The investment announced yesterday will bring a number of new services including cytotoxicity testing, cell-based assays, plus endotoxin and ELISA testing to the pharma services company’s site in Shanghai, China, which is set to expand from 1500m2 to 2000m2 by mid-2015.
“SGS has been offering Life Science services in China since 2006,” a company spokesperson told Outsourcing-Pharma.com. “Partly as a result of an ageing society in China, the pharmaceutical industry is expected to be a booming market in the next decade. This is reflected by recent big pharma investments in China.”
Citing figures from China’s National Development and Reform Commission, we were told the pharmaceutical industry in China has seen a Compound Annual Growth Rate (CAGR) of 22% over the past ten years.
The investment in the facility will therefore service overall market demands in China, and “given the high quality requirements for a cGMP lab, there are few competitors in China that can offer and meet such high standards for this market,” SGS said.
Currently the site provides services for method development and validation, testing of raw materials, APIs and finished products, as well as testing of Traditional Chinese Medicines.
On top of the additional services listed above, SGS will begin packaging testing - including extractables and leachables – as well as offer generic drug stability studies, a mycoplasma lab focused on the biological market, and a highly active compound (HAC) testing laboratory.
Regulatory differences
SGS has 21 laboratories worldwide offering services to international pharma companies, so we asked how regulations in China differed to those in Europe and the US.
“Typically, for multinational customers, they need the services in China to meet the same level of compliance in US and Europe. When offering these services in China, they must also comply with Chinese local regulations,” SGS said.
“The Shanghai lab has implemented, and has been operating both compliance systems in the lab for several years, and the new investment will also follow the same compliance levels to meet both local and multinational requirements.”