BioPhorum approach to the registration of innovative raw materials using quality by design principles – Appendix 2: Protein A resins

In January 2022, the biopharmaceutical industry came together through BioPhorum to publish a pragmatic, simple and regulatory-acceptable solution to the supply shortage challenges it currently faces.

Our paper, the BioPhorum approach to the registration of innovative raw materials using quality by design principles, explored the diversity of registration practices for innovative and complex materials and illustrated this through a survey of the current state. We then offered a harmonized and simplified approach for the registration of materials through a ‘quality by design’ (QbD) approach. To supplement this paper, we have produced Appendix 2: Protein A Resins.

When constrained supply chain conditions or new resin technology drives the need to change to a new Protein A resin, there is currently no standardized approach to the technical assessment and regulatory framework necessary for successful alternate Protein A resin implementation.

Because the most urgent issues for BioPhorum member organizations are linked to commercial products, the approach demonstrated in this Appendix is set in the context of post-approval commercial support activities. A similar approach would be expected for a new submission, especially if supply chain intelligence indicates that enhanced Protein A resins may be available or desirable in the future.

The Appendix consists of an introduction to Protein A, the process followed for identifying critical material attributes, and controls and principles for registration that would offer future flexibility of supply.