Product Code: 26EL-642-2035
Please note: This is a Single Viewer eCast registration for one participant for this eCast for both the live and on-demand version of this eCast. If you are interested in presenting this program to a group, please see the “eCast Registration Form– Group Viewing” form on the eCast program page.
Access instructions for the live eCast will be provided via email approximately 2-3 business days prior to the live program date. Access instructions for the on-demand version of this program will be provided via email approximately 3-10 business days after the live program has occurred and the on-demand version is available.
Program Description: This program challenges the conventional application of allogeneic infectious disease marker (IDM) testing standards to autologous cell therapy donors. Despite fundamental differences in risk profiles between allogeneic and autologous therapies, current regulations often mandate extensive IDM testing for autologous donations, creating a significant misalignment between scientific rationale and regulatory requirements. The program will address a critical knowledge gap in understanding how current testing practices may actually hinder patient care by creating unnecessary barriers to treatment while contributing minimal value to manufacturing safety or personnel protection. Through case studies and expert analysis, participants will examine evidence demonstrating how these requirements delay therapies, increase costs, and potentially compromise patient outcomes without proportional safety benefits. Industry experts will share experiences implementing modified testing protocols while maintaining GMP compliance and personnel safety. It will explore risk-based alternatives better aligned with autologous therapy principles and provide practical strategies for maintaining appropriate manufacturing safety measures without imposing unnecessary testing burdens on patients receiving their own cells.
