Technology
XOFLX™ stable technology and corresponding packaging and producer cell lines offer a simplified high-yielding LVV manufacturing system that lowers costs & improves process consistency.
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Streamlined and Low Cost LVV Production
No need to construct and transfect multiple plasmids.
Comparable titers across multiple GOIs.
Yields equivalent or greater than transient 4 plasmid approaches.
The simplified process results in consistent yield and lower batch to batch variation.
Reduce or eliminate transfection – de-risking and accelerating the process.
Producer cell lines eliminate transfection and make scaling up to 2000L feasible.
XOFLX™ packaging and producer cell lines stably express genes needed for LVV production, eliminating the need and expense of multiple plasmids.
The system utilizes an integrated Tet-inducible VSV-G and Gag-Pol expression strategy and is engineered for low homology between expression cassettes for an improved safety profile.
The XOFLX™ cell line was selected for high growth and viability, low aggregation, and high productivity. It has robust scalability, and the low complexity process results in decreased batch to batch variation.
XOFLX™ LVV production is a streamlined and more economical process than conventional four plasmid approaches.
Transient four plasmid systems require the independent creation of VSV-G, GagPol, Rev, and GOI Plasmids. With XOFLX™ the plasmids needed for LVV production are already integrated, as is the TetR gene which confers inducible control.
The integrated sequences have been optimized for productivity and have low homology for improved safety. Once a producer line is established, no further plasmid is needed.
The LVV Production Comparison chart shows a comparison of eight different transgenes for transient, XOFLX™ packaging, and XOFLX™ producer approaches.
XOFLX™ worked well for all transgenes, with infectious titers generally increased when compared to the transient approach.
XOFLX™ packaging and producer cell lines provide more consistency than transient systems.
The data below shows comparison of GOI titer CV for transient, XOFLX™ packaging, and XOFLX™ producer lines.
Compared to transient, both XOFLX™ packaging and producer lines have less variation.
If you are interested in exploring the application of custom XOFLX™ packaging or producer cell lines you can obtain a research-use-only license and receive the cell lines to test on your own.
For use during in-house manufacturing, you will need a clinical and commercial use license. Contact us for more information.
If you are interested in exploring the application of custom XOFLX™ packaging or producer cell lines you can obtain a research-use-only license and receive the cell lines to test on your own.
For use during in-house manufacturing, you will need a clinical and commercial use license. Contact us for more information.
The team at WuXi Advanced Therapies can work with you to develop your custom packaging and producer cell lines, and manufacture LVVs from the cell lines at our site in Philadelphia, PA, United States.
This would be a fee-for-service project and you can contact us to discuss your requirements.
You may access an off-the-shelf XOFLX™ packaging cell line for evaluation under a Material Transfer Agreement (MTA.) The expert team from WuXi Advanced Therapies will provide technical support throughout your evaluation and can also conduct a service evaluation using your GOIs at the OXGENE site in the UK.
After initial evaluation, you can continue to conduct in-house R&D under a Research Use Only (RUO) license or transition in-house GMP manufacturing under a Clinical and Commercial Use License or with the help of WuXi Advanced Therapies development and manufacturing services in Philadelphia, Pennsylvania.
We have fully qualified analytical assays for both characterization and release of LVV manufactured using XOFLX™ ready for GMP manufacture at WuXi Advanced Therapies.
We are happy to discuss optimizing your GOI for use in XOFLX™.
The XOFLX™ research cell bank is available now for evaluation under RUO licensing.
We can create and manufacture XOFLX™ producer cell lines utilizing WuXi Advanced Therapies integrated PD and MFG services.
Contact us to discuss In-house RUO and manufacturing licensing.
Please contact us and we can schedule a time for you to meet with our scientists. Once we have a CDA in place, we can share a great deal more information about the technology, timelines, commercial arrangements and more.