Scaling For Commercialization: Considerations For Large-Scale API Production
Source: MilliporeSigma
Scaling up programs from clinical development to larger batch sizes presents several challenges and complexities that need to be addressed for a successful scale-up. Key considerations such as risk mitigation, production scalability, regulatory filing support, and specialized technological capabilities should be thoroughly evaluated. Collaborating with a reliable and experienced commercial partner is crucial for program success.
MilliporeSigma's experts share insights about choosing the right Contract Development and Manufacturing Organization (CDMO) partner for large-scale API production and key considerations to ensure the success of your small molecule API program.
In this webinar, you will learn:
- Process optimizations and efficiencies at commercial scale
- Production scalability, from lab to plant
- Regulatory considerations for clinical and commercial filings