Antibody Drug Conjugates (ADCs) are a class of biomolecules that has seen rapid growth with multiple new commercial products. Adoption of single-use (SU) systems has been slow due to concerns about the safe handling of organic solvents and the toxic small molecule payload. Recent advances in single-use technology have overcome these concerns and now provide an understanding of the suitability, scalability, and fluid compatibility of both the single-use components as well as the supporting hardware and controls. In this webinar, we show how single-use technology can deliver consistent and scalable ADC chemistry and functionality with desired final product specifications and high yield.
In this webinar, you will learn:
- How SU assemblies are used in the ADC development space
- Recommendations for consistent transfer of SU processes to manufacturing
- Understand if SU technology is right for your product
- Evaluate the pros and cons of SU for ADCs
Speakers
Lisa McDermott
Merck
Director Process and Analytical Development
Lisa joined Merck in January 2010 as an analytical project lead, responsible for ADCs. She brings with her more than 25 years of experience in both organic synthesis and analytical sciences and has had the opportunity to contribute to many projects ranging from discovery to full development, but none has been as exciting as the emergence of ADCs. She also has an extensive chromatography background with experience in integrated LC/MS screening systems.
Gary Conway
Merck
Principal Production Scientist
During his 8 years as principal production scientist at Merck, Gary has been actively involved in the transfer, scale-up, validation and manufacture of numerous projects of clinical and commercial bioconjugations . He has 25+ years of experience in upstream and downstream manufacturing and management, all in cGMP regulated environments.
Pharma and biopharma manufacturing
- Antibody drug conjugate manufacturing
期間:1h
言語:English
セッション 1:presented November 12, 2020
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