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.