CMC Biologics, a leading contract manufacturing organization (CMO) known for its technical excellence in process development and cGMP manufacture, has received a Certificate of Good Manufacturing Practice (GMP) Compliance for commercial manufacturing issued by 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 world class 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."
In response to the growing demand of customers, CMC Biologics expanded its state-of-the-art stainless steel biopharmaceutical manufacturing facility. This expansion added significant production capacity to accommodate additional cGMP manufacture of biopharmaceuticals and to support added demand for commercial manufacturing in a multi‑purpose facility.
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