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From mAbs to tailored approaches for bsAb expression—moving biologics faster to the clinic with Selexis’ SUREtechnology Platform

Apr 15, 2022 7:08:00 AM

Selexis - Biotech Daily Feature 2022

For more than 20 years, Selexis has been helping its partners predictably, rapidly and cost-effectively generate life-saving biologic medicines and vaccines. Their SUREtechnology Platform is used by clients worldwide, resulting in more than 157 drug candidates in preclinical and clinical development and the manufacture of ten commercial products. Selexis is able to generate stable and high-expressing (2-7 g/L for mAbs, 1-5g/L for bi-specific antibodies, fed batch in shake flask, >10 g/L in bioreactor) research cell banks (RCBs) in as little as eight weeks. And now with a state-of-the-art European facility, Selexis and KBI Biopharma, can facilitate their expedited GENE to GMP process for bulk drug substance.

Biologics development is a fast-evolving field and Selexis maintains its leadership position in cell line development through constant innovation. The SUREtechnology Platform is among the most comprehensive cell line development platforms in the industry and incorporates a number of key proprietary technologies unique to Selexis: Selexis SGE (Selexis Genetic Elements), SUREtech Vectors and SURE CHO-M Cell Line. These form the backbone of the SUREtechnology Platform and provide the foundation for the rapid generation of high-expressing cell lines.

  • Selexis SGEs are unique epigenetic DNA elements that promote higher and more stable transcription of recombinant genes.
  • SUREtech Vectors are proprietary vectors designed around Selexis Genetic Elements to ensure stable integration of a transgene into the host chromosome and efficiency of transfection.
  • Selexis SURE CHO-M Cell Line (CHO-M) is a proprietary high-performance CHO-K1-derived cell line, whose genome and transcriptome have been extensively characterized. The growth and production properties of the CHO-M Cell Line are well-defined, allowing for faster and more efficient scale-up to bioreactors.

As bispecific antibodies (bsABs) continue to demonstrate impressive results in clinical trials, Selexis continues to support partners in the development of this expanding class of therapeutics with its SUREtechnology Platform. The Selexis’ SUREtechnology Platform provides a modular approach to cell line development that has the capabilities to address the myriad challenges associated with producing these complex proteins, including translation/secretion bottlenecks (CHO-Mplus Libraries) and manufacturing cell line clonality and integrity (SUREscan).

  • SURE CHO-Mplus Libraries offer unparalleled solutions for generating manufacturing cell lines that are specifically tailored to the expression and secretory needs of most recombinant proteins. This sophisticated approach significantly de-risks expression and production issues of difficult-to-express recombinant proteins, helping reduce attrition rates in biologic drug discovery and development.
  • SUREscan combines next-generation sequencing technologies with Selexis’ exclusive bioinformatics tools. Selexis can quickly analyze the entire genome and transcriptome of any generated RCB. SUREscan gives Selexis’ partners insights into integration sites and copy numbers, transgene integrity and can establish clonality of RCBs.

As the biopharmaceutical industry develops complex molecules to address difficult-to-treat diseases such as cancer, Selexis continues to innovate ensuring that its SUREtechnology Platform will remain an unparalleled solution for the rapid, stable, and cost-effective production of virtually any recombinant protein and provide seamless integration with the bioproduction continuum..

For more information, visit selexis.com or visit us at booth #1337 in the BioProcess Zone.