Merck’s California manufacturing facility passes regulatory inspections

Merck has announced that its manufacturing facility in Carlsbad, California has successfully completed inspections by the US Food and Drug Administration and a European Medicines Agency.

The site has been developed for the production of BioReliance viral and gene therapy products, with the successful inspections allowing one of Merck's key customers to launch its novel gene therapy in both the US and Europe.

The Carlsbad facility provides contract development and manufacturing services to accelerate the development of lifesaving therapies. It underwent a major expansion in 2016 that nearly doubled its former production capacity.

It now offers 16 modular viral bulk manufacturing cleanroom suites with single-use equipment and two fill/finish suites for gene therapy, viral vaccine and immunotherapy products.

This landmark underlines Merck's position as a leading contract manufacturing organisation (CMO) for the production of next-generation gene therapies.

Udit Batra, member of the Merck executive board and chief executive officer for life science, said: "As one of the first CMOs in the industry to complete pre-licensure inspections for this class of therapies, this achievement underscores our commitment to bring our customers one step closer to commercialisation of novel therapies."

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