This new Us$110m, 140,000-square foot facility sees production capacity doubled to support commercialization and industrialization of viral vectors. The idea is to help innovators produce at a scale ensuring that these therapies reach more patients in need.
Viral vectors are often called the most complex therapeutic manufactured today. The gene therapy market, which accounted for $1bn in 2018, is expected to reach $10bn by 2026, according to a Biotech Forecasts global market analysis and industry forecast.
With a rapidly growing pipeline, there are notable issues with capacity constraints across the contract development and manufacturing organization space.
The new facility allows suspension production of viral vectors up to 1,000-liter scale, using Merck’s Mobius single-use equipment.
'Cornerstone of future biopharmaceuticals'
Udit Batra, former CEO of MilliporeSigma, who is now CEO at Waters Corporation, said, in April 2020, that viral vector manufacturing would become the ‘cornerstone’ of future biopharmaceuticals.
Regarding the demand that the company is seeing for viral vector-based therapies, Jerry Keybl, head of cell and gene therapy at MilliporeSigma, told BioPharma-Reporter then that the company was seeing ‘rapid adoption’ of viral vector-based therapies.
“Drug developers and tool providers [need] to work in harmony to help meet patient demand by ensuring product efficacy, safety and commercial readiness to accelerate therapy to market,” he added.
Long history of cell and gene therapy work
MilliporeSigma has close to three decades of experience in cell and gene therapy, and the Carlsbad site has been involved in the gene therapy area since 1997, near the time that clinical trials for gene therapy began.
This expansion, said Merck, marks the second major investment at its Carlsbad facility in recent years. In 2016, it also doubled former production capacity at the site. The upgraded facility grew from 44,000 square feet to 65,000 square feet, and saw the addition of 16 modular bulk manufacturing cleanroom suites with single-use equipment and two fill/finish suites for gene therapy, viral vaccine and immunotherapy products.
With this latest investment, the company adds 11 suites, bringing the total to 27; they are used in various steps of manufacturing.
As well as its CDMO services for viral vectors, Merck also has seamless manufacturing and testing services at its pharma and biopharma testing sites globally.