Product Development: Production Scale-up and Optimization

Recap critical factors (i.e., rate change, mechanistic properties, equipment design) for scale-up, the impact on manufacturability, and options to increase and/or optimize production. Review modeling techniques for optimization of product cycle time, and factors that can positively or negatively affect scale-up. At the conclusion of this online course, participants will have knowledge of:

  • Options to increase and/or optimize production
  • Critical factors (for example, rate change, mechanistic properties, equipment design) of scale-up and their impact on manufacturability
  • Impact of factors that can positively or negatively affect scale-up
  • Modeling techniques for optimization of product cycle time

Attendance suggested for

  • Years in industry: 0-4 to 5-14
  • Ideal audiences are those with 2+ years of industry experience that want to supplement their industry knowledge about a specific topic(s)
Mr. Charles F. Carney
Senior Affiliate Consultant
Seraphim Life Sciences Consulting

Charles F. Carney has nearly 40 years of experience in pharmaceutical drug product development, manufacturing, and analytical control. His industrial experience was gained at Wyeth (formerly Ayerst Laboratories) and Boehringer Ingelheim. For the last 15 years of his corporate service, he was the associate director of investigational supplies in the Connecticut R&D Center of Boehringer Ingelheim. Since 2003 he has been a consultant for Seraphim Life Sciences Consulting, LLC. His responsibilities have included performing and managing pharmaceutical, analytical, and GMP compliance aspects of drug product development, including the outsourcing, validation, and technology transfer aspects and the quality control, and facility design for commercial drug products. He is a member of ISPE, ACS, and AAAS. He has published and presented papers extensively in the areas of pre-formulation, formulation, and control of manufacturing operations for clinical drug products. He also has published and presented concepts in the areas of outsourcing of manufacturing and control, and for optimizing international operations. He is a co-editor of the second edition of “Drug Products for Clinical Trials” (Taylor & Francis, 2006).

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