Merck KGaA, Darmstadt, Germany, Completes New Viral Vector Contract Development Manufacturing Facility for Gene Therapy

Merck KGaA, Darmstadt, Germany, today announced the opening of its second Carlsbad, California-based facility, significantly expanding its global CDMO footprint.

12 Oct 2021 | Darmstadt, Germany
  • Expansion in Carlsbad, California, USA, doubles production capacity to support commercialization and industrialization of viral vectors
  • Investment serves customers in addressing larger patient populations with new curative treatments
  • Enables suspension production of viral vectors up to 1,000-liter scale
  • Project adds to company’s ambition to accelerate growth through investments in “Big 3” businesses, which includes plans to expand Process Solutions’ contract manufacturing and development organization (CDMO) services for traditional and novel modalities

Merck KGaA, Darmstadt, Germany, a leading science and technology company, today announced the opening of its second Carlsbad, California-based facility, significantly expanding its global CDMO footprint. This new €100 million, 140,000-square foot facility will more than double the company’s existing capacity to support large-scale commercial and industrial manufacturing for viral gene therapy, in a market expected to grow to $10 billion by 2026.

“Today, most gene therapies target rare diseases, but there is an urgent need to efficiently manufacture these treatments to reach larger patient populations,” said Matthias Heinzel, Member of the Executive Board of Merck KGaA, Darmstadt, Germany, and CEO Life Science. “As a leader in viral vector manufacturing, this increase in capacity and scale is the next step in enabling our customers to bring new curative treatments to market.”

This is the company’s second Carlsbad, California-based facility to serve cell and gene therapy customers driven by the industry’s rapid adoption of viral vector-based therapies. Between the two facilities, there are 30 cleanroom suites to support all aspects of manufacturing from small- to large-scale clinical and commercial production. The new facility leverages cutting-edge suspension technology to enable scalable and cost-effective manufacturing.

“We are continuing to invest in solving cell and gene therapy challenges in development and manufacturing, working alongside drug developers to industrialize, scale and accelerate the path to deliver therapies to patients,” Heinzel added.

The expansion of the Carlsbad facility adds to the company’s ambition to accelerate growth through investments in the “Big 3”, including the Process Solutions business unit within the Life Science business sector as a key driver.

Merck KGaA, Darmstadt, Germany, has proven its commercial execution and global regulatory success as one of the first CDMOs to be granted U.S. Food and Drug Administration and European Medicines Agency approval for viral vector manufacturing. With nearly 30 years of experience in cell and gene therapy, Merck KGaA, Darmstadt, Germany, offers unique CDMO services streamlined as a single, highly experienced provider.

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About Merck KGaA, Darmstadt, Germany

Merck KGaA, Darmstadt, Germany, a leading science and technology company, operates across healthcare, life science and electronics. Around 58,000 employees work to make a positive difference to millions of people’s lives every day by creating more joyful and sustainable ways to live. From advancing gene editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2020, Merck KGaA, Darmstadt, Germany, generated sales of € 17.5 billion in 66 countries.

The company holds the global rights to the name and trademark “Merck” internationally. The only exceptions are the United States and Canada, where the business sectors of Merck KGaA, Darmstadt, Germany operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Electronics. Since its founding in 1668, scientific exploration and responsible entrepreneurship have been key to the company’s technological and scientific advances. To this day, the founding family remains the majority owner of the publicly listed company.

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