MilliporeSigma, a subsidiary of Merck KGaA, announced the $100m (€92m) facility will double its existing production capacity for viral and gene therapy products.
The US facility will be able to produce therapies up to the commercial scale and is equipped with 1,000L Mobius single-use equipment, which are Millipore’s own bioreactors.
The plant will cover 140,000-square-feet and be located in Carlsbad, California, where the company already owns an existing facility that is able to produce viral and gene therapies from clinical to commercial scale.
Once completed, the number of suites available for production will expand from 16 to 27.
The company expects the construction of the new facility to be completed in 2021, though a spokesperson was unable to confirm in which quarter this is expected.
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, that the company has seen ‘rapid adoption’ of viral vector-based therapies.
As such, he said that, related to the company’s latest development, “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.”
The demand has been fueled by a rapidly expanding pipeline of cell and gene therapies, which saw the number of such candidates in clinical trials expand by 25% year-on-year in 2019.
As a result, Udit Batra, CEO of MilliporeSigma, suggested that viral vector manufacturing would become the ‘cornerstone’ of future biopharmaceuticals. The company noted that the gene therapy market is expected to grow to be worth $10bn by 2026, at a compound annual growth rate of 33.3% from 2018.
However, with the pipeline expanding so quickly, there have been notable issues with capacity constraints across contract development and manufacturing organization industry.