Biostorage: A Critical Component of the Medical Research Development Process

Mon, Sep 16, 2019 | By Nathan Dai, Senior Director, Business Development, Cryoport

The human genome and diseases interact in mysterious ways. Along with external factors, these interactions can affect who gets an illness, how serious it gets, at what rate, how the patient responds to treatments and the longer prognosis.  Hypothetically, if there were enough temperature-controlled bio storage such that diseased and normal specimens from every representative case could be archived, cross-examined, and data-captured, we could use revolutionary tools that were unimaginable just twenty years ago. These tools include artificial intelligence, deep-learning, big data, cloud computing, and supercomputers that could run iterative algorithms of hypothesis- model-test-adjustment and hopefully discover elusive patterns far beyond the limits of human brain power. Such patterns could then be used to design customized treatment, with superior precision and predictability. We are already seeing a prelude of that with DNA sequencing in oncology for example, but that is the tip of a Himalaya-sized iceberg. 

The bio storage sites in this hypothetical scenario are often called “biobanks” or “biorepositories.”  For example, National Cancer Institute’s BBRB-Biorepository and Biospecimen Researches Branch is a large and well-known one. There are various levels of sophistication for biobanks. Most are established in hospitals, academic institutes, research organizations, national health agencies, and international organizations.  They may be population focused, disease focused, or general purposed. Some are operated following cGMP standards, but most are used to store research grade materials. The largest and newest sites often feature smart technologies with the use of sensors, robots, and automation. 

The work inside a biobank usually includes collection, processing, storing, monitoring, data management, and distribution of biomaterials, under strict legal and ethical guidelines. Although there is already a vast quantity of biomaterials such as organs, tissues, blood products, cells and others stored worldwide, due to deficiencies in protocol and practices, it was estimated that a sizeable portion of such materials cannot be used for medical research and especially GMP grade work. Quality system, operations protocol, and operator proficiency make a significant difference in the capabilities of biobanks.  

Cryoport’s 2019 acquisition of Cryogene in Houston Texas is an important step for the company to add fully validated biobanking capabilities to its portfolio of solutions. Cryogene is an industry leader in the management of critical biological commodities to support the advancement of cell and gene therapies, GMP biologics, and public health research.    

For customers in the pre-clinical and clinical stage, Cryogene enables the kind of cutting-edge research described earlier. For customers with cell and gene therapies approved for commercial release, Cryogene and Cryoport provide a stronger chain of compliance for the storage, distribution, and transportation of highly condition-sensitive medicine across town or across the globe. Cryoport is uniquely positioned to provide an end-to-end storage and distribution solutions for life science and especially regenerative therapy companies. 

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