Forum Session: The GMP core lab: Expectations, realities, and success strategies

Vaccine development, translational research, and small-core facilities. Technical issues, regulatory compliance, and costs make GMP labs for product scale-up and/or small-volume product manufacturing for clinical trials or commercial launches a complex facility undertaking. Here, session leaders use GMP case studies at Université de Montréal, Hopîtal Enfant-Jesus, Hopîtal Maisonneuve-Rosemont, and Dana Farber Cancer Institute to detail success strategies for developing GMP core lab facilities. They examine the special technical challenges in planning process-driven GMP facilities, and they define critical systems, quality and compliance criteria, initial capital costs for construction and equipment, and ongoing operating costs.

This session is approved by the AIA for continuing education credit.

• Alan E. Orton , Principal - NFOE/NXL Architects
  
• Julie-Léa Lipszyc, Project Manager & Compliance Specialist - SNC Lavalin Pharma