Baizensel Completes GMP Center Construction... "Accelerating Clinical Trials"

[Asia Economy Reporter Lee Gwan-ju] VigenCell announced on the 28th that it has opened the VigenCell GMP (Good Manufacturing Practice) Center located in Geumcheon-gu, Seoul.

The VigenCell GMP Center is a state-of-the-art biopharmaceutical GMP center with a dedicated area of 1,375.70㎡ (420 pyeong), equipped with a full-cycle system capable of producing immunocyte therapeutics, immunocyte gene therapeutics, peripheral blood banking, and mRNA production.

The manufacturing facility includes seven aseptic processing rooms (clean rooms), two finished product storage rooms, one aseptic preprocessing room, raw material storage room, general testing area, aseptic testing room, adventitious virus testing room, biological testing room, and microbiological testing room. Additionally, the QC (Quality Control) system is equipped to perform mycoplasma testing, sterility testing, endotoxin testing, and adventitious virus testing.

VigenCell plans to obtain advanced biopharmaceutical manufacturing business licenses and human cell management business licenses in the second half of the year, and to report the cell processing facility. Furthermore, it will begin full-scale production of clinical trial drugs starting in August.

Kim Tae-gyu, CEO of VigenCell, said, “With the completion of the GMP center, we can now produce clinical trial drugs in-house, reducing time and costs, which will accelerate pipeline development. Designed as a fully automated, full-cycle advanced biopharmaceutical GMP center, we will continue to actively conduct research and development and announcements of new pipelines.”

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