Minimizing the impact of stability testing on low-yield biopharmaceuticals
Description
In this episode of BioPhorum connect, we explore the newly published ASTM International standard guide 'Guide for Minimizing the impact of stability testing on batch yield of low yield biopharmaceutical products.'
This guide, authored by BioPhorum members, builds on a foundational BioPhorum publication developed through collaboration among 12 companies in the Advanced Therapy Medicinal Products (ATMP) space, particularly focused on gene therapies.
Simon Walker, Global Change Facilitator at BioPhorum, is joined by two key contributors to both the original BioPhorum deliverable and the ASTM guide:
- Gael Debauve, Head of Gene Therapy Analytical Sciences at UCB
- Madison Lee, Associate Director of CMC Program Management at Regeneron
Together, they discuss:
- Why minimizing the impact of stability testing is critical for low-yield products
- How the ASTM International guide expands the scope beyond gene therapies
- The value of using a mock gene therapy product to quantify potential savings
- Who in the industry will benefit most from this guidance
- The collaborative advantage of working through BioPhorum
Whether you're in QC, QA, regulatory affairs, or CMC leadership, this episode offers valuable insights into improving efficiency and conserving product in early-stage development.
United States
