Ori Biotech Industry News: Project A-Cell, integrating Quality by Design principles in cell-based therapy CMC programs

Project A-Cell: Collaborative efforts across the industry to improve patient access

The Alliance for Regenerative Medicine and the NIIMBL | The National Institute for Innovation in Manufacturing Biopharmaceuticals have released Project A-Cell, a collaborative effort from across the cell-based industry to create a standardized methodology for Chemistry, Manufacturing and Controls – intended to support the industry in overcoming manufacturing challenges that currently limit patient access to cell therapies.

A-Cell draws on insights from more than 50 industry experts and over 30 leading therapeutic developers – including Ori’s very own Quentin VICARD, who contributed his insights in chapter 10 ‘Control Strategy’, and Kevin Gordon who provided editorial review. Also including insights from regulatory experts and the Standards Coordinating Body, A-cell initially focuses on CAR-T therapy, due to the industry’s early regulatory success and notable interest from investors. 

We are very excited about the project because cell therapies have demonstrated a transformational impact on patients. Now is a critical time to have the biopharmaceutical manufacturing community share best practices to accelerate access to these treatments for patients in need.

Gene Schaefer, NIIMBL Senior Fellow

Following the success of Project A-Gene launched in 2021, we’re confident that A-Cell will support the advancement of the field and development of cell-based therapies. We’re proud that members of our team have contributed to such a momentous milestone for the industry, as we take a step closer to achieving our mission of enabling widespread patient access to CAR-T cell therapies. 

Learn more about Project A-Cell