CMC Biologics Site Renews MIA

CMC Biologics has received renewal of its manufacturing and importation authorization (MIA) for cGMP production of clinical and commercial manufacturing following a successful inspection from the Danish Medicines Agency (DKMA). The DKMA inspected the company’s optimized manufacturing and testing facilities in Copenhagen, Denmark and issued the certificate based on the positive outcome. 
 
“This important regulatory milestone helps drive our strategy to satisfy our customers’ growing clinical and commercial cGMP manufacturing requirements, and takes this site to the next level as a global leader in commercial production of protein therapeutics,” said Patricio Massera, general manager of CMC Biologics Copenhagen. “We are committed to the highest quality standards and extremely pleased with the results of the agency’s inspection.”