Advertisement

Picture Eurasanté BioFIT 2017 Strasbourg France November 600x60px
Document › Details

Merck KGaA. (10/19/17). "Press Release: Merck Brings Customers Closer to Gene Therapy Product Commercialization". Darmstadt.

Region Region Carlsbad, CA
  Country United States (USA)
Organisation Organisation EMA (European Medicines Agency)
  Group EU (govt)
Product Product contract manufacturing (biologicals)
Persons Person Batra, Udit (Merck (DE) 201507– Head Life Science Business before CEO Merck Millipore + Novartis + JnJ + McKinsey)
  Person 2 Schrimpf, Gangolf (Merck (DE) 201708)
     


> Company’s Carlsbad, U.S., manufacturing facility passes FDA and EMA inspections

> Underscores capabilities as commercial manufacturer of viral and gene therapy products

> Highlights position as leading contract manufacturing organization (CMO) for production of next-generation gene therapies


Merck today announced that its Carlsbad, California-based manufacturing facility for the production of BioReliance® viral and gene therapy products has completed both a U.S. Food & Drug Administration (FDA) Pre-License inspection and a European Medicines Agency (EMA) Marketing Authorization Application inspection.

“The successful FDA and EMA inspections of our Carlsbad manufacturing facility mark an important milestone for Merck and our customers who are manufacturing exciting new treatments for cancer and many other diseases,” said Udit Batra, Member of the Merck Executive Board and CEO, Life Science. “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 commercialization of novel therapies.”

These inspections will enable one of Merck’s key customers 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. The inspections were significant milestones in the approval process to obtain the licenses necessary to manufacture the gene therapy as a commercial product.

This key benchmark underscores Merck’s continued investment in viral and gene therapies from clinical to commercial scale. Merck 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 speed 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 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.

Gene therapy involves the delivery of genetic material into patient cells to produce a therapeutic effect such as correction of a mutated gene or retargeting of an immune cell to fight cancer. Diseases such as haemophilia and cancer are being investigated using this technique where a single dose may cure the disease.

Merck recognizes the potential benefits of conducting properly defined research with genome editing because of the breakthrough therapeutic potential. Therefore, research with genome editing is allowed with careful consideration of ethical and legal standards. The company has established the Merck Bioethics Advisory Panel to provide guidance for research in which Merck is involved, including research on or using genome editing.


For more Information, contact Gangolf Schrimpf
+49 6151 72-9591
Email


All Merck news releases are distributed by email at the same time they become available on the Merck website. Please go to www.merckgroup.com/subscribe to register online, change your selection or discontinue this service.


About Merck

Merck is a leading science and technology company in healthcare, life science and performance materials. Around 50,000 employees work to further develop technologies that improve and enhance life – from biopharmaceutical therapies to treat cancer or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD televisions. In 2016, Merck generated sales of €15 billion in 66 countries.

Founded in 1668, Merck is the world's oldest pharmaceutical and chemical company. The founding family remains the majority owner of the publicly listed corporate group. Merck holds the global rights to the “Merck” name and brand. The only exceptions are the United States and Canada, where the company operates as EMD Serono, MilliporeSigma and EMD Performance Materials.

   
Record changed: 2017-10-30

Advertisement

Picture Fairtec GmbH Worldwide Event Solutions 600x60px

More documents for Merck (DE) (Group)


To subscribe to our free, monthly mass spectrometry newsletter, please send an e-mail to info@iito.de and simply fill the subject line with the word »MSC newsletter«

To get even more information, please take a look at our [gs] professional services offering and read the gene-sensor Product Flyer [PDF file]

Please visit also our web portals for the Eurpean life sciences and the life sciences in German-speaking Europe (DE, AT & CH) at Life-Sciences-Germany.com and Life-Sciences-Europe.com

Advertisement

Picture Eurasanté BioFIT 2017 Strasbourg France November 600x60px




» top

Advertisements

Picture [iito] Twitter iitoLifeScience Life Sciences Mass Spec 120x120px Picture Eurasanté BioFIT 2017 Strasbourg France November 120x80px Picture [LSE] Life-Sciences-Europe.com – The Business Web Portal 120x600px Banner Fairtec GmbH Solutions for Smarter Business Events Exhibitions 120x120px Picture [iito] Twitter iitoLifeScience Life Sciences Mass Spec 120x120px Picture Eurasanté BioFIT 2017 Strasbourg France November 120x80px