In Cell Therapy Markets, the Process is the Product

cell therapy market

Storage and distribution of cell therapy products need to be impeccably organized to be able to positively impact patients’ health. Perfect cold chain of custody must be guaranteed at all stages, via fully automated workflows. Enter Brooks Life Sciences’ automated storage system and transport solutions.

About two decades ago, automation took hold of the drug discovery industry. High throughput workflows were necessary to advance the field, and more and more processes were performed by robotic systems, which minimized sample variability and eliminated human error. The automated processes included assay development,1,2 two- and three-dimensional cell culture techniques, 3 and imaging technologies. 4,5 Automation subsequently also made its mark in stem cell development, where novel workflows were developed to robotically manufacture induced pluripotent stem cells. 6,7

Not surprisingly, automation is also taking a firm foothold in the cell therapy market, where in the past five years thought leaders have boldly pushed for complete automated solutions that can produce, store and deliver autologous cell therapy products directly at the point-of-care facility. 8 Automation is particularly helpful to ascertain perfect cold chain of custody for biosamples that require cryogenic storage conditions. Brooks Life Sciences has released a new video, in which David Lewandowski, the company’s Product Marketing Manager and President-Elect of the International Society for Biological and Environmental Repositories, explains why the focus on automation and the process of storing biospecimens is essential in the cell therapy market.

“If we do not pay attention to the process of storing biospecimens, then we should not pay attention to the outcomes of scientific studies which are based on them,” Mr. Lewandowski observes. Indeed, scientific progress can be achieved much faster when research is conducted using high quality, perfectly preserved biosamples with impeccable cold chain of custody histories. When considering cell-based products, this paradigm becomes even more important as cell degradation due to gaps in cold chain strategies have even more serious consequences. These consequences came on full display in the recent mishaps in fertility clinics in San Francisco, CA and Cleveland, OH, where cryogenic storage tanks malfunctioned, rendering the viability of thousands of human eggs and embryos questionable. 9

Especially when cell-based products are to be employed in the medical field, such as in the cell therapy market, scientists and health care professionals need to be mindful of the production and distribution process of the cell therapy, to be able to determine where thermal risks can enter the equation. As Mr. Lewandowski mentions, “The ultimate goal is to work with, or administer, perfectly preserved products. This requires a comprehensive cold chain strategy… Regardless of your frozen storage application, we all have to agree the process is the product.”

Automation is immensely helpful in this endeavor, and Brooks Life Sciences has a suite of products that can help cell therapy markets to maintain perfect cold chain of custody for all their samples. With the BioStore™ III Cryo -190°C System, the CryoPod™ Carrier and the CryoPod™ LN2 Filling Station, Brooks Life Sciences is poised to support cell therapy markets moving forward. These products are designed for reliable, monitored and audited storage and transport of cryogenic samples. Together, these three components conflate to a cryogenic storage and intra-lab transport solution that combines sample protection, safety, and easy accessibility with inventory control and cost-effective cold-chain management. Mr. Lewandowski concludes, “With Brooks Life Sciences cryogenic solutions, sample integrity will improve by avoiding unintended sample warming events while tracking all security, access and sample data associated with these important collections.”

 

 

 

References

1. Rasmussen L, Tigabu B, White EL, Bostwick R, Tower N, Bukreyev A, Rockx B, LeDuc JW, Noah JW. Adapting high-throughput screening methods and assays for biocontainment laboratories. Assay Drug Dev Technol. 2015. 13(1):44-54. PMCID: PMC4340648; https://www.ncbi.nlm.nih.gov/pubmed/25710545

2. Szymański P, Markowicz M, Mikiciuk-Olasik E. Adaptation of high-throughput screening in drug discovery-toxicological screening tests. Int J Mol Sci 2012. 13(1):427-52. PMCID: PMC3269696; https://www.ncbi.nlm.nih.gov/pubmed/22312262

3. Esch EW, Bahinski A, Huh D. Organs-on-chips at the frontiers of drug discovery. Nat Rev Drug Discov 2015. 14(4):24.8-60. PMCID: PMC4826389; https://www.ncbi.nlm.nih.gov/pubmed/25792263

4. Martinez NJ, Titus SA, Wagner AK, Simeonov A. High-throughput fluorescence imaging approaches for drug discovery using in vitro and in vivo three-dimensional models. Expert Opin Drug Discov 2015. 10(12):1347-61. PMCID: PMC4863443; https://www.ncbi.nlm.nih.gov/pubmed/26394277

5. Li L, Zhou Q, Voss TC, Quick KL, LaBarbera DV. High-throughput imaging: Focusing in on drug discovery in 3D. Methods. 2016 Mar 1;96:97-102. PMCID: PMC4766031; https://www.ncbi.nlm.nih.gov/pubmed/26608110

6. Paull D, Sevilla A, Zhou H, Hahn AK, Kim H, Napolitano C,. et al. Automated, high-throughput derivation, characterization and differentiation of induced pluripotent stem cells. Nat Methods. 2015. 12(9):885-92; PMID: 26237226; https://www.ncbi.nlm.nih.gov/pubmed/26237226

7. Ankam S, Teo BK, Kukumberg M, Yim EK. High throughput screening to investigate the interaction of stem cells with their extracellular microenvironment. Organogenesis. 2013. Jul-Sep;9(3):128-42. PMCID: PMC3896583. https://www.ncbi.nlm.nih.gov/pubmed/23899508

8. Trainor N, Pietak A, Smith T. Rethinking clinical delivery of adult stem cell therapies. Nat Biotechnol 2014. 32(8):729-35. PMID: 25093878; https://www.ncbi.nlm.nih.gov/pubmed/25093878

9. Chappell, B. Fertility clinic says failure may have damaged thousands of eggs and embryos. National Public Radio March 12, 2018. https://www.npr.org/sections/thetwo-way/2018/03/12/592855998/fertility-clinic-says-a-failure-may-have-damaged-thousands-of-eggs-and-embryos

Steffen Porwollik

Steffen Porwollik, PhD

Steffen Porwollik, PhD, is a senior scientific writing consultant with APEX Think Corporation. With a background in genetics he has over 80 peer-reviewed research articles. He graduated with a Masters equivalent in Biochemistry from Humboldt University, Berlin, Germany and with a PhD in Molecular Biology from Massey University, Palmerston North, New Zealand. Steffen has been involved in genome sequencing from the get-go, being part of the team that published the very first complete bacterial genome, B. subtilis. He is currently involved in developing innovative high-throughput methods and tools to investigate functions of the entire repertoire of Salmonella genes on a systems biology level.