Ancillary materials play a critical role in the manufacture of cell and gene therapies, and best practices for their quality management are the subject of ongoing discussion. Given that these therapies cannot be sterilized, ancillary material quality is critical to clinical advancement and commercialization.
At Akron, we believe that a harmonized definition of what constitutes current good manufacturing practices (cGMPs) for ancillary materials is important to the advancement of the industry, as it will enable a significant reduction in uncertainty and costs among advanced therapy developers.
For this reason, we have developed a three-stage approach to achieving cGMP compliance for ancillary materials. In this framework, ancillary material quality – consistency, compliance, and control – increases in accordance with the therapy developer’s need for greater quality and documentation.
This framework will be published as part of a larger paper on ancillary material quality in Cytotherapy in the coming weeks. It is our attempt to drive greater transparency and harmonization among ancillary material suppliers, thereby reducing uncertainty and costs for advanced therapy developers.
We will be presenting this framework at the annual TERMIS meeting in Orlando at 13:00 on Monday, December 2nd and at the Cell Therapy Manufacturing Congress in Amsterdam at 14:15 on Tuesday, December 4th. Join the conversation!
Akron will continue working with customers, competitors, and industry stakeholders to further develop this framework in the coming weeks and months, driving our industry towards greater standardization. Learn more about Quality at Akron, and reach out to engage with us on this important initiative.