The Need for CDMOs
Significant capital is now required for equipment and facilities to meet testing and manufacturing requirements for other new advanced molecules. This has increased the popularity of outsourcing regulatory compliance responsibilities to CDMO partners. To make complex biologic products safely, new and sophisticated delivery systems are also necessary for the transport of these treatments. CDMOs are working to develop and optimize delivery for treatments with specific environmental, storage, and transport requirements.
In addition to reducing time and cost by localizing production to one facility, one-stop shops take country-specific regulatory requirements into account and offer packaging customization for optimal product safety. One-stop-shop CDMOs can monitor the entire value chain of a developing treatment with accuracy that can’t be achieved over multiple partners.
CDMOs have further expanded production capacity by integrating single-use systems in production plants. The application of single-use bioreactors, disposable plastic containers, continuous purification processing, and in-time quality analysis increases efficiency. Single-use products provide a quick turnaround during development and limit joint activities, including validation for cleaning and changeover. CDMOs can improve project performance and product quality by progressing towards automation and the integration of new technology.
CDMOs also help biopharma companies with more stringent government and regulatory compliance, as well as economic pressures over profit margins. Without the help of CDMOs, biopharma manufacturers would need to make significant investments in personnel, consultants, facilities, equipment, and machinery to maintain regulatory compliance.