Merck brings customers closer to gene therapy product commercialization

MerckMerck 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 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 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 hemophilia 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.

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.

Most Popular Now

GSK reaches agreement with Novartis to acquire ful…

GlaxoSmithKline plc (LSE/NYSE: GSK) today announces that it has reached an agreement with Novartis for the buyout of Novartis' 36.5% stake in their Consumer Healthcare Jo...

Canadian neuroscientists say daily ibuprofen can p…

A Vancouver-based research team led by Canada's most cited neuroscientist, Dr. Patrick McGeer, has successfully carried out studies suggesting that, if started early enou...

Merck partners with Medisafe to help improve medic…

Merck, a leading science and technology company, today announced a new collaboration with US-based Medisafe to help its cardiometabolic patients better manage medication ...

New immunotherapy for lung cancer shows promise of…

In a groundbreaking development, results from a recent clinical trial to treat lung cancer show that a novel immunotherapy combination is surprisingly effective at contro...

Boehringer Ingelheim and OSE Immunotherapeutics an…

Boehringer Ingelheim and OSE Immunotherapeutics, a biotechnology company focused on the development of innovative immunotherapies, have announced a collaboration and excl...

Taking a standard prostate cancer drug with food b…

By taking a high-cost drug with a low-fat meal - instead of on an empty stomach, as prescribed - prostate cancer patients could decrease their daily dose, prevent digesti...

Personalized tumor vaccine shows promise in pilot …

A new type of cancer vaccine has yielded promising results in an initial clinical trial conducted at the Perelman School of Medicine at the University of Pennsylvania and...

New targeted therapy schedule could keep melanoma …

Skin melanoma, a particularly insidious cancer, accounts for the vast majority skin cancer deaths and is one of the most common cancers in people under 30. Treatment for ...

Researchers identify chemical compound that inhibi…

An organic chemical compound shows effective antiviral activity against Ebola virus and several other viruses, according to a study led by Georgia State University. The r...

When drugs are wrong, skipped or make you sick: Th…

Rising drug prices have gotten a lot of attention lately, but the actual cost of prescription medications is more than just the dollars and cents on the bill. Researchers...

New class of drugs could help tackle treatment-res…

Researchers have discovered a new class of drug that has the potential to help cancer patients who no longer respond to existing therapies. The drug may not become availa...

Researchers propose key elements of antimicrobial …

Antimicrobial stewardship programs (ASPs) in hospitals play a vital role in managing the threat of antibiotic resistance. To be of maximum effectiveness, essential elemen...