Two groups look to bring standardization to cell therapy manufacturing in their latest paper
As cell therapies are becoming used more and more in medicine, two groups are looking to standardize cell therapy manufacturing so it can eventually become more widely available.
The Alliance for Regenerative Medicine (ARM) and the National Institute for Innovation in Manufacturing BioPharmaceuticals (NIIMBL) have released a paper called Project A-Cell, a collaboration meant to analyze how to incorporate Quality by Design (QbD) principles specifically in the manufacturing of CAR-T cell therapies.
The paper aims to bring best practices and standard methods for CMC to the cell-based therapy sector. According to ARM, the field still faces challenges to scale-up manufacturing efforts, primarily due to a lack of standardized methods and training around CMC programs.
According to Michael Lehmicke, ARM’s VP for science and industry affairs in an email to Endpoints News, the field still is highly complex given that the cells often come from individual patients and have a great deal of variability.
The paper is an effort to create best practices and bend the learning curve for the sector, particularly for newcomers. The goal is to facilitate more predictability around cell therapy CMC programs, which then hopefully will lead to greater access for patients.
Project A-Cell, which has been in development for about a year, has taken lessons that have been applied to the manufacturing of monoclonal antibodies and vaccines before. ARM said these sectors have previously faced similar hurdles to what CAR-T cell manufacturing is facing now when developers sought to advance from small-batch manufacturing to full-scale commercial production.
Both sectors helped to increase manufacturing by reducing barriers to technology transfers and better training.
“We think A-Cell will similarly advance the cell therapy field and help to deliver durable and potentially curative treatments for a range of serious cancers and other diseases,” Lehmicke said.
As for its adoption in the industry, ARM said that both educational institutions and private companies are looking at the paper and Lehmicke is expecting it will be widely used soon.
“Ultimately, there is no ‘one size fits all’ approach to cell therapy CMC. Risk assessment to develop the proper CMC strategies tailored to each product is paramount — this is a point we make in each chapter of the document,” Lehmicke said.