Implementing Commercial GMP Compliance Frameworks to Strengthen Donor-Derived Cell Therapy Manufacturing Readiness

• Establishing donor qualification and documentation workflows to meeting commercial GMP requirements while reducing regulatory compliance risks
• Implementing chain of identity and custody controls to strengthening donor material traceability across manufacturing operations
• Aligning quality, manufacturing and regulatory oversight to maintaining inspection readiness throughout commercial scale-up activities

Speakers:

Cokey Nguyen

President & Chief Executive Officer

Atara Biotherapeutics Inc.