The new services offered at the labs, which were first announced in July 2014, include a compound laboratory designed to test products such as antibodies and hormones, as well as cytotoxicity, cell-based assay, endotoxin, and ELISA testing. In addition to new office space, a drug compatibility study lab has also been introduced.
The company will also increase its microbiology lab at the site in July 2015, expanding from 250 square meters to 750 square meters. The number of personnel employed at the facility has grown from 74 in 2014 to 120 currently, and SGS anticipates the headcount will grow to 135 by the end of 2015.
“The plans for investment and expansion at the Shanghai facility that we originally announced in July 2014 have been superseded by demand from international and domestic customers, particularly in the Extractables and Leachables testing market,” said Andy Yi, General Manager, SGS Life Science Services, Shanghai. “As a result of this demand, the projected growth to 2,000 square meters has increased to 3,200 square meters, with staffing levels rising accordingly.”
The FDA inspected the site a couple of weeks ago, SGS spokesman Ferdinand Dabu, explained to us.
The facility also currently provides services for method development and validation, testing of raw materials, APIs and finished products, as well as testing of traditional Chinese medicines. Other new capabilities at the Shanghai site include a dissolution laboratory for generic drug stability studies.
The Shanghai site’s completion follows SGS’s announcement in April that it had completed a further expansion of its Mumbai, India, cGMP facility, which saw the 1,393 square meter laboratory space more than double in size, with the workforce increasing from 65 to 115.
SGS now has 18 laboratories offering contract analytical and bioanalytical services in North America, Europe, and Asia.