ISCT Open Access Webinars

Webinar Description:
In the second half of 6-part Cold Chain Webinar Series, we will cover common solutions to issues encountered in logistics and supply of getting ATMPs to intended destinations and patients.  Part 4 revisits formulation and container selection by addressing how these considerations affect shipping options and product custody. 

Key Learning Objectives:

• Explore various durability tests and considerations on primary, secondary, and transport packaging for cell and gene products
• Understand the importance of cell therapy formulation and its impact on product performance during cryopreservation, storage, and transport
• Gain an introduction to Chain of Identity and Chain of Custody tracking documentation and why this is an important industry guidance

Protecting Cell and Gene Therapies in the Cold Chain including Primary Packaging, storage and transport equipment and components. Webinar 4 of the Process Development & Manufacturing Cold Chain Series Sponsored by

Chaired By: 

Shannon Eaker, PhD ISCT Process Automation, Analytics & Development Working Group Chair Chief Technology Officer, XCell BioSciences United States Dr. Shannon Eaker is the Chief Technology Officer at Xcell Biosciences. He earned his Ph.D. from the University of Tennessee, Knoxville in Biochemistry, Cellular and Molecular Biology. His expertise is primarily focused on T-cell, hematopoietic stem cell (HSC), and undifferentiated embryonic stem (ES) and induced pluripotent stem (iPS) cell biology. Shannon has built and supported process development and manufacturing activities and platforms within cell and gene therapy. Prior to Xcell, Shannon was with Cytiva (formerly GE Healthcare) Cell and Gene Therapy where he spent more than 12 years. He is a member of the International Society for Cell Therapy (ISCT) Process Development and Manufacturing (PDM) committee and has authored numerous papers within the field of cell and gene therapy and regenerative medicine.

Speakers:

Joe Cintavey, BSME, MBA Product Manager, W.L. Gore & Associates United States

Joe Cintavey is a Product Manager with W.L. Gore & Associates.  He has over 15 years of experience at Gore working in the biopharmaceutical and medical industry. While at Gore he has been a Product Manager for their medical wire & cable products and Lyoguard trays.  For the last 8 plus years, he has been working in the cold chain handling area, focused on storage of bulk drug substances and is currently the Product Manager for the GORE® STA-PURE® Flexible Freeze Containers.  Prior to Gore, he worked as a connection systems product manager in the automotive industry.  He received a BSME & MBA from the University of Cincinnati.

Sean Werner, PhD Chief Technology Officer, Cell Processing, BioLife Solutions United States

Sean Werner is the Chief Technology Officer – Cell Processing at BioLife Solutions, a leading provider of bioproduction tools and services to the cell and gene therapy and broader biopharma markets. BioLife acquired Sexton Biotechnologies in 2021 where Sean was President of the company known for providing processing and handling solutions for the CGT industry. Sean received his PhD from Purdue University in Biology followed by post-doctoral positions at the Indiana University School of Medicine and Eli Lilly. Sean has previous experience filling various roles in the global regulatory and general management functions supporting medical devices, autologous cell therapy, and single use disposable development programs. In his 15 years working in the life science industry, he has guided pre-clinical and clinical testing and submission strategies leading to global commercialization of multiple medical devices and bioprocessing tools.

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Bill Shingleton, BSc, PhD Director, Applications, and Biology: Cell and Gene Therapy R&D, Cytiva United Kingdom

Bill is passionate about delivering Advanced Therapeutic Medicinal Products (ATMPs) to patients. Focussed on developing technology that will enable successful translation and commercialization. As an experienced Biological Scientist, with a background in inflammation, the biology of aging and connective tissues, he is applying this research knowledge in the fields of auto-immune, degenerative diseases and oncology. His experience was gained in academia at the Universities of Cambridge and Newcastle-upon-Tyne, combined with 20 years of industrial research with Unilever R&D, GE Healthcare Life Sciences and now Cytiva. Recent roles have been supporting the Cell Therapy Industry through and the application of in-vivo imaging to enable safety, efficacy and mode of action studies. He is now driving the development of tools and technology for cell therapy manufacturing and cryo-preservation. In his current role, he leads a global team of biologists and engineers developing equipment, consumables, software and processes that enable the manufacture of cell and gene therapies.