SGS Life Science Services announced plans to expand its Shanghai, China, cGMP chemistry and microbiology laboratories to 2000-m2 by Q2 2015 and will offer new services from the facility, including a new biotechnology laboratory for cytotoxicity testing, cell-based assays, plus endotoxin and ELISA testing.
The current 1500-m2 facility provides services for method development and validation, testing of raw materials, APIs and finished products, as well as testing of traditional Chinese medicines.
The expansion program, which is due to commence in August 2014, will also see the introduction of packaging testing, including extractables and leachables; an inductively coupled plasma mass spectrometer, for USP<233> Elemental Impurities, will also be located within the laboratory.
Other new capabilities at the Shanghai site will include a dissolution lab for generic drug stability studies, a mycoplasma lab focused on the biological market, and a highly active compound (HAC) testing laboratory to meet growing market demand. In addition to new office space, a drug compatibility study lab, designed to meet regulatory requirements, will also be introduced.
Source: SGS Life Science Services