A chilling impact: cold chain process control in advanced therapies
Successful cell and gene therapies (CGTs) are faced with many challenges, such as managing cold chain and distribution. To accomplish this, a comprehensive approach is needed. Incredible focus has been placed on bioprocessing, analytics, fill finish and other detailed steps. And of course, with success, new issues arise.
Understanding the impact and variability cold chain can introduce to your work is critical in executing successful programs. From time and temperature documentation and rigor, to patient-facing service and integrated platforms, a seamless cold chain is critical in maintaining safety and efficacy at scale. This webinar discusses the challenges and opportunities around considerations for scaling distribution. Also, the importance of data rigor and process control to improve reproducibility.
This webinar was recorded on 1 April 2021.
What will you learn?
- Current scientific thought, demonstrating the path to improved quality
- Planning for downstream cold chain compatibility from the start
- Pathways and considerations for scaling cold chain distribution
Who may this interest?
- CGT supply chain
- CGT process engineers
- CGT QA/QC personnel
Speaker
David Lewandowski
Director, Business Development, Cell & Gene Therapy
Brooks Life Sciences
In his current role at Brooks Life Sciences (MA, USA), David visits with leading research, manufacturing and patient care facilities who require cryogenic infrastructure to support their efforts. He recently completed his elected term as President for the International Society of Biological and Environmental Repositories (ISBER.org). As President, he initiated an effort with the Society of Cryobiology to create and publish the first Liquid Nitrogen-Based Storage Facility Best Practices. This consensus document includes contributions from over 20 experts with a broad range of expertise. David enjoys working with managers in supply chain, operations, facilities, QA/QC and others to define systems which are adaptable, scalable and repeatable.
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