CGBIO announced on March 4 that its second manufacturing facility, NOVO Factory, located in Hyangnam, Hwaseong, Gyeonggi Province, has received official completion approval and begun operations as a dedicated production base for NOVOSIS PUTTY and orthopedic surgery (OS) products.
The new facility is expected to serve as a strategic manufacturing hub supporting the company’s expansion into advanced markets such as the United States and Japan.
While CGBIO’s first production facility, the S-Campus in Hyangnam, operates as a smart factory specialized in filler production, the NOVO Factory has been designed as a strategic manufacturing base for regenerative medicine products that comply with the U.S. Food and Drug Administration’s manufacturing and quality standards.
In particular, the factory is dedicated to the global supply of NOVOSIS PUTTY and NOVOSIS OS products. NOVOSIS PUTTY is a key strategic product currently seeking entry into advanced markets including the United States and Japan based on FDA investigational device exemption (IDE) clinical approval.
Because regulatory standards for medical device quality and clinical data are particularly stringent in the U.S. and Japan, securing stable manufacturing capacity is considered essential for global market expansion.
NOVOSIS is CGBIO’s flagship bone graft substitute brand that combines a hydroxyapatite ceramic scaffold designed to mimic human bone structure with the osteogenic protein rhBMP-2. NOVOSIS PUTTY applies this technology in a semi-solid putty formulation designed to improve handling convenience during surgical procedures. NOVOSIS OS is a bone graft product used in orthopedic surgery that is produced according to global clinical specifications and quality standards.
The NOVO Factory has an annual production capacity of up to one million syringes of NOVOSIS PUTTY based on the 3 mg dosage format.
The synthetic bone manufacturing zone integrates several proprietary technologies, including molding and coating equipment designed to create precise porous structures, customized grinding systems, and high-capacity sintering facilities. These systems allow the company to achieve both mass production and consistent product quality.
Production lines can initially support approximately 400,000 units annually for products such as NOVOSIS and BONGROS, with room for phased expansion. The facility is also capable of producing key products including NOVOSIS PUTTY, Excelos Inject, and Novomax Fusion.
Automated medical device production lines are also installed for products such as Curasys, Curavac, Belluna and Cellunit, improving operational efficiency and supply stability.
The facility also houses CG Materials, a raw materials subsidiary established last year. The company synthesizes hydroxyapatite (HAP), beta-tricalcium phosphate (β-TCP), and bioactive glass ceramic BGS-7, which are processed and supplied as key materials for products such as NOVOSIS bone graft substitutes and the premium collagen stimulator DeClassy CaHA (exported under the brand name Facetem).
Through this structure, CGBIO has established a vertically integrated system covering everything from raw material synthesis to finished product manufacturing, strengthening both quality consistency and cost competitiveness.
NOVO Factory was designed from the outset to comply with regulatory standards including the U.S. FDA’s current Good Manufacturing Practice (cGMP) requirements and Japan’s PMDA review framework. The facility meets international medical device quality management standards including 21 CFR Part 820 (QSR), QMSR and ISO 13485.
The facility minimizes contamination risks through cleanroom-based automated production systems and incorporates operational frameworks for documentation management, corrective and preventive action (CAPA), and environmental monitoring to prepare for FDA inspections. Sterilization and packaging processes have also been internally validated in accordance with global regulatory standards.
“NOVO Factory is more than just a manufacturing site; it is a strategic production hub designed to accelerate our expansion into advanced regulatory markets such as the U.S. and Japan, centered around NOVOSIS PUTTY,” said Yoo Hyun-seung, CEO of CGBIO. “With manufacturing infrastructure capable of meeting FDA cGMP and Japan PMDA regulatory standards, we plan to strengthen our presence in global markets.”
