Pharmatech Associates in first design for first FDA-licensed biomanufacturing facility in China

Pharmatech Associates, a leading consultancy in the regulated life sciences industry in the San Francisco Bay area, US, has been chosen by Pacific Biopharma Group (PBG) to provide the Basis of Design for the first FDA- and EMEA-approved biotechnology manufacturing facility ever built in China.

The Basis of Design for the 181,000 square foot facility will be the first reference document reviewed by the FDA as part of any licensure activity in China.

The new facility is a showcase cGMP laboratory that uses state-of-the-art "single-use" technology throughout the biomanufacturing process. It is located in Taizhou, Jiangsu Province, in the emerging biomedical science park known as China Medical City (CMC).

CMC is considered to be one of the largest and most ambitious undertakings by any nation to establish biomedical capabilities for the development of novel therapies for the world marketplace.

"Pharmatech Associates understands every phase of the drug development lifecycle not just pharmaceutical construction," said Dr S. Chang, vice president of manufacturing at the Pacific Biopharma Group. "Their ability to integrate the critical considerations necessary for international biological market approval is essential to the success of our program in China."

"We are delighted that PBG chose Pharmatech for this endeavour. The project caters directly to our deep understanding of product development, technology and international compliance," said Bikash Chatterjee, president and CTO of Pharmatech Associates.

The project is a joint venture between PBG and CMC. In addition to manufacturing biotechnology products for late-stage clinical supplies, the facility will be used for development projects borne at the California Institute for Quantitative Biosciences (QB3) whose lead campus is at University of California, San Francisco.