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Headquartered in Burlington, MA, with bases in North America and Europe, SEKISUI Diagnostics has a broad product portfolio covering clinical chemistry (reagents), point-of-care testing (immunoassay systems, rapid test kits and readers), as well as specialty biochemicals and enzymes for diagnostic reagent and biosensor manufacturers.
November 19, 2010
Bob Schruender
590
One Wall Street, Burlington, MA 01803, USA
The diagnostics business is the core of the Group. It focuses on developing, manufacturing, and marketing in vitro diagnostics for hospitals laboratories, clinics and physician offices. Meeting the needs of customers through quality assays, our reagents and point-of-care tests are used to diagnose and monitor a wide range of conditions such as cardiovascular health, diabetes, and infectious diseases.
Our range of clinical chemistry reagents are used in measuring liver and renal function, lipid values, and more to help physicians diagnose and monitor patients. Through proprietary latex technology, we have also developed high-sensitivity reagents that can exclusively be used on certain instruments, as well as new reagents for biomarker measurement. This allows us to meet an even wider range of global diagnostic needs.
Our product lineup ranges from blood glucose control markers such as hemoglobin A1c and glycoalbumin, in addition to biomarkers for complication management and prediction involving insulin and other hormones, urinary L-FABP, urinary trace albumin and cystatin C. We contribute to diabetes medical examination by providing timely and accurate data to medical professionals and patients, during diagnosis and in understanding pathophysiology, follow-up and complication management.
Our compact instruments are effective in confined spaces and can quickly process a large number of samples. This contributes to a wide range of laboratory and diagnostics testing, including screening tests for blood coagulation abnormalities to biomarkers.
Our point-of-care testing (POCT) product line includes quantitative and qualitative tests based on immunochromatography technology developed over many years. These tests are especially crucial in diagnoses that require rapid response, such as infectious disease and immunology tests. In addition to using immunochromatography readers, we also provide molecular diagnostic products that support POCT.
Our biopharma CDMO offers specialized CDMO services with expertise in microbial fermentation and downstream processing. We support the development and manufacturing of biologics, including enzymes, recombinant proteins, and viral vectors. Our advanced UK facility provides comprehensive biomanufacturing services, including GMP compliance and sustainability initiatives. We also specialize in plasmid and viral vector production for research and therapeutics.
Our UK-based facility boasts diverse fermentation capacities, integrating advanced chromatography and lyophilization techniques. As we expand our cGMP capacity for clinical-grade drug substances, we prioritize adherence to ISO standards and environmental safety. Our commitment to continuous improvement and sustainability positions us as a partner of choice for global leaders in biomanufacturing.
BioProduction by SEKISUI is a highly regarded provider of specialized Contract Development and Manufacturing Organization (CDMO) services. We offer comprehensive biomanufacturing solutions that are grounded in decades of expertise in microbial fermentation and downstream processing. Our services encompass the entire development lifecycle, from the initial optimization of microbial strains to the large-scale manufacturing required for clinical applications. This extensive support is available for a diverse array of biologics, which includes enzymes, recombinant proteins, antibody fragments, viral vectors, and plasmids. By leveraging their deep experience and specialized knowledge,
Our microbial expertise encompasses a wide range of expression platforms, including E. coli, Pichia pastoris, Bacillus, Streptomyces, Streptococcus, fungi, and yeast. This extensive knowledge allows us to tailor our biomanufacturing processes to the specific needs of each biologic, ensuring high flexibility and efficiency.
By leveraging these diverse microbial systems, we can optimize the production process for a wide array of biologics, ensuring high yield, purity, and functionality. This versatility is crucial for meeting the specific requirements of different biopharmaceutical programs and achieving successful outcomes in both research and clinical applications.
Our advanced UK facility based in Kent is equipped for full spectrum biomanufacturing services and features:
・Fermentation capacity from 2 L R&D scale up to 5,000 L production
・Integrated protein expression services for high-yield production
・Advanced chromatography and purification suites
・End-to-end antibody production services
・Lyophilization and bulk formulation
・GMP-aligned systems under ISO 9001 and ISO 8 cleanroom classifications
・In-progress GMP plasmid manufacturing and clinical-grade expansion
・Environmental control and zero-emissions sustainability framework
We also provide expert plasmid production for research and therapeutics, with growing capabilities in viral vector manufacturing for cell and gene therapy markets. As established recombinant protein manufacturers, we support custom expression and scale-up for diverse biopharmaceutical programs.
We manufacture high-quality enzymes and specialty biochemicals for the global healthcare market, working with global partners to supply materials for a wide range of applications, including pharmaceutical production, clinical chemistry reagents, and POC/biosensor devices.
By leveraging our robust outsourcing capabilities, we employ advanced fermentation techniques using microorganisms and cutting-edge bioreactors to optimize production processes. This ensures that we deliver superior quality enzyme products efficiently and reliably.
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