Scaling for commercialization: considerations for large-scale API production

December 17, 2025

Remove from favorites

Add to favorites

As drug development programs move from clinical scale to commercial manufacturing, scaling up active pharmaceutical ingredient (API) production introduces significant challenges that go beyond simply increasing batch sizes. The article emphasizes that successful large-scale API production requires careful attention to process optimization, scalability, risk mitigation, and regulatory support to ensure consistent quality and supply for commercialization. A critical element is selecting the right CDMO partner — one with experience in large-scale API synthesis, robust quality systems, and the ability to support both clinical and commercial regulatory filings. Planning for commercial scale should also address technology transfer, analytical methods, and supply-chain readiness to avoid setbacks as production ramps up. With the right infrastructure and strategy, organizations can navigate the complexities of scaling API production efficiently and reliably