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Alphalyse Inc. Receives GLP Accreditation to Determine Serum Concentration of Protein Biologics


1/31/2011 10:50:27 AM

31 January 2011 -- Alphalyse (www.alphalyse.com) has received Good Laboratory Practice accreditation by the Danish Medicines Agency, and now performs protein analysis in compliance with the OECD principles of GLP.

Alphalyse provides development of protein specific quantification assays based on isotope dilution LC MS/MS and MRM analysis of specific peptides from protein biologics. Applications include development and manufacture of monoclonal antibodies, protein therapeutics and vaccines. With the GLP accreditation, the validated bioanalytical assays are now also provided for pre-clinical and clinical pharmacokinetics/ toxicokinetics of protein biologics in animal and human serum samples.

“The Alpha-QuantTM assays developed by Alphalyse have significant advantages over antibody-based ELISA assays“ says Ejvind Mørtz, COO of Alphalyse A/S. “This includes high accuracy, short assay development time, and multiplex quantitation of several specific proteins. We are very happy that the analysis can now help our clients to move faster into early clinical trials without the need for time-consuming antibody development”.

For more information, see www.alphalyse.com/protein-quantification.html

Contact

Europe: Ejvind Mørtz, COO, Alphalyse A/S +45 63106500, email mortz@alphalyse.com

USA/Canada: Thomas Kofoed, CEO, Alphalyse Inc. (650) 534-3193, email kofoed@alphalyse.com

Alphalyse is a specialized contract research organization (CRO) providing high-quality protein analysis service to support the research, manufacturing and clinical development of natural and recombinant proteins. The company provides through its PICK ‘n POST Protein Analysis services and Contract Analysis Services a range of unique high quality protein analysis to identify and characterize proteins. The services are used by the Biotech industry, Pharmaceutical companies and Academic Research Groups all over the world. Alphalyse has offices in Odense, Denmark, and Palo Alto, California.



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