SGS France lab cleared to release biopharma batches

SGS has been cleared to conduct tests for the batch release of biopharmaceutical products at its laboratory in Poitiers, France.

The facility – which has provided analysis services since 1994 – was approved by the Agence National de Securitie du Medicament et des Produits de Sante (ANSM), the Government agency charged with ensuring the safety of drugs, this week.

Following the approval the lab will offer analysis services for biopharmaceutical industry customers and compliment SGS’ facility in Clichy just outside Paris, which provides equivalent analysis services for small molecule drugmakers.

SGS Life Science Services’ executive VP, Anne Hays, said: “Bringing GMP to the Poitiers site allows us to offer cell-based assays for the testing of biologics, with some of the initial projects coming from companies developing biosimilars.

Hayes added that SGS also plans to start providing equivalent bioanalysis services at its facility in Carson, California in the US.

No 1 by 2014

The approval follows just under 18-months after SGS established a cell-based assay laboratory at the Poitiers site, which was an investment designed to support a large unnamed pharmaceutical industry customer’s efforts to develop therapeutic antibodies.

The launch of new services at the Poitiers site also fits with SGS’ wider efforts to build in biopharmaceuticals testing in Europe, which began with the acquisition of Wokingham, UK-based M-Scan in 2010 and continued with the purchase of Glasgow, Scotland-headquartered Vitrology in 2012.

The planned addition of biopharmaceutical bioanalysis service at the Carson site would also fit with investments has made in recent years. In September 2012, for example, SGS doubled capacity at its laboratory in New Jersey citing demand.

SGS has set itself the target of being the world’s leading bioanalysis services firm for biopharmaceutical products – including biosimilars - by next year.

Speaking to BioPharma-Reporter.com when we visited SGS’ facility in Warve, Belgium in 2010 spokesman Cedric Volanti said: “We anticipate an increase in demand for validation services for biosimilars as more make their way to the market.”