Pharmatech Associates, a compliance consulting firm for the pharma, biotech and medical device industries, was selected by Innovent Biologics to provide facility design and compliance support for its new biosimilars manufacturing facility in Suzhou, China.
Pharmatech Associates will prepare a meeting with the UK Medicines and Healthcare Products Regulatory Agency (MHRA) on Innovent’s behalf to obtain comments on the Basis of Design (BoD) for the new manufacturing facility and to discuss compliance aspects.
Innovent began construction of a new Suzhou campus near Shanghai, which will house a commercial manufacturing plant with 6X12000 L bioreactors, and a pilot plant with 2x300L and 2x1000L bioreactors for production of clinical testing materials, as well as labs and offices. Both plants are designed to comply with international requirements for cGMPs, as defined by the European EMA and the U.S. FDA, and with China sFDA cGMP regulations.
“As a global leader in compliance, pharmaceutical and biopharmaceutical manufacturers rely on us to meet their design and compliance requirements quickly and effectively,” said Bikash Chatterjee, president and chief technology officer of Pharmatech Associates. “We enable them to receive regulatory pre-approval of their new or renovated facilities, by establishing the technical approach and design parameters that will speed time-to-market for the project, and ultimately, ensure the highest quality pharmaceutical end-product.”