A recent project applied process improvement methodology to the process validation step. The multifaceted approach defined manufacturing parameters without the expense of surplus experimentation, as well as identified process improvements that ultimately provided an optimized, robust process in addition to an economic advantage.
Throughout the pandemic, painkiller and sedative demands spiked, and demand for bupivacaine HCl, a powerful analgesic and anesthetic medicine, dramatically increased. As global authorities work to fill gaps, drug manufacturers and CDMOs have become critical in the efforts to stabilize the supply of bupivacaine HCl and other essential drugs.
Sponsors spend considerable time and resources on process development and validation to create a launch-ready manufacturing process, which might require minor refinement. More often, however, significant process refinement is needed when adding additional CDMOs in preparation for process validation and commercial launch.
High potent APIs (HPAPIs) require advanced consideration for development and manufacturing, including highly regimented protocols and specialized facilities to ensure safety. Discover how Cambrex can reliably develop and manufacture a broad spectrum of HPAPIs and compounds.
Our dedication to quality and safety of energetic chemistry has laid a solid foundation for supplying cGMP high-energy compounds to world-leading pharmaceutical companies. We offer world-class expertise in energetic chemistry combined with quality cGMP capabilities.
