An Appreciation of Cryopreservation and Its Impact on Cell and Gene Therapy Manufacturing

When:  Sep 22, 2021 from 09:00 to 10:30 (PT)
Wednesday, September 22 - 9:00 PST / 12:00 EST
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An Appreciation of Cryopreservation and Its Impact on Cell and Gene Therapy Manufacturing

An ISCT Process and Product Development Webinar
Part 1 of 6 of the The ISCT Process and Product Development
Cold Chain Webinar Series


Sponsored in part by: 



Webinar Description:

Cell and gene therapies rely heavily on proper cold chain management to ensure proper quality and consistency is maintained from the starting source materials to the final therapeutic product. Maintaining cell quality and extending shelf-life are necessary to expand availability. Cryopreservation has long been an attractive option as it offers numerous advantages from preserving cell quality and extending stability to enabling process flexibility and reducing logistics constraints. However, while commonly used in practice, many of the basic aspects involved with cryopreservation of cell therapies are overlooked or unknown which can result in delays and risks.

To achieve optimal success, it is essential that the entire protocol from freezing, storage and thawing be optimized and implemented. The aim of this webinar is to describe the core elements of cryopreservation which includes the critical process steps along with a keen awareness of the quality and regulatory requirements fundamental to developing safe and effective cell therapies.

Chaired By: 

Dominic Clarke, PhD
Co-Chair, ISCT PPD
Discovery Life Sciences
United States

Dr. Clarke has over 15 years of experience developing enabling solutions to support cell and gene therapies. He was the Global Head of Cell Therapy at HemaCare, a leading provider of source material for clinical development and commercial manufacturing of cell-based therapies.

His 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.

Speakers:

 

Erik Woods, PhD
Ossium Health
United States

Dr. Woods has devoted his career to advancing cell culture and cryopreservation to facilitate mainstream clinical use of cellular therapies. Originally co-founding General BioTechnology, LLC (GBT) in 1997 which he led for 15 years through successful acquisition by COOK Medical in 2012, and now as Co-Founder, EVP and CSO of Ossium Health, the world’s first organ and tissue donor derived cryopreserved bone marrow bank.

In addition to his executive role, Dr. Woods oversees Ossium’s CLIA testing lab as a board-certified High Complexity Clinical Laboratory Director. Dr. Woods is a Fellow of the Society for Cryobiology, has published numerous peer reviewed manuscripts and book chapters, and holds multiple patents in the field.

Marlin Frechette
FUJIFILM Irvine Scientific
United States

Marlin Frechette has over 30 years of experience in the Medical Device industry, servicing Pharmaceutical and Biopharmaceutical customers. As Chief Quality & Compliance Officer at FUJIFILM Irvine Scientific she is responsible for the Company’s quality, regulatory & compliance departments including Quality Systems, Global Regulatory, Corporate Compliance, and EHS. She holds a Bachelor’s of Science with a major in Business Administration & Personnel Management.


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