CG Bio said Wednesday that its second manufacturing facility, Novo Factory, has received final regulatory approval and begun full-scale operations, strengthening the company’s production capacity for regenerative medicine.
The new facility will focus on manufacturing Novosis Putty and other orthopedic surgery products, supporting the company’s expansion into advanced markets such as the United States and Japan.
While CG Bio’s first plant, S-Campus, specializes in dermal filler production, Novo Factory was designed as a strategic manufacturing base that meets US Food and Drug Administration regulatory standards.
Novosis is the company’s flagship bone substitute, combining hydroxyapatite ceramic scaffolds that mimic human bone structure with recombinant human bone morphogenetic protein-2. Novosis Putty features a semi-solid formulation designed for easier handling during surgery, while Novosis OS targets orthopedic procedures in line with global clinical standards.
Novo Factory can produce up to 1 million syringes annually based on a 3-milligram formulation of Novosis Putty.
The facility incorporates core technologies for synthetic bone production, including precision molding and coating systems, optimized grinding technology and high-capacity sintering equipment designed to ensure scalable and consistent manufacturing.
CG Bio said the plant initially has an annual production capacity of 400,000 units for its Novosis and Bongros product lines, with additional capacity planned through phased expansion.
Raw material subsidiary CG Materials has also relocated to the Novo Factory complex, enabling in-house synthesis of hydroxyapatite, beta-TCP and BGS-7, key materials used in products such as Novosis and the premium collagen stimulator DClassy CaHA.
The facility was built to comply with FDA current Good Manufacturing Practice standards and international quality requirements such as ISO 13485. It features cleanroom systems, automated production lines and validated sterilization processes to support global regulatory compliance.
CEO Yu Hyun-seung said the new plant would serve as a strategic production hub to support the company’s global expansion.
“With strengthened manufacturing infrastructure, we will accelerate our entry into advanced regulatory markets such as the US and Japan,” Yu said.
jwjeon7625@heraldcorp.com
