CGT Manufacturing: Distributed & Digital with Deloitte Consulting's Omkar Kawalekar, Ph.D.
Feb 27, 2025
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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.
Distributed manufacturing models enhance patient access to cell therapies by addressing capacity constraints and ensuring timely delivery through coordinated production sites.
The integration of automation and digital technologies in manufacturing processes is crucial for reducing variability and optimizing efficiency in cell and gene therapy production.
Deep dives
The Evolution of Distributed Manufacturing in Cell Therapies
Distributed manufacturing in cell therapies involves a network of centrally coordinated sites spread across various locations. This model differs from decentralized manufacturing, which operates multiple independent sites, and point of care manufacturing, where therapies are produced at the treatment location. Distributed manufacturing aims to enhance patient access to life-saving therapies by increasing scalability and flexibility, which is essential given the demand fluctuations in cell and gene therapies. By employing multiple production sites, companies can better manage capacity constraints and ensure prompt delivery of therapies to patients.
Automation as a Key to Reducing Variability
Automation plays a crucial role in reducing batch-to-batch variability in cell therapy manufacturing through improved operational consistency. The process is divided into four stages, beginning with manual operations and advancing to fully closed automation, where entire workflows are managed automatically. By integrating real-time data-driven monitoring and automated unit operations, companies can minimize human intervention, leading to more reliable production results. However, implementing automation faces challenges, including legacy infrastructure, data interoperability, high costs, and a lack of skilled workforce, all of which need addressing to achieve optimal results.
Leveraging Digital Technologies for Enhanced Manufacturing
Digital technologies and data analytics are essential for optimizing manufacturing processes in the cell and gene therapy sector. Strategies such as manufacturing capacity management, control towers for operational oversight, and process optimization analytics help streamline production and increase efficiency. By employing AI technologies, manufacturers can maximize the utilization of production slots and anticipate potential issues that may arise during the manufacturing process. Ultimately, the integration of digital tools is pivotal for improving patient access and maintaining a competitive edge in the rapidly evolving market.
Omkar Kawalekar, Ph.D., Senior Manager, NextGen Therapies Manufacturing & Supply Chain Lead, Deloitte Consulting joins Host Erin Harris to share his expert take on how distributed manufacturing models address capacity constraints and supply chain risks, the role of automation in reducing batch-to-batch variability, as well as the power of digital technologies in optimizing production processes. He also covers the key considerations for CGT companies when choosing between in-house manufacturing and CDMO partnerships, and much more.