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SGS Life Science Services expands cGMP chemistry and biotechnology testing facilities in Shanghai.
SGS Life Science Services announced on June 24 that the company had completed construction of its Shanghai, China, cGMP chemistry and biotechnology testing laboratories. The company also reported it will commence work to increase its microbiology laboratory at the site in July 2015, expanding from 250 sq-m to 750 sq-m, taking the total floor plan to 3200 sq-m. The number of personnel employed at the facility has grown from 74 in 2014, to a current headcount of 120; the company anticipates the number of employees will grow to 135 by the end of 2015.
Services available as a result of the completion include a highly active 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 services offered in Shanghai to include cytotoxicity, cell-based assay, endotoxin, and ELISA testing. 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; and 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“The plans for investment and expansion at the Shanghai facility that we originally announced in July 2014 have been superseded by demand from international and domestic customers, particularly in the Extractables and Leachables testing market,” commented Andy Yi, General Manager, SGS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 expansion at its Mumbai, India, cGMP facility, which saw the previous 1393-sq-m laboratory space more than double in size, to 3400 sq-m, with the workforce increasing from 65 to 115.
Source: SGS Life Science Services