Preserving the future of medicine: standardizing leukapheresis materials with cryopreservation for scalable cell therapies
Dec
12
2024
On demand

Preserving the future of medicine: standardizing leukapheresis materials with cryopreservation for scalable cell therapies

Thursday 08:00 PST / 11:00 EST / 16:00 GMT / 17:00 CET
Sponsor
Preserving the future of medicine: standardizing leukapheresis materials with cryopreservation for scalable cell therapies

With the rapid advancement of cell therapy, ensuring reliable and consistent cellular starting material is critical for therapeutic manufacturing. A growing challenge in this space is managing variability in leukapheresis starting materials, which impacts the scalability and manufacturability of life-saving cell therapies. Standardizing processes across multiple collection, processing, and manufacturing sites is vital to maintain consistent quality across different regions. For companies navigating complex processes for cryopreservation, challenges such as site qualification, material transport, and resource allocation will arise.

This webinar panel will bring together experts to discuss these industry challenges, focusing on the differences between fresh and cryopreserved starting materials, and how to efficiently scale cell therapies from clinical to commercial phases using an optimized, end-to-end supply chain. Insights on the latest advancements in cryopreservation and strategies to address common challenges associated with leukapheresis starting materials will be shared. The discussion will also highlight the criticality of an integrated supply chain approach to support the scaling of cell therapy programs.

Attend this webinar to:

  • Gain a deep understanding of how variability in leukapheresis starting material affects cell therapy product manufacturability and scalability
  • Discover recent advancements in cryopreservation processes that minimize variability and improve standardization across collection and manufacturing sites
  • Learn how to navigate the time, resource, and process complexities of qualifying multiple sites, with insights from a panel of industry experts
  • Understand how streamlined, end-to-end logistics solutions enable seamless transportation of cryopreserved materials, ensuring the successful scale-up of cell therapy programs
Ray Luke
Ray Luke
Director, MSAT at Verismo Therapeutics

Leader in cell therapy with early and late phase product experience. Skilled in Process analytics, product characterization, Process development, CMO management and technical support.

Marty Giedlin
Marty Giedlin
Senior Team Lead at MG Consulting: Cell & Gene Therapy

Currently a consultant providing preclinical and CMC expertise for cell & gene therapies. He is a pharmacologist and Immunologist with over fifteen years of recombinant protein, monoclonal antibody, gene therapy, and vaccine development experience in research, Pharm/Tox, process development and manufacturing.

Dominic Clarke
Dominic Clarke
VP of Technical Operations, IntegriCell at Cryoport Systems

Dominic Clarke currently serves as Vice President of Technical Operations, IntegriCell for Cryoport Systems after spending the past 2 years as CSO at Discovery Life Sciences. Previously, he held the role of Director of Global Cell Therapy Strategy and Innovation at Charles River Laboratories (CRL) with overall responsibilities for developing and expanding the cell supply business unit. Prior to joining CRL, he was the Global Head of Cell Therapy at HemaCare where he helped expand overall visibility and market growth. He started his career in cryobiology and led the research & development efforts for BioLife Solutions before transitioning to delivering industry leading single-use solutions at Charter Medical. Dominic has nearly 20 years in cell & gene therapies and has been serving as the Chair of the International Society for Cell & Gene Therapies (ISCT) Process Development and Manufacturing industry sub-committee for the past 5 years.

Mark Sawicki
Mark Sawicki
President & CEO at Cryoport Systems

Mark Sawicki has over 20 years’ business development and sales management experience. He has consistently delivered on corporate revenue and market share goals in the pharmaceutical and biotechnology industries. Sawicki holds a bachelor’s in biochemistry from the State University of New York at Buffalo. He also has a Ph.D. in biochemistry from the State University of New York at Buffalo, School of Medicine and Biomedical Sciences. He received graduate training at the Hauptman Woodard Medical Research Institute. Sawicki has authored a dozen scientific publications in drug discovery with a focus on oncology and immunology.