Managing Starting Material Stability to Maximize Manufacturing Flexibility & Downstream EfficiencyPublished: March 28, 2019
One of the most critical components for any cellular therapy for both development and clinical application is the starting material. As more products are developed, and clinical trials increase, the current model for managing the starting material will need to evolve in an effort to support growth of the cell and gene therapy industry.
Watch this On Demand webinar to hear from Dominic Clarke, Global Head of Cell Therapy, HemaCare and David Smith, Head of Innovation and Engineering, Hitachi Chemical Advanced Therapeutics Solutions, as they discuss:
- Starting material shelf-life limitations.
- Impact on the product quality and downstream manufacturing processes.
- Approaches to extend the stability of starting material through cryopreservation or hypothermic storage.
- Insight into initial studies designed to demonstrate the efficacy and potential to extend the stability window.
- How this can help alleviate some of the logistics constraints faced by manufacturers, in addition to preserving the material quality and reducing downstream processing variability.
Dominic Clarke, Global Head of Cell Therapy, HemaCare
Dominic Clarke, Ph.D., has 15+ years of experience developing enabling solutions for cell therapy and bioprocessing applications. Prior to joining HemaCare as Global Head of Cell Therapy, Dr. Clarke was the Global Product Manager for Charter Medical’s cell therapy and bioprocessing disposables portfolio focused on collaborating with Cell Therapy and Biopharma end-users to develop flexible closed-system solutions for early and late stage production. Previously, Dominic worked as the Director of Research and Development at BioLife Solutions, developing novel storage media and methods to support extended stability of cells and tissues. Dr. Clarke has authored numerous papers detailing closed-system strategies and extending cell and tissue stability and has been the Principal Investigator on multiple NIH SBIR awarded grants. He received his Ph.D. in Cell and Molecular Biology from the State University of New York at Binghamton and performed his post-doctoral studies in Cellular and Developmental Biology at Syracuse University Upstate Medical Center.
David Smith, Head of Innovation and Engineering, Hitachi Chemical Advanced Therapeutics Solutions
David Smith leads the Innovation & Engineering Center at Hitachi Chemical Advanced Therapeutics Solutions’ with the drive to develop, evaluate and provide novel technology solutions in order to realize commercial success of cell therapies. Before joining the company in 2015, David completed his PhD at Loughborough University establishing Quality by Design principles within cell therapy manufacturing with an interest in Process Analytical Control. Prior to this, David completed a Masters in Biochemical Engineering based at University of Bath, along with extensive periods at UNSW, Australia and DSM, Netherlands. This interdisciplinary background allows David to enhance the robustness and reproducibility of processes whilst analyzing costs and sustainability to supplement Hitachi Chemical Advanced Therapeutics Solutions’ drive to ensure access and deliverability of cell and gene therapies to all.