Managing starting material stability to maximize manufacturing flexibility and downstream efficiency

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 at HemaCare Corporation

Dr. Clarke has over 15 years of experience developing enabling solutions to support cell and gene therapies. He is the Global Head of Cell Therapy at HemaCare, a leading provider of source material for clinical development and commercial manufacturing of cell-based therapies. Previous roles include, Global Product Manager for Charter Medical’s cell therapy and bioprocessing single-use systems portfolio and Director of Research and Development for BioLife Solutions.

Dominic currently serves as the co-chair for the International Society for Cell and Gene Therapies Process and Product Development Committee with efforts directed towards translating research and process development from bench to clinic.

David Smith

Senior Biomedical Engineer at 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.

Watch now

SPEAKERS

Dominic Clarke

Global Head of Cell Therapy at HemaCare Corporation

David Smith

Senior Biomedical Engineer at Hitachi Chemical Advanced Therapeutics Solutions

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