This webinar will take you through the story of a CMO preparing for the manufacture of a commercial antibody drug conjugate (ADC). Join us to learn about how we grew as a CMO to develop a Commercial ADC program. We will walk through the full timeline from development, process risk assessment, and control strategy development and validation, finishing off with preparation for a Commercial ADC Pre-Approval Inspection Audit.
In this webinar you will learn how to:
- Properly structure your development work
- Perform a thorough process risk assessment
- Prepare for pre-approval inspection
Speakers
Elizabeth McKee
Merck
Commercial Project Manager
Elizabeth is a commercial project manager in St. Louis, MO, mainly supporting ADC projects. Prior to her current role, Elizabeth was a quality engineer within the organization, supporting cleaning, change control, and validation, and she was instrumental in getting the site prepared for the commercial manufacture of ADCs. She has a bachelor’s degree in pharmaceutical sciences from Purdue University.
Jake Spies
Merck
Senior Scientist Group Lead Process & Analytical Development
Jake has been with Merck for 8 years, developing and manufacturing ADCs ranging from preclinical to commercial. During this time, he has developed, optimized, intensified, characterized, and scaled-up ADC processes.
Kerry Keith
Merck
Head of Site Quality
Kerry has 15 years of experience in the pharmaceutical industry within the quality assurance group and 7 years as a forensic scientist with the Illinois State Police. Kerry works in Merck's site quality area for the St. Louis site which manufactures APIs, excipients, and biological buffers for the pharmaceutical industry, including antibody drug conjugates (ADCs). She received a bachelor’s degree in chemistry from Truman State University.
Pharma and biopharma manufacturing
- Antibody drug conjugate manufacturing
Duration:45min
Language:English
Session 1:presented June 18, 2020
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