BioPharm April eBook: Outsourcing Resources 2019

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28 BioPharm International eBook April 2019 Outsourcing Resources Business Developments Bio's viral vector capabilities with our GMP production expertise and pro- prietary bioprocessing and cell cul- ture technologies uniquely positions us to partner with our customers to drive the evolution of this incredibly fast-growing market." Fujifilm announced on March 12, 2019 that it has agreed to acquire Biogen (Denmark) Manufacturing ApS, a large-scale biologics manufac- turing site located in Hillerød near Copenhagen, Denmark, from Biogen. The acquisition is expected to close around August 2019, subject to cus- tomary closing conditions (2). Upon closing, Biogen Hillerød will become Fujifilm's fourth biophar- maceutical CDMO site. The existing 800-employee workforce at the site will be retained by Fujifilm. The acqui- sition boosts the company's CDMO, Fujifilm Diosynth Biotechnologies, which will be responsible for the new site as well as all of Fujifilm's biophar- maceutical CDMO sites. Biogen Hillerød is equipped with six 15,000-L bioreactors for the man- ufacture of cell-culture derived bio- logics. This facility will significantly expand Fujifilm's capacity and pro- vides the ability to scale up to large production volumes, complementing the current scale-out manufacturing model implemented under the com- pany's Saturn monoclonal antibody (mAb) services. In addition, on Jan. 7, 2019, Fujifilm announced plans to invest approximately JPY 10 billion (approx- imately US$90 million) in Fujifilm Diosynth Biotechnologies (3) to expand existing production facili- ties at its North Carolina location. Investments will include the addi- tion of 2000-L single-use cell-culture manufacturing trains, cell-culture purification suites, and new micro- bial recovery suites to increase cell- culture manufacturing capacity by approximately 25% and microbial capacity by approximately 50% at the North Carolina location. The company expects that the increased production capacity will be ready for cGMP manufacture by early 2020. PARTNERSHIPS FOR EMERGING THERAPIES On April 2, 2019, Lonza and Chr. Hansen Holding, a global bioscience company, entered into an agreement to establish a 50/50 joint venture to develop live biotherapeutic prod- ucts (LBPs). The joint venture will operate from headquarters in Basel, Analytical contract service provider, SGS, has expanded capabilities and capacity for testing cell banks and routine bulk harvest for vaccines, gene and cell therapies, monoclonal antibodies, and other recombinant protein- based biological medicines at the company's Glasgow, UK facility (1). The $10-million (£7.6-million) investment is supported in part by a Scottish Enterprise Research and Development grant award of $2.2 million (£1.7 million). "The growth of the biologics medicine outsourcing market is projected to significantly increase for the next five years. SGS testing services in Glasgow operate from early in the bio-production roadmap (master cell bank characterization) to the lot release of the bio-therapeutic," says Archie Lovatt, SGS' scientific director. "The expanded facility will provide all testing required for cell bank, virus seed/vectors, unprocessed bulk and purified drug, therapy, and vaccine [products]. The Glasgow facility offers services to meet ICH [International Council for Harmonization] Q5A, Q5B, Q5D; European Pharmacopoeia 5.2.3, 5.14, and 2.6.21, including FDA Vaccine guidelines 2010 and WHO [World Health Organization] TRS 978," Lovatt adds. The investment includes an additional 1200 m 2 of space, bringing the total to 2400 m 2 , increasing the site's services by three times. The expanded facility will support human biological medicines and viral vaccines in early development pre-Phase I, Phase I/II, Phase III, and commercial product for recombinant proteins, viral vaccines, and gene and cell therapies. The new laboratory will increase the company's capacity for existing biosafety services and enhanced real-time polymerase chain reaction platforms; SGS will develop and validate cell-based viral detection systems at the site. According to Lovatt, the Glasgow facility's pathogen detection technologies increase the speed at which safe bio-therapeutic and vaccines products are delivered to patients. "This is particularly true for personalized medicines and vaccines, cell-, and viral- based gene therapies, which have a more complex testing requirement," Lovatt adds. The facility, which is operational, is being validated in a phased approach, Lovatt adds. Reference 1. SGS, "SGS Expands Biologics, Viral Vaccine, Gene and Cell Therapy Testing Capabilities at Its Glasgow, UK Facility," Press Release, Jan. 29, 2019. SGS Expands Testing Capabilities at Glasgow Facility

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