A primary liquid and its sterile preparation’s cGMP production base of Wuxi Biologics Co. Ltd, based at the Wuxi (Mashan) National Life Science Park, passed a Food and Drug Administration’s (FDA) assessment on Aug 3.
Wuxi Biologics is the first biopharmaceutical company to pass the FDA assessment in China, and the biopharmaceutical production base in Wuxi is also the only facility in China to comply with cGMP standards of the US, the European Union (EU) and China.
Dr Chen Zhisheng, CEO of Wuxi Biologics, said the bio-drug primary liquid and its sterile-preparation production base for FDA assessment are to make a new drug, lbalizumab, for the treatment of AIDS. The new drug, certified by the FDA in July, is scheduled to be mass-produced in the production base by the end of the year, Chen said.
