SEKISUI Diagnostics’ microbial CDMO business has completed construction of its £15.7 million ($20.7 million) cGMP capacity expansion at its UK site for clinical-grade drug substance manufacturing.
 
Upon obtaining the necessary licenses, this expansion will enhance manufacturing capabilities for various drug types, including enzymes, proteins, antibody fragment therapies, as well as plasmids and enzymes designed for advanced gene therapy production.
 
BioProduction by SEKISUI serves as SEKISUI Diagnostics’ contract service offering as a CDMO with expertise in proteins and downstream purification. Their robust experience in microbial process development and production facilitates effective technical transfers and process scale-ups. The new Grade C microbial fermentation and purification facilities are designed to support production scales of up to 1,000L.
 
“This investment supports the vision and mission of SEKISUI Diagnostics and the broader SEKISUI Medical Group by enabling the continued growth of our share of the biologics CDMO market,” said Robert Schruender, President & CEO of SEKISUI Diagnostics. “We look forward to working with biopharma companies seeking an experienced partner at a time when demand is outstripping manufacturing capacity.”
 
Louise Digby, Vice President, Enzymes & BioProduction at SEKISUI Diagnostics added: “Over many years we have honed our technical and operational competency and expertise in enzyme production and microbial fermentation to serve our partners globally. This cGMP expansion enables us to support a broader customer base and expand our offering to existing customers.”