Process Optimization for Monoclonal Antibody (mAb) Commercial Manufacturing

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Webinar Date/Time: Tue, Apr 25, 2023 11:00 AM EDT

In this webcast, Catalent will share a case study of a monoclonal antibody (mAb) from clinical to commercial phase under a highly compressed timeline.

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Event Overview:

Process characterization and validation is an important step in the product development journey and late-phase development. In some cases, process optimization is required for an existing manufacturing process before process characterization begins. Catalent will share a case study of a monoclonal antibody (mAb) from clinical to commercial phase under a highly compressed timeline. This presentation highlights the strategic plan Catalent executed to meet the needs of the program without sacrificing the thorough scientific evaluation of the process required for a successful validation campaign.

Key Learning Objectives:

  • Details on the optimization process for both upstream and downstream manufacturing processes.
  • Catalent’s workflows for process characterization of the optimized process with examples.
  • A case study of how to strategically decrease the timeline from process optimization to commercial manufacturing.


Nicole Kavanaugh
Manager, Downstream Process Development
Catalent Biologics

Nicole Kavanaugh manages a team of scientists in Catalent Madison’s Downstream Process Development Department. Her group is focused on the development of scalable biomanufacturing processes, tech transfer and late-stage process characterization.

Nicole obtained her B.S. in Biology from Hofstra University and her Ph.D. in Microbiology from MIT. She has worked at protein CDMOs for the duration of her professional career, spending 5 years at Aldevron before joining Catalent in October 2020. Her tenure at Catalent was initially focused on building the Downstream Process Characterization capabilities for the Madison site. Her role has since expanded to include early phase development and tech transfer to GMP.

Daniel Pirsch
Senior Scientist, Upstream Process Development
Catalent Biologics

Daniel Pirsch is a Senior Scientist in Upstream Process Development at the Catalent facility in Madison, WI, where he maintains a focus on late-phase projects, including those that were developed within Catalent from an early stage, as well as late-phase projects transferred to Catalent for clinical and commercial manufacturing. At Catalent, he leads efforts in process optimization and process characterization, while also supporting activities enabling GMP manufacturing, process performance qualification and continued process verification.
Daniel obtained his B.A. in Biology from the University of Minnesota – Twin Cities and his M.S. in Biotechnology from the University of Wisconsin – Madison. He has worked in the biopharmaceutical industry since 2016, focusing on upstream process development for biologics and cell therapies.

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