Material and component risk control is a key consideration for the manufacture of cell and gene therapies and must adequately address the risks associated with each material and component to ensure patient safety. Regulatory and standards bodies guide us to establish the reliability of the certificate of analysis for each material through validation of the stated specifications, proportionate to the risks posed. However, determining what is adequate can be challenging.

The requirements set-forth by the FDA and EMA present a range of compliance within which manufacturers may operate under the governance of adequate policies and standard operating procedures for material qualification. The USP provides a solid framework for application of these requirements through material classification, based on their intended usage. This approach should also be leveraged to drive selection and characterization of raw materials in a phase-appropriate manner. This extends to control of critical consumable components as well, as more recent guidance requires in-depth assessment of plastic components.

This talk will provide a framework for material and component selection based on risk classification, risk assessment of critical consumables, phase-appropriate characterization and control of both materials and components, and lastly, managing supply chain risk based on criticality.

Speaker Slides