Laboratory Products focus on
Effective Sample Storage and Retrieval Kiara Biagioni Product Marketing Manager, Storage Tracking, Thermo Fisher Scientific
In this highly competitive era of drug discovery and life sciences research, millions of samples are now analysed in order to further scientific knowledge and develop commercial products. High throughput drug discovery processes have resulted in a growing pool of samples with larger, more diverse compound libraries. In addition, regulatory requirements demand that ever increasing numbers of samples have to be stored over long periods of time under various different conditions, requiring a range of specialised equipment. This represents considerable scientific and financial investment, necessitating highly effective and efficient methods of sample management.
Changing landscape
The drug discovery landscape has altered significantly over the past decade and continues to evolve in response to new discoveries and technologies. New developments are enabling the design of small, novel and more specific small molecule compound libraries. An escalating knowledge of biological structures and molecular biology, through the use of genomics and proteomics, has transformed the drug discovery and therapeutic target process. As a result, cell based assays are now an important aspect of many drug discovery protocols. In order to maximise efficiency and accelerate the hit-to-lead process, the trend in high throughput screening has been towards testing compounds in cell based and biochemical assays at increasing rates and in small microlitre volumes.
The pharmaceutical market has also seen a dramatic shift in the growth of biological and biotechnology products. Vaccines, for example, constitute one of the fastest growing pharmaceutical markets with major investment not just in research and development, but also in downstream areas such as manufacturing. The vaccine market is predicted to grow at an annual rate of 14%, generating $35.1 billion in sales in 2012 (EvaluatePharma June 2008) and is set to record the highest growth of all major therapy categories to 2014 (EvaluatePharma World Preview 2014). Of the 26 new drug approvals in 2009, seven were for therapies developed out of biotechnology research programs. Analyst forecasts also predict (EvaluatePharma June 2009) that biotechnology drugs will account for 50% of the top 100 drugs in 2014, generating revenues of $169 billion, compared to just 28% in 2008 and 11% in 2000.
Despite the global economic downturn, there are relatively positive signs of growth within biotechnology and biopharmaceutical markets. As an indication of anticipation of market growth, the FDA was approved to receive $2.35 billion for the 2010 fiscal year, compared with $2.06 billion in 2009. This is the largest increase in the regulator’s history. Meanwhile the National Institutes of Health (NIH) budget and funding for basic research, which includes translational medicine grants, are both expected to double over the next ten years.
Additional product considerations will come from the promising era of personalised medicine, where drugs that target specific genes and proteins may eventually become widespread; and stem cell research, which is moving ahead rapidly.
Dynamic changes in requirements
The increasing diversity in compounds and targets for screening and testing has led to more complex requirements in sample management. In addition to the traditional small molecules, there is an increasing need to store biological materials, such as cells, and tissues, as well as assay reagents and components.
Sample management is of paramount importance when faced with such an explosion in diversity and numbers – both in terms of effective storage as well as efficient identification and retrieval. Any problems caused by a loss of sample viability, tracking or identification could have potential cost and time implications – both on upstream medicinal chemistry teams and downstream drug discovery scientists. Advances in equipment design and technology have led to more efficient sample management options providing seamless integration into the laboratory workflow and increased efficiency.
Optimised sample management
The range of materials requiring long term storage necessitates a number of different conditions. For example, the optimal storage temperature for small molecule compounds is -20°C, whereas ultra-low temperature (ULT) freezers are necessary for storing biological samples, such as proteins, antibodies, assay reagents at or below -80°C, minimising possible biological activity. Typically, lower storage temperatures are required for frozen cells, most of which should be maintained at temperatures of -130°C or below in order to completely halt cellular degradation. Here, liquid nitrogen has traditionally provided and continues to be used for secure long term storage.
In order to maintain sample viability, it is critical that sample storage units provide effective storage of valuable samples. As well as maintaining a consistent temperature across the entire cabinet or dewar, it is essential that temperature changes are minimal when retrieving samples and that they are not exposed to ambient conditions.
Efficient compressor technology, good insulation and interior cabinet design, as well as effective door seals are all important factors in improved freezer performance. For liquid nitrogen storage, the principles are identical, shape, design and unit seals are of paramount importance to limit nitrogen evaporation and maintain stable environmental conditions.
Identification of stored samples
Sample identification is a vital process for all scientific laboratories. However with many samples remaining in cold storage for longer periods, there are a number of potential issues with regards to the identification of the correct sample. The misidentification of samples, for example, could result in incorrect experimental data. With the need to track and handle thousands, or even millions of individual samples, an increasing number of laboratories require an effective method of high- throughput sample identification and retrieval.
In order to facilitate this process and eliminate the issues associated with handwritten labels, two dimensional (2D) barcoded sample storage tubes offer the capability to uniquely identify the sample contained within every tube. Such barcoding technologies make the retrieval and identification of samples much quicker and easier for the user. As a result, the laboratory can effectively streamline its processes, freeing up more time for other experimental procedures.
Effective storage environment
Early stages of drug discovery and vaccine research lead to secondary screening validation, and clinical development, which together involve the screening of hundreds of thousands if not millions of compounds or samples.
This also requires that facilities are in place to store samples throughout every phase of a discovery program – from initial screening through pre-clinical to production and scale up. Sample integrity is critical to experimental reproducibility and is intimately linked with consistent storage conditions.
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