Baizencell Obtains GMP Center Advanced Biopharmaceutical Manufacturing License from MFDS

[Asia Economy Reporter Lee Gwan-joo] ViGenCell announced on the 11th that it has received a license for manufacturing advanced biopharmaceuticals from the Ministry of Food and Drug Safety.

In October last year, ViGenCell began construction of a commercial GMP (Good Manufacturing Practice) center at ‘The Reason Valley Knowledge Industry Center’ in Gasan Digital Complex and completed the construction in April this year.

With the acquisition of the advanced biopharmaceutical manufacturing license, ViGenCell can now conduct business encompassing manufacturing and development of advanced biopharmaceuticals including cell therapies, quality testing, regulatory approval, support, storage, and delivery.

ViGenCell plans to produce clinical trial drugs for the ViTier platform’s pipeline ‘VT-Tri(2)-G’ as well as the ViMedier and ViRanger platforms at the GMP center once all certifications and approvals, including the human cell management license and cell processing facility registration, are completed.

Kim Tae-gyu, CEO of ViGenCell, said, “With the ViGenCell GMP center receiving the advanced biopharmaceutical manufacturing license, we have taken a step closer to our goal of producing clinical trial drugs planned for the second half of the year,” adding, “We will steadily achieve our targeted research and development and clinical trial plans, including obtaining various certifications and approvals, and continue to grow as a specialized immunocellular therapy company.”

This content was produced with the assistance of AI translation services.