Scaling for commercialization: considerations for large-scale API production

November 04, 2024

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Scaling up from clinical development to larger batch sizes involves numerous challenges and complexities that must be addressed to ensure successful outcomes. Key factors such as risk mitigation, production scalability, regulatory filing support, and specialized technological capabilities require careful assessment. Partnering with a reliable and experienced Contract Development and Manufacturing Organization (CDMO) is essential for the success of these programs.

Experts from MilliporeSigma emphasize the importance of selecting the right CDMO for large-scale active pharmaceutical ingredient (API) production and outline critical considerations for the success of small molecule API programs. In their upcoming webinar, participants will gain insights into:

- Process optimizations and efficiencies at a commercial scale

- The scalability of production from laboratory to plant

- Regulatory considerations for both clinical and commercial filings

For more detailed information, refer to the original article by MilliporeSigma on Pharmaceutical Online.