Merck
HomeWebinarsCommercializing Antibody Drug Conjugates: A CMO’s Journey

Commercializing Antibody Drug Conjugates: A CMO’s Journey



WEBINAR

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

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

Jake Spies

Merck

Project Lead Scientist

Jake is a project lead scientist in Merck's process and analytical development group in St. Louis which manufactures antibody drug conjugates (ADCs). Jake has previously held multiple positions in the ADC manufacturing group and brings experience in scale-up and technology transfer. He received a bachelor’s degree in chemistry from the Southeast Missouri State University.

Kerry Keith

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.

Webinar Information

Pharma and biopharma manufacturing

  • Antibody drug conjugate manufacturing
  • Duration:53min

  • Language:English

  • Presented:Thu, June 18, 2020

    Watch Now