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CMC Expertise Accelerating Biologics Development for 20 Years and Counting

Working with my co-founders, colleagues, and clients on many fascinating projects over the last twenty years has been an honor. From the founding of the firm with former Pfizer colleagues until today, we have specialized in supporting the CMC and regulatory programs...

WEBINAR ON-DEMAND

Strengthening Your Gene Therapy Process Control Strategy

Given the incredible diversity of gene therapy product characteristics, there is no “one solution fits all” process control toolbox to assure consistent, quality product.

Manufacturers of some approved gene therapy products struggle to meet their own release specifications—join BioTechLogic for an on-line discussion exploring ways to avoid this fate.

  • What is a gene therapy process control strategy?
  • Raw material impacts on product quality
  • Applying QbD principles to gene therapy development
  • Developing Manufacturing Development Studies; Manufacturing Process and Process Controls aligning with Q11 Guidance
  • Defining Normal Operating Range (NOR), Proven Acceptable Range (PAR) and Critical Process Parameters (CPP)
  • Executing Process Characterization Studies

About the Presenter
David Fetterolf, Senior Consultant, Technical Operations at BioTechLogic, Inc. has more than 30 years of process design and manufacturing experience in the biologics industry. Having focused on gene and cell therapy process development and manufacturing execution for the last 15 years and playing a key role in dozens of gene and cell therapy products, Dave has a wealth of experience to share.

 

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