TaiMed Biologics Inc. received the official approval letter from the US FDA of the pre-approval inspection (PAI) of the company's new cGMP monoclonal antibody manufacturing and testing facilities in Taiwan. The PAI was conducted on April 18 22, 2022 by the Agency and resulted in no Form 483 observations. This excellent outcome demonstrates TaiMed's competence and readiness in full-scale clinical and commercial contract manufacturing.
With its 4 x 2,000L single-use bioreactors, full downstream purification and state-of-the-art QC testing facilities, the company announced previously that it is entering the CDMO business in addition to supporting its own monoclonal antibody development programs.