Production Scale-Up and Optimization

Session Type: Recorded Webinars
Knowledge Element: Product Development
Speaker: Charles F. Carney, Seraphim Life Sciences Consultants LLC
Duration: 45 minutes

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An understanding of manufacturing processes and of the materials and controls necessary for successful production of finished goods must include the predictive capabilities for optimization of processes and for increasing the scale of any or all operations. This understanding must be gained from first principles of the physics and chemistry of materials and the engineering activities required to bring the materials together into a product. Trial and error methods used in the past are being replaced by predictive modeling approaches for increasing and decreasing scale of production processes. Such methods as dimensional analysis and similarities analysis can be useful in providing the basis for designing and testing a scaled process.

This online seminar will address the issues for optimizing and increasing the scale of production processes. Some examples from the literature will be presented to reinforce the concepts that will be presented. This overview will identify and emphasize some of the critical factors associated with scale change for production of products containing solid powders, liquid and semisolid products, and biotechnology derived products.

Learning Objectives:

• Elements of optimization for materials and processes in pharmaceutical production
• Some key critical factors in selected processes as examples of the various issues in scale-up which will include:
  • Interactions between powder particles that can impact mixing, granulation, flow, compression
  • Impact of surface area and volume on transport phenomena for mixing, heating, cooling, and pH adjustment for liquids
  • Importance of equipment geometry and its effect on scale-ability of a process
  • Effects of temperature, local domain effects in mixing, and shear on the scale-ability for biotechnology derived products
  • Overview of the principles involved in dimensional analysis and similarities analysis for describing systems in support of scale-up experiments
  • Importance of considering facility capabilities in terms of materials storage, handling and testing as an important aspect of process optimization and scale-up.

Who should attend:

• Pharmaceutical product development and production operations professionals who will participate in scale-up activities and need to understand the issues and want to receive some pointers on finding helpful literature information
• Other pharmaceutical professionals who want an overview of the breadth of issues involved in scaling production processes

Speaker Biography

Charles Carney has nearly 40 years of experience in pharmaceutical drug product development, manufacturing, and analytical control. 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 co-editor of the second edition of “Drug Products for Clinical Trials.”

What is a Recorded Webinar?

Previously held webinars are available as recorded sessions, which you can view at your convenience. Registration orders are processed within two business days, after which participants will receive an email confirmation with a link to the Recorded Webinar. After receiving the link to the Recorded Webinar, you have 15 days to view it.

What are CPIP^SM Recorded Webinars?

CPIP^SM Recorded Webinars are a group of Recorded Webinarswas developed to help individuals in preparation for the Certified Pharmaceutical Industry Professional^SM (CPIP^SM) examination.

The Certified Pharmaceutical Industry Professional^SM (CPIP^SM) credential recognizes “change agents” as the necessary ingredient to foster industry innovation and enhance drug product quality. The credential establishes a global competency standard for industry professionals, and candidates are assessed through demonstrated education, experience, and a rigorous examination. Completion of any of these seminars does not guarantee successful completion of the CPIP certification exam, and these seminars do not include every subject to the depth of what will be covered on the CPIP exam.

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