Corporate Profile
Leaders in healthcare measurement T
he National Physical Laboratory (NPL) is the United Kingdom’s national standards laboratory, an internationally respected and independent centre of excellence in research, develop- ment and knowledge transfer in measure- ment and materials science. NPL’s Bio-analytical and Bio-diagnostic teams assist innovation in the area of life science research. Whether you are trying to develop products that depend on biological manipulation, are under pressure to reduce product development timescales or looking to improve an existing assay with the high- est accuracy and precision, validated to international standards, NPL will be the ideal partner.
Bio-diagnostics
The team at NPL is focused on delivering services that are relevant to industry in four key areas:
1 Innovative technologies
NPL has the expertise to develop new generic platforms for handheld digital mul- tiplexing bioassays through its optical and electrochemical measurement and bio- assay capabilities. Through this it has already developed Argento – a point-of- care immuno-assay biosensor technology that can provide rapid, laboratory grade sensitivity and specificity, from a handheld device. Argento’s innovative technology will give fully quantitative results, for mul- tiple analytes from a single sample in less than 10 minutes.
2 Assay development support Bio-diagnostics in conjunction with NPL’s range of capabilities and facilities allow it to offer services in assay validation using a validated orthogonal measurement method. This identifies where uncertainties are within an assay to assist in trou- bleshooting assay development problems.
3 Underpinning metrology
NPL can create validated reference methods to ascertain the accuracy and precision of an assay measurement. Through the interna-
Drug Discovery World Summer 2010
tional Bioanalysis Working Group Committee (BAWG) it has worked on improving standard bio-assay measurement. NPL has also established validated studies to test products for the US Pharmacopoeia.
4 Regulatory support and reference standards
By working with the correct regulators, clinical and regulatory trade bodies, NPL is always up to date on changing needs with- in the Bio-diagnostics sector. This allows it to provide reference standards and regula- tory support that helps get products to market quickly.
Bio-analytical NPL’s Bio-analytical team is focused on delivering services in the area of drug devel- opment and mass-spectrometry that are of value to both industry and academia. Specific areas where the team has high lev- els of experience include:
l Drug development
Access to a range of multiple techniques in NPL’s state of the art facilities ensures it can help with assessments and comparisons of biopharmaceutical drug formulation
preparations to the troubleshooting of problematic samples. NPL’s in-house calorimetric and top of the range Biacore facilities can offer small mole- cule and bio interaction characterisation in terms of specificity, kinetics or affinity through sensitive, accurate measurements. NPL has substantial expertise in a num- ber of spectroscopy techniques for the analysis of biopharmaceuticals – these include Circular Dichroism (CD) and FTIR Spectroscopy. Through working closely with industry and regulators in the area of protein interaction, NPL has developed sig- nificant capabilities in the detailed analysis of post-translational modification (espe- cially glycosylation).
The importance of utilising measurement as a key tool in the biotechnology industry is growing rapidly. This has led to a signif- icant increase in the need to develop and apply quantitative methods from the phys- ical sciences to biological problems. Through strong collaborations with both industry and academia, NPL’s Biotechnology team is helping drive inno- vation and support across the sector by developing accurate measurements fuelled by the increasing awareness of the need for comparability and traceability for product conformance, quality control and regulato- ry compliance.
For more information, log on to
www.npl.co.uk/healthcare.
Techniques available from the Bio-diagnostics team
The NPL Bio-diagnostics team is committed to developing standards for bio-diagnostic and sensor measurements. It is developing new reference materials and methods in order to sup- port the EU In Vitro Diagnostic Device Directive (98/79/EC) for the detection of trace amounts of specific biological molecules in complex biological environments and sensors to monitor biological activity. The importance of standardised measurement in the biotechnology industry is growing
rapidly. This has led to a significant increase in the need to develop and apply quantitative methods from the physical sciences to biological problems. As the UK’s national standards laboratory, NPL is uniquely positioned to aid in these development processes.
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