Bikash Chatterjee, president and CTO of Pharmatech Associates, was in our Itasca, Illinois offices recently for discussions on a variety of pharmaceutical topics. Chatterjee is the kind of person who can speak at length on almost anything pharmaceutical, but the thing that had him excited this day was his company’s early work on the Basis of Design for the first FDA- and EMEA-approved biotechnology manufacturing facility ever built in China. The Basis of Design will be the first reference document reviewed by the FDA as part of any licensure activity in China.
Pharmatech was selected by Pacific Biopharma Group (PBG) to provide the Basis of Design for the 181,000-square-foot facility, which will serve as a showcase cGMP laboratory relying upon "single-use" or disposable technology throughout the biomanufacturing process. It is located in Taizhou, Jiangsu Province, in the emerging biomedical science park known as China Medical City (CMC).
Chatterjee told us that this facility will be a game-changer for the entire biopharmaceutical contracting industry. It will serve notice that China is serious about cGMP biologics manufacturing and facilities and processes based upon ideas of Quality by Design and other leading practices. And the project should also be a cause of concern to global contract manufacturers in the biotech arena that have until now not had stiff competition from China.
And, while Chatterjee could not discuss timelines for the expected completion of the project, he did say that the speed with which the facility will be up and running will raise quite a few eyebrows. We’ll have the full video interview with Chatterjee regarding the project soon on PharmaManufacturing.com.
What follows is the last several paragraphs of a press release on the project:
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, 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."
"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 CTO, 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.
About Pharmatech Associates
Based in the San Francisco Bay Area, Pharmatech Associates is a full service consultancy serving the regulated life sciences market with tailored project management, validation services and quality process optimization solutions that ensure optimal outcomes. Pharmatech Associates' consulting services focus on cGMP readiness and Quality System development, and include product development guidance to negotiate the complexities of the development life cycle on pharmaceutical, biotech, biopharma, and medical device projects. Please visit: www.pharmatechassociates.com
About Pacific Biopharma Group
PBG is a private multinational corporation focused on translational development and international commercialization of drug candidates for human diseases with significant unmet medical needs.