SGS introduces new comprehensive drug compatibility study testing at expanded Shanghai facility

New service offers analysis of potential extractable and leachable contamination within pharmaceutical products.

China’s Center for Drug Evaluation (CDE) made drug compatibility studies mandatory for all New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) in 2014. SGS’s investment in these services comes after a multi-stage expansion of its laboratory in Shanghai, which was completed in 2015. It includes the installation and validation of new quadrupole time-of-flight (Q-TOF), liquid chromatography-diode array-mass spectrometry (LC-DAD-MS) and gas chromatography–mass spectrometry (GC-MS) instruments.

“We have seen an increased demand for these services since the regulations have been tightened, and we have been working with regulatory bodies and industry associations to help define and establish definitive testing guidelines in this area going forward,” commented Andy Yi, General Manager, SGS Life Sciences, Shanghai. “With this investment, SGS has been able to build on its strong reputation to attract new customers, as well as increase business with pharmaceutical R&D teams looking to engage with experts earlier in the process to ensure compliance.”

SGS has been providing extractable and leachable testing services from its Shanghai facility to local clients, and international clients with a presence in China since the facility opened in 2006. Expansion of the facility commenced in 2014 and initially included increased capabilities in cGMP chemistry and biotechnology testing laboratories. The microbiology laboratory was expanded subsequently, increasing the total floor space to 3,200 m2.