Scaling For Commercialization: Considerations For Large-Scale API Production

Scaling up a program from clinical development to a larger batch size introduces numerous challenges and complexities that must be addressed to ensure a successful scale-up process. Crucial considerations including risk management, production scalability, regulatory compliance, and specialized technological capabilities must be thoroughly assessed. Partnering with a reliable and experienced Contract Development and Manufacturing Organization (CDMO) can be the key to achieving program success. Here, experts from MilliporeSigma provide valuable insights on selecting the right CDMO for large-scale API production, as well as critical factors to ensure your small molecule API program is successful.