Scott Burger, MD
This is part three of a four-part series from Scott Burger, MD, Principal, Advanced Cell & Gene Therapy, LLC.
III. ENHANCING STABILITY – HYPOTHERMIC STORAGE
Hypothermic storage is a simpler and perhaps more broadly applicable method to achieve extended cell stability.
Cells maintained in the presence of an effective hypothermic preservation agent at 2-8°C can increase stability by days or weeks, with varying results obtained with different cell types (see Mathew, et. al.) – some more than others.
Ideally, the hypothermic preservation solution will serve as an excipient as well, enabling administration of the product with no additional manipulation at the clinical site.
The potential for hypothermic storage to increase stability merits investigation for many cell-based products and associated cellular raw material. Extended shelf-life can eliminate several operational problems and make clinical and commercial success far more attainable.
Hypothermic storage may be particularly valuable for cell/scaffold combination products, and other three-dimensional tissue-engineered products for which cryopreservation is not currently feasible.
See:
Biopreservation Stability (Part 1): Impact of Stability
Biopreservation Stability (Part 2): Enhancing Stability – Cryopreservation
Biopreservation Stability (Part 4): New Reagents, New Methods – Effective Process Modification
