CMC Biologics Achieves Successful Pre-Approval European GMP Inspection by MHRA for Commercial Manufacturing
Published: Jun 18, 2012
SEATTLE, June 18, 2012 /PRNewswire/ -- 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 multipurpose facility.
About CMC Biologics
CMC Biologics is a leading contract development and manufacturing organization that provides fully integrated biopharmaceutical development and manufacturing solutions to clients around the world, from its facilities in Europe and the USA. The company has proven expertise in delivering custom solutions for the scale-up and cGMP manufacture of protein-based therapeutics for pre-clinical, clinical trials and in-market production. The company's wide range of integrated services includes cell line development, bioprocess development, formulation and comprehensive analytical testing. Clients can also benefit from CMC Biologics' proprietary CHEF1® expression system for mammalian production. CMC Biologics has fully segregated microbial fermentation and mammalian cell culture suites and offers both fed-batch and perfusion production processes. CMC Biologics is located in Copenhagen, Denmark, and Seattle, Washington. Visit www.cmcbio.com to learn more.
SOURCE CMC Biologics