Join us in-person in San Francisco, CA at the 2025 ISPE Facilities of the Future Conference event. Learn more about our involvement in the event below.
Evotec at 2025 ISPE Facilities of the Future Conference
Implementing ASTM E2500 in Continuous Manufacturing
Date and Time: Monday, 27 January at 11:15 - 11.45
Speaker: Jeremiah Genest, Senior Director Quality Technical and Risk Services, Just - Evotec Biologics
This presentation will explore the application of ASTM E2500 (Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment) in the context of a continuous manufacturing facility for monoclonal antibodies. We will discuss the challenges and opportunities in adapting this standard to the unique requirements of continuous bioprocessing and how Just-Evotec Biologics has implemented this in constructing two mAb facilities. This presentation will provide valuable insights for biopharmaceutical professionals involved in facility design, quality assurance, and regulatory compliance. Attendees will gain a deeper understanding of how to leverage ASTM E2500 to enhance the efficiency and quality of continuous mAb manufacturing processes.