New Points to Consider on Materials in ATMP Manufacturing Available Now

The Parenteral Drug Association (PDA) has announced the release of its latest technical document, Points to Consider No. 13: Materials in ATMP Manufacturing. This comprehensive report provides critical guidance for managing raw materials in the production of advanced therapy medicinal products (ATMPs), aiming to support stakeholders in developing robust material control strategies and promoting best practices across the industry.

ATMPs pose unique challenges compared to traditional pharmaceuticals with their raw materials come from nontraditional sources, such as animals and humans. They typically are not covered in national pharmacopeias nor manufactured for GMP applications. Additionally, they typically are produced by single-sourced small, specialized suppliers.

"The recently released Points to Consider No. 13: Materials in ATMP Manufacturing is a great resource to support the industry's growing focus on ATMP / cell- and gene-therapies," said Joshua Eaton, PDA Sr. Dir. of Scientific and Regulatory Affairs. "PDA is grateful to the authoring team for their time and commitment to produce this document. Special thanks go to the leadership of the Co-Chairs Friedrich von Wintzingerode, PhD of Roche-Genentech and Marc Glogovsky of ValSource, Inc. for guiding the team and effort to success."

The new PDA document applies to all raw materials that interact with the ATMP manufacturing process stream, including:

• Starting and ancillary materials
• Excipients
• Consumables
• Container-closure systems

It addresses both clinical and commercial manufacturing stages across a range of ATMP modalities, including:

• Cell-free mRNA therapeutics
• Viral vector-based in vivo gene therapies
• Human cells for autologous or allogeneic cell therapies
• Tissue-engineered medicinal products