Analytical Strategy & Lifecycle Execution Roadmap & Examples to Support Commercial Readiness & Operational Execution Success

• Using an enhanced analytical development program via appropriate analytical target profiles (ATP) and development staging opportunities to optimize analytical performance.
• Aligning analytical development, manufacturing, and QC controls strategy conditions.
• Pre-/post-commercial capacity expansion and validation considerations for QC operations for autologous cell therapies.

Speakers:

Stephan Krause

Executive Director, Analytical Strategy, Cell Therapy Global Quality

Bristol Myers Squibb