23EL-866 On-Demand eCast: New Approaches to Cryopreservation, Techniques and Validations

Live Program Date: Wednesday, August 23, 2023
Program Number: 23EL-866

Educational Track: Scientific
Topics: Biotherapies
Intended Audience: COOs, Directors, Hospital Blood Banks, Hospitals, Laboratory Staff, Managers/Supervisors, Medical Directors, Nurses, Physicians, Research Scientists, Residents/Fellows, Scientists, Students (MD, MT, SBB), Technologists, Transfusion Safety Officers
Teaching Level: Advanced, Basic, Intermediate

Faculty
(titles and affiliations at the time of the live program)
Director: Asawari Bapat, MD (DPB) (CPS), PGDHHM, Vice President, Quality and Regulatory Affairs, Regenerative Medicine, Infohealth FZE, Dubai, The United Arab Emirates
Moderator: Christina Celluzzi, PhD, MS,CABP(H), Director, Biotherapies, AABB, Bethesda, MD
Speakers: Michael, H. Creer, MD, Laurence M. Demers Distinguished Professor of Pathology and Laboratory Medicine, Division Chief of Laboratory Medicine and Director of Clinical Laboratories, Vice Chair of Clinical Laboratory Operations, Penn State University Hershey Medical Center, Hershey, PA; Ronit Slotky, PhD, MSc, Director, Cell Therapies Manufacturing Facility, Associate Professor of Oncology, Hackensack Meridian School of Medicine, Hackensack University Medical Center, Hackensack, NJ

Program Description
Biotherapies are conferring hope in the treatment of incurable rare diseases and hold a promise of curing untreatable conditions in the near future. Cryopreservation has been the main method for preserving biological samples for long term storage. It has allowed us to use samples collected for research and therapies from decades ago to do new research and obtain new cures.

Most systems of cellular cryopreservation use a controlled-rate freezer (CRF), or employ dump freezing methods, which are also known as uncontrolled rate (or passive) freezing methods. The CRF freezing system delivers liquid nitrogen into a closed chamber into which the cell suspension is placed. Careful monitoring of the rate of freezing helps to prevent rapid cellular dehydration and ice-crystal formation. The dump freezing method relies heavily on the variability of source of samples, the process of manufacturing and on the variability in the temperature of the freezers. Both methods have been studied for their advantages and disadvantages. A long-term, practical solution to these difficulties lies in successful cryopreservation that offers secure, stable storage at temperatures below −130°C where metabolic change will not occur.

In this program, the faculty explore the challenges with cryopreservation, the new techniques being utilized for innovative products and for the emerging advances that could improve these methods. The essential elements of the cryopreservation process that have to be taken into consideration for process development, with the science underlying cryopreservation at a more fundamental level such as the method of freezing, the correct methods for validations of products and the acceptable release criteria to support successful Biotherapies will be presented in this program.

Learning Objectives
After participating in this educational activity, participants should be able to:

• Identify the basic techniques used for cryopreservation of Cell and Gene Therapy Products (CTPs and GTP’s) and to recognize the scope, advantages, and limitations of each technique.
• Apply and choose the most suitable method/ technology based on the type of product for cryopreservation, and to perform the validations and follow the release criteria for the products.
• Employ the cryopreservation techniques and perform the appropriate validations.
• Recommend the process development for cryopreservation suited for their product and facility.

How to Claim Continuing Education Credit

• Single Viewers: if you registered as a single viewer, complete the evaluation found on the "CE Information" tab after watching the video. By submitting the evaluation, you are attesting to watching the presentation in its entirety.

• Group Viewers: This is applicable for groups/facilities that purchased Group Viewing access for this program (registration will be verified prior to processing a group viewing attendance log). Group Viewing Coordinators should submit the attendance log to eLearning@aabb.org within 72 hours of the completion/viewing date. Once AABB receives an attendance log, each participant on the attendance log will be granted access as a single viewer to this program and will be required to complete the evaluation in order to claim continuing education credit. Each participant will be required to have an AABB account in order to access this program/platform. If a participant does not have an account, he/she can create one using the same email address provided on the attendance log.