Merck KGaA is reaffirming its gene therapy presence via a doubling of its viral vector manufacturing capacity in a EUR 100 million expansion of its Carlsbad facility in the US, the German company said on Tuesday.
The Carlsbad facility currently houses Merck KGaA’s BioReliance viral and gene therapy service offering. The second 140,000 square-foot facility will support viral and gene therapy production at the 1,000-liter scale using Merck’s Mobius single-use equipment and is expected to open next year.
“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 of itss life sciences subsidiary, MilliporeSigma. “Few companies have the scale and quality systems in place for manufacturing commercial viral vector products. Building on our success in helping customers commercialize their gene therapies made possible by viral vectors, our expansion will help innovators produce at a scale that ensures these therapies reach more patients in need.”
The Carlsbad unit manufactures gene therapies currently being investigated to treat and cure diseases such as haemophilia and cancer with as little as one single dose.
It is currently home to 16 modular viral bulk manufacturing cleanroom suites with single-use equipment and two fill/finish suites for gene therapy, viral vaccine and immunotherapy products. With the expansion, the company will add 11 suites, bringing the total to 27, used in various steps of manufacturing.
Merck KGaA has been at the forefront of cell and gene therapy, with the Carlsbad site opening in 1997, near the time that clinical trials for gene therapy began. Since then, the company has manufactured viral vectors for two cell and gene therapy products.
The gene therapy market, which accounted for USD 1 billion in 2018, is expected to reach $ 10 billion by 2026, according to a recent Biotech Forecasts global market analysis and industry forecast.