Date: 2017-10-19
Type of information: Opening of new premises
Compound: Carlsbad facility
Company: Merck KGaA (Germany)
Therapeutic area: Technology - Services
Type agreement: opening of new premises
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- • On October 19, 2017, Merck KGaA announced that its Carlsbad manufacturing facility for the production of BioReliance® viral and gene therapy products has completed both a FDA Pre-License inspection and a European Medicines Agency (EMA) Marketing Authorization Application inspection. These inspections will enable one of the key customers of Merck KGaA to launch its novel gene therapy in both the U.S. and in Europe, which is currently under review by both the FDA and EMA.
- This key benchmark underscores the continued investment of Merck KGaA in viral and gene therapies from clinical to commercial scale. The group has close to three decades of experience in gene therapy, and its Carlsbad site has been involved in the gene therapy area since 1997, near the time clinical trials for gene therapy began.
The Carlsbad facility provides contract development and manufacturing services that can contribute to a more efficient delivery of these lifesaving therapies to market. The business serves many leading developers of viral and gene therapy products globally.
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.
- • On May 4, 2016, Merck KGaA announced an expansion of its Carlsbad, California facility to meet growing demand for viral and gene therapy products. Scheduled for completion in 2016, the Carlsbad campus will increase from 44,000 square feet to 65,000 square feet, with 16 modular viral bulk manufacturing cleanroom suites, two fill/finish suites and twice the warehouse capacity. The expansion will incorporate single-use equipment in a flexible, scalable format for clinical and commercial bulk drug production. The Carlsbad facility – Merck’s flagship site for SAFC's viral and gene therapies offering – will remain fully operational throughout the expansion. The Carlsbad campus features segregated fill/finish capacity for gene therapy, viral vaccine and immunotherapy products.
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