BIOBANKING
commercial companies struggle with, and it does slow down the development and approval of products to be used in laboratory-based diagnostics. In 2020 a significant expansion of biobanking was seen, as was the recognition of its importance by the Medical Research Council (MRC), the Wellcome Trust and the Department of Health, leading to support and comment from the then Prime Minister. We still have some way to go with this recognition, to further enable product development. Of note were issues that arose for access to biological samples during the COVID-19 pandemic to commercial IVD manufacturing companies. Multiple positive and negative samples
were required to be tested by companies introducing kits that were needed due to high demand, and testing had to be independent, in a UKAS approval laboratory, with a gold standard and comparison to kits already approved. Given the pressure that testing sites were under, be they NHS or commercial, this did lead to issues with availability of tests, and frustration for commercial companies looking for market access. Whilst the need to ensure the quality and performance of tests being introduced and marketed is fully understood and respected, there is the question: was Coronavirus Test Device Approvals (CTDA) restrictive or as supportive as it could have been? That is a debate that will continue for some time and the date of repeal of the CDTA for SARS-CoV-2 assays in the UK is welcomed. Present indications are that it will be repealed as soon as the amendment becomes law.
Storage challenges The storage of serum samples represents a significant proportion of the biobanking undertaken internationally. Laboratory-
The availability of diverse, high-quality samples and associated data is valuable for advancing personalised or precision medicine, where
treatments are tailored to an individual’s unique genetic makeup and disease characteristics
based diagnostic tests using blood and serum samples account for almost 65% of the sample types submited to pathology departments on a daily basis. Sample numbers can often run into thousands each day, depending on the population area served. Clinical laboratory testing is moving at a tremendous pace and the appropriate biobanking of the samples has to be very carefully considered and planned. Consider now the storage of living cells in a biobank. The intention here is not to maintain the integrity of a measurable parameter in a biological sample, but to retain living cells with genotypic and phenotypic characteristics intact over a short or preferably long period of time at –20°C to –70°C. The storage of bacterial and fungal
isolates presents its own challenges and is faced with all of those encountered with biological associated data on lifestyle, location, age, environmental and clinical information. Tissue biobanks are also common, particularly for transplantation research and as virtual biobanks that integrate epidemiological cohorts into a common accessible pool. The most widely used systems for
storage of bacterial and fungal cultures include cryopreservation and freeze- drying. Cryopreservation means that
materials are stored at low (from –20°C to –80°C in freezers) or ultra- low temperatures (–150°C in liquid nitrogen containers); in the later case, cryopreservation takes place in the liquid or in the vapour phase of nitrogen. Freeze drying can present practical hurdles and is not ideally suited to smaller, localised culture collections. Feltham et al. developed a simple
method for storage of bacteria at –70°C. Their work revolutionised the way bacteria and fungi could be stored with simple preparations of a glycerol broth using small carrier beads in a vial that could be prepared by individual laboratories. This had a limited scale of application as the need for cultures to be stored for research, quality control and reference applications increased. The advent of International Organization for Standardization (ISO) regulatory requirements for diagnostics manufacturers and laboratories requires a far more sophisticated product.
Culture collections Established collections of microorganisms permit the characterisation of microbial diversity and microbial evolution. As microorganisms are essential parts of the biosphere then secure and effective storage is essential. Microbial and fungal culture collections face a huge task: consider that there are potentially over 1.5 million fungal species estimated worldwide, and less than 20% have been described to date. Culture collections range from
localised research projects to laboratory quality control collections, to national and international resource collections. Regardless of the size of microbial and fungal cultures, biobanks are an invaluable tool for accelerated discovery and characterisation of microorganisms and for promoting their beneficial use. Culture collections must be maintained
While cryogenic freezers can maintain temperatures of –80°C, liquid nitrogen is capable of lows of –196°C.
reliably with minimal deterioration over time, and they must be protected from physical damage, both accidental and intentional, and the registration of each sample should be stored centrally, usually on a computer-based system that can be backed up frequently.
April 2026
WWW.PATHOLOGYINPRACTICE.COM 25
AdobeStock / RFBSIP
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56
