Previously part of Genzyme Corp., Sekisui Diagnostics’ Enzyme business launched its microbial biopharma CDMO service offering, BioProduction by Sekisui, in 2017. The facility expansion and cGMP upgrades will enable Sekisui to take on drug substance contract manufacturing for clinical trials. The new cGMP certified microbial fermentation and purification suites will accommodate production scales up to 1,000L, complementing its existing capabilities which range from 20L to 5,000L fermentation scale.
Sekisui has experience with projects from preclinical to commercialization, including recombinant systems such as E. coli and Pichia pastoris, and associated purification and analytical technologies. Its main expertise is the production of enzymes, however capabilities also includes plasmids, antibody fragments, and other protein production.
“This investment represents our commitment to serve our Biopharma customers with much needed cGMP microbial CDMO production capacity.” said Robert Schruender, President & CEO of Sekisui Diagnostics and Sekisui Medical Board Member. “Over many years we have built both a technical and operational competency and expertise in enzyme production and microbial fermentation. As the Biopharma CDMO market grows, we aim to further leverage this capability to grow our share in this market.”