Regenerative medicine company CGBio is launching its production facility "Novo Factory" to expand into the U.S. and Japanese markets.
CGBio announced on the 4th that its Novo Factory at the Hwaseong Hyangnam No. 2 plant recently received completion approval and has officially begun operations. While the existing Hyangnam "S-Campus" is a smart factory focused on filler production, Novo Factory is a strategic facility for regenerative medicine products. The facility was specifically designed as a core production hub responsible for global supply of Novosis Putty and "Novosis OS" among the Novosis product line.
Novosis Putty is a bone substitute that applies bone morphogenetic protein (rhBMP-2) to a hydroxyapatite (HA) ceramic scaffold that mimics human bone structure. The product features a viscous semi-solid (putty) formulation designed for easy handling during surgical procedures. Based on U.S. Food and Drug Administration (FDA) pivotal clinical trial approval, the product is pursuing entry into advanced markets including the United States and Japan.
Novo Factory has production capacity of up to 1 million syringes annually based on the Novosis Putty 3mg specification. The synthetic bone production area is equipped with molding and coating facilities that precisely implement porous structures, along with high-capacity sintering equipment, securing both mass production capability and quality uniformity. This establishes a foundation for stable production of major product lines including Novosis and BoneGros.
CGMaterials, a subsidiary specializing in raw materials, has also moved into the factory. The subsidiary directly synthesizes bio-ceramic materials including hydroxyapatite (HAP), β-TCP, and BGS-7, supplying them as raw materials for bone substitute "Novosis" and collagen stimulator "Facestem." Through this arrangement, CGBio has established a vertically integrated structure spanning from core raw material synthesis to finished product manufacturing.
Novo Factory incorporated U.S. FDA cGMP and Japan PMDA regulatory requirements from the design stage. Based on cleanrooms and automated production facilities, contamination risks have been minimized, with global regulatory compliance systems including document management, corrective and preventive action (CAPA), and environmental monitoring applied throughout production.
"Novo Factory is a strategic production facility for targeting advanced regulatory markets including the United States and Japan, centered on Novosis Putty," said Hyun-seung Yoo, CEO of CGBio. "Based on manufacturing infrastructure aligned with global regulatory standards, we will accelerate expansion into overseas markets."