German pharmaceuticals and chemicals producer Merck KGaA has announced plans to start up a second commercial manufacturing facility for viral and gene therapy products at its Carlsbad, California, US site next year. 

The new €100 million investment, which will nearly double the Darmstadt-based group’s existing production capacity, will support viral and gene therapy production at the 1,000-liter scale, using Merck’ Mobius single-use equipment.

Merck’s continued investment in viral and gene therapies from clinical to commercial scale spans three decades. The Carlsbad site has been involved in gene therapy since 1997, around the time clinical trials for such products began. Since then the group’s Life Science arm has manufactured viral vectors – in some estimates the most complex therapeutics – for two cell and gene therapy products.

Currently, the Carlsbad site has 16 modular viral bulk manufacturing cleanroom suites with single-use equipment and two fill/finish suites for gene therapy, viral vaccine and immunotherapy products. The ongoing expansion will add 11 suites, bringing the total to 27. It is the second major investment at the facility in recent years. In 2106 existing capacity was nearly doubled.

In addition to contract development and manufacturing services for viral vectors, Merck also provides seamless manufacturing and testing services at its pharma and biopharma testing sites globally.

“Viral vector manufacturing has transitioned from a niche industry to the cornerstone of the future of biopharmaceuticals,” said Udit Batra, member of the Merck executive board and CEO, Life Science. ”Few companies have the scale and quality systems in place for manufacturing these products at commercial scale,” he added.

At Carlsbad Merck manufactures gene therapies for its customers globally, investigating diseases such as hemophilia and cancer. The gene therapy market, which accounted for $ 1 billion in 2018, is expected to reach $10 billion by 2026, according to a recent Biotech Forecasts global market analysis and industry forecast.