A CDMO is a contract development and manufacturing organization, meaning they not only handle the manufacturing needs of their clients but are also part of the innovation and development process that leads to manufacturing high-quality inventory. A contract manufacturing business can manage the business from the development and raw material stage to the shop floor and distribution. These contract manufacturers can include development, production and analysis, and material sourcing, allowing their customers to limit the need to build and staff dedicated innovation and inventory manufacturing facilities.
Services often offered by CDMO companies include formulation, analytical services, blending, coating, converting, packaging, serialization, and inventory shipment. Many CDMOs based on their business focus, can start with a ready-to-go formula, or at the concept level, provide pre-formulation and formulation development services at volumes that will support both clinical trials and commercial production management.
When life science companies find the right CDMO, they gain flexibility, collaboration, and innovation services to lower process manufacturing costs and increase speed to market for new inventory. The right CDMO provides expertise and equipment at a lower overall investment that the customer does not have access to in-house. As cell and gene, pharmaceutical, and biotech components and materials become more complex and the need for innovation and production accelerates, CDMOs can provide a scalable solution delivering development and improving life science companies’ bottom lines.
Both the CMO and CDMO should be operating under current good manufacturing practices (cGMP), which is necessary for compliance with regulatory guidelines.