MilliporeSigma, the U.S. and Canada Life Science business of Merck KGaA, Darmstadt, Germany, is increasing its biomanufacturing capacity globally by implementing high-efficiency processes and by expanding its global footprint.

“Our life science strategy is focused on strengthening our core business and expanding in high-growth areas,” Darren Verlenden, head of process solutions, life science business sector, Merck KGaA, Darmstadt, Germany, tells GEN. Soon, that may include an increased presence in the Asia-Pacific region.

The company recently signed a non-binding memorandum of understanding with South Korea’s Ministry of Trade, Industry and Energy to possibly create a new Asia-Pacific BioProcessing Center to provide comprehensive support for its commercial manufacturing customers throughout the region. South Korea was chosen based upon a detailed assessment of such critical factors as market dynamics, operational considerations, talent availability, political stability, governmental policy and regulatory landscape.

Additionally, MilliporeSigma has expended more than €250 million to expand single-use manufacturing capacities at its facilities in Molsheim, France, and Wuxi, China. It also has invested more than €580 million to expand its filtration manufacturing capacity. “This includes investments in immersion membrane casting capacity at our Carrigtwohill, Ireland and Darmstadt, Germany facilities, and a new filtration manufacturing facility in Blarney, Ireland,” Verlenden says. Plans call for continuing such innovation throughout the world.

Rapidly evolving market

“In the rapidly evolving market for advanced bioprocesses, we are investing in the development of new technologies to intensify bioprocesses and maximize a facility’s utilization,” Verlenden notes. That combination helps their processes and thus bring products to market more quickly and efficiently.

Single-use technologies, closed processing, and process intensification help minimize the bioprocessing footprint and reduce water and energy usage, thereby creating more sustainable, multi-product and multi-modality manufacturing, he says.

For example, MilliporeSigma’s Eshmuno® CP-FT cation exchange (CEX) resin “reduces the scale of the CEX step within the downstream processes, and uses 10-times less resin and 9-times less buffer for the same amount of product yield.”

Likewise, Verlenden continues, “Our viscosity reduction platform…helps overcome manufacturing and formulation challenges associated with highly concentrated protein solutions. By reducing viscosity, higher concentrations can be achieved during tangential flow filtration, along with shorter processing times and improved downstream process economics.”

Closed processing enhances efficiency by mitigating contamination and safety risks. It “reduces costly and environmentally demanding cleanroom control measures and increases operational flexibility,” Verlenden says.

MilliporeSigma is developing an end-to-end portfolio of products for batch and intensified bioprocesses, Verlenden adds. “These technologies will eliminate the need for operators to perform any pre-use sanitization or sterilization steps and enable plug-and-play processing from vial thaw to final fill, with much less infrastructure.”

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