BRUSSELS/FRANKFURT/PARIS (dpa-AFX) - Merck KGaA (MKGAY.PK) announced that its Carlsbad, California-based manufacturing facility for the production of BioReliance viral and gene therapy products has completed both a U.S. FDA Pre-License inspection and a European Medicines Agency Marketing Authorization Application inspection. The company said these inspections will enable one of its key customers to launch gene therapy in both the U.S. and in Europe, which is currently under review by both the FDA and EMA.
The Carlsbad facility provides contract development and manufacturing services. The business serves many leading developers of viral and gene therapy products globally. The Carlsbad facility underwent a major expansion in 2016, and is now nearly double its former production capacity.
Copyright RTT News/dpa-AFX