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WUXI, China, April 6, 2021 /PRNewswire/ WuXi Biologics ( WuXi Bio ) (2269.HK), a global company with leading open-access biologics technology platforms, today announced that it has successfully completed both a Pre-License Inspection (PLI) and a routine GMP inspection by the U.S. FDA (FDA). The inspections focused on the two different innovative biologics manufactured at the company s facilities including MFG1, MFG2 and DP1 in Wuxi, China. With an excellent track record during all inspections and audits to date, WuXi Biologics further demonstrated its established premier-quality systems are in compliance with the highest global regulatory standards.
During the 15 working day inspections, 9 inspectors evaluated the manufacturing, raw material, warehousing, laboratory, equipment, utilities and quality systems. Virtual assessment using innovative digital solutions (e.g., due diligence, GMP audits and inspections, persons-in-plant) developed by
WuXi Biologics Successfully Completed Pre-License Inspection and Routine GMP Inspection by U.S. FDA prnewswire.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from prnewswire.com Daily Mail and Mail on Sunday newspapers.
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On March 25, 2021, biosimilar manufacturer mAbxience announced that it is expanding its León, Spain manufacturing facility with a new 4,000 L Custom Single Run (“CSR”) bioreactor. mAbxience claims its León plant is “the biggest biologic plant in Spain and the first in Europe with fully integrated single-use technology in most processes.” The new 4,000 L single-use bioreactor system is expected to be installed in the coming months, which, according to mAbxience, “will significantly increase biosimilar and CDMO manufacturing capacity.”
On March 17, 2021, WuXi Biologics, a Chinese biologics company, announced that it entered into an equity agreement with Pfizer China to acquire Pfizer’s biologics manufacturing facilities and labor force in Hangzhou, China. XuWi indicated that the transaction is expected to close in the first half of 2021, and “will immediately boost the commercial Drug Substance (DS)
WuXi Biologics to Acquire Biologics DS and DP Manufacturing Facilities from Pfizer China
- Quick access to high-demand DS and DP capacities and complement WuXi Biologics existing network in China to address surging commercial manufacturing demands
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HANGZHOU, China, March 16, 2021 /PRNewswire/ WuXi Biologics ( WuXi Bio ) (2269.HK), a global company with leading open-access biologics technology platforms, today announced that it has entered into an equity agreement with Pfizer China ( Pfizer ) to acquire its state-of-the-art biologics manufacturing facilities as well as its labor force in Hangzhou, China. The transaction is expected to close in the first half of 2021, which will immediately boost the commercial Drug Substance (DS) and Drug Product (DP) capacities for WuXi Biologics to address surging manufacturing demands.