SEKISUI Diagnostics has completed a £15.7 million ($20.7 million) expansion of its cGMP manufacturing capacity at its UK facility, a move aimed at strengthening the supply of critical drug substances for biopharmaceutical products. With this expansion, SEKISUI aims to enhance its capabilities in clinical-grade production of various drug types, including enzymes, proteins, antibody fragment therapies, plasmids, and enzymes required for emerging gene therapies, upon appropriate regulatory licensure.
The upgraded facility adds Grade C microbial fermentation and purification suites, enabling fermentation capacities up to 1,000 liters. This expansion supports BioProduction by SEKISUI, the company's contract development and manufacturing organization (CDMO) service, which focuses on microbial fermentation and downstream purification processes. The investment, according to SEKISUI, aligns with the company’s commitment to meeting the demand for high-quality biopharmaceutical manufacturing—a demand that continues to outpace available production capacity globally.
Robert Schruender, president & CEO of SEKISUI Diagnostics, commented on the facility's expansion, describing it as a strategic step toward growing SEKISUI's presence in the biologics CDMO market.
He said: “This investment supports SEKISUI’s vision and mission, allowing us to further partner with biopharma companies in need of an experienced manufacturing collaborator,” Schruender noted.
The company emphasized the importance of this expanded capacity in meeting the demands of biopharma clients navigating technical transfer and process scale-up challenges. With an established focus on microbial process development, BioProduction by SEKISUI is structured to facilitate a smooth transition from development to production, aiding companies in reducing time to market.
Louise Digby, vice president of Enzymes & BioProduction at SEKISUI Diagnostics, highlighted the company’s expertise in enzyme production and microbial fermentation, noting how this expansion will further support both new and existing clients.
She said: “Over the years, we have refined our technical and operational capabilities in enzyme production and microbial fermentation to serve our partners globally,” said Digby. “This cGMP expansion enhances our ability to reach a broader customer base and strengthen our support for current clients seeking reliable, large-scale production solutions.”
SEKISUI Medical Group is a global network encompassing diagnostics and pharmaceutical sciences, offering drug development and manufacturing services for a broad range of applications, including active pharmaceutical ingredients, amino acids, pharmaceutical intermediates, enzymes for diagnostics, and biopharmaceutical contract manufacturing.
With this expansion, SEKISUI Diagnostics says it will reinforce its position within the biopharma manufacturing landscape, with ambitions to support a wide range of customers and drug development needs in an increasingly capacity-constrained industry.
