February 5, 2020
Akron Biotechnology says biopharma needs a common GMP framework for ancillary materials used in the production of advanced therapies
Ancillary materials (AMs) are components and reagents used during cell therapy production. They are not supposed to be present in the finished products, but often are which can impact quality and safety.
Despite this, at present there are no specific regulations governing the composition, compliance, and qualification of AMs.
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Instead there are several independent GMP frameworks for such materials. These include an ISO document developed by the Standard Coordinated Body (SCB) as well as guidance set forth in USP Chapter <1043>.
The lack of harmonization is a challenge according to Akron, which set out a plan for a common framework in a white paper in Cytotherapy,
CEO Claudia Zylberberg told Bioprocess Insider at present, materials are made according to interpretations of ‘under GMP’ that can vary significantly.
“These materials cross over the globe in different geographies and local agencies have their own interpretation of GMP. Ancillary Material are not regulated under any agency so the expectation for compliance looks very different making suppliers very worried about it.”
The aim of Akron’s white paper is to foster debate on the current approach and prompt industry to develop a common framework according to Zylberberg.
“Several positioning papers were presented in terms of AM that created the base for the ISO currently published technical document, it is very general but covers the basics.
“Now this paper creates the opportunity to discuss the GMP approach one level deeper and proposed a revision of the ISO document.”
Zylberberg added “This framework will bring transparency and compliance for product that do not have a pharmaceutical presence, but have risks associate with them in the manufacture of ATMPs.”
Akron is on the board of the Standard Coordinated Body, a US FDA-backed organization tasked with ensuring “new or revised standards provide the greatest benefits to the broad regenerative medicine community.”
The firm is implementing the standards set out in the paper and has already shared the plan with the FDA according to Zylberberg.
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