Reyon Pharmaceutical announced on the 12th that its Chungju plant has received GMP certification from the Ministry of Food and Drug Safety (MFDS) as a specialized manufacturer for biopharmaceutical contract manufacturing. Having previously obtained KGMP certification in 2023, this newly acquired GMP status recognizes the Chungju plant as a manufacturing facility fully capable of specialized biopharmaceutical contract development and manufacturing (CDMO).
Amid growing interest in the CMO business driven by the expanding biopharmaceutical market, specialized biopharmaceutical contract manufacturing GMP certification is essential to professionally operate in the biopharmaceutical manufacturing contract business. The global bio-CDMO market is projected to exceed $20 billion by next year.
Reyon Pharmaceutical's Chungju plant was constructed to meet the Current Good Manufacturing Practice (cGMP) standards required by the U.S. FDA and is already equipped with the latest technologies and equipment for biopharmaceutical development and production. It houses Korea's only facility dedicated to E. coli fermentation-based pDNA production and has completed the development of animal cell culture-based AAV process technology. Consequently, the Chungju plant is expected to become the only facility in Korea capable of providing one-stop production for both plasmid DNA (pDNA) and AAV.
Reyon Pharmaceutical holds an unrivaled position in pDNA production technology within Korea. When the U.S. Biosecurity Act is finalized around next year, interest from global clients regarding pDNA is highly likely to increase significantly. Utilizing its existing expertise in fermentation and cell disruption processes, Reyon Pharmaceutical can produce various DNAs that meet strict quality standards, and its production processes have also obtained Freedom to Operate (FTO) validation. The company is currently signing research and supply agreements for the production of pDNA research samples with both domestic and international clients, with discussions for additional supplies ongoing. For instance, in 2025, the company plans to supply clinical samples for a senile macular degeneration treatment (NG101) in the U.S. and Canada for Neuracle Genetics, its co-development partner.
