Issue link: https://www.e-digitaleditions.com/i/1373953
Pharmaceutical Technology BIOLOGICS AND STERILE DRUG MANUFACTURING EBOOK 2021 61 manufacturing capacity while creating more than 1500 jobs at 11 manufacturing sites in the Americas, Europe, and Asia. Specific expansions include: • Single-use technologies—the company will expand its single-use technologies business at its sites in Logan, Utah; Millersburg, Pa.; Cramlington, United Kingdom; Singapore; and Suzhou, China. • Purification—Thermo Fisher plans to expand its POROS resin manufacturing site in Bedford, Mass., and launch a new 85,000-ft 2 manufacturing facility in Chelmsford, Mass. • Cell culture media and process liquid— expansions will take place at the company's Grand Island, NY; Miami, Fla.; and Inchinnan, Scotland, sites to increase the production of cell culture media, supplements, and process liquids as well as the manufacturing of customer- owned proprietary media formulations. Fujifilm Diosynth Biotechnologies started its large-scale cell culture expansion project, which will double the existing bulk drug substance production capacity with the addition of 6 x 20,000 L bioreactors (3). Additionally, the expansion will include a fully automated, fill/finish capability for large-scale production of up to approximately 35 million units per annum, along with a new packaging line for multiple types of auto-injectors and automatic labeling. "The expansion will be transformative, significantly expanding our ability to support current and future partners, infusing sustainability efforts into future operations, and further strengthening our leadership in biologic drug substance manufacturing. We are excited to see the site grow and to welcome 300 new employees," said Lars Petersen, chief operating officer and senior vice president, Fujifilm Diosynth Biotechnologies Denmark, in a company press release. New locations Abzena has chosen Sanford, NC, as the location for its new good manufacturing practices (GMP) faci lit y (4). The new faci lit y, which w i l l be designed specifically for Phase III and commercial manufacturing of biologics, will initially include four modu la r suites w it h up to t wo 20 0 0 -L bioreactors, followed by the addition of two more 2000 L suites. The facility will also handle continuous manufacturing and perfusion, with manufacturing beginning in 2022. "We are delighted to announce the investment of our newest site in Sanford, NC," said Jonathan Goldman, MD, CEO of Abzena, in a press release. "Our goal is to support our partners and the patients they serve with this expansion in GMP biologics manufacturing services. We are pleased to provide integrated asset development with a full suite of in-house services from discovery through clinical and commercial phases without the need for technology transfer. We are very pleased to be welcomed by North Carolina." Evotec has started the construction of its new J.POD 2 EU CGMP biomanufacturing facility in France (5). The new facility, which will be Evotec's first in Europe, will aim to offer capacity, flexibility, and quality for biotherapeutic development and manufacturing while utilizing its subsidiary Just – Evotec Biologics' technology that employs small, automated, highly intensified, and continuous bioprocessing operations inside autonomous cleanrooms. "The global availability and accessibility of highly effective biotherapeutics has been Just – Evotec Biologics' mission right from the start," said Werner Lanthaler, CEO of Evotec, in a press release. "The ongoing coronavirus pandemic has underlined the need for f lexible and nearshore biomanufacturing