Collaboration

CGT Material and Supplier Qualification Working Group

Background on initiative

This initiative emerged from discussions at the 2nd CGT Raw Materials Summit, where Basak Clements (biomatria) and Ezequiel Zylberberg (Akron Bio) held a joint session on harmonizing raw-material expectations across suppliers and developers.

• The session highlighted several common challenges, including:

• Misaligned expectations between suppliers and drug developers for information exchange

• Necessary data content and availability to enable thorough assessment of risk and material suitability

• Significant inefficiencies in supplier and raw material qualification processes

What we heard from the industry?

During and immediately after the conference, multiple suppliers, CDMOs, and CGT developers expressed strong alignment with the idea of creating a shared, risk-based, cross-stakeholder framework for supplier and material qualification data. Companies asked to join the effort, noting the need for:

• Clearer, standardized minimum datasets

• Reduced duplication of qualification work

• More efficient technical exchanges between suppliers and users

• A scalable approach suitable for CGT’s unique materials and regulatory expectations

Motivation for forming a Working Group:

This WG brings together the organizations representing both suppliers and end-users across CGT manufacturing. The goal is to enable non-competitive exchange of best practices and set the direction for developing a cohesive, actionable and mutually agreed upon framework with direct inputs from experts.

Get in touch for more information

A practical, consensus-based guidance document and leading to a future documentary standard is the immediate goal of the working group – target first draft May 2026. Please email if you would like to join the working group or would like to have more information.