Thawing
While freezing processes garner attention, few recommendations exist for the thawing of biospecimens. Improper thawing can affect sample viability just as much as imprecise freezing procedures, justifying additional care in this regard, particularly for live cells and tissues. Cell death, or apoptosis, that occurs after thawing is largely a delayed effect of mechanical and chemical stresses during both the freezing and thawing processes. Inhibitors of apoptosis added post-thaw can mitigate the effects of this stress, resulting in higher cell survival rates7, but these inhibitors can have unwanted effects on cell function. A thawing process that is removed from personal judgment and human variability is ideal, and recent efforts have been made in designing instruments that can help standardize the thawing process12.
The need for Standardization
Variability in biobanking processes seriously impacts the reproducibility and validity of scientific findings on cryopreserved material13, signaling an urgent need for extensive standardization of all processes involved in banking frozen biospecimens14. Authoritative guidelines such as those published by the International Society for Biological and Environmental Repositories (ISBER)15 which are developed and accepted by a panel of leading scientists, should be implemented to maximize the incredible potential that biobanks hold. Furthermore, emphasis on proper education of all personnel involved in collection, handling, and storage of samples is necessary. Finally, record keeping and annotation about the sample source, quality and processing need to be standardized in a way that maintains confidentiality and follows consent requirements, but provides the optimal amount of information for the research community.
References
1 Polge, C. et al. Revival of spermatozoa after vitrification and dehydration at low temperatures. Nature 164, 666, doi:http://www.ncbi.nlm.nih.gov/pubmed/18143360 (1949).
2 Hewitt, R. E. Biobanking: the foundation of personalized medicine. Current opinion in oncology 23, 112-119, doi:10.1097/CCO.0b013e32834161b8 (2011).
3 Olson, J. E. et al. Biobanks and personalized medicine. Clinical genetics 86, 50-55, doi:10.1111/cge.12370 (2014).
4 Ehrhardt, R. O. et al. Playing it cool. European Biopharmaceutical Review, 40-44 (2014).
5 Li, Y. et al. Comparison of three methods for cryopreservation of human embryonic stem cells. Fertility and sterility 93, 999-1005, doi:10.1016/j.fertnstert.2008.10.052 (2010).
6 Smith, G. D. et al. Prospective randomized comparison of human oocyte cryopreservation with slow-rate freezing or vitrification. Fertility and sterility 94, 2088-2095, doi:10.1016/j.fertnstert.2009.12.065 (2010).
7 Bissoyi, A. et al. Targeting cryopreservation-induced cell death: a review. Biopreservation and biobanking 12, 23-34, doi:10.1089/bio.2013.0032 (2014).
8 Scheppke, L. in Sampling Science Vol. 2014 (ed Thompson, M. L.) (2014).
9 Ramos, T. V. et al. Standardized cryopreservation of human primary cells. Current protocols in cell biology / editorial board, Juan S. Bonifacino ... [et al.] 64, A 3I 1-8, doi:10.1002/0471143030.cba03is64 (2014).
10 Katkov, II et al. DMSO-Free Programmed Cryopreservation of Fully Dissociated and Adherent Human Induced Pluripotent Stem Cells. Stem cells international 2011, 981606, doi:10.4061/2011/981606 (2011).
11 Miyazaki, T. et al. Cryopreservation of human pluripotent stem cells: a general protocol. Methods in molecular biology 1235, 97-104, doi:10.1007/978-1-4939-1785-3_9 (2015).
12 Standardized thawing using breakthrough solid-state technology. BioCision. ThawSTAR Automated Cell Thawing System
13 Barnes, R. O. et al. Influence of evolution in tumor biobanking on the interpretation of translational research. Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology 17, 3344-3350, doi:10.1158/1055-9965.EPI-08-0622 (2008).
14 Esmon, A. Standardization Will Enhance Sharing Between International Biobanks. Accelerating Science (2014).
15 Best practices for Repositories: Collection, Storage, Retrieval, and Distribution, of Biological Material for Research. ISBER 3rd Edition, 2012
Rolf Ehrhardt, MD, PhD - President and Chief Executive Officer
Dr. Rolf Ehrhardt co-founded BioCision in 2007, after more than 25 years of experience in leadership and innovation in medical research and product development. Prior to growing BioCision into the leading provider of temperature-sensitive sample and drug handling solutions, he was responsible for the early (phase 1a) clinical development of a novel HCV protease inhibitor at Intermune. Before that, Dr. Ehrhardt was the vice president of preclinical development at Corgentech. He was the founding president of BioSeek, where he raised close to $20 million in private financing. Prior to founding BioSeek, Dr. Ehrhardt led a scientific group focused on new target discovery and immuno-therapeutics development at Protein Design Labs (now PDL BioPharma Inc.). Dr. Ehrhardt was a Deutsche Forschungsgemeinschaft (DFG: German Research Foundation) and Fogarty Fellow at the National Institutes of Health, where his focus was on mucosal immunology and inflammatory bowel disease. He has authored more than 40 peer reviewed publications and holds multiple patents. Dr. Ehrhardt earned his M.D. and Ph.D. with distinction from the Technical University of Munich, Germany.
Eric J. Kunkel, PhD - Senior Vice President, Research and Development
Dr. Kunkel has over 12 years of experience in biotechnology including executive positions in R&D, entrepreneurship and start-ups, and consulting for technology and diagnostics companies. As an entrepreneur, he co-founded Ascellna Life Science Group, a business development and commercialization company for small companies with innovative technologies and Extend Biopharma, a start-up company developing a chemoenzymatic technology for creating next generation biologics. As VP, Assay Development and Screening at Catalyst Biosciences, Inc., Dr. Kunkel led the optimization of the company’s Alterase technology platform, which successfully generated multiple development candidates. Dr. Kunkel has published thirty-seven articles in peer-reviewed journals and has contributed to multiple patents and patent applications. He holds a B.Sc in Chemical Engineering from the University of Notre Dame, M.S. and Ph.D. degrees in Biomedical Engineering from the University of Virginia, and was a postdoctoral fellow at Stanford University.