Headquartered in Geneva, Switzerland, Selexis SA is a global life science company with technologies for drug discovery, cell-line development and scale-up to manufacturing of therapeutic proteins. For over ten years, the company has been an innovator of technologies and world-class expert services that significantly reduce the time, effort, and costs associated with developing high-performance mammalian cell lines for therapeutic protein production (i.e., monoclonal antibodies (mAbs), growth factors, enzymes).
From discovery to late-stage clinical trials, Selexis’ technology has been and is currently being used by more than 100 companies worldwide. Selexis addresses critical issues in the development of clonal cell lines for protein manufacturing while providing innovative and reliable solutions to drug discovery. The Selexis SUREtechnology Platform™ can be applied to R&D, bioproduction, preclinical production, target discovery, cell-based assays, and diagnostics.
Selexis SUREtechnology Platform
The Selexis SUREtechnology Platform is based on Selexis Genetic Elements™ (SGE)—novel DNA-based elements that control the dynamic organization of chromatin within all mammalian cell lines, allowing for higher and more stable expression of recombinant proteins. Using the SUREtechnology Platform, Selexis can generate high-producing manufacturing cell lines in as little as 12 weeks with typical expression levels (for mAbs) between 2–5 g/L that are stable for more than 100 generations. The company has generated over 1,300 clonal cell lines being used in a variety of programs from discovery to late-stage clinical trials. The company anticipates three products manufactured from cell lines using the Selexis SUREtechnology Platform to be launched in 2012.
Proprietary High-Performance Selexis SURE CHO-M™ Cell Line
Over the past decade, Selexis has led the life science industry in developing reliable solutions for the generation of stable, high-yield manufacturing cell lines. In continuous efforts to address industry needs, the company has developed the next generation of the Selexis SUREtechnology Platform.
This major platform upgrade starts with the completion of the genome sequencing of the Selexis SURE CHO-M Cell Line, a proprietary high-performance mammalian cell line used for the production of therapeutic recombinant proteins. The growth and production properties of the Selexis SURE CHO-M Cell Line are well defined and feed strategies have been designed for efficient scale-up into bioreactors.
Data from the sequencing will be used to generate detailed characterization packages of production cell lines to support filings with regulatory agencies such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Additionally, the data will also be used to engineer novel CHO cell lines with unique and more predictable expression capabilities. Currently drug candidates manufactured with Selexis SURE CHO-M Cell Lines are in number of clinical trials worldwide including the U.S. and Europe.
Debottlenecking Protein Expression in Mammalian Cells with SURE HTSchaperones™
Selexis has enhanced the technology platfrom with SURE HTSchaperones to address production bottlenecks in protein expression, including difficult-to-express proteins, such as protein scaffolds, cell membrane receptors (GPCRs and ion channels) and blood-derived proteins. The company has demonstrated that co-expressing panels of chaperones with a gene of interest using the Selexis SUREtechnology Platform significantly increases protein expression levels, thus enabling stalled research programs to progress forward. This approach has shown significant potential to improve the production of difficult-to-express proteins.
Today, the platform is being further expanded to include larger panels of chaperones with several that impact different compartments of the metabolism of the SURE CHO-M Cell Line. Since expression bottlenecks are specific to each recombinant protein, determining the optimal chaperone combination is best achieved by high-throughput screening of various chaperones. This debottlenecking concept has been demonstrated by Selexis with an extra 10-fold increase in expression of certain difficult-to-express proteins when compared to already optimized baselines and an extra fivefold increase in normally secreted recombinant proteins (mAbs).
Decreasing the Attrition Rate with Selexis SUREvariant Screening™
The company recently launched the Selexis’ SUREvariant Screening service to accelerate and improve outcomes from displayed library selection campaigns by reducing the time and the number of steps to identify potential lead candidates. SUREvariant Screening is another of the next-generation applications of the Selexis SUREtechnology Platform. The platform can generate panels of up to 500 SURE CHO-M cell pools (SUREpools™), each expressing a different protein variant in approximately 3 weeks.
The SUREpools are expressed in a stably transfected SURE CHO-M cell line thus ensuring a steady supply of homogenous preclinical material, allowing for faster and more-informed decision-making from discovery. Once clinical candidates are chosen, the relevant SUREpools are transferred to the Selexis’ SURE Cell Line Development Platform™ to generate a high-producing clonal cell line ready for cGMP manufacturing. The entire process from SUREvariant Screening to the clonal cell line can be as short as 14 weeks and can reduce development costs by over $500,000 per clinical candidate.
The Selexis SUREtechnology Platform not only generates high-quality, high-yield manufacturing cell lines for therapeutic proteins, but now provides unique solutions for R&D programs, by increasing overall productivity and decreasing attrition rates associated with development of drug candidates.