Bridge Laboratories, a preclinical contract research organisation (CRO) based in the US and with accredited facilities both in Gaithersburg, Maryland and Beijing, China, has seen its hybrid model validated through acceptance of toxicology data from its Beijing facility by the US Food and Drug Administration (FDA).
The primate study data were generated and filed with the FDA last month as part of an investigational new drug application (IND) package for an unnamed US biotechnology company. FDA acceptance bears out “the wisdom of conducting preclinical research in China for clients looking to complete studies economically”, said Tom Oakley, president and chief executive officer of Bridge Laboratories.
As the company – formerly known as Bridge Global Pharmaceutical Services – pointed out, the Beijing facility was purpose-built to conduct Good Laboratory Practice (GLP)-standard studies in support of regulatory submissions worldwide. The laboratory in Beijing’s Zhongguancun Life Science Park opened in 2006 and, according to Bridge, was the first in China to be built from the ground up to meet international GLP standards.
In late July Bridge announced that it had secured agreement to construct a second preclinical facility adjacent to its existing laboratory in Beijing. Work will begin on this purpose-built, 150,000sq ft laboratory in the fourth quarter of 2008. The new facility, which is expected to be completed late in the fourth quarter of 2009, will provide GLP toxicology, immunology, vaccine, and bioanalytical services, quadrupling Bridge’s available laboratory space in Beijing.
According to a recent Bloomberg report citing data from the Boston Consulting Group, research personnel and supplies can cost 60% less in China than in the US, while Ernst & Young estimates the cost of a two-month primate study in China at around $20,000, one tenth as much as in the US.
In June, US-based CRO Covance agreed to form a preclinical joint venture in Suzhou with Shanghai-based WuXi PharmaTech, Another US CRO, MPI Research, had already announced a joint venture in January with Shanghai Medicilon to set up a 50,000sq ft preclinical testing facility in Shanghai’s Chuansha Economic Park.
