- How do Selexis Genetic Elements™ work?
- What vectors are compatible with the Selexis Genetic Elements™?
- What cell types have been tested with the Selexis Genetic Elements™?
- What typical productivity boost can be expected with the Selexis SUREtechnology™?
- How stable are the SUREclones™ derived from the Selexis SUREtechnology™?
- How many clonal cell lines have been generated with the Selexis SUREtechnology Platform™?
- Are there regulatory issues concerning the use of the Selexis SUREtechnology Platform™?
- How to submit questions / comments about your technology or ask for additional information?
- I have published a paper using Selexis Genetic Elements. How do I get this information to Selexis?
1. How do Selexis Genetic Elements™ work?
To establish a novel high-producing clonal cell lines, Selexis Genetic Elements™, SGEs, (from 2 to 4Kb long) are used to control the promoter accessibility of the expression cassette. The SGEs function by insulating nearby genes from the silencing effects of surrounding chromatin thereby increasing copy number-dependent and position-independent expression of genes. For this reason, the SGEs increase the amount of recombinant protein produced. In addition, the increased number of clones that have integrated the transgene cassette (post transfection) allows a fast isolation of high-yield expressing cell clones. This last generation production technology represents significant savings both in the production of research grade materials (e.g. R&D) and in the selection of very high producing single cell clones for large-scale bioproduction.
2. What vectors are compatible with the Selexis Genetic Elements™?
The SGEs can be used with any expression vector system. Several expression vectors were successfully tested along with the SGEs. The genetics of the host cell line is not altered, except for the production of the recombinant protein. Many different promoters have also been tested in combination with the SGEs such as different versions of the CMV promoter, the ubiquitin promoter, the SV40 early promoter as well as inducible promoters. Selexis SUREtech Vectors™ used in the Selexis SUREtechnology Platform™ have been designed and optimized to further maximize the potency of the SGEs. The Selexis SUREtech Vectors™ are non-viral, fully documented and regulatory compliant. The Selexis SUREtech Vectors™ naturally integrate at a random single chromosomal site in multiple copies without any gene amplification required.
3. What cell types have been tested with the Selexis Genetic Elements™?
The SGEs have been tested in a variety of cell types including: CHO, HEK 293, BHK, C2C12, NS0, HeLa, a B cell derivative and adult stem cells. The SGEs’ activity has also been validated in vivo in animal models. The SURE CHO-M Cell line™ used in the Selexis SUREtechnology Platform™ is a high-performance host cell line, easy to handle, with full parental pedigree and complete traceability of cell treatment and utilized media and reagents (FDA and EMA compliant). They are cultured in commercially available medium (serum free and no animal derived compound) with established feed strategy up to large-scale bioreactors.
4. What typical productivity boost can be expected with the Selexis SUREtechnology™?
For antibody production, Selexis has demonstrated that Selexis Genetic Elements™ were able to boost the productivity of cell clones by a factor of 20 to 40 folds. With the most recent enhancements of the platform, Selexis SUREHTSOptimization™, Selexis has demonstrated an extra 10 fold increase in expression of certain difficult-to-express proteins when compared to already optimized baselines and an extra 5 fold increase in normally secreted recombinant proteins.
5. How stable are the SUREclones™ derived from the Selexis SUREtechnology™?
Selexis has tested the stability of both pools of transfected cells and individual clones. The individual SUREclones™ were stable, as assayed by specific productivity, for over 14 months and SUREpools™ were stable for at least 6 months.
6. How many clonal cell lines have been generated with the Selexis SUREtechnology Platform™?
Selexis has generated over 1300 clonal cell lines for about 100 different programs. These include clonal cell lines expressing Green Fluorescent Protein (GFP) and a wide variety of recombinant therapeutic proteins such as monoclonal antibodies and biosimilars, clotting factors, enzymes, hormones, erythropoietin as well as membrane bound receptors. About 20 SUREclones™ have been developed forward to the production of cGMP material for use in human clinical trials. The SUREclones™ were compared with clonal cell lines made the traditional manner and were found to maintain the high level of expression and yield stable production at this high level during optimization in the bioreactor. Therefore the yield improvement seen during the creation of the cell lines was seen to translate into increased yields in bioreactors. The SUREclones™ were successfully cultured in wave, glass, plastic and stainless steel bioreactors and using optimized feed strategies. Three products are anticipated to be launched in 2012.
7. Are there regulatory issues concerning the use of the Selexis SUREtechnology Platform™?
Detailed information regarding the vector and the Selexis Genetic Elements™ used in the expression vectors, are provided by Selexis to clients for any regulatory filings (i.e. FDA, EMA…). This information includes a description of the source and function of the all component parts of the vector, including the SGEs. Full cell line development documentation according ICH guidelines is provided for proper transfer to cGMP manufacturing CMO and is fully regulatory compliant.
8. How to submit questions / comments about your technology or ask for additional information?
You can email us directly at info@selexis.com
9. I have published a paper using Selexis Genetic Elements. How do I get this information to Selexis?
Please send your paper along with full contact information to info@selexis.com
