Safe handling of highly potent molecules is complex, and the associated regulatory requirements are growing. As a result, pharmaceutical companies recognize the importance of selecting the right partner for the development, manufacturing, packaging and commercialization of products containing high-potency active pharmaceutical ingredients (HPAPIs). Some companies work with one contract development and manufacturing organization (CDMO) throughout the entire life cycle, while others partner with multiple vendors. To ensure success, teams must conduct due diligence to identify CDMOs that meet their safety, technology, process, economic and schedule requirements.
A panel of experts discussed the key areas for consideration and best practices when outsourcing HPAPI development, manufacturing and packaging to a CDMO.