Cell Therapy Liaision Meeting
November 23, 2020
Click this link for a summary of the 2020 CTLM meeting with the FDA. Links are embedded in the document to each presentation.
**While the dates to particpate live have passed, the recorded course lectures and packet remain available for online viewing. Registration for the online course closes October 31st, 2020. See the Course Home Page for registration details.
- Fundamentals of cryopreservation including mechanism of damage and strategies to prevent damaging cells during freezing, storage and warming,
- Step-by-step protocol development including methods by which to construct a new preservation protocol and debugging an old protocol that is no longer working well,
- Equipment, reagents and supplies used in preservation,
- The challenges in implementing preservation in a clinical/GMP environment,
- Fundamentals of quality control (QC) and quality assurance (QA) as well as application of the program to preservation,
- Design and operation of a storage facility for cryopreserved cells,
- Regulatory issues associated with preservation of a therapeutic product,
- Emerging technology and approaches for the preservation of cells.
The course is designed for a wide range of participants. The preservation of cells has applications in the fields of recombinant cell biotechnology, cell banking, cell therapy, regenerative medicine, and cell-based assays, for example. Previous attendees have ranged from manufacturing engineers, laboratory managers, technicians, nurses, and scientists, and several companies have used the course as standard training for their employees. The course material is designed for those who have little experience with preservation, as well as those proficient in preservation who is interested in improving their practices.
Allison Hubel, PhD is Professor of Mechanical Engineering and Director of the Biopreservation Core Resource (BioCoR, www.biocor.umn.edu), a national resource in biopreservation.
Diane Kadidlo received her B.S. from Iowa State University. She has served as the Supervisor for the University of Minnesota Medical Center Clinical Cell Therapy Laboratory since 1996 overseeing the production of cell and tissue products.
David McKenna, MD is a Professor of Laboratory Medicine & Pathology at the University of Minnesota where he holds the American Red Cross Chair in Transfusion Medicine. He is the Scientific and Medical Director of Molecular & Cellular Therapeutics.
Ian M Pope, PhD, MBA, BSc is the Global Director of Cryo Solutions at Brooks Life Sciences. Ian has worked in the area of cryogenic systems for over 25 years, His expertise lies in the area of the practical application of cryogenics to the storage and preservation of biological materials.
Fran Rabe has over 20 years of experience working in the areas of tissue and cell quality assurance and regulatory compliance. She currently oversees the quality assurance aspect of operations at the University of Minnesota Molecular and Cellular Therapeutics (MCT) Facility.
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