The new 60,000 square foot site is designed to serve both the emerging Chinese and global drug sectors and is compliant with rules laid down by the US Food and Drug Administration (FDA), the Chinese state regulators (SFDA) and the Organization for Economic Cooperation and Development (OECD).
The US Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) and the Canadian Council of Animal Care (CCAC) have also approved operations at the site, enabling it to carry out the full range of preclinical development work.
The Shanghai site is expected to begin providing good laboratory practice (GLP) accredited development services in the first quarter next year.
James Foster, Charles River’s CEO, commented that: “As our clients make their initial forays into China, we are creating a centre of excellence that embodies global best practices along side them.
“The same high standards of research, safety, humane care and good laboratory practices that globally distinguish Charles River are replicated [at the] facility,” added Foster.
In a press statement the company also laid out its belief that China’s emerging drug market will see the country evolve into a key innovation hub for the global pharmaceutical industry in the coming years.
Charles River said that its new base “will help foster this culture by helping multinationals as well as local biopharmaceutical organizations accelerate their drug development programmes”.
While some emerging pharmaceutical markets like India and Southeast Asia have focused on providing manufacturing rather than development capacity, in China the preclinical and trial sectors are already quite well established.
A recent Ewing Marion Kauffman Foundation report, “The globalization of innovation: Pharmaceuticals” which was published earlier this year, concluded that part of the difference lies in the fact that Chinese scientists are developing the ability to innovate due to the influx of R&D from big pharma that has taken place in recent years.
As a result there is considerable and growing demand for preclinical services in the country. Further evidence for this is indicated by WuXi Pharmaceuticals decision to press ahead with the development of a preclinical facility despite the withdrawal of partner Covance.