Taiwanbio announced that their cell therapy factory passed the inspection by the Taiwan FDA

撰文GlobalBio & Investment
日期2024-05-31
Taiwanbio announced that their cell therapy factory passed the inspection by the Taiwan FDA
Congratulations to Taiwan Bio Therapeutics Co., Ltd. (6892.TW) on a groundbreaking achievement!

On May 22, Taiwanbio announced that their cell therapy factory passed the inspection by the Taiwan FDA (#TFDA), securing the prestigious PIC/S GMP pilot plant certification. This milestone makes them the first in Taiwan to meet #GMP requirements for allogeneic mesenchymal stem cell new drugs. Achieving GMP standards at the Phase II clinical stage promises to accelerate the progression of clinical trials and expand their CDMO orders in the U.S. and other international markets.

COO Cyrus Yang emphasized Taiwanbio's expertise in the CDMO sector, focusing on early-stage advanced cell therapy products. Their seamless, one-stop solutions encompass everything from tech transfer and process development to mass production.

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