Merck KGaA Gets FDA, EMA OK for Gene Therapy Mfg Facility
Merck KGaA has completed both a US Food and Drug Administration (FDA) pre-license inspection and a European Medicines Agency (EMA) marketing authorization application inspection at its Carlsbad, California-based manufacturing facility for producing viral and gene therapy products.
These inspections will enable one of the customers of Merck KGaA to launch its gene therapy in both the US and in Europe, which is currently under review by both the FDA and EMA. The inspections were milestones in the approval process to obtain the licenses necessary to manufacture the gene therapy as a commercial product.
The company’s Carlsbad facility underwent a major expansion in 2016 and is now nearly double its former production capacity. The upgraded facility grew from 44,000 square feet to 65,000 square feet and now includes 16 modular viral bulk manufacturing cleanroom suites with single-use equipment and two fill/finish suites for gene therapy, viral vaccine, and immunotherapy products.
Merck KGaA also offers viral and gene therapy manufacturing capacity in Glasgow, Scotland, has cell-banking services in Rockville, Maryland, and offers BioReliance biosafety testing globally for both clinical and commercial-stage gene therapy products.
Source: Merck KGaA