BioPharm April eBook: Outsourcing Resources 2019

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Page 28 of 28 April 2019 BioPharm International eBook 29 Outsourcing Resources Business Developments Switzerland, and have production facilities in Denmark and Switzerland. The agreement will create the first CDMO globally to provide manu- facturing of bacteria strains for ther- apeutic use, the companies report, using Chr. Hansen's expertise in developing, upscaling, and manufac- turing bacteria strains, and Lonza's capabilities in pharma contract man- ufacturing, formulation, and drug delivery technologies. The companies plan to upgrade existing facilities in Hørsholm, Denmark, and equip new facilities in Basel to serve pre-clinical to Phase II projects. Additional facilities for Phase III and commercial manufac- turing will be developed as the pipe- line matures, the companies report. The joint venture will house com- petences in handling, characteriz- ing, formulating, manufacturing, and encapsulating strict anaerobe bacteria in one facility; seamless exchanges between drug substance and drug product activities are expected to decrease development timelines, the companies report. The venture will target the emerg- ing pre-clinical and clinical supply industry for LBP in anticipation of serving commercial demand, once the first live biotherapeutic products are approved (4). INVESTMENTS Outsourcing companies also made investments in their facilities and ser- vices in early 2019. MaSTherCell SA, a subsidiary of Masthercell Global Inc., a cell and gene therapy-dedicated CDMO, has signed a lease agreement for a 5700- m 2 (61,354-ft 2 ) facility located in Belgium. The new facility will be a manufacturing and production site designed for late-stage and commer- cially approved cell and gene therapy products. The commercial facility is expected to be operational in early 2021 and will include software inte- gration, intelligent equipment, and integrated processes. The company will continue to use its existing site for both industrialization and early to mid-stage clinical programs (5). Ajinomoto Bio-Pharma Services, a provider of biopharmaceutical con- tract development and manufactur- ing, announced several expansions of its capabilities and service offer- ings in the United States and Belgium totaling more than $100 million in March (6). In addition to a previously announced highly potent product conjugation and isolated fill line, the company is adding an isolated, nested flexible fill line; installing automated packaging and labeling equipment; and upgrading its continuous flow and small-molecule API manufactur- ing capabilities. Catalent announced on Jan. 7, 2019 a $200-million investment in its biologics business to expand drug- substance manufacturing capacity and drug-product fill/finish capacity. The investments, phased over a three-year program, will be carried out at the company's biologics manu- facturing sites in Madison, WI, and Bloomington, IN (7). Mammalian cell-culture capacity will be increased at Madison with the build-out of two new suites, each with a 2 x 2000-L single-use bioreactor system, providing addi- tional clinical and commercial production capacity at the 2000- or 4000-L batch scale, as well new laboratories. Work is expected to be completed by mid-2021 and will more than double Catalent's com- mercial biomanufacturing capacity, the company reports. Additionally, fill/finish capac- ity at the Bloomington site will be expanded by 79,000-sq. 2 . A high- speed flexible vial line, using both ready-to-use components and bulk filling at a filling speed of 30 0 units per minute, will be installed along with a high-speed flexible syringe/cartridge line with a fill- ing speed of more than 300 units per minute, and an automated vial inspection machine. REFERENCES 1. ThermoFisher Scientific, "Thermo Fisher Scientific to Acquire Brammer Bio, a Leader in Viral Vector Manufacturing," Press Release, March 24, 2019. 2. Fujifilm, "Fujifilm to Acquire Large-Scale Biologics Manufacturing Site from Bio- gen to Accelerate Growth of Its Bio CDMO Business," March 12, 2019. 3. Fujifilm, "FUJIFILM to Invest 10 Billion Yen in Its Bio CDMO Business," Press Release, Jan. 7, 2019. 4. Lonza, "Lonza and Chr. Hansen in Joint Venture to Accelerate Momentum in Mi- crobiome," Press Release, April 2, 2019. 5. MaSTherCell, "MaSTherCell SA An- nounces Creation of a new Commercial Manufacturing Facility for Cell & Gene Therapies," Press Release, March 26, 2019. 6. Ajinomoto Bio-Pharma Services, "Ajino- moto Bio-Pharma Services Announces Capital Expansion to Fuel Growth," Press Release, March 12, 2019. 7. Catalent, "Catalent Invests $200 Million to Expand Biologics Capacity and Capa- bilities," Press Release, Jan. 7, 2019. BP Ad Index Company Page AJINOMOTO ALTHEA 9 BAXTER HEALTHCARE CORP 15 EUROFINS LANCASTER LABORATORIES 5 PYRAMID LABORATORIES 23 WUXI BIOLOGICS US 2

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