Work Item
ASTM WK86634
New Guide for Minimizing the impact of stability testing on gene therapy batch yield
1. Scope
It is widely recognized that gene therapy manufacturing processes result in low yields compared to traditional biologics, particularly in early product development stages. Often, if gene therapy manufacturers were to adhere to common paradigms for stability studies, the outcome would be little, if any, remaining product for patients or studies to support Investigational New Drug applications (INDs). Using a mock product to visualise the impact, we show how volumes required for stability studies can be reduced with the goal of conserving product for patient, while remaining compliant and delivering data on critical quality attributes across the shelf life of gene therapy products.s.
Keywords
gene therapy; stability
Rationale
It is widely recognized that gene therapy manufacturing processes result in low yields compared to traditional biologics, particularly in early product development stages. Often, if gene therapy manufacturers were to adhere to common paradigms for stability studies, the outcome would be little, if any, remaining product for patients or studies to support Investigational New Drug applications (INDs). Using a mock product to visualise the impact, we show how volumes required for stability studies can be reduced with the goal of conserving product for patient, while remaining compliant and delivering data on critical quality attributes across the shelf life of gene therapy products.
The title and scope are in draft form and are under development within this ASTM Committee.
Work Item Status
Date Initiated: 06-02-2023
Technical Contact: John Logar
Item: 000
Ballot:
Status: