Session I - Autologous Cell-based Therapies

Autologous Cell-Based Medicinal Products

Comparison of new manufacturing processes against established ones is crucial for ensuring the quality, safety, and efficacy of biotherapeutic products. The assessment of comparability for Chemistry, Manufacturing, and Controls (CMC) changes becomes particularly paramount in the pharmaceutical industry when transitioning from earlier to newer production methods. Autologous cell-based medicinal products (referred to autologous products herein), derived from a patient's own cells, present unique challenges when it comes to evaluating changes in CMC parameters due to their inherent variability and intricacies in manufacturing.

This abstract highlights the significance of an autologous session dedicated to discussing comparability assessment strategies for CMC changes in the context of evolving manufacturing processes. Such sessions serve as platforms for industry experts, regulators, and stakeholders to collaborate, share insights, and develop standardized approaches that ensure the safety and efficacy of autologous products.

This session's main objectives include outlining best practices for characterizing the critical quality attributes (CQAs) of autologous products, establishing robust comparability protocols, and addressing regulatory expectations for CMC changes in autologous therapies. Participants will delve into the complexities of autologous product manufacturing and explore analytical methodologies that can effectively capture the nuances of these personalized treatments.

Key topics to be covered during the session may include the identification of critical process parameters (CPPs) for autologous products, risk assessment strategies for CMC changes, and the utilization of advanced analytical techniques such as mass spectrometry, next-generation sequencing, and bioinformatics for comprehensive comparability evaluation. Case studies illustrating successful comparability assessments for autologous products will be presented to showcase real-world applications of the discussed methodologies.

In conclusion, the autologous session focusing on comparability assessment for CMC changes represents a critical initiative in advancing the field of personalized medicine. By fostering collaboration, innovation, and regulatory alignment, this session aims to drive the development of robust CMC strategies that support the continued advancement and commercialization of autologous products while upholding stringent quality and safety standards.

Session Speakers:

Comparability Considerations for In-Licensing an Early-Stage Academic Program

Annie Chiu, CARGO Therapeutics, Inc.

Comparability Study Considerations in the Development and Approval of AMTAGVI™ (Lifileucel)

Arvind Natarajan, IOVANCE Biotherapeutics, Inc.

Approaches for Establishing Comparability for Cell Therapy Products

Nitin Agarwal, Kite Pharma

Analytical Comparability for Autologous CAR-T Products

Hai Yue, Bristol-Myers Squibb Company