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Standardizing the Production of Cellular Therapy Products
Industry Insight

Standardizing the Production of Cellular Therapy Products

Standardizing the Production of Cellular Therapy Products
Industry Insight

Standardizing the Production of Cellular Therapy Products

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Cellular therapy holds great promise; offering hope to people with diseases that have traditionally been thought of as incurable. More than a thousand cell-based clinical trials are actively underway,[1] many with positive early results. 

Cellular therapies rely on having reliable, high quality source material. This can be a difficult task, especially when we consider that for clinical availability to become widespread, research institutions and the pharmaceutical industry face a unique challenge in bringing standardization to the manufacture of these products, without sacrificing the quality assurance that makes them effective. A recent BioProcess International[2] article makes a strong case for regularly assessing new technologies that can potentially both optimize and standardize cell handling procedures.

The article is a collaborative effort between Dr. Mars Stone at the Blood Systems Research Institute, and BioCision, a life sciences company that specializes in temperature standardization technologies. Both groups saw a need for streamlining the way in which peripheral blood mononuclear cells (PBMCs) are isolated and cryopreserved. PBMCs are the raw material from which many immune therapies are manufactured, and as such, the need to safeguard their quality and efficacy can’t be overstated.

In this new publication, Dr. Stone and her colleagues tested two PBMC isolation methods, as well as two different cell thawing methods for their cryopreserved cells. Standard practice for isolating PBMCs is by density gradient centrifugation, which necessitates a very time consuming, meticulous layering over cells over a Ficoll gradient. A new method was validated in the form of Stemcell Technologies’ SepMateTM tubes, which are self-contained and capable of isolating cells more quickly.

Cryopreserving cells for cellular therapy, whether the cells serve as starting material for other cell types, or will themselves be administered to patients, gives clinical studies and physicians the leeway they need to avoid shortages, and to have treatment ready to hand at short notice, a situation which is not simply convenient, but potentially life-saving. Years of research have been spent on optimizing cell freezing techniques, the main goal of which is keeping cells cold enough to stop the biological processes that cause degradation, genetic drift, and aging, as well as preventing the physical damage caused by ice crystal formation during freezing. Conversely, there is often little thought put into preventing the damage caused by cell thawing, which kick starts these same biological processes back into play, and, if not done quickly or steadily enough, can lead to cell damage due to ice recrystallization.


BioCision’s ThawSTARTM Automated Cell Thawing System

The most common method of thawing cryopreserved cells is to use a heated water bath, but any water based system introduces the risk of contamination, and water bath thawing is also prone to having a subjective thaw time and endpoint. To circumvent these weaknesses, Dr. Stone and her colleagues elected to assess BioCision’s ThawSTARTM Automated Cell Thawing System, which is designed to reproduce the heating profile of a water bath, while reducing variability and the risk of contamination, due to its automated, water-free operation. After comparing PBMC yield, viability, and leukocyte cell subset frequencies between ThawSTAR System and a water bath, the scientists were pleased to report that not only was the ThawSTAR a suitable substitute for a water bath, but cells thawed using the automated system actually had a higher rate of viability, with lower vial-to-vial variability.

Launching new therapies and technologies is always a challenge. Research and development scientists should be vigilant in ensuring that their methods support optimal and reproducible biological activity. Refining and improving those methods is often a matter of implementing the right technological solution.

For the full text of the BioProcess article, please read here

[1] Heathman TRJ, et al. The translation of cell-based therapies: clinical landscape and manufacturing challenges Regenerative Medicine 10(1), 49–64. 2015.
[2] Stone M, et al. Maximizing PMBC Recovery and Viability: A Method to Optimize and Streamline Peripheral Blood Mononuclear Cell Isolation, Cryopreservation, and Thawing. BioProcess International. April 2015.