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

Delivering insulin in a pill

Given the choice of taking a pill or injecting oneself with a needle, most of us would opt to regulate a chronic health condition by swallowing a pill. But for millions o...

Can aspirin treat Alzheimer's?

A regimen of low-dose aspirin potentially may reduce plaques in the brain, which will reduce Alzheimer's disease pathology and protect memory, according to neurological r...

FDA approves first drug comprised of an active ing…

The U.S. Food and Drug Administration today approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with two rare and severe forms o...

Researchers develop a new method for turning skin …

Our bodies consist of many different kinds of cells, each with their own role. The Japanese scientist Shinya Yamanaka had made earlier the discovery, earning the Nobel Pr...

Some existing anti-cancer drugs may act in part by…

Bolstering the notion that RNA should be considered an important drug-discovery target, scientists at Scripps Research have found that several existing, FDA-approved anti...

Poliovirus therapy for recurrent glioblastoma has …

A genetically modified poliovirus therapy developed at Duke Cancer Institute shows significantly improved long-term survival for patients with recurrent glioblastoma, wit...

Human clinical trial reveals verapamil as an effec…

Researchers at the University of Alabama at Birmingham Comprehensive Diabetes Center have discovered a safe and effective novel therapy to reduce insulin requirements and...

Novartis Clear about Psoriasis survey data highlig…

Novartis announced today the publication of global Clear about Psoriasis survey data in the Journal of the European Academy of Dermatology and Venereology[1]. The publica...

New small molecules pave the way for treating auto…

The innate immune system is the first line of defense, with cells that quickly identify "foreign" motifs from viruses and bacteria and mount up a counterattack to elimina...

How targeting metabolism can defeat cancer stem ce…

Researchers are the University of Michigan Rogel Cancer are unraveling a crucial thread that explains why cancer so often becomes resistant to treatment. In a breakthroug...

Amgen and MBC Biolabs announce winners of the Amge…

Amgen (NASDAQ:AMGN) and MBC BioLabs (formerly QB3@953) announced that Delve Therapeutics and Mitokinin have won the Amgen Golden Ticket at MBC BioLabs. Each company recei...

FDA warns of imposters sending consumers fake warn…

The U.S. Food and Drug Administration is warning consumers about criminals forging FDA warning letters to target individuals who tried to purchase medicines online or ove...