SGS Life Science Services has announced the completed construction of its Shanghai, China, cGMP chemistry and biotechnology testing laboratories. The company will commence work to increase its microbiology laboratory at the site in July 2015, expanding from 250 square meters to 750 square meters, taking the total floor plan to 3,200 square meters.
The number of personnel employed at the facility has grown from 74 in 2014, to a current headcount of 120, with SGS anticipating that this will grow to 135 by the end of 2015.
New services available as a result of the completion include a compound laboratory designed to test products such as antibodies and hormones. While the testing of these compounds involves physical and chemical analyses, based upon pharmacopeia methods and/or client methods, greater controls are implemented to avoid cross contamination.
In addition, the new biotechnology testing laboratories will expand the portfolio of services offered in Shanghai to include cytotoxicity, cell-based assay, endotoxin, and ELISA testing. In addition to new office space, a drug compatibility study lab, designed to meet regulatory requirements, has also been introduced.
The facility 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“The plans for investment and expansion at the Shanghai facility that we originally announced in July 2014 have been superseded by demand from international and domestic customers, particularly in the Extractables and Leachables testing market” commented Andy Yi, General Manager, SGS Life Science Services, Shanghai. “As a result of this demand, the projected growth to 2,000 sq. m. has increased to 3,200 square meters, with staffing levels rising accordingly.”
The Shanghai completion follows SGS’s announcement in April 2015 that it had completed a further strategic Asian expansion, at its Mumbai, India, cGMP facility, which saw the previous 1,393 square meter laboratory space more than double in size, to 3,400 square meters, with the workforce increasing from 65 to 115.
With 18 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 clinical trial management (Phase I to IV) and services encompassing data management and statistics, PK/PD modeling and simulation, pharmacovigilance and regulatory consultancy.