Document will be used as reference by the FDA for licensure activity.
Pacific Biopharma Group has chosen Pharmatech Associates to provide the basis of design for what it reports will be the first FDA- and EMEA-approved biotechnology manufacturing facility in China. The basis of design for the 181,000 square foot site will be the reference document reviewed by the FDA as part of any licensure activity in China.
The new facility will be a cGMP laboratory that uses single-use technology throughout the biomanufacturing process. 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. It is located in Taizhou, Jiangsu Province, in the biomedical science park known as China Medical City.
“Pharmatech Associates understands every phase of the drug development lifecycle—not just pharmaceutical construction,” points out S. Chang, vp 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.”