Pharmatech Associates has been chosen by Pacific Biopharma Group (PBG) to provide the design for the first FDA- and EMEA-approved biomanufacturing facility to be built in China, which will represent the first reference document reviewed by the FDA as part of any licensure activity in China.
   
The new 181,000-sq.-ft. facility is a cGMP lab that uses single-use technology throughout the biomanufacturing process. The facility will be located in Taizhou, Jiangsu Province, in the emerging biomedical science park known as China Medical City (CMC). 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 from the California Institute for Quantitative Biosciences (QB3).   
   
“Pharmatech Associates understands every phase of the drug development lifecycle, not just pharmaceutical construction,” said Dr. S. Chang, vice president manufacturing, 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 endeavor. The project caters directly to our deep understanding of product development, technology and international compliance,” said Bikash Chatterjee, president and chief technology officer, Pharmatech Associates.