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CMC Biologics Passes PAI

MHRA issues GMP certification

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

CMC Biologics has received a certificate of GMP compliance for commercial manufacturing from the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA inspected CMC Biologics’ manufacturing and testing facilities in Bothell, WA in late March 2012 and issued the certificate based on the positive outcome of the inspection.

“We are extremely pleased with the results of the recent inspection of our manufacturing facility in Bothell. Our continued commitment toward compliance and high quality systems resulted in the success of this important regulatory milestone,” said Gustavo Mahler, Ph.D., Chief Operations Officer of CMC Biologics. “This achievement demonstrates the viability of our manufacturing, process, and quality systems, which is the foundation for our customers’ clinical and commercial success.”

CMC has expanded its stainless steel biopharmaceutical manufacturing facility in response to client demand. This expansion added production capacity to accommodate cGMP manufacture of biopharmaceuticals and to support added demand for commercial manufacturing in a multi‑purpose facility.

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