SGS Life Science Services has announced that it is now able to offer a full range of analytical methods to identify amino acid impurities within pharmaceutical and biopharmaceutical manufacturing, at its laboratory in Taunusstein, Germany, in line with the European Pharmacopoeia (Ph.Eur.).
This facility is the only contract lab in Germany able to offer these services under GMP in accordance with Ph.Eur. 2.2.56, Method 1 - Post-Column Ninhydrin Derivatisation, which began to be rolled out in January 2014. Ninhydrin is a reagent used to derivatise amino acids and was traditionally tested using thin layer chromatography, combined with visual and qualitative determination.
The newer method, outlined in Ph.Eur.’s most recent edition and employed at the SGS facility, utilizes spectrophotometry and liquid chromatographic techniques for greater resolution and sensitivity.
SGS anticipates that qualification will be completed in March 2015, with the amino acid analytical function fully operational by May 2015. The new offer in Germany complements SGS’s existing amino acid analytical services provided from its laboratories in Clichy, France, Wavre, Belgium and Lincolnshire, US.
“As many pharmaceutical companies only buy one or two batches of amino acid per year, it would not be feasible for them to carry out this analysis in-house,” commented Dr. Sheida Hoenlinger, Director, SGS Life Science Services Germany. “With the addition of GMP amino acid analysis at our Taunusstein facility, we are now able to offer our German and global customers an integrated service for the entire respective amino acid monograph.”
With 19 laboratories offering contract analytical and bioanalytical services, SGS leverages its wholly-owned global network, present in North America, Europe, and Asia, to deliver harmonized solutions to large pharmaceutical and biotechnology firms.
In addition to testing services for the bio/pharmaceutical market, SGS also provides Phase I to IV clinical trial management and services encompassing data management and statistics, PK/PD modeling and simulation, pharmacovigilance and regulatory consultancy.