· Global-level turnkey solution for CDMO supporting development, manufacture, quality testing, and regulatory approval
· Securing the foundation for stable profits and sustained growth by expanding the scope of the CDMO business for cell and gene therapy products besides existing businesses
Medipost (CEO Won-Il Oh) announced on the 17th its new GMP facilities will house ten cleanrooms and production facilities equipped with up-to-date equipment exclusively for Contract Development and Manufacturing Organization (CDMO), marking the launch of its CDMO business for cell and gene therapy products in Korea.
Unlike Contract Manufacturing Organization (CMO) entrusted to manufacture pharmaceuticals for clinical studies and commercial uses, CDMO is a high value-added business that requires sufficient process-developing ability and knowledge to provide a collaborative service throughout the life cycle of new pharmaceutical products, from development to clinical study and marketing approval. In particular, cell and gene therapy products involve sophisticated technologies from development to production and rely heavily on outsourcing. All processes, including cell development, manufacturing process, clinical study, approval, and commercialization, must be conducted through a close partnership with a qualified CDMO company.
Medipost plans to provide one-stop total services that embrace the entire process of developing advanced biopharmaceutical products: product development services; services producing various cells and active ingredients for advanced biopharmaceuticals; services analyzing production quality; and services storing produced products (cells).
By conducting the life cycle development of CARTISTEM® as the world’s first stem cell therapy product and maintaining GMP for over 20 years, Medipost has differentiated its competitiveness with skilled human resources and abundant experience. In addition, the company has the best technologies for sorting and mass-culturing stem cells in the world, and is capable of supplying biopharmaceutical ingredients to many hospitals.
Medipost has formed a synergy with OmniaBio, a Canadian company specializing in CDMO for cell and gene therapy products by acquiring the company on the strength of its multiple Process Development (PD) capabilities for autologous and allogeneic cell therapy products, gene therapy products, and viral vectors, production platforms, Standard Operating Procedures (SOPs) to manage and maintain product quality, and intellectual property rights. OmniaBio has secured many clients developing cell and gene therapy products in North America.
Based on OmniaBio’s knowledge in PD and production and the implementation of viral vectors, the core element for developing and manufacturing cell and gene therapy products, Medipost can offer global CDMO services and contribute to producing and supplying viral vectors, whose global demand is increasing rapidly.
An official of Medipost explained, “We will provide turnkey solutions that meet the global standards for supporting the development, manufacture, quality testing, and approval process for advanced biopharmaceuticals based on the world’s best development and production knowledge accumulated for 20 years.” The authority added, “We will prepare the foundation for stable profits and sustained growth by diversifying the business structure through CDMO for cell and gene therapy products on top of our existing businesses of cord blood banks and cell therapy products.
Meanwhile, by securing global-level CDMO technologies for cell and gene therapy products through the M&A of OmniaBio, Medipost was certified by the Korea Core Industrial Technology Investment Association (KITIA) under the Ministry of Trade, Industry and Energy as a company that implemented excellent foreign technologies. Medipost is entitled to apply for the International XnD Industrial Technology Development Project supervised by the Ministry of Trade, Industry and Energy in 2023.