Cell & Gene: The Podcast CGT Manufacturing: Distributed & Digital with Deloitte Consulting's Omkar Kawalekar, Ph.D.
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Feb 27, 2025 Omkar Kawalekar, Ph.D., a Senior Manager and NextGen Therapies Manufacturing & Supply Chain Lead at Deloitte Consulting, dives into the future of cell and gene therapy manufacturing. He discusses how distributed manufacturing models can tackle capacity issues and supply chain threats. Omkar emphasizes the role of automation in minimizing variability between batches and the significance of digital technologies in optimizing production. He explores vital decisions for CGT companies regarding in-house versus CDMO partnerships, providing insights on efficiency and innovation.
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Distributed Manufacturing Defined
- Distributed manufacturing differs from decentralized or point-of-care manufacturing.
- It uses a network of centrally coordinated sites spread across locations.
Benefits of Distributed Manufacturing
- Distributed manufacturing expands capacity, de-risks supply chains, and accelerates market access.
- It achieves this by using multiple sites, reducing reliance on long-distance shipping, and placing facilities closer to patients.
Automation Stages and Benefits
- Automation in cell therapy manufacturing has four stages, from manual to AI-driven.
- It reduces batch-to-batch variability through data-driven monitoring, automated operations, and closed systems.