Article: Establishing a Rigorous and Robust Approach to Process Development
The aim of process development is to establish optimal process parameters and conditions for future large-scale batches or commercialization, ensuring that the product can be successfully manufactured in compliance with required quality and regulatory standards. This ultimately means that an in-depth understanding of the formulation is key.
In a recent two-part article with Manufacturing Chemist, Joseph Holt, Head of Process Development at MedPharm, explores the challenges facing developers when scaling-up processes for semisolid drug product production and highlights the additional difficulties associated with generic drug development and manufacturing.
About The Author
Joseph Holt joined MedPharm’s Formulation Development team in 2013 and now serves as the organization’s Head of Process Development. His expertise includes semi-solid product development, scale-up, and tech transfer. Holt has supported the development of more than 50 semi-solid and liquid products over the past decade, with many moving forward to commercialisation.
MedPharm is a global contract provider of topical and transdermal formulation development services specializing in reducing risk through unique, cost-effective, and industry-leading performance testing models. MedPharm offers innovative dermal/transdermal, respiratory, mucosal membrane, ophthalmic, and ungual product development solutions with locations in the United Kingdom and the United States. For more information, visit MedPharm.com or follow us on LinkedIn