The Alliance for Regenerative Medicine will hold a 1.5-day workshop on Advanced Manufacturing in CGT on May 16-17, 2024, in the Rockville, MD area. This workshop will discuss opportunities and challenges in emerging technologies and innovations in CGT manufacturing, including advances in manufacturing / analytics automation, role of AI/ML in CGT manufacturing, and decentralized manufacturing.
As the Cell and Gene Therapy field progresses and the number of product approvals continues to grow, there is a rising demand to accommodate higher volume production and increased capacity to deliver these therapies to more patients. ARM’s Advanced Manufacturing in CGT workshop will explore the successes, challenges, and opportunities in developing and implementing advanced manufacturing technologies to meet this demand.
The workshop will consist of formal presentations and panel discussions that will provide opportunities for attendees to ask speakers questions and dig deeper into the presented content.
Key topics
• Automation principles, ideas, challenges, pros and cons of modular semi-automated systems vs end-to end systems
• Business case for automation, phase-appropriate implementation
• Process & analytical automation
• Data digitalization & manufacturing systems
• Parallel processing considerations
• AI in CGT: opportunities and challenges
• Use of AI to optimize manufacturing conditions & process consistency
• AI use in QC / release
• Decentralized Manufacturing model: nomenclature, considerations, pros and cons vs centralized approach
• Control of manufacturing, comparability, raw material management in a decentralized approach
• Analytics requirements in a decentralized model
• Site-specific vs centralized quality program
Who should attend?
• Scientists & engineers who are developing/implementing advanced manufacturing technology for CGTs, or anyone interested in the subject
• Decision makers for manufacturing platforms
• QA/QC analysts interested in process analytical technology
• Quality and regulatory staff
• Contract research and manufacturing organizations
• Vendors developing novel technologies for Advanced Manufacturing
• Data acquisition and analytics specialists
5701 Marinelli Rd, Rockville, MD 20852
Please contact Josephine Lembong at jlembong@alliancerm.org
