This accreditation, from the German Society for Certification of Management Systems, covers Proteome Sciences’ biomarker activities, rapid assay development, chemical and peptide synthesis and isobaric tagging development and production.
The Frankfurt facility was specifically designed to deliver a growing product line of isobaric Tandem Mass Tags® (TMT®) for quantitative mass spectrometry and to undertake biomarker programmes for customers.
Proteome Sciences now provides a comprehensive range of contract biomarker services under ISO 9001: 2008 for discovery and validation of protein and peptide biomarkers, for rapid development of mass spectrometry based assays and for the measurement of protein and peptide drugs and their metabolites in pharmacokinetics.
The ISO 9001:2008 certification is an important milestone for the company in supporting the global marketing strategy underpinned by the expansion of its high quality services and products based on the proprietary isobaric Tandem Mass Tag® technology and from PS Biomarker Services™ available through the ProteoSHOP® platform.
Christopher Pearce, CEO of Proteome Sciences, commented:
“We have made a considerable investment in time and effort to establish the highest international standard of quality management systems into our biomarker services and we are delighted to be one of the first companies globally to be awarded ISO 9001:2008 accreditation. This further underpins our compelling TMT® isobaric tagging products and allows us to more comprehensively exploit the fast growing field of protein biomarker qualification and mass spectrometry assays through the provision of ISO certified biomarker services for our customers.
“It is highly opportune timing to obtain the ISO 9001:2008 standard, with isobaric Tandem Mass Tag® technology at the point where pharmaceutical developers can use protein biomarkers as part of the drug development decision-making process and when global regulators require increasing biomarker data to support drug approval.
“Protein biomarkers are increasingly a key part of early disease detection, drug development and disease management and our expertise addresses all of these applications.
“We regard ISO 9001:2008 as another important development making PS Biomarker Services the first point of call for any organisation requiring services associated with protein biomarker discovery, validation and rapid assay development.”
About Proteome Sciences:
Proteome Sciences is a leading biomarker CRO providing protein biomarker discovery, validation and assay development services. The Company’s MS Biomarker Assay system (MBA) uses its proprietary isobaric Tandem Mass Tags (TMT®) and reference materials combined with isotope dilution mass spectrometry. Highly multiplexed assays can be developed in weeks and are suitable for screening 10's to 100's of candidate biomarkers in validation studies. Assays for validated biomarkers can be rapidly developed using the same isotope dilution mass spectrometry format, or can be transferred for immunoassay development.
The Company’s own research is focused on neurological and neurodegenerative conditions and it has discovered and patented blood biomarkers in stroke and brain damage as well as several cancers, solid organ transplant rejection and Alzheimer’s disease. Proteome Sciences is based in Cobham, UK with facilities in London and Frankfurt.
