Measurements for Biotechnology
The high-level objectives of the programme include the improvement of the mutual recognition of biomeasurement capability at an international level; and the development of a measurement infrastructure which is accepted in both the industrial and regulatory arenas.
Some specific technical objectives of the programme are:
- To improve the quantification of DNA and establish the equivalence of DNA measurements produced by National Measurement Institutes
- To enable the correct interpretation of trace DNA measurement for on-site testing
- To compare the leading candidate separation techniques for protein separation and prepare a reference sample characterised by these techniques
- To develop methods for the absolute quantification of protein and peptide standards
- To develop improved approaches for the characterisation of post-translationally modified proteins
- To improve the reliability and reproducibility of cell-based assays
- To develop best practice and calibration tools to facilitate the validation of imaging approaches to cellular screening
- To enhance the acceptance by both industry and regulator of methods for quantifying micro-heterogeneity of biopharmaceuticals
- To improve the acceptance at international level of circular dichroism for the confirmation of protein structure
The bulk of industrial activity in biotechnology focuses on pharmaceutical markets, with an impetus increased by the success of the human genome project. It is becoming clearer that the benefits of genome knowledge will be realised only through a greatly increased understanding of protein science, and that measurement of protein concentration and structure are central. Functional proteomics is becoming more prominent in the discovery of small-molecule drugs, through identifying key protein pathways and ways to disrupt them. Emerging biotherapies and more complex biopharmaceuticals are expected to begin to challenge the market dominance of small-molecule drugs.
The Measurements for Biotechnology Programme has the following technical themes:
- Gene Measurement – the objective of this theme is to provide the tools and leadership to foster the application of metrology to DNA analysis, thereby enabling practitioners to make valid, comparable measurements
- Protein Measurement – the objective of this theme is to provide improved methodology in all the steps in protein analysis: extraction, separation, identification and determination of structure / function
- Cell-based Technology – the objective of this theme is to develop and improve the understanding of cellular systems for high-throughput screening of candidate pharmaceuticals and biomaterials in the early to middle stages of development. The potential of this technology is currently hampered by unacceptable accuracy and precision; the proposed work will seek to improve them
- Product Characterisation – the objective of this theme are to improve the validation of physicochemical measurements and to broaden the applicability of such methods.
Knowledge transfer in MfB faces a central challenge. The concepts and language of metrology are foreign to biotechnology. The technical projects of MfB seek to develop and demonstrate the value of the concepts of metrology. MfB will be effective only if there is a complementary, cross-programme effort in knowledge transfer, acknowledging the immaturity of metrology for much of the biosciences.
The programme seeks to:
- Build communities of interest in comparable measurement
- Capitalise upon the UK lead in international initiatives in biometrology
- Improve communication on measurement at the regulatory interface, and
- Foster the introduction of the concepts of metrology into the bioscience education and training sector.
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