Minimizing the impact of stability testing on low-yield biopharmaceuticals

JUL 15, 20256 MIN
BioPhorum Connect

Minimizing the impact of stability testing on low-yield biopharmaceuticals

JUL 15, 20256 MIN

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 UCBMadison Lee, Associate Director of CMC Program Management at RegeneronTogether, they discuss:Why minimizing the impact of stability testing is critical for low-yield productsHow the ASTM International guide expands the scope beyond gene therapiesThe value of using a mock gene therapy product to quantify potential savingsWho in the industry will benefit most from this guidanceThe collaborative advantage of working through BioPhorumWhether 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.