseptic filling lines using state-of-the-art isolator technology, expanded lyophilization (freeze-drying) capabilities, formulation areas, a dedicated warehouse for raw materials and components and an administration building with conference center, laboratories, office space and cafeteria.

Fresenius Kabi will invest the $250 million in the project over the next decade. The project is expected to be completed in 2026.

"This project will create many opportunities for our employees, who work around-the-clock to produce life-saving medicines for patients who need them," said Steven Nowicki, senior vice president of global operations for North America, pharmaceuticals division, Fresenius Kabi. "Our expectation is that the positive effects of this extensive construction project and our continued growth will benefit the people and business community of Melrose Park and Illinois."

Sharp Packaging Reaches Fiftieth Serialization Line Milestone

Sharp, a global provider of pharmaceutical packaging and clinical services, part of UDG Healthcare, has reached a milestone in its track and trace program by equipping its fiftieth line with serialization capabilities ahead of the US and European regulatory deadlines in 2018/19 aimed at preventing counterfeit product from entering the supply chain

The fiftieth line, located at the Allentown facility in Pennsylvania, marks the latest milestone in Sharp’s ongoing serialization program to meet the new legislative requirements in the US and Europe.

Having started serializing products more than nine years ago, the company currently runs more than 70 serialization projects, supplying products across the globe, supporting eight international serialization programs.

Rick Seibert, Senior VP of Global Innovation & Technology Service at Sharp, said: “Many industry players have underestimated the impact that implementing serialization can have on an organization and have delayed their preparations for the Drug Supply Chain Security Act (DSCSA) and the EU Falsified Medicines Directive (EFMD), meaning they are underprepared and unlikely to be fully compliant in time for the deadlines.”

“Serialization is not a new concept. Sharp has been serializing products for almost a decade, meaning we have a team of industry leaders with considerable expertise and depth of knowledge in this area.”

“As a result, we can offer our customers a scalable and accelerated onboarding process, making their journey to compliance more streamlined, and less time and cost intensive. We expect to see many companies, particularly small and mid-sized players, relying on outsourced packaging solutions to maintain continuity of supply post-enforcement dates.”

The company’s first serialization project for Cephalon began in 2008 ahead of the Californian e-Pedigree deadline in January 2009.

Sharp was responsible for validating and packaging several products for the biopharmaceutical company from its Allentown facility.

Gerry Frank, former Senior Director of Packaging Technology at Cephalon, said: “At the time that we approached Sharp we were exploring how packaging technology could allow us track product through the supply chain. Sharp’s expertise and innovative approach to serialization was invaluable throughout the project.”

“Now, nine years later, it is fascinating to see how the pharmaceutical industry is adopting serialization programs as we face the regulation deadlines globally.”

Lonza to Buy US Clinical Manufacturing Site

Lonza is acquiring a clinical-stage mammalian manufacturing site in the US from Shire. Financial details of the deal were not disclosed.

The 58,000-ft2 (approx. 5,388m2) site, located in Hayward, California, has been operating as a multi-product cGMP facility since 1990 and has a successful regulatory track record.

Assets include 1,000L and 2,000L single-use bioreactors and associated downstream capabilities. Currently the site employs more than 100 personnel, all of whom will have the opportunity to continue in their role with Lonza.

In response to Lonza’s Pharma&Biotech customers’ increasing demand for clinical-stage manufacturing capacity, the acquisition of the site will provide additional cGMP capacity and will supplement our existing assets in Slough (UK). Lonza customer batches will be initiated in 2018.

“As a committed partner to the pharmaceutical and biotechnology industry, Lonza recognizes the need for established and dependable global manufacturing facilities,” said Karen Fallen, Vice President, Business Unit Head, Clinical Development, for Lonza. "The acquisition of this site allows our customers greater access to clinical capacity from a US site. The additional capacity will support the needs of our customers to secure manufacture for their products’ complete lifecycle across Lonza’s global manufacturing network."

“We are confident in Lonza’s ability to continue the important work happening in Hayward and are pleased that they recognized the talent of the team already in place,” said Matt Walker, Shire’s Head of Technical Operations. “Moving forward, Lonza will serve as a partner to Shire, managing the manufacture and supply of reagents used in a number of Shire products.”

Lonza's recently completed the acquisition of Capsugel increasing its ability to supply the pharmaceutical, biotech and specialty ingredients markets.

Abeona Therapeutics Dedication of Gene Therapy Manufacturing Facility

Abeona Therapeutics Inc., a clinical-stage biopharmaceutical company focused on developing novel gene and cell therapies for life-threatening rare diseases, announced the ground-breaking of the first anticipated commercial gene therapy manufacturing facility in Ohio.

The Cleveland-based facility, named The Elisa Linton Center for Rare Disease Therapies, will have the capacity to produce advanced gene and cell therapies to treat serious and debilitating rare diseases. The dedication and ground-breaking ceremony was held October 4.

“We are very excited to announce the creation of The Elisa Linton Center for Rare Disease Therapies, which will be a global resource for production of gene therapies with the potential to bring new treatments to rare disease patients around the world,” said Timothy J. Miller, Ph.D., President and CEO of Abeona Therapeutics. “It is especially fitting that this center is named for Elisa Linton, who was born with Sanfilippo syndrome, a rare terminal disease. The memory of Elisa and courage of her family continue to be a great inspiration to all members of the rare disease community.”

The Elisa Linton Center for Rare Disease Therapies will initially be used to produce ABO-101 and ABO-102, investigational gene therapies currently in development at Abeona for the treatment of patients with Sanfilippo syndrome, and EB-101, an investigational autologous cell therapy for the treatment of recessive dystrophic epidermolysis bullosa (RDEB), a rare and devastating skin disorder.

The center will also house Abeona’s expanded viral-vector lab, which will develop and produce unique and proprietary vectors used for the delivery of gene therapies. The 6,000 square foot center will be built-out and validated over the next 12 months.

“The Epidermolysis Bullosa Medical Research Foundation, along with the EB Research Partnership, is a longtime supporter of research that may help patients living with EB including the development of EB-101. The development of EB-101 is a great example of the progress we are making in EB research today,” said Paul Joseph, Chief Financial Officer of the Epidermolysis Bullosa Medical Research Foundation. “We are very pleased to support Abeona taking steps to establish a world-class gene therapy production facility that will bring new hope to people living with EB and other serious diseases and conditions.”

Several leaders from local government and life sciences were scheduled to attend the dedication ceremony of the center, including representatives from United States Senator Sherrod Brown’s office, Case Western Reserve University, BioEnterprise, MidTown Cleveland, Inc. and JumpStart Inc.

MilliporeSigma Opens New Life Science Center in Massachusetts

MilliporeSigma officially opened its new Life Science Center in Burlington, Massachusetts. The new center serves as a regional hub for scientific advancement and customer collaboration.

MilliporeSigma's new 280,000-square-foot Life Science Center — now home to nearly 1,000 employees — is designed to leverage the expertise and skills of the best talent in the life science industry. In addition to housing both a customer service and call center, the new campus features an M Lab Collaboration Center, a shared exploratory environment where the company's scientists and engineers work with customers to learn about the latest techniques in biomanufacturing.

At year-end, MilliporeSigma will also open the region's first BioReliance End-to-End Biodevelopment Center for small-scale drug manufacturers who will use the lab for their early-phase clinical trials. MilliporeSigma has 30 years of process development experience and a track record of delivering robust clinical production process and clinical material within nine to 12 months.

MilliporeSigma's Burlington facility was designed and constructed to LEED (Leadership in Energy and Environmental Design) standards — minimizing energy and water consumption, while creating an attractive, convenient and healthy place to work. Some of its innovative features include daylight streaming in from all angles, high-efficiency LED lighting and water fixtures and a 182kW solar photovoltaic system blanketing the roof. Twelve electric vehicle-charging stations, with 24 reserved parking spaces, are available at no cost to employees and visitors.

The Life Science business of Merck KGaA, Darmstadt, Germany operates as MilliporeSigma in the U.S. and Canada. Merck KGaA, Darmstadt, Germany acquired Millipore in 2010 and Sigma-Aldrich in 2015. Prior to the latter acquisition, MilliporeSigma was known as EMD Millipore.

Brammer Plans Cell & Gene Therapy Plant Expansions

The contract development and manufacturing organization (CDMO) has selected Pall Life Sciences as its single-use equipment partner at its sites in Florida and Massachusetts.

This year, Brammer Bio has invested in its biomanufacturing capabilities, with a $40m expansion at its late-stage and commercial-ready cell and gene therapy facility in Cambridge, Massachusetts and a $10m expansion at a Phase I/II plant in Alachua, Florida.

And at Biotech Week Boston, Pall Life Science announced it had been chosen as a preferred technology partner “to deliver an end-to-end single-use platform solution from upstream to downstream,” according to Mario Philips, vice president and general manager of Pall Biotech.

The Alachua site will feature cell culture capabilities of up to 500L, while Cambridge will have a scale of up to 2,000L, both fully equipped by Pall. This includes Allegro STR single-use stirred-tank bioreactors range, fixed-bed bioreactors for the scale-up of adherent processes, and 25 bi-axial rocking bioreactors.

In the downstream, Pall will supply the sites single-use tangential flow filtration (TFF) systems, Allegro MVP systems for fluid automation, and Allegro single-use chromatography systems.

“With Pall’s critical process solutions and process support, we look forward to building on more than 100 executed projects and 150 clinical cell and gene therapy lots in Florida—including many first-in-human trials—and 600 plus commercial biologics batches produced in Massachusetts,” Brammer’s CSO Richard Snyder said in a statement.

Rutgers and NJII to Set Up Continuous Manufacturing Institute

The New Jersey Innovation Institute and Rutgers University have teamed up to establish an institute to promote the development of continuous manufacturing technologies for drug production.

The New Jersey Continuous Manufacturing Institute (NJCMI) will let pharma firms develop processes and production technologies in collaboration with NJII and Rutgers experts. The center will also house a training center.

Rutgers has a history of working with drug companies on manufacturing.

The organization helped Janssen develop the continuous production method for the HIV treatment Prezista (darunavir). The US Food and Drug Administration (FDA) approved the process in 2016.

Donald H. Sebastian, president of NJII said, “This partnership with Rutgers builds on over a decade of leading edge R&D, and deep faculty expertise that NJCMI can leverage to make available pilot-scale technologies that meet pharmaceutical industry demands for higher production volume, greater efficiency and reduced cost.

He added that, “I expect the center will be a strong magnet attracting all the links of the pharmaceutical value chain to make New Jersey a place of business.”

Regulators in the US and Europe have been encouraging drug firms to use continuous processes to make the products for the past few years.

Douglas Hausner from Rutgers University-based Centre for Structured Organic Particulate Systems’ (C-SOPS) underlined this point at the Oral Solid Dosage (OSD) Continuous Manufacturing in the Current Regulatory Landscape summit in Malta in June.

He told delegates ““Currently the FDA is strongly advocating for the adoption of the technology.

“They have created specific offices to facilitate this technology, funded work at universities, re-aligned internally, and hired a significant number of engineers all within the last 2-3 years,” adding “In my opinion, they really could not be encouraging this more than they are already are.”

Piramal Boosts HPAPI Site in Michigan

Piramal Pharma Solutions will expand its high potency active pharmaceutical ingredient (HPAPI) capabilities at its Riverview site in Michigan, US.

A media spokesperson for the contract development and manufacturing organization (CDMO) said details on the expansion will be released soon.

The news comes two days after Piramal announced plans to expand its active pharmaceutical ingredient (API) manufacturing capabilities.

The firm said it will invest $55m (€47m) in pre-existing and new facilities – with 270kl (kilolitre) total capacity – across North America and Asia.

Piramal Pharma Solutions' CEO Vivek Sharma said the expansion aims to address the future needs of current customers.

“A significant portion of this capacity expansion will go towards meeting the commercialization needs of our current customers’ late stage pipeline,” he said.

“We fully expect our business to grow with these investments,” he added.

Upgrades at existing API sites include analytical capabilities, R&D labs, automation and IT systems.

According to Sharma, the firm expects to increase throughput by up to 40%.

“A large part of this increase comes from the addition of the fourth manufacturing block at our commercial API site in Digwal [India], where we expect to launch commercial products for our customers in the next year or two,” he said.

As part of the expansion, the firm will increase development capabilities in Ennore, India with the addition of good manufacturing practice (GMP) kilo labs and a pilot plant.

In addition, Piramal will boost drug substance and product services at its Morpeth, UK-based site, and add high speed lines and automation to its aseptic manufacturing site in Lexington, Kentucky, US.

Piramal said the sites will come on line in the next 12 to 18 months.

The CDMO has API development and manufacturing facilities in North America, Europe and Asia.

Alewife Research Centre (ARC), Cambridge, MA

The Davis Companies (TDC) has developed a new research center in West Cambridge, Massachusetts.

The Alewife Research Centre (ARC) will be located at 35 Cambridge Park Drive. Initiated in February 2017, it will provide laboratory space for life science and pharmaceutical companies.

Scheduled to be completed by mid-2018, the center will enable more companies to contribute to Cambridge's reputation as a prime center for research and development (R&D).

Alewife Research Centre is being constructed next to Alewife subway station, which is nearby Kendall Square and Harvard Square. The area can be accessed via the MBTA Red Line subway and the Metro West suburbs via Route 2.

The ARC will be situated in a five-story building with a total floor space of 223,000ft². It will feature flexible lab and R&D spaces, an employee lounge, conference and meeting areas, a fitness workout area with showers and lockers, and a bike room with secure storage.

In addition, the building will include a 29,000ft² penthouse to support the tenant roof-top equipment.

A grand lobby with a two-story atrium and gathering spaces will be provided, as well as a service elevator with a capacity of 5,000lb running between the first floor main lobby and the penthouse.

The center will also include a loading dock area with dock levers and feature concrete slab floors with a live load capacity up to 100 per ft². It will have a floor-to-floor height of 11ft on the first floor and 14ft 6in on the other floors. The column bay spacing will be 22ft 6in x 22ft 6in for the first floor and 22ft 6in x 45ft for floors two to five.

The laboratory in the ARC will feature air-handling units with pre-filters, final filters, and chilled and hot water coils. It will have a paring at a ratio of 1.5 spaces per 1,000ft².

Spagnolo Gisness & Associates (SGA) was awarded a contract to design the core, shell, and lobby elements of the research building. McNamara Salvia, VHB, and AHA Consulting Engineers were awarded the structural engineering services contract.

John Moriarty & Associates was awarded the general construction contract for the research facility. Ipswitch Bay Glass (IBG) was contracted to provide curtainwalls and windows for lab building.

Headquartered in Boston, The Davis Companies (TDC) is a real estate investment, development, and management firm. The company has invested more than $4bn in gross asset value through real estate equity, debt and fixed-income securities. It owns real estate portfolio of approximately 12 million ft² across the Eastern US.

Alcami's Analytical Testing Facility, Missouri, United States of America

Alcami has relocated its existing analytical testing facility in Missouri to the Cortex Innovation Center in Central West End, St. Louis.

The old facility has been operational since 1992, with approximately 80 employees. The workforce is expected to reach 125 by 2021.

Alcami announced an investment of $10.7m for the facility's relocation in February 2017, and construction began in September. Located at 4260 Forest Park Avenue, the new site provides easy access to the company's domestic and international business partners. It also offers 30% more laboratory space and 14% more stability space.

The new laboratory is intended to perform microbial and chemical analysis, covering raw material and antibiotic testing, drug product release, stability testing, water testing, in-process evaluations, and environmental monitoring for both sterile and non-sterile drugs.

Featuring advanced equipment, the facility will strengthen Alcami's ability to expand customized services and client-centric innovations for pharmaceutical and biotechnology markets.

Features of Alcami's new St. Louis analytical testing laboratory

In addition to the existing equipment, a wide range of technologies have been installed at Alcami's new state-of-the-art facility to support development and analytical testing for the drug manufacturing and packaging sectors.

The site incorporates a lab for handling photo-sensitive materials, a low-humidity room for testing and handling hygroscopic materials, pharmaceutical isolators for sterility testing, and ultra performance liquid chromatography (UPLC) equipment for the analysis of drugs.

"The facility will strengthen Alcami's ability to expand customized services and client-centric innovations for pharmaceutical and biotechnology markets."

The laboratory is also equipped with inductively coupled plasma mass spectrometry (ICP-MS) analytical equipment, which allows pharmaceutical companies in their transitions from USP wet chemistry heavy metals.

Alcami's new analytical testing laboratory occupies the top two floors of a 5,574m² three-story building in the Cortex Innovation Community complex. This 809,371m² innovation center promotes bioscience and technology research and development (R&D).

The second floor of the building accommodates a conference room, a large multi-purpose room, 497.5m² of cubicles and office spaces, and a reception area.

The third floor houses sample storage room, a locker room, separate laboratories for chemical and microbiological analysis, lab supervisors, glassware wash and storage areas, and a cleanroom with specialty laboratory areas.

Alcami plans to replace the cleanroom testing equipment with sterility test isolators to reduce the laboratory space.

Headquartered in North Carolina, US, Alcami is engaged in providing customizable services to pharmaceutical and biotechnology companies. With an employee base of 1,000, the company operates seven facilities worldwide.

Alcami offers various technologies for applications including analytical development and testing services, active pharmaceutical ingredients (API) development and manufacturing, formulation development, packaging, solid-state chemistry, and clinical and commercial finished dosage form manufacturing.

Alcami owns two other analytical testing centers in the US, including one in Wilmington, North Carolina, and the other at Edison township in New Jersey.

Tulex Completes NJ Development and Manufacturing Facility

Tulex Pharmaceuticals, a specialty pharmaceutical company located in Cranbury, NJ, has recently completed its new, multi-million-dollar, cGMP development and manufacturing facility capable of handling solvent processing and Wurster coating for commercial scale oral solid and liquid dosage forms.

Tulex has two proprietary technologies that focus on bio-availability enhancement and delivering predesigned drug release profiles that can be tailored to meet specific customer requirements.

Tulex out-licenses its technologies, as well as collaborates with customers in various stages of development for ANDA and NDA products. Tulex also serves as a CMO for commercial products or clinical supplies.

Cambrex Invests in Highly Potent API Manufacturing Plant

Cambrex, a specialist manufacturer of small molecule innovator and generic active pharmaceutical ingredients (APIs), has invested $24 million in a new facility to manufacture highly potent APIs (HPAPIs) at its Charles City, Iowa plant

The 4500 sq. ft. production area will operate to an occupational exposure limit (OEL) down to 0.1 µg/m3 and have a total reactor capacity of 2200 gallons, which will be made up from a range of 200, 500 and 1000 gallon glass and Hastelloy vessels to manufacture batches from 50 to

300 kg.

The project will also reconfigure the existing small scale manufacturing area providing a single high containment building to support early stage development and manufacturing, providing flexibility across a broad scale range.

Construction and installation of all new equipment is expected to be completed by Q1 2019.

“This expansion is in line with Cambrex’s commitment to ongoing investment in small molecule manufacturing, as well as responding to the rising number of APIs that require specialized handling due to potency and toxicity,” commented Shawn Cavanagh, COO of Cambrex.

He added: “Cambrex has built a strong reputation in the clinical-scale supply of potent and extremely potent molecules, and the flexibility that this facility will give allows us to effectively handle projects throughout their development and commercial lifecycle.”

This latest expansion is part of an ongoing strategic campaign to invest in small molecule API development and manufacturing across Cambrex’s global network of facilities, and follows the opening of a $50 million, 7500 sq. ft. multipurpose manufacturing facility at Charles City in 2016, which added a total of 70 m3 of manufacturing capacity to the site.

Cambrex’s Charles City, Iowa facility is located on a 45 acre site and manufactures a wide range of APIs and pharmaceutical intermediates, including highly potent molecules and controlled substances.

The facility is one of a limited number authorized by the US DEA to import narcotic raw materials at commercial scale.

CordenPharma Acquires Pfizer API Facility in Colorado

CordenPharma, a contract development and manufacturing organization (CDMO), has entered into definite agreements to acquire the former Hospira Boulder high-containment API site from Pfizer, the company announced in an Oct. 10, 2017 press release. The closing of the transaction is anticipated to occur in November 2017.

Located in proximity to the existing CordenPharma Colorado facility, Hospira Boulder produces APIs and intermediate products with specialized capabilities in small- to medium-scale highly potent and cytotoxic API manufacturing. Previously owned by Pfizer/Hospira, the 54,000-ft2 facility with more than 100 employees has API production capabilities ranging from small scale up to 3000 L.

CordenPharma will also enter into a multi-year supply arrangement with Pfizer, with the expectation that the agreement will help defray costs associated with running the site for the next few years while it adds new client work into the facility.

CordenPharma represents the global pharmaceutical manufacturing and service platform of International Chemical Investors Group (ICIG). “The acquisition will augment CordenPharma’s Highly Potent & Oncology platform and integrated supply service offering in association with its drug product manufacturing expertise in the area of solid dosage and sterile injectables in CordenPharma Plankstadt [Germany] and CordenPharma Latina [Italy], respectively,” said Dr. Achim Riemann, managing director of ICIG, in a press release.

CordenPharma Colorado completed the construction of a new API process bay in 2016, equipped to handle highly potent compounds up to OEB Level 4, to accommodate increasing customer demand in this segment.

Hospira Boulder, to be renamed CordenPharma Boulder, will be managed by Brian McCudden, the current CEO of CordenPharma Colorado, who was responsible for Hospira Boulder during one of his previous assignments as an employee of Hospira.

Batavia Adding 50 Jobs in US Viral Vector and EU Cleanroom Expansion

Batavia Biosciences will expand a Dutch production facility and build a viral vector plant in the US to cater for demand for its bioprocessing services.

The mammalian cell line generation and bioprocess development firm is adding 3,500 sq. ft. of lab and cleanroom space across the expansions at its GMP site in Leiden, The Netherlands, and at its R&D facility in Cambridge, Massachusetts.

Batavia Biosciences did not divulge the size of the investment but said the expansions were driven by an increase in general demand for its range of bioprocessing services.

These include “developing production and purification processes for vaccines, viral vectors, antibodies and proteins from the earliest product idea via full development to manufacturing of clinical material,” said commercial director Vincent Franssen.

“With the increased number of projects, the GMP extension fills in the increased need for the production of cell banks, master virus seeds, drug substance and drug product. At the same time, more projects demand more lab space, which is now covered with the creation of a new dedicated viral vector facility in the US. ”

He added the expansions will increase headcount by 50 across the two sites.

The Cambridge expansion will bolster Batavia’s offering to include complete pre-clinical process development capabilities for viral vectors including AAV, Lentivirus, VSV and Adenovirus systems to its portfolio of CHO cell line generation and process development for recombinant proteins and antibodies.

Franssen said Batavia “is continuously attracting new projects and customers” due to its experience in viral vector projects and the growing interest in such products across the biopharma space.

“With the popularity of adenovirus, lentivirus, and AAV for vector vaccines and gene therapy products the demand for Batavia Biosciences’ viral vector work is rapidly increasing.”

Among the projects the firm is involved in is an attempt to produce an affordable rotavirus vaccine through an $8m grant from the Bill and Melinda Gates Foundation.

The program is based on the RV3-BB rotavirus strain, a naturally occurring attenuated strain developed by the Murdoch Children’s Research Institute, and incorporating fixed-bed, high cell density single-use bioreactors instead of more traditional and expensive vessels. Bio Farm, an Indonesia state-owned vaccine producer and distributor, is charged with manufacturing the vaccine itself.

Hitachi Chemical to Expand Site

Hitachi Chemical is expanding manufacturing and cleanroom capacity at its cell therapy-focused CDMO site in Allendale, New Jersey, US.

The expansion will see Hitachi Chemical Advanced Therapeutics Solutions (HCATS) add 49,700 sq. ft. to its contract development and manufacturing organization’s (CDMO) branch, PCT.

The site will house manufacturing development labs, quality control and microbiology labs, additional Grade B/ISO 7 cleanrooms, warehousing and office space.

Validation for the facility is planned before the end of 2018.

The firm said it expects the expansion to attract new business to PCT.

“HCATS anticipates that the increase in demand for cell therapy development and manufacturing services will result in substantial growth of the company’s employee base in the company year,” said the company.

The firm also announced plans to upgrade its Pearl Court site in Allendale, and said its regenerative cell-focused CDMO site in Yokohama, Japan, which is under construction, will be validated by April, 2018.

Hitachi Chemical Co. America – the US off-shoot of Japan-based Hitachi Chemical – purchased PTC from majority shareholder Caladrius Biosciences earlier this year.

The Shriram Center for Bioengineering & Chemical Engineering

The Shriram Center for Bioengineering & Chemical Engineering is the fourth and final building for the Science and Engineering Quad (SEQ) on the main campus of Stanford University, providing a new home for both the Department of Bioengineering and the Department of Chemical Engineering, which were previously dispersed among several locations on campus. Serving both graduate and undergraduate education, Shriram houses 34 custom tailored research laboratories, an undergraduate teaching floor with five teaching labs (Biology, Chemistry, Tissue Culture, Optics and Senior Design), a small animal vivarium for rodents, fish and birds, office spaces for 450 PhD students and 34 faculty, departmental administration centers, a lecture hall, staffed core labs and a host of other amenities designed to facilitate social and academic interactions. Via underground and aboveground connections, the facility also links to the other three SEQ buildings, allowing researchers to easily access all the amenities and shared resources of the entire quad including other core labs, specialty instruments, lecture halls, meeting spaces and dining facilities.

The conceptual program and design of the Shriram Center began in 2004 with a Master Plan for the new Science and Engineering Quad. At that time, the Department of Bioengineering at Stanford was still in its early years of development, and only just beginning to accept students. But by 2010, when the Shriram Center was programmed, the rapid growth of the Bioengineering department and of the undergraduate educational programs for both Bioengineering and Chemical Engineering resulted in a building program 30 percent larger than the Master Plan. The increased program required another 40,000 sq. ft. to accommodate 13 more research labs and five undergraduate teaching labs, plus a small animal vivarium. With the SEQ master plan restricting the size and footprint of the building, the only opportunity to expand was underground. Yet basement spaces, inherently challenged for light and often lacking the quality of upper floors, have a stigma attached to them unless research warrants vibration sensitive spaces or the need for darkness. Locating 13 additional research labs and associated faculty offices, PhD and staff spaces below grade, and competing with the qualities of the spaces above grade was one of the biggest challenges the design team faced. The team ultimately chose to introduce a sunken courtyard and expand the basement under the quad, while adding a partial sub-basement level. Labs, offices and shared spaces surround the courtyard, bringing daylight and access to the outdoors to what is typically a dark and isolated space. Light sensitive spaces were displaced to the sub-basement, where the vivarium is also located. Interestingly, the sunken courtyard has made the basement one of the most desirable areas of the building. The popular “Tea Room,” adjacent to both the central stair and the largest of the building’s full kitchens, is a lounge space that doubles as a venue for special events with large sliding doors that open onto the courtyard. In turn, the courtyard stairs offer convenient direct access from the quad to the core labs, conference rooms and research labs on this level, encouraging people to pass through Shriram at multiple entry points and enhancing its connection to the rest of the quad and campus.

An open, central staircase is the focal point of the building and a key design concept in fostering community among and between the Bioengineering and Chemical Engineering departments. Most of the human attractors—meeting rooms, kitchens, break out spaces with writable surfaces and even restrooms—are all located adjacent to the central stair, drawing people out of their labs and offices into these highly visible shared common areas that encourage introductions, friendships and partnerships between people who might not normally cross paths. Completely open, flooded with light from the curtain wall, highlighted by a five-story mural and with the elevator deliberately tucked around the corner, the central stair is the building’s main means of vertical circulation and serves as an organic way for Shriram’s communities to mix and intersect.

Part of the social culture of the Bioengineering and Chemical Engineering departments included regularly gathering in various locations for cooking club activities where they informally discussed their ongoing research. To capture the energy of this communal activity, the design team located three full kitchens, complete with ranges and wood finishes, at the heart of the building adjacent to the central stair.

Teaching labs occupy the ground floor of the building, embodying Stanford’s commitment to undergraduate education as well as research and gives users and visitors a front row seat to learning as it happens. Flexible furniture accommodates a variety of teaching styles and class sizes. A series of shared equipment, instrument lab and lab support spaces connect most of the teaching labs together into a single suite. This interconnected teaching suite allows students to move between spaces within the controlled lab environment and aids in the accessibility and sharing of all the teaching facilities. After hours, access to the other floors of the building is restricted, but the teaching suite remains open to students.

The extensive customization of the Shriram Center’s labs for each researcher is unusual, particularly in light of the trend for labs to emphasize generic design for flexibility. The School of Engineering’s decision to adopt this tailored approach stemmed from several factors including recruitment, questionable utility of flexible labs in other Stanford buildings and the sheer variety of lab types that prevented a more generic layout from meeting the needs of the research. As the design team met extensively with each lab group and analyzed their research and flexibility requirements, factors such as the need for future growth or the ease of changing out equipment were factored into both the location of specific labs within the building and their internal layout to create the most effective and efficient plan possible. Special attention to details such as the distribution of utilities, cabling, continuity of toe kicks, wiremold and turret placement, bottle storage areas, warm and cold rooms and access panel placement all enhance functional efficiency, maintainability and the clean look and feel of the labs.

The Shriram Center’s core labs include a Soft & Hybrid Materials Facility, Bio-Chemical Lab and Imaging Lab. Staffed by full time technicians who can offer instruction on operation, maintenance and best practices for these shared resources, the core labs provide access to cutting edge equipment. These facilities are located on the basement loop that connects all four buildings on the quad, making them easy to access by many researchers from outside the Shriram Center.

Transparency plays a critical role in nearly every aspect of the Shriram Center’s design, allowing more natural light to spill into the interior spaces, enhancing the safety of the labs where people sometimes work alone and drawing more people in and out of the labs to engage with colleagues. When possible, walls between labs were removed completely, creating open and flexible environments where the ebbs and flows of space demands could be accommodated by collegial cooperation. Such transparency also helps users orient themselves within the building, and encourages staff, students and faculty to feel connected to a larger community, even when they are quietly at work within their own office or lab.

Almost all of the labs are located along exterior walls with the vast majority placed against the north wall to minimize direct sunlight and heat gain and allow for northern light to spill into the spaces throughout the day. Daylight harvesting along the perimeter allows light fixtures to dim as necessary for energy savings, and motorized shades were installed on west facing windows for daylight control.

The challenge for the Shriram Center’s mechanical system lay in the fact that the building is largely outside air driven due to the high percentage of labs and the density of fume hoods. Additionally, since chilled water and heating hot water were being supplied as part of the centralized campus distribution system, it left only the air side of the system to make substantial gains. Building on empirical data and lessons learned from previous projects, the solution was an innovative mechanical system that distributes outside air directly to each zone within the building, where it is then cooled or heated locally instead of at the main air handler. Together with an energy recovery system, which preconditions the incoming outside air on hot and cold days, this design eliminates the need to mechanically precool or preheat at the air handler level, and then reheat the same air at the zone level. This decision created additional challenges to accommodate additional piping and large mechanical systems above the ceilings without impacting ceiling heights. Preliminary data from the Shriram Center’s metering program are tracking the building’s normalized energy usage at approximately 50 percent below Labs21 benchmarking for similar laboratories in the Bay Area. A payback analysis shows the additional cost of this system over a baseline system to be less than three years. Current energy performance data projects the Shriram Center to become the most efficient lab building on the Stanford campus, outperforming the previous best performing facility by 10 to 15 percent.

Befitting the goals for the Shriram Center to be a welcoming, human space, the School of Engineering and the faculty wanted to integrate storytelling artwork throughout the building. This aspiration became the collaborative effort of Bora, The Felt Hat creative agency, Drew Endy, Associate Professor of Bioengineering, and Curt Frank, Chemical Engineering Department Chair. The artwork, which features imagery provided by the faculty from their own research groups, captures the nature of the work underway within the building, aids in wayfinding and offers an unexpected visual surprise for occupants and visitors alike.

The mural is a five-story vertical tapestry representing the history of biological and chemical technologies, inspired by the past and future of the two departments housed within the building. It incorporates a vertical motif, which was inspired by the atomic backbone of double stranded DNA. From these two backbones each floor’s examples of chemical and biological technologies are presented for interaction with one another, like the base pairing that holds DNA together. This metaphor serves to celebrate how the two separate departments can exist and flourish together.

Located on a wall at the main entrance to the Shriram Center’s lecture hall, this sculptural piece reflects the ongoing process of investigation and discovery underway in the building. Five thousand crumpled pieces of paper—printouts of syllabi from the Stanford course catalogue—colored differently and positioned in a grid, create a series of patterns depending upon the five possible perspective of the viewer. Purposefully, the “top-down” and “head-on” perspectives produce two very chaotic patterns. However, as a viewer opens either the left or right door to enter the lecture hall, distinctive peripheral perspectives emerge from which a very clear maze becomes apparent. A third and even more obvious maze with a cluster of gold balls at its center reveals itself from the “bottom-up” perspective achieved at the basement level.

Throughout the building glass panels represent aspects of research pioneered by labs within Shriram. Each panel juxtaposes two scales of the same image, an esoteric microscopic image with a charismatic macroscopic motif. For example, a watercolor painting of all the molecules inside a cell overlaid with the world’s first computer simulation for an entire cell. These charismatic elements of each panel create a visual waypoint that supports the generation of memories, so that people can more readily form mental maps of the building.

The design team for this project included Bora Architects, Architecture + Interior Design; CAS Architects, Laboratory Planner; Whiting-Turner, Contractor; Gayner Engineers, MEP Engineer; Rutherford & Chekene, Structural Engineer; BKF Engineers, Civil Engineer; RMA Design Studios, Furniture; Hargreaves Associates, Landscape Architect; Testmarc Solutions, Commissioning Agent; Gayner Engineers, Environmental Consultant; Arup North America, Specialty Lighting and Specialty Acoustics; and The Felt Hat, Art/Signage.

REST OF WORLD

Torbay Pharma Opens Plant with Sterile Injectables Capacity in UK

Torbay Pharmaceuticals has opened a £26m injectable drug manufacturing facility in Paignton, UK.

The firm, which is part of the Torbay and South Devon NHS Foundation Trust, said the facility will make a range of pharmaceutical products for NHS hospitals in the UK and “healthcare organizations” across the world.

A spokeswoman said the facility produces terminally sterilized injectable products and is approved by the MHRA.

The 78,000 sq. ft. facility consolidates Torbay’s manufacturing operations, which were previously based at four separate sites in the region. Construction of the plant was initiated in 2013.

The facility houses automated production lines, two autoclaves for sterilization and the ability to produce larger batch sizes. The site also has capacity for on-site storage and distribution.

Global sterile drug contracting capacity was reduced by the closure of US contractor Ben Venue, which shut down for good in October 2013 after years of problems at its manufacturing facility in Bedford, Ohio.

In 2014 Aesica pulled out of sterile injectables production. A few months after SCM Pharma lost its manufacturing license due to GMP violations at its site in Prudhoe.

Prior to that Moorfields Pharmaceuticals – a division of Moorfields Eye Hospital - was deemed to have breached GMP guidelines by the MHRA, which reduced UK capacity for ocular injectables.

Oxford Genetics Expands UK Facility

Oxford Genetics will expand its bioproduction services in the UK and target the US market through an office in Boston after receiving a £7.5m ($9.6m) investment.

The investment comes from existing investor Mercia Technologies PLC, and Invesco Perpetual and will help the bioprocessing support firm expand its global presence and increase its DNA, protein, viral and cell line service offerings.

The UK extension adds another floor in its building in Oxford which will be fitted out to increase capacity across the firm’s entire service offering, allowing the segregation of material flow and the isolation of individual projects, said a spokesperson from Oxford Genetics.

“This will allow us to continue to exceed regulatory requirements and provide quality assurance for our clients. We will also add more analytical, purification and process development equipment, for instance small scale bioreactors, to enable us to fully support our clients from research up to the point of GMP bioproduction.”

The 6,000 sq. ft. extension is expected to be ready by November, and will include cell line engineering capabilities, viral vector production and purification suites, high-throughput robotic screening systems and process development facilities.

The US expansion, meanwhile, will see the firm open an office in Boston to target the large US market.

“A US office is integral because it is the single largest market for our technologies and services. There has been a significant increase in the demand for our viral expression systems and cell line development for virus production.”

The firm, founded in 2011, licenses its technology platforms on a non-exclusive basis to all biopharma and according to the spokesperson has had “tremendous interest” from firms looking for bioproduction optimization solutions.

“We have already begun to sign licenses and collaboration deals. The latter agreements are particularly interesting since they are allowing our collaborators accelerated access to some of our virus production platform technologies, which will fully mature over the next 18 months.”

In the past year, Oxford Genetics has benefitted from several funding projects including a £1.6m and £1m, both from Innovate UK, to explore computational and synthetic biology approaches for optimizing mammalian biomanufacturing processes, and to overcome the inefficient and costly scale-up of viral vector production, respectively.

BASF Opens Pharma Formulations Lab in India

BASF has set up a pharmaceutical technical laboratory in Navi Mumbai, India citing Asia’s fast growing generic drug manufacturing sector as its target customer base.

The German chemicals firm inaugurated the laboratory this month, explained that the site will provide formulation development, active pharmaceutical ingredient (API) solubilisation and taste masking services.

Tina Low, Vice President of BASF’s Nutrition & Health in Asia Pacific, said: “We see rapidly rising demand and great opportunities for pharmaceutical solutions in Asia.

“This technical lab in Mumbai will provide generic drug manufacturing customers with comprehensive solutions for superior product efficacy. It will also optimize the performance of raw materials in formulation” she added.

The lab is one of five such facilities BASF has set up, the others being at sites in Germany, North America, South America, and Shanghai, China.

Micro-Sphere Expands Capsule Filling Facility

Spray drying and capsule filling-focused Micro-Sphere is expanding manufacturing capabilities at its facility in Ticino, Switzerland.

The firm is investing 21m CHF ($21.7m) in the site, which will see the 15,231 sq. ft. (1,415m²) facility expand to 31,269 sq. ft. (2,905m²).

Managing director Stefano Console said the decision to expand came from growing market demand, predominantly in Europe and North America.

The company’s founder Michele Müller also observed an increased demand for fill & finish services.

“Both GMP spray drying as a particle engineering technique and low dose capsule filling are becoming increasingly popular across the market and at present there are very few CDMOs [contract development and manufacturing organizations] offering this level of capability,” said Müller.

“From our expanded facility, we will continue to produce both clinical and commercial products, with a particular specialism in dry powder inhalers,” he added.

Console said he expects the increased GMP capabilities to increase the company’s client base, which currently includes firms in the US, Europe, New Zealand and Asia.

“The expansion is already attracting new business, and we expect this to continue in the coming months,”he said.

The expanded facility - expected to be operational by Q4 2017 - will create 20 new roles, he told us.

Kaneka Eurogentec to Build Biologics Facility

Kaneka Eurogentec, a custom service and FDA inspected contract development and manufacturing organization (CDMO), unveiled plans to build a new state of-the-art GMP facility adjacent to its current facility and equipped with a 2200 L fermenter in Liege, Belgium. The expansion will allow for the large-scale production of biopharmaceuticals including recombinant proteins, antibody fragments and plasmid DNA.

The multi-product facility will include the capability for large-scale production using innovative Eurogentec technologies such as the improved production of complex proteins by secretion from yeasts and the production of kilo-scale plasmid DNA for viral and non-viral gene and cell therapies. This expansion will be complementary to the current capabilities and together will provide small and industrial scale production. It will offer on a single site to clients on a worldwide basis biologics manufacturing intended to clinical studies and commercialization.

“The rapid growth in cell and gene therapy products is driving the need for large batches of plasmid DNA,” said Lieven Janssens, executive vice president, Kaneka Eurogentec. “Our existing pharma and biotech customers have already expressed the need for kilo-scale manufacturing capabilities and we have developed equipment and methods to respond to these needs with the new facility.”

Ingrid Dheur, vice president biologics, Kaneka Eurogentec, said, “Complex protein structures such as new antibody formats are generating rapid growth in the use of Pichia pastoris for these types of biologics; the new facility will also be equipped for large scale production using such yeast expression systems.”

Construction is expected to start in fall of 2017. The state-of-the-art facility will be equipped for the production and purification of new biomedicines using cost-effective and safe microbial strains and will include the installation of a 2200 L fermenter, harvest and purification equipment for all expression strategies. Additionally, the expansion will result in the hiring of 40 full time scientific staff trained in the production of GMP therapeutic products.

Ardena Launches Following Pharmavize and Crystallics Merger

A new early-phase contract development and manufacturing organization (CDMO), Ardena, has launched following the merging of Pharmavize and Crystallics.

The two companies came together in 2016 with backing from investor Mentha Capital. The new brand name, Ardena, reveals the increased service offering and complementary capabilities of Pharmavize in Belgium and Crystallics in the Netherlands.

The new company will deliver integrated services that include a.o. solid-state chemistry, analytical and formulation development, and early-phase clinical supply manufacturing.

With a team of 85 employees, the new Belgium-headquartered company is supporting customers across the globe in reaching important milestones.

“We made the decision to combine the specialist capabilities of both Pharmavize and Crystallics last year so that we would be better placed to help our customers navigate the hurdles and pitfalls of early phase drug development,” said Harry Christiaens, chief executive officer, Ardena. “The launch of Ardena as a new brand is the next step in this journey and solidifies our collaboration; we are now one company, operating under one name. Looking to the future, we plan to continue this ‘buy and build’ strategy to further strengthen our service offering to customers. New acquisitions will follow soon.”

With facilities in Ghent, Belgium and Amsterdam, the Netherlands, Ardena has particular expertise in bioavailability enhancement and modified drug release and takes a dossier-centric approach to drug development.

“Drug developers need clinical materials on time in order to generate valuable clinical data and reach their next milestone, yet many face formulation challenges or lack the in-house infrastructure or regulatory knowledge required,” said Mr. Christiaens. “Quite simply, our focus is to create strong formulations and regulatory-compliant drug products for clients planning early phase clinical trials.

“With product and dossier developed together, quality and regulatory compliance can be ensured from the start of a project. With drug developers under increasing time and cost pressures, this helps to streamline the drug’s progress to clinic and eventually to commercial production.”

MilliporeSigma Expands Celonic's Capabilities

MilliporeSigma announced that Celonic AG, a Swiss contract development and manufacturing organization (CDMO), is upgrading its manufacturing facility with five of MilliporeSigma's Mobius single-use bioreactors.

Celonic, which produces biosimilars and also offers a cell line development platform, will add 50-, 200- and 2,000-liter bioreactors to its development and manufacturing facility in Basel, Switzerland. The upgrade will expand Celonic's upstream capabilities, improving flexibility and scalability.

"Our extensive portfolio of single-use technologies allows us to support CDMO customers like Celonic as they adopt new technologies and expand their capabilities," said Andrew Bulpin, Head of Process Solutions, MilliporeSigma. "Our new Mobius single-use bioreactors will help Celonic streamline its processes and expand its capacity to better serve clients."

"For our biotech customers, each step towards market authorization boosts the valuation of their assets, and that's where Celonic's breadth of services has been instrumental in creating tremendous value for our partners," said Konstantin Matentzoglu, CEO, Celonic. "MilliporeSigma's Mobius single-use bioreactors offer a flexible, scalable system that addresses our needs and those of our clients. With the addition of the 2,000-liter bioreactor, we are moving a step closer to our objective of serving customers with commercial manufacturing needs."

Single-use, disposable equipment and systems have increased in popularity in the biopharmaceutical industry, as they offer many advantages over conventional stainless steel systems, such as improved batch success rates, less cross-contamination risk, decreased water and waste water requirements, shortened project duration and reduced project costs.

At the same time, biopharmaceutical manufacturers are moving toward end-to-end solutions—from process development and scale-up through to manufacturing for pre-clinical, clinical and commercial supply—as they seek to cut costs while increasing quality and efficiency.

MilliporeSigma's portfolio of 3- to 2,000- liter Mobius single-use bioreactors delivers greater flexibility and continuity for scale-up, reducing the need for retraining operators. These are some of the multiple reasons that CDMOs such as Celonic have become early adopters of MilliporeSigma's technologies.

MilliporeSigma is a premier supplier of process development and clinical-stage manufacturing solutions, materials and services needed for the production of biopharmaceutical drugs. The company is committed to delivering superior bioreactor technology to manufacturers, several of which are already collaborating with the company in that space in North America, Europe and Asia.

The life science business of Merck KGaA, Darmstadt, Germany, which operates as MilliporeSigma in the U.S. and Canada, has 20,000 employees and 65 manufacturing sites worldwide, with a portfolio of more than 300,000 products enabling scientific discovery.

Nemera Receives Authorization for Neuenburg Plant

Nemera received pharmaceutical drug manufacturing authorization from the German Government Drug Administration in accordance with German Drug and Medicinal Product law, at its Neuenburg manufacturing facility in Germany

The certification gives the manufacturing plant the approval to handle, assemble, sterilize and store pharmaceutical drugs and medicinal products for auto injectors.

This approval reflects Nemera’s commitment to quality in developing and manufacturing drug delivery devices.

Marc Haeml, CEO at Nemera, said: “There is no limit to Nemera’s ambition to serve patients. We already market devices in more than 40 countries for millions of users. We will keep investing in new products and in state-of-the-art manufacturing equipment, to help even more patients with high quality devices all over the world.”

The pharmaceutical drug manufacturing certification is a required regulatory step to allow Nemera to provide a complete set of services and additional support for the development and manufacturing of pharmaceutical combination products and drug delivery devices to its customers.

Neunburg plant produces billions of injection molded parts and assembled devices every year.

Nemera's Neuenburg plant quality management key achievements are:

short reaction times
detailed and comprehensive root cause analysis
elimination of quality problems
reduction of scrap rates

Elimination of inefficiencies.Christian Meusinger, Quality VP of Nemera, said: “Achieving this pharmaceutical drug manufacturing approval is highlighting our commitment to ensure the safety of our drug delivery devices for the benefit of patients. It is also the confirmation that our quality systems and processes are meeting consistently regulatory requirements and patient expectations."

ADC Biotechnology Plans Commercial Biomanufacturing Plant

ADC Biotechnology has announced it will spend $11m ($9.2m) build a bio-conjugation facility at a site in Deeside, North Wales.

The facility – which is due to be operational in 2018 – will produce antibody-drug conjugates (ADC) for clinical trials and small scale commercial batches. It will also house R&D technical services and quality control laboratories, warehousing and capacity for process development.

Funding for the plant will be provided by Maven VCTs, Seneca and Finance Wales. The Welsh Assembly Government is also providing ADC with a grant.

The investment marks the Wales-based contractor’s move into clinical and commercial production. Previously, its manufacturing focus has been on the production of ADCs for R&D and preclinical development.

ADC’s core technology is its “lock-release” platform. It works by covalently ‘locking’ an antibody to solid polymer beads, prior to conjugation, releasing them as a clean drug substance.

ADC claims its technology is used by 20 customers, including several major pharmaceutical firms.

CEO Charlie Johnson said: “We already have confirmation that many of our existing customers will use the facility for clinical development.

“We anticipate adding a number of the new targets entering clinical development from customers in the USA and Europe - especially in light of the added value we can provide through Lock-Release” he added.

Milliporesigma Opens Chinese Bioprocessing Centre

MilliporeSigma has opened a biopharma process development and technology center in China.

The site in Shanghai, China will offer biopharma customers access to MilliporeSigma’s range of end-to-end process development capabilities and services, including cell line development, upstream and downstream process development and non-GMP clinical production.

The center will be operated under the Bioreliance brand, added to Germany’s Merck through its acquisition of Sigma-Aldrich in 2015, and is the first such center to open its doors outside of Europe.

“Our new BioReliance End-to-End Biodevelopment Center will host small-scale drug manufacturers working on early-phase clinical trials,” MilliporeSigma CEO Udit Batra said in a statement.

It is designed to target customers in the APAC region through an integrated suite of services for biopharmaceutical helping to accelerate clinical drug development from molecule to commercial production.

The center is modelled on the firm’s site in Martillac, France which offers a single-use, GMP facility for manufacturing clinical-stage batches and is equipped with MilliporeSigma technologies, including the 2000-liter single-use Mobius bioreactor.

The firm has also planned a 280,000 sq. ft. facility in Burlington, Massachusetts.

ALS Opens Coatbridge Laboratory in Scotland

ALS Environmental has opened an analytical laboratory in Coatbridge, Scotland. The new laboratory will be able to process microbiology samples under the ALS Environmental accreditation number 1314.

The site has been visited by UKAS and ALS is in the process of completing its mandatory close-out actions prior to undertaking any analytical services from this new laboratory.

The laboratory in Coatbridge has been designed and commissioned following the acquisition of ALcontrol in November 2016.

The laboratory has been designed to process over 300 microbiology samples a day and will be supported for chemistry analysis by ALS Coventry for Waste Water testing and ALS Wakefield for Drinking Water chemistry and Cryptosporidium.

SCHOTT Expands in China

SCHOTT, a technology-based group of glass manufacturers and developers, has opened a new packaging production plant in China that will produce upwards of 2 billion pieces of pharmaceutical packaging per year. The new site allows the company to more effectively provide Chinese pharmaceutical manufacturers with packaging products.

The plant is located at the SCHOTT Xinkang headquarters in Jinyun, Zhejiang, and will manufacture ampoules, vials and cartridges made of premium glass tubing for the domestic pharma industry.

The new production facility adds to the company’s global network of manufacturing sites in 13 countries. This year, the group also invested in its plants in Müllheim (Germany), Lebanon (U.S.) and St. Gallen (Switzerland), among others.

Novasep to Expand Cryogenic Production Capacity

Novasep is investing €4 million to expand cGMP capacity for clinical and commercial supply of APIs at its Chasse-sur-Rhône (FR) facility.

The investment includes the installation of a new cGMP cryogenic production line, capable of operating at temperatures as low as -80°C. It is equipped with a 4m3 Hastelloy reactor, filter drier and cleanroom.

The investment also includes an expansion of the cGMP pilot-plant capabilities with the addition of a new stream comprising a 400L Hastelloy reactor, filter drier and cleanroom. This will add flexible small-scale manufacturing capacity and enhance the site's capability to handle both clinical development needs and low volume APIs.

The expansion will bring Novasep's total low temperature capacity to more than 35m3 and is expected to be operational in early 2018.

"By increasing cryogenics capacity at the current Chasse-sur-Rhône facility, we strengthen Novasep's small and large-scale volume offering for low temperature manufacturing." Jean-Pierre Pilleux, General Manager of the Chasse-sur-Rhône site said, "It will give us more flexibility and allow us to address the increasing market demand for these types of capabilities."

Vetter Breaks Ground for New Ravensburg Building

Vetter began construction of a new administration building at its Ravensburg Schuetzenstrasse site, which is scheduled to be completed by mid-2019. The new building is part of an ongoing investment strategy to further develop Vetter sites and make additional manufacturing capacities available.

Following completion, the new building will have a useable area of 269,000 sq.-ft. with flexible usability. The office concept is designed to continue the avoidance of interfaces between administrative processes by arranging working spaces in a process-oriented manner. This approach aims to enable project-related and interdisciplinary project teams to work together on common tasks in close proximity. In addition, cooperation between elements of the administrative departments as well as the development and manufacturing sites, also located at the Schuetzenstrasse site, will be simplified.

“As managing directors of Vetter, we are thrilled to be in the position to help create an additional part of Vetter’s future today. This new office building represents yet another milestone in our strategy for growth,” said Thomas Otto, managing director, Vetter.

Recipharm Equips Lisbon Facility for US and European Serialization

Recipharm, a leading contract development and manufacturing organization (CDMO) has equipped its sixth facility with serialization capabilities ahead of the US and European regulation enforcement deadlines

Recipharm’s facility in Lisbon is the latest one to be prepared to start supplying serialized products to the US and Europe, following a €40 million investment into its company-wide implementation program in 2016.

Recipharm has already delivered more than 1.3 million serialized and aggregated packs to markets such as, China, South Korea, Saudi Arabia and Turkey, where serialization regulations are currently in place.

The Lisbon site is the sixth to become serialization ready for the US and European markets and adds an additional four packaging lines to the company’s current serialization capabilities.

This will be followed by a further seven lines at the facility by Q2 in 2018.

Staffan Widengren, Director of Corporate Projects at Recipharm and head of the Global Steering Committee for Recipharm’s serialization project, said: “Recipharm recognized the complexity of implementing serialization at a very early stage and so we have been preparing for the new regulations in the US and Europe for a long time now. The Lisbon facility brings us to more than a third of the way through our implementation project and is an important milestone in our journey.”

“We introduced our serialization program to ensure a consistent roll-out of our standard solution, without the implementation process having a significant impact on production activities. It is important our solution works at a local level, as well as company-wide, and the central team that heads up the programme is tasked with making this happen.”

“Effective serialization capabilities can eventually help companies to improve their overall equipment effectiveness and streamline their operations. The program also helps us to ensure that serialization data integrates with our enterprise resource planning activity and our manufacturing execution systems so that we can achieve wider business benefits beyond compliance.”

The central team is responsible for identifying, purchasing, installing and qualifying serialization systems in line with customer requirements. The next site to be equipped will be the company’s facility in Brescia, Italy, which will supply serialized product to the US.

Recipharm’s serialization program was recently recognized in the TRACKTS Awards 2017 as an example of best practice for its execution of a track and trace system at the Lisbon facility following a detailed assessment of the project’s methodology, use of technology and innovation.

Eurofins Investment in New Scottish Facility

Eurofins Scientific, a specialist in bioanalytical testing, has opened a new pharmaceutical chemistry and microbiology facility in Livingston, Scotland, following a £4 million investment.

The 62,430 sq. ft. (5800 m2) facility will become one of the largest dedicated testing sites of its kind in the UK and the biopharmaceutical product testing (BPT) UK business, plans to double employee numbers in the next five years.

The new facility will allow the BPT business to expand its finished product and raw materials testing, and increase capacity to deal with higher volumes.

A greater number of technical specialists will also be available to work on method development and validation.

GMP microbiology contract testing will be a focus, alongside elemental impurity testing, which has benefited from the purchase of new equipment to enhance the capability of inductively coupled plasma mass spectrometry (ICP-MS) testing, enabling the company to meet growing demand for this service.

Eurofins will also invest in more high-performance liquid chromatography equipment, increasing its capacity by 40%.

Alison Clayton, General Manager, said the Livingston site would be one of the largest of all the Eurofins UK sites, which form part of a network of laboratories working together across the UK, Ireland and Europe.

“The large investment in the facility will position the company in the best place to attract new customers thanks to greatly increased capacity and is in line with Eurofins’ intent to attract significant future growth and development opportunities,” she said.

Eurofins BPT UK business will move from its current site in Newbridge, Edinburgh. The Livingston facility will also house new laboratories for Eurofins’ water testing business.

The investment follows Eurofins’ acquisition of Exova’s pharmaceutical, food and water testing business in the UK and Ireland in July 2016, and the subsequent purchase of ILS’s pharmaceutical business in October 2016.

Eurofins BPT UK’s work is critical to drug development compliance testing prior to products being released to market. The company is a crucial part of the supply chain in facilitating the release of products and ultimately benefiting patient health.

The business is part of Eurofins Scientific, an international life sciences company, which provides a unique range of analytical testing services to clients across multiple industries worldwide.

Sterling Steps-Up Solid Form Services with UK Facility

Sterling Pharma Solutions has announced a £6m ($8m) investment in solid form capabilities at its Dudley, UK-based site.

The contract development and manufacturing organization (CDMO) said the facility – located at its 40-acre site in North East England – will boost its milling and micronization capabilities.

As part of the investment Sterling will set up four milling areas, where it will reduce drug particle size with mechanical and spiral jet milling technologies, and small-scale trial mills.

It will also add polymorph screening, salt selection, particle engineering and crystallization scale-up capabilities to improve its drug development services, as well as occupational exposure band (OEB) 4 classified molecule capabilities and International Standards Organization (ISO) 9 cleanrooms.

CEO Kevin Cook said the facility responds to increased demand for active pharmaceutical ingredient (API) particle size control.

“This latest investment is an important step in bolstering our offering so we can cater for growing market demand, including the need for high potency capabilities to reflect the global drug pipeline,” he said.

The firm said it expects the facility to open by mid-2018, and create more than 15 jobs.

C2 Pharma Gains CEP Approval and Invests In Manufacturing

C2 Pharma (formerly Centroflora CMS) is announcing major expansions of its service offering.

C2 Pharma is a Luxembourg-based pharmaceutical group which manufactures and distributes its active pharmaceutical ingredients (API) and complex chemical compounds from phytochemical and chemical origins.

C2 Pharma has recently received from EDQM the Certificate of Suitability (CEP) for the production of atropine sulfate at its CMO, Laurus Labs, one of the best known API manufacturers in India.

The approval was received within 12 months. The US-DMF for atropine sulfate has been available since January 2017. For homatropine methylbromide, CEP approval is expected by year-end and the US-DMF has been available since May 2017. Samples and a full set of reference standards for both atropine sulfate and homatropine methylbromide are available upon request.

C2 Pharma has invested in a state-of-the art, dedicated production facility for the manufacturing of digoxin at the Laurus Labs site in Vizag. Laurus Labs will run the facility and C2 Pharma will market the API.

The total investment from both parties exceeds $5 million, and the facility, which covers an area of more than 19,375 sq. ft. (1800 m2), will have an annual production output of more than 1000 kg, well in excess of the global demand for digoxin. The building was erected in May 2017 and the manufacturing equipment has been installed. Equipment qualification and validation is currently under way and should be wrapped up by the end of Q4, 2017.

Andrew Badrot, CEO of C2 Pharma, said: “This investment marks a major development in our global API offering and underline our uncompromising approach to product quality and reliability.”

STA to Open Catalyst Screening Center in China

STA Pharmaceutical Co is setting up a metal catalyst-screening center at its facility in Changzhou, China.

The firm – a subsidiary of WuXi AppTec – said the center would support screening activities for metal catalysts, ligands, bases, acids, chemical resolving reagents and amide formation coupling reagents.

STA said the center would open next month adding that staff in training at its facility in Shanghai will relocate to Changzhou when the facility is up and running.

News of the new center comes just months after WuXi merged STA’s active pharmaceutical ingredient (API) business with its development services operation.

Earlier this year STA said it would employ a staff of 300 people at the Changzhou site, including 230 process chemists and 70 analytical chemists.

Avara Buys French Site

AstraZeneca said the sale of the northern France-based facility coincided with patent losses for some of its high-volume brands – such as cholesterol drug Crestor (rosuvastatin calcium) – meaning the firm will under-utilized some of its manufacturing capacity.

In addition, the company said it is increasing its focus on developing specialized medicines, with lower volumes than traditional drugs.

“Specifically for the site in Reims, AstraZeneca Operations has been working with a specialist company since July 2016 to find divestment opportunities to credible buyers who can offer a sustainable future for the site, with a priority on maintaining employment,” the company said.

AstraZeneca said it has signed a multi-year, multi-product agreement with Avara Pharmaceutical Services for packing and distribution services.

“Avara will continue to provide packing and distribution services for the products which are currently packed and distributed at the Reims site,” said AstraZeneca.

Further, the majority of AstraZeneca’s Reims-based employees will be transferred to Avara, with a small number opting for voluntary leave.

The Reims facility houses secondary solid dose form manufacturing (including granulation, blending, coating, compression and drying), packaging and distribution capabilities.

AstraZeneca makes packed products in bulk, including Crestor, Atacand, Inderal, Zestril and Tenormin, in the 23,690 sq. ft. (2,200m²) manufacturing space.

The firm told us the facility’s research and development (R&D) area covers 15,069 sq. ft. (1,400m²), and its packaging center – which houses seven automated packing lines - covers 20,451 sq. ft. (1,900m²), and can process 1.5 bn oral solid dose tablets.

The site’s distribution center includes cold chain storage, can house 4,900 pallets, and supplies all AstraZeneca products in France, North Africa and French Western Africa.

Batavia Adding 50 Jobs in US Viral Vector and EU Cleanroom Expansion

Batavia Biosciences will expand a Dutch production facility and build a viral vector plant in the US to cater for demand for its bioprocessing services.

Batavia Biosciences did not divulge the size of the investment but said the expansions were driven by an increase in general demand for its range of bioprocessing services.

He added the expansions will increase headcount by 50 across the two sites.

Franssen said Batavia “is continuously attracting new projects and customers” due to its experience in viral vector projects and the growing interest in such products across the biopharma space.

“With the popularity of adenovirus, lentivirus, and AAV for vector vaccines and gene therapy products the demand for Batavia Biosciences’ viral vector work is rapidly increasing.”

Among the projects the firm is involved in is an attempt to produce an affordable rotavirus vaccine through an $8m grant from the Bill and Melinda Gates Foundation.

Pfizer Expands Japan Contracting Offering

Pfizer has expanded its contract manufacturing offering in Japan, adding capacity to make highly potent solid dosage forms at its facility in Nagoya.

The US firm announced the manufacturing expansion, adding it has also set up inspection, packaging and testing capacity for both oral solid dosage forms and sterile injectable drugs at the site.

The investment – financial terms of which were not disclosed – is part of an effort to attract drug developers interested in the Japanese market according to Pfizer.

A spokeswoman said, “Japan is the second largest individual pharmaceutical market and many of Pfizer CentreOne’s biopharmaceutical partners are looking to expand into this important market."

“However,” she continued “the Japanese pharmaceutical marketplace is like no other” adding the country’s exacting quality and aesthetic standards, pharmacy expectations make it a challenge for manufacturers.

She cited Japan’s ease of use requirements as an example, explaining that to be compliant “the package design itself, not just the label, should help the patient know when and how to take the drug.”

She added that: “Japan presents a great growth opportunity for small, mid-sized and large biopharmaceutical companies if they can overcome the obstacles for entering the market.”

While the Nagoya expansion is focused on helping drug firms tap the Japanese market, the facility will also make drugs for other countries.

The Pfizer spokeswoman stated, “Pfizer Nagoya supports the local Japan market but also exports products to Asia Pacific markets. Nagoya has been inspected by MHLW, PMDA, US FDA, EMA, Korean FDA, ANVISA and AIFA.”

Promethera Biosciences, Shibuya Collaborate on Cell Therapy Manufacturing

Promethera Biosciences and Shibuya announced a strategic collaboration to establish a high-throughput, commercial-scale and clinical-grade cell therapy and regenerative medicine manufacturing platform.

For Promethera, the collaboration will act as a cornerstone to optimize and expand the manufacturing capabilities for its current and future portfolio of liver-derived cell therapies to treat Non-Alcoholic Steatohepatitis (NASH), acute-on-chronic liver-failure (ACLF) and other indications.

For Shibuya, the deal represents a significant step towards bringing the company’s expertise to the European market and becoming a global leader in the manufacturing of regenerative medicine products. Both parties will combine their capabilities and expertise to establish a first-in-class manufacturing facility starting at Promethera’s new premises in Gosselies, Belgium. Financial terms of the agreement were not disclosed.

“Japan in particular is leading the charge when it comes to making the cell therapy revolution a reality. It is widely accepted that commercial manufacturing in the cell therapy space represents a key hurdle to overcome in this regard. We therefore welcome the opportunity to conquer this challenge together with our partners from Shibuya Corporation,” said Dr. John Tchelingerian, CEO of Promethera Biosciences. “Once successfully established, starting in Europe, the joint production platform will significantly increase our and our partners’ manufacturing capabilities in the cell therapy space reinforcing our claim to offer treatment to potentially thousands of patients from one donated liver.”

Shibuya has manufactured and installed a variety of aseptic systems and equipment for hospitals and universities which includes cell culture isolators, robotic cell culture isolators and 3D bio printers. All systems are suited for very high level disinfection processes and operate without direct human intervention. This allows Shibuya to achieve unprecedented control over cell processing and culture conditions to ensure highest product quality and safety standards.

Janssen Expands Ringaskiddy Facility

Janssen Science Ireland will invest €300m to expand its biologics plant in Ringaskiddy, county Cork.

Janssen will build a new 1,291,669 sq. ft. (19,100m2) manufacturing building, expand existing warehouses and offices and modify site infrastructure. The Johnson & Johnson (J&J) unit also said it will expand the facility’s water treatment plant to cope with increased production activities.

The project, which is scheduled to take around two years, will create 200 jobs when completed.

The Ringaskiddy site was opened in 2005 as a hub for the production of biopharmaceuticals for treatments for immune diseases and cancer. According to Janssen, three commercial products and various clinical candidates are made at the plant.

Abbvie Opens Biologics Plant in Singapore

AbbVie has opened a mammalian cell culture-based drug manufacturing facility equipped with both stainless and single-use equipment, as part of a $320m investment in Singapore.

The $320m (€274m) investment announced in 2014 marked AbbVie’s first manufacturing venture in Asia. And just over a year on from the opening of a small molecule API plant at the 1,291,669 sq. ft. (120,000m2) site in Tuas, Singapore, the firm has opened its biologics manufacturing facility.

“We indicated expectations to be operational by 2018,” AbbVie’s director at the Singapore site said Marc O'Donoghue. “The opening this week is on schedule with validations ongoing.”

He added the mammalian cell culture facility will be used for both clinical and commercial supply and has a mix of single use and stainless steel equipment.

Between the small and large molecule plants, AbbVie will employ 250 staff in Singapore to support its global immunology and oncology products.

With a small and large molecule production facility now open, there is scope to make antibody-drug conjugates (ADC) in Singapore, something discussed when the ground was broken at the site.

According to AbbVie: “Our strength in discovering and developing highly specific monoclonal antibodies and our experience in small molecule chemistry and analytics make ADCs a strong focus area of development for AbbVie.”

AbbVie has a partnership with Seattle Genetics, for access to its pyrrolobenzodiazepine (PBD) dimer ADC technology and EC-mAb site-specific conjugation technology, and last year added a stem-cell based ADC to its pipeline through the $5.8bn acquisition of Stemcentrix.

Xellia Starts Construction on Copenhagen Sterile Drug Plant

Xellia Pharmaceutical ApS has started constructing a sterile manufacturing building at its plant in Copenhagen, Denmark.

The building – which cost $25m (€21m) – will increase production capacity for both active pharmaceutical ingredients (APIs) and finished dose anti-infective pharmaceuticals like vancomycin and colistimethate sodium.

In August, Xellia completed the expansion of its API and drug product testing facility in Budapest, Hungary.

The firm is also expanding its US sterile injectables with a production facility in Cleveland, Ohio, which is scheduled to open next year. The facility will complement an existing plant in Raleigh, North Carolina.

Xellia Opens API Testing Site

Xellia Pharmaceuticals has completed the expansion of its anti-infective API and drug product testing facility in Budapest, Hungary.

The firm paid $13m (€11m) for the 32, 292 sq. ft. (3,000m²) Centralized Laboratory Services expansion, which is comprised of microbiology and chemical analytical laboratories, and a product stability center, and administrative offices.

The firm said the site will test active pharmaceutical ingredient (APIs) and finished dosage form (FDF) products, such as including vancomycin, colistimethate sodium and daptomycin.

CEO Carl-Åke Carlsson said the facility – located next to a Xellia API plant – is a critical component of servicing increased demand for the firm’s anti-infective products.

“Xellia has experienced significant growth in the past couple of years and expects this to continue over the next five year period,” he said.

Hungarian history

According to Carlsson, the Copenhagen, Denmark-headquartered firm has a long history of operating in Budapest.

“Over the past years we have invested in increased manufacturing capacity and a new fermentation pilot facility in Budapest. Hungary has strong roots in pharmaceutical operations and offers competitive conditions for establishing such a central laboratory service,” he said.

The expansion has resulted in the creation of more than 40 new roles, which Xellia aims to increase to 80 by 2019.

Carlsson added, Xellia, which develops, manufactures and supplies fermented and semi-synthetic APIs and FDFs to the pharmaceutical industry, is also expanding its injectables capacity.

“The company is significantly expanding its sterile injectable manufacturing capacity in the US with the Cleveland facility becoming operational during 2018,” Carlsson said.

Capella Biomedical Research Laboratory, Cambridge Biomedical Campus

Construction of a new laboratory building known as Project Capella was initiated at the Cambridge Biomedical Campus in February 2016.

Located next to the Cancer Research UK building near Addenbrookes hospital, the new facility will allow collaborations between scientists and clinicians to further advance the application of stem cell discoveries into the patient setting.

The University of Cambridge was granted planning permission for the Capella building in February 2016. The project is expected to be completed with an estimated investment of £79m ($112.48m) by Q2, 2018.

The Capella research facility will be a six-story building with a total floor space of

193,750 sq. ft. (18,000m²). The exterior will feature a two-story glazed box with gold metal detail and double-height entrance foyer. The spine of the building will be clad with flat-faced graphite panels.

The building will include a green screen to enhance the public area surrounding the development. It also will feature a bespoke timber frame structure with green roof, which will provide 324 cycle spaces on site.

The facility will include sophisticated laboratory spaces, offices, cafés, seminar rooms, exhibition spaces, and meeting suites to accommodate a variety of biomedical research groups.

It will also accommodate the Cambridge Institute for Immunotherapeutics and Infectious Disease, the Milner Therapeutics Institute, and Cambridge Stem Cell Institute. It aims to advance a center of excellence and initiate a foundation for the development of new medical treatments.

The facility will also include robotics suites for customized drug screening and gene editing, as well as bioinformatics support.

Construction of the Capella biomedical laboratory began in February 2016. The facility is being constructed using building information modelling (BIM) techniques. More than 80% of the frame and façade was built off-site as precast modules comprise precast columns, edge beams, and precast floor slabs with structural toppings. The topping out ceremony was held in April 2017.

Installation of mechanical services inside the building commenced after installing 6m pre-fabricated modules on the ground floor and fan coil units from ground to third floor in January 2017.

Installation of all external cladding panels and gold box glazing was completed in March 2107.

The designs for the Capella biomedical research laboratory were provided by Fairhurst Design Group (FDG).

The building construction contract was awarded to Kier Construction, which is being assisted by a team of consultants including Arup (consulting engineer), Arcadis (project manager), and Aecom (cost consultant).

PCE was selected as offsite superstructure construction partner, which provides hybrid precast columns with a combination of precast concrete edge beams and structural steel delta beam spine beams.

Alcrete Building Systems was appointed by PCE to provide design, manufacture, deliver, and install more than 100 precast units.

The building is being constructed with the aim of achieving Building Research Establishment Environmental Assessment Method (BREEAM) excellent rating.

Navesta Pharmaceuticals' Plant, Sri Lanka

Sri Lanka-based company Navesta Pharmaceuticals has opened a sterile manufacturing facility in the town of Horana in August 2017.

Construction began in October 2015, and the plant is said to be the first of its kind in Sri Lanka. The facility is intended to produce sterile dry powder injectables of beta lactam antibiotics, which were previously imported to the country.

Built with an investment of more than LKR1.4bn ($9.1m), the Horana facility has generated more than 100 direct and 500 indirect jobs for locals in areas including bio-chemistry, pharmaceutical sciences, molecular bio-science, drugs, engineering, and ancillary services.

The factory will allow Navesta to export its pharmaceutical products to markets globally, contributing to the country's economic development. It will also support the Government of Sri Lanka's aim to achieve self-sufficiency in the pharmaceutical industry by 2020.

Located in the Kalutara district, Navesta's new factory has a total floor area of 40,000ft².

The plant is designed to comply with good manufacturing practice (GMP) standards set by the EU and the Pharmaceutical Inspection Cooperation Scheme (PIC/S).

An advanced building management system (BMS) at the facility ensures compliance with the EU-GMP and PIC/S standards. It is used to control humidity, temperature, and differential pressure at production and testing rooms to destroy all viable microorganisms.

The interior of the factory features cleanroom panels built with pre-coated galvanized iron to provide protection from external contaminants.

The facility is also fitted with environmentally sustainable features including energy efficient lighting and comprehensive waste water treatment systems.

The sterile pharmaceutical manufacturing factory is installed with 13 incubator chambers and two walk-in incubators, which are designed in compliance with 21 Code of Federal Regulations (CFR).

The plant also incorporates a Grade A and Grade B microbiology laboratory, which helps develop comprehensive advanced in-house testing methods.

The testing and measuring equipment installed in the facility are calibrated as per accreditation standard ISO 17025 and ISO 9001 to achieve valid results.

Navesta's Horana sterile pharmaceutical manufacturing facility will initially produce 50 million vials a year for filling sterile dry powder injectables of Beta Lactam.

Pharmaceutical products to be produced at the factory will primarily serve the requirement of 12 penicillin-based beta-lactam antibiotics in the form of dry powder for the local market. They will also be exported to global markets, which accept EU-GMP and PIC/S accreditations.

The plant is planned to be expanded in future to further increase Navesta's production capacity by three times in the coming years. If undertaken, the expansion will provide approximately $500m of savings to the country, which currently imports $800m-worth pharmaceutical products a year.

Headquartered in Rajagiriya, Navesta Pharmaceuticals is engaged in manufacturing beta lactam antibiotics.

The company's products include Ticarcillin-clavulanic, Piperacillin-tazobactam, Co-amoxiclav, Flucloxacillin, Cloxacillin, Ampicillin, Benzathine penicillin, Fortified Procaine Penicillin, and Benzylpenicillin.

Central Institute for Translational Cancer Research (TranslaTUM), Technical University of Munich, Germany

The Central Institute for Translational Cancer Research (TranslaTUM) is a new interdisciplinary research building officially inaugurated at the Technical University of Munich in September 2017.

The building was developed by Free Federal State of Bavaria with the support of the German Federal Ministry of Education and Research.

Developed at a cost of €60m ($71.64m), the research facility received a €24m ($28.65m) contribution from the federal Government of Germany.

The six-story, S-shaped TranslaTUM research building has a total floor space of 60,278 sq. ft. (5,600m²). It features an entrance hall with an open and curving staircase.

The facade of the building is arranged horizontally with a number of long, thin windows. It also includes white, grooved ceramic plates, which highlight the wave-shaped structure.

Public areas include a cafeteria, a seminar area, and an auditorium.

The building features 43,056 sq. ft. (4,000m²) research labs, which can accommodate up to 230 researchers.

Designed to carry out research in translational oncology, the facility is constructed adjacent to the Technical University of Munich's (TUM) hospital Klinikum rechts der Isar to support rapid translation of novel knowledge and technology into patient care. It provides physicists, engineers, and physicians with a shared new laboratory for transdisciplinary research.

The facility's staff will focus on tumor diseases of bone marrow and the digestive tract, exploring the process of recognizing and sending molecular signals in tumor cells. They will also study the impact of cancer cells on the immune system with the help of new imaging and analysis methods.

The facility will allow collaboration among different disciplines including biology, biomedicine, biochemistry, physics, engineering sciences, and the doctors in clinics.

The facility includes a 7,535 sq. ft. (700m²) seminar and conference area and an underground garage with 50 parking spaces.

The TranslaTUM research building has core facilities including imaging, preclinical research, and cell analysis. It also features state-of-the-art laboratory equipment in core facilities including a central sequencing unit, a microscopy unit, a histology lab, and a central bioinformatics unit.

The facility is equipped to offer a broad variety of imaging studies using established and validated methods such as good manufacturing practice (GMP) produced radiopharmaceuticals. The imaging infrastructure at the facility includes magnetic resonance (MR), multi-spectral optoacoustic tomography (MSOT), ultrasound (US), positron emission tomography (PET), single-photon emission computed tomography (SPECT), computed tomography (CT), and phase contrast-CT technology.

The laboratory at the facility is in compliance with S2-biolevel safety standards. A 7,535 sq. ft. (700m²) area is meant for animal holding, where mice and rats can be retained in sealed rooms.

Animal holding areas comply with animal welfare and hygiene standards, and are equipped with high-efficiency particulate absolute (HEPA) and odor filters to stop the spread of incoming or outgoing particles.

Construction of the new research building began in 2014 and the first floor of the building was completed in July 2015. The topping out ceremony was held in November 2015.

doranth post architekten was awarded a contract to provide designs for laboratories, offices, the seminar area, the cafeteria and underground parking in the research building.

Merck to Replace Filling Line at Bari Facility

Merck KGaA will install a new aseptic filling line at its facility in Bari, Italy for multiple sclerosis drugs, fertility treatments and growth hormones.

The German drug manufacture announced the plan, explaining it will spend €35m ($41m) to replacing an existing filling line at the facility.

A spokeswoman said, “The new line will replace an existing one, leveraging the latest technological developments while providing an increase in capacity.

She explained the plan “is part of continuous investments in our manufacturing network to maintain state-of-the-art industry level and adapt its capacity to patient needs for our medicines.”

The line will be used to fill Merck’s multiple sclerosis Rebif, its fertility disorder treatments Gonal-f and Ovidrel as well as the growth hormone Saizen. It is due to become operational in 2022.

The Bari facility was established in 1992 as a hub for fill finish activities. Drugs made at the site are shipped to 150 countries.

The new investment is the second in the past five years. In 2014 Merck spent €50m to install a fully automated production line under isolator and set up an automated warehouse at the site.

CordenPharma Invests in Small Molecule API Development Capacity

CordenPharma said it is investing €3.7 million in the manufacturing site infrastructure of its CordenPharma Switzerland facility, located in Liestal, Switzerland. The investment will include an expansion of the square footage dedicated to small molecule, peptide and carbohydrate development services. In addition, an approximately €2 million investment in new automated development and optimization equipment is currently being realized to facilitate development services and an extensive upgrading and expansion of analytical equipment, which has already been made partially available to the development chemists. The expanded lab space will also enable an increase in the overall headcount of development FTE’s available to work on customer projects, which will ultimately increase the capacity of the CordenPharma Switzerland facility in the small molecule, peptide and carbohydrate space.

A further feature of the facility investment is to expand and refurbish the current purification capabilities as well as the construction of a new mini-plant, intended to meet the growing market demands in the g to kg’s range at the scale of 1 – 70 liters. The new design, with movable and interchangeable equipment, will create a highly flexible manufacturing space geared towards meeting our customers’ wide ranging requirements and aggressive timelines.

The total investment will allow CordenPharma Switzerland to run an increasing number of early-phase projects in parallel, to both support its own pipeline development as well as that of other facilities within the integrated CordenPharma network of manufacturing facilities across Europe and the US.

“The expansion at our CordenPharma Switzerland site is part of an ongoing strategic initiative to invest in small molecule API manufacturing across our global network of facilities. The additional development FTE’s will enable us to service our existing and future customers more efficiently,” said Stephen Houldsworth, director, global small molecules and antibiotics platforms, CordenPharma International.

Juerg Burger, managing director, CordenPharma Switzerland, said, “The introduction of this new mini-plant will enable us to run small-scale batches for our customers, while at the same time demonstrating the routes readiness for further scale-up and addressing their material requirements for early-phase clinical stages.”

Cambrex Expands API Capabilities

Cambrex Corporation, a manufacturer of small molecule innovator and generic active pharmaceutical ingredients (APIs), has made a number of investments, in both R&D and manufacturing capabilities to support the development and production of generic APIs, at its site in Paullo, Milan, Italy.

The investments include the installation of development and analytical equipment to support the development of highly potent APIs (HPAPIs), as well as a new 2,800-liter hydrogenator and 1,500mm diameter centrifuge, for increased flexibility and capacity within the manufacturing plant. All equipment will be installed and validated by the end of 2017.

“We have seen increased growth of activity among highly potent molecules in the past decade for use in therapeutics for cancer and other indications, and it is now becoming more appropriate in the generic API business as patents on these begin to expire,” said Aldo Magnini, managing director, Cambrex Milan. “This investment is consistent with the Cambrex strategic plan to increase the company’s small molecule development and manufacturing capabilities, ensuring our facilities continue to meet the future demands of the industry.”

This investment comes after the installation of a new pilot plant at the site in 2017, and recent announcements of expansions across the Cambrex network of manufacturing sites, including the construction of a $24 million, 4,500 sq. ft. highly potent API manufacturing facility at its Charles City, IA site, which is due to open in 2019.

J&J Invests in Manufacturing Capacity in Ireland

Johnson & Johnson’s Janssen Sciences Ireland UC will invest more than EUR 300 million (US$355 million) to expand manufacturing capacity for biologic medicines at its Ireland facility.

On Oct. 5, 2017, Janssen Sciences Ireland UC, a Johnson & Johnson company, announced an expansion of its Ringaskiddy, Co. Cork, facility in Ireland, in which the company will make an investment of more than EUR 300 million (US$355 million). The expansion will add an additional 205,590 sq. ft. (19,100 m2) of manufacturing space for biologic medicines to the already existing manufacturing structure and will allow the company to continue to meet patient needs in the areas of multiple myeloma, rheumatoid arthritis, and Crohns disease.

The company has operated a biopharmaceutical supply-chain facility on its 40-hectare site in Ringaskiddy since 2005. The proposed expansion project includes: construction of a new manufacturing building; expansion of the existing warehouse building, laboratory, and administration buildings; and modification or expansion of other aspects of the existing site and infrastructure, including utilities, car parking, underground services, internal roads, yards, and pipe racks. In addition, the on-site wastewater treatment plant will be expanded to accommodate increased volumes.

Construction is expected to take approximately two years, beginning in October 2017, and will provide employment for up to 450 people during construction and an extra 200 people once completed.

Confirming the expansion announcement on behalf of Janssen, Remo Colarusso, vice-president, Manufacturing and Technical Operations, said in a company press release, “[T]his expansion will increase Janssen’s global manufacturing capacity of biologic medicines, which is in keeping with our Credo commitment to provide the highest quality products to patients. Our Ringaskiddy site is an important part of Janssen’s global manufacturing network and this expansion will allow us to grow in a location that offers an advanced infrastructure, a high-performance culture, and top-level talent.”

FDA and Baxter Work Together to Secure Manufacturing in Puerto Rico

FDA Commissioner Scott Gottlieb released a statement on Oct. 13, 2017 detailing the agency’s work to help prevent a shortage of Baxter’s sodium chloride 0.9% injection bags, which are manufactured in Puerto Rico. Lack of availability of the product, already in short supply prior to the destruction brought by Hurricanes Irma and Maria, could put the health of US citizens at risk, Gottlieb stated.

The company’s plants in Puerto Rico manufacture small-volume parenterals used primarily in drug compounding. Baxter stressed in a press release that large-volume sterile solutions are not produced in Puerto Rico and are, therefore, not impacted. According to Baxter, the company’s three manufacturing sites in Puerto Rico “sustained minimal structural damage” and limited production activities had resumed as of October 12. The company is using diesel generators to power its facilities and using satellites to restore communications.

In preparation for the hurricanes, Baxter had moved some finished product off of the island. After the hurricanes, it has been working with FDA and states it has been “granted regulatory discretion for temporary special importation of certain products from Baxter facilities in Ireland and Australia to help support product supply for the US market.” FDA has also helped the company to restore its operations and move product off of the island.

“While these actions will help mitigate some of the projected shortfall in supply, they will not be adequate to fully bridge the gap in the near term. Baxter will continue to do everything it can to ramp up production in Puerto Rico in the weeks ahead and, with the support of special importation granting from FDA, continue to utilize its other facilities to help address product demand in the United States,” the company stated in a press release.

In addition, FDA is helping to secure fuel and manufacturing supplies, and Gottlieb assures the public that the agency will continue to work to secure the drug supply chain. “FDA and Baxter will continue to keep in close consultation as we monitor the challenging situation on the island. The agency is also continuing its work with other manufacturers on steps to prevent or mitigate shortages of other types of critical medical products … FDA is also expediting reviews and approvals of other dosage forms and generic versions of products as alternate sources of critical products. Above all else, we at FDA remain fully committed—for the long run—to the people of Puerto Rico to help them recover from this tragedy,” Gottlieb stated.

Baxter is helping their employees affected by the storms by providing food, gas, and water and setting up a relief fund. “The devastation of Hurricane Maria is heartbreaking and tragic,” said José (Joe) E. Almeida, Baxter chairman and CEO, in the press release. “I met recently with many of our dedicated employees in Puerto Rico, and I am both inspired and humbled by their commitment to our mission, our patients, their communities and each other in the face of the unimaginable damage and loss they’ve experienced. Our mission to save and sustain lives calls on us to give back in times of crisis; Puerto Rico has our support.”

Hitachi Chemical Expands in Japan

Hitachi Chemical is expanding manufacturing and cleanroom capacity at its cell therapy-focused CDMO site in Allendale, New Jersey, US.

The expansion will see Hitachi Chemical Advanced Therapeutics Solutions (HCATS) add 49,700 sq. ft. to its contract development and manufacturing organization’s (CDMO) branch, PCT.

The site will house manufacturing development labs, quality control and microbiology labs, additional Grade B/ISO 7 cleanrooms, warehousing and office space.

Validation for the facility is planned before the end of 2018.

The firm also announced plans to upgrade its Pearl Court site in Allendale, NJ, and said its regenerative cell-focused CDMO site in Yokohama, Japan, which is under construction, will be validated by April, 2018.

Hitachi Chemical Co. America – the US off-shoot of Japan-based Hitachi Chemical – purchased PTC from majority shareholder Caladrius Biosciences earlier this year.

US FDA Approves Production at Samsung Biologics Plant in South Korea

The world’s largest single bioproduction plant has received its first US regulatory approval to make a monoclonal antibody, says CDMO Samsung Biologics.

Samsung Biologics’ second facility at its site in Incheon, South Korea was commissioned in 2013 and received GMP accreditation last year.

The contract development and manufacturing organization (CDMO) announced it has received its first approval at the site for the manufacture of a monoclonal antibody drug substance by the US Food and Drug Administration (FDA).

Samsung Biologics would not provide further details of the drug or the scale of production when asked due to client confidentiality.

The manufacturer has a number of Big Biopharma clients on its books, including Bristol-Myers Squibb for which it makes Yervoy (ipilimumab) which is used to treat late-stage melanoma. The firm also has contracts with Roche and Samsung Bioepis.

Samsung Biologics has a 91% stake in Samsung Bioepis and Benepali – a biosimilar version of Amgen’s Enbrel owned by Samsung Bioepis – was named as the CMO’s ‘main’ product when it launched an IPO in August 2016.

The facility which houses five times more bioreactor capacity than Samsung Biologics’ first facility housing 150,000L in ten stainless steel vessels supplied by Swiss firm Bioengineering AG, plus 2,000L of single-use capacity.

But while the facility is the largest single biomanufacturing facility in the world in terms of bioreactor capacity, it is soon to be topped by a third plant under construction at the site.

The $740m facility is expected to be completed by the end of the year, adding a further 180,000L of capacity. Once operational, Samsung Biologics will offer a total of 362,000L mammalian cell culture capacity.

Sanofi Expanding in France

Sanofi has invested €170m ($201m) in a facility in France to expand supply of its quadrivalent influenza vaccine, VaxigripTetra.

The investment has been made to increase supply of Sanofi Pasteur’s VaxigripTetra, an influenza vaccine containing two A strains (A/H1N1 and A/H3N2) and two B strains (B/Victoria and B/Yamagata).

“Influenza continues be a major public health problem around the world, causing serious complications, hospitalizations and deaths, mostly for certain high-risk individuals,” Sanofi Pasteru head David Loew said in a statement.

He added the “expansion reinforces Sanofi Pasteur's ability to tackle this underestimated health challenge.”

The dedicated facility is expected to commence operations in 2021 and will supply up to 70 countries.

Spokeswoman Laurence Bollack said the plant will replace an existing facility at the site, with 335 jobs transferred over.

The site in Val de Reuil, about 100km northwest of Paris, manufactures a number of antigens for Sanofi-Pasteur’s vaccine portfolio, including meningococcal meningitis, yellow fever, mumps, influenza, hepatitis B, poliomyelitis, rabies.

The investment comes weeks after Sanofi completed its acquisition of Protein Sciences adding the US FDA approved recombinant protein-based influenza vaccine Flublok.

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