SEKISUI Completes CDMO Capacity Expansion for CGMP Biopharma Manufacturing

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SEKISUI Diagnostics announced on Nov. 14, 2024 the completion of a £15.7 million (US$20.7 million) expansion of current good manufacturing practice (CGMP) capacity at the company’s UK site for its microbial contract development and manufacturing business (CDMO), BioProduction by SEKISUI. The expanded capacity will be used for manufacturing clinical-grade drug substances.

Following appropriate licensure, the expanded capacity will enable the CDMO business’ manufacturing capabilities for common drug types, including enzymes, proteins, and antibody fragment therapies as well as plasmids and enzymes for gene therapy manufacture. BioProduction by SEKISUI is a fermentation-focused CDMO. The business has expertise in proteins and downstream purification, and its microbial process development and production experience facilitates technical transfer and process scale-up. The recent expansion includes new Grade C microbial fermentation and purification suites that will accommodate production scales up to 1000 L.

“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 and CEO of SEKISUI Diagnostics, in a company press release (1). “We look forward to working with biopharma companies seeking an experienced partner at a time when demand is outstripping manufacturing capacity.”

A part of SEKISUI Medical Group, SEKISUI Diagnostics has over 40 years of experience supplying innovative medical diagnostics globally to physicians, hospitals, laboratories, and alternate testing locations. Its product lines include clinical chemistry reagents, point-of-care tests, pre-analytic systems, and enzymes and specialty biochemicals as well as its offerings in its microbial CDMO business.

“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,” said Louise Digby, vice-president, Enzymes & BioProduction, SEKISUI Diagnostics in the press release (1).

It has been noted that many companies ranging from biotech startups working on early-phase biologics to mature companies with products in commercial production have switched from mammalian cell culture to microbial fermentation. The switch has been largely attributed to the cost-savings that microbial expression systems bring. Microbial expression systems have also demonstrated that they are well built for newer modalities such as messenger RNA (mRNA) and cell and gene therapies. Furthermore, microbial fermentation offers shorter production runs that can be completed in days instead of weeks, compared to mammalian cell culture (2).

However, microbial fermentation poses its own challenges, such as the need to maintain sufficient oxygen transfer while removing metabolic heat. Such challenges are being addressed via equipment changes, facility design, and process development (2).

References

1. SEKISUI Diagnostics. SEKISUI Completes £15.7 Million Expansion in cGMP Biopharma CDMO Capacity. Press Release. Nov. 14, 2024.
2. Graham, C.; Awang, G. High-Growth Microbial Fermentation for the Manufacture of Biologics. BioPharm International online. Feb. 20, 2024.

Source: SEKISUI Diagnostics