The setup and payoff: entering the clinic and the market efficiently by leveraging a platform lentiviral vector process

Lentiviral vector (LV) is a proven technology for cell and gene therapies, yet many process and manufacturing hurdles still exist in working with full service CDMOs (contract development and manufacturing organizations). Robust process development is still a requirement in many industry segments, and there’s the need of developing phase-appropriate analytical processes in addition to gaining extensive process knowledge. On top of the time and repetition that it takes to tackle those elements, there are various lead-times developers need to take into consideration – such as those associated with raw material procurement, unparallel project activities, and time to deliver consistent manufacturing output. 

It’s typical to use more than one CDMO to reach commercial manufacturing, yet cell-based therapeutic development in any setting requires reliable workflows, sufficient production capacity, quality oversight, transfer plans, and comprehensive regulatory support. Many organizations manufacture GMP LV, but only a few can offer commercially relevant LV and a path to it. A change in LV manufacturer during development is detrimental; extending timelines and project complexity via tech transfer, comparability studies, and regulatory amendments. Miltenyi offers solutions carefully engineered for unique cell therapies with gene therapy workflows. To support this, our new LV production facility will begin commercial production in 2022. 

This talk will address Miltenyi’s LV platform and approach of simple technology assessment and minimal process development – for scalable and reproducible manufacturing that reduces time to clinic and subsequently, time to market. Join us to learn about standardizing the manufacture of unique cell therapies.

• Robust LV platforms for technology enablement and GMP manufacturing     
• Getting support in bespoke clinical journeys     
• Process characterization and important considerations for commercial viability

Kevin D Beck PhD

Associate Director of Account Management, Miltenyi Biotec

Kevin D. Beck, Ph.D., has more than 10 years of experience in all aspects of GMP manufacturing for cell and gene therapy. As a member of Miltenyi Biotec’s Lentigen Technology division, he works closely with clients to facilitate customized lentiviral vector manufacturing services with intended uses in research applications, clinical trials, and commercial development. Dr. Beck’s interest in the power of immune cells began during his graduate studies where he developed flow cytometric methods supporting his research on the role of neuroinflammation in traumatic spinal cord injury at University of California, Irvine. Dr. Beck completed his academic training as a post-doctoral fellow at the University of California, San Diego studying mechanisms of differentiation and function of T regulatory cells.

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SPEAKERS

Kevin D Beck PhD

Associate Director of Account Management, Miltenyi Biotec

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