Merck KGaA's gene therapy facility passes FDA and EMA inspections

19 October 2017
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Germany’s Merck KGaA (MRK: DE) has announced that US and EU inspectors have given the all clear to its Californian factory for the production of BioReliance viral and gene therapy products.

The company's Carlsbad facility underwent a major expansion in 2016, and is now nearly double its former production capacity.

Merck said the facility will enable one of its key customers to launch novel gene therapies in both the USA and in Europe, which are currently under review by both the US Food and Drug Administration and European Medicines Agency.

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