Cell therapy applications are quickly moving into the clinic. Cell quality is critical in providing an end product with optimal therapeutic efficacy. In the previous blogs for this series, we summarized the role of starting material in cell therapy presented by Dr. Burger and then Dr. Minger presented how cells are obtained and grown on an industrial scale. The next presenter at the HemaCare hosted panel at the International Society for Cell Therapy was Dr. Aby Mathew, Ph.D., a Scientific Advisory Board member at HemaCare and Senior VP & CTO, BioLife Solutions, Inc. presented on best practices in stability and biopreservation of cells.
Why is biopreservation important?
Cell stability is critical in maintaining cell viability and functionality throughout cell processing. As soon as samples are collected, cell viability and functionality begins to decline.
From Dr. Mathew: "How do we maintain yield, viability, functionality throughout process to achieve optimal therapeutic efficacy? When dealing with biopreservation, we’re running against this wall in the sense that maximum yield, viability, and functionality is from that starting point of the source material”
As cells are removed from their native environment, they become stressed. A stressed cells prioritizes survival, recovery, and it’s least important characteristic is functional performance. However, therapeutic objectives are centered on the function the cells provide. Stability stresses occur at multiple levels including genomic and mitochondrial instability. It’s critical at the cell processing endpoint for cells to have the expected characteristics necessary.
When is biopreservation most important?
Biopreservation is often implemented at the processing endpoint. Dr. Mathew questions this practice: "Historically, biopreservation focuses on the back-end, the final product. When you think about the amount of time in put into characterizing cell, optimizing process. Then cells are sent for banking or preservation. You have to ask – are these practices aligned? As a best practice, I recommend biopreservation should be implemented from beginning."
Given that cell viability and function begin to decline immediately after cell isolation, it’s important for biopreservation to be implemented along the entire processing continuum. In particular, biopreservation is extremely important during the initial cell isolation. BioLife and HemaCare have partnered to implement the most favorable preservation of cells during cell isolation to provide the best cells as source material.
Dr. Mathew shared data demonstrating that from "the initiatives HemaCare is taking to provide optimal cells for testing, both non-frozen and cryo-preservation, you can see that cells can last for a longer period of time." BioLife has found that implementation of biopreservation throughout all cell processing greatly increases product yield.
How should you preserve your cells?
[pullquote]Minimize the stresses throughout the process. Maximize the output. [/pullquote]
Well characterized biopreservation options are plentiful. Exploring the different options can improve outcomes for your specific study or application. One big question is room temperature preservation versus cryopreservation.
Watch the video to see Dr. Mathew’s comparison of these processes. As biopreservation capabilities have improved, there are great options for both avenues. A major improvement is biopreservation medium is the ability to store cells in a serum and protein free environment. This is particularly of interest in regenerative medicine applications. This expands the formulation and delivery mechanisms available for the cells.
Starting with the highest quality cells, maintaining cell quality, and cell characterization are the foundation of cell therapy. Bottom line: maximizing sourcing, biopreservation, processing and characterization maximizes cell capabilities.