LV Edge System
Integrating stable cell lines and software design tools to achieve lentiviral titers of 1E9 TU/mL for therapeutic transgenes
The LV Edge System consists of three components: (1) A clonal, suspension-adapted engineered cell line with stably-integrated lentiviral genes under inducible control, (2) Model-guided DNA design to optimize expression of your Gene of Interest (GOI) - powered by Kernel, Asimov's computer-aided design (CAD) software, and (3) Robust, ready-to-transfer processes and protocols across multiple scales.
Choose from the off-the-shelf Packaging system to use in your own lab, or a Producer cell line development service performed by Asimov.
How to work with us
We provide tools for you to develop a cell line
We will ship the software, cells, and genes you need to design your cell line in-house.
We develop a cell line for you
Using our platform, we will design a custom cell line specifically for your needs and ship it to you.
We provide tools for you to develop a cell line
We will ship the software, cells, and genes you need to design your cell line in-house.
You design DNA
You use our software to design and optimize genetic constructs using best-in-class parts and models.
We build DNA
We will ship the software, cells, and genes you need to design your cell line in-house.
You transfect cells
You transfect and generate stable cell lines and use our software for data analysis.
You request producer cells
You request a producer cell line for a biologic or gene therapy.
We do cell line development
We do cell line development and process development at our site.
We share progress
We share progress and data with you using our software.
We ship you producer cell banks
We ship you clonal cell banks and transfer the process to your site.
We provide tools for you to develop a cell line
We will ship the software, cells, and genes you need to design your cell line in-house.
We develop a cell line for you
Using our platform, we will design a custom cell line specifically for your needs and ship it to you.
We provide tools for you to develop a cell line
We will ship the software, cells, and genes you need to design your cell line in-house.
You design DNA
You use our software to design and optimize genetic constructs using best-in-class parts and models.
We build DNA
We will ship the software, cells, and genes you need to design your cell line in-house.
You transfect cells
You transfect and generate stable cell lines and use our software for data analysis.
You request producer cells
You request a producer cell line for a biologic or gene therapy.
We do cell line development
We do cell line development and process development at our site.
We share progress
We share progress and data with you using our software.
We ship you producer cell banks
We ship you clonal cell banks and transfer theprocess to your site.
We develop a cell line for you
Using our platform, we will design a custom cell line specifically for your needs and ship it to you.
We provide tools for you to develop a cell line
We will ship the software, cells, and genes you need to design your cell line in-house.
You design DNA
You use our software to design and optimize genetic constructs using best-in-class parts and models.
We build DNA
We will ship the software, cells, and genes you need to design your cell line in-house.
You transfect cells
You transfect and generate stable cell lines and use our software for data analysis.
You request producer cells
You request a producer cell line for a biologic or gene therapy.
We do cell line development
We do cell line development and process development at our site.
We share progress
We share progress and data with you using our software.
We ship you producer cell banks
We ship you clonal cell banks and transfer the process to your site.
Choose the right system for you
LV Edge Packaging System
Best for: Speed
We transfer our system to your lab
We ship you our clonal suspension packaging host cell line and grant access to our software, which you use to design and request plasmid DNA for your GOI. You use our system to perform lentiviral production at your facility.
Transient
Packaging
Batch-to-batch consistency
Low manufacturing complexity
Low supply chain risk
Scalability
Rapid development timeline
Low cost
LV Edge Producer System
Best for: Scale and reproducibility
We perform services in our lab
We perform fully-stable cell line development and bioreactor process development, transferring them to your facility for lentiviral production.
Transient
Producer
Batch-to-batch consistency
Low manufacturing complexity
Low supply chain risk
Scalability
Rapid development timeline
Low cost
We provide tools for you to develop a cell line
We will ship the software, cells, and genes you need to design your cell line in-house.
We develop a cell line for you
Using our platform, we will design a custom cell line specifically for your needs and ship it to you.
We provide tools for you to develop a cell line
We will ship the software, cells, and genes you need to design your cell line in-house.
You design DNA
You use our software to design and optimize genetic constructs using best-in-class parts and models.
We build DNA
We will ship the software, cells, and genes you need to design your cell line in-house.
You transfect cells
You transfect and generate stable cell lines and use our software for data analysis.
You request producer cells
You request a producer cell line for a biologic or gene therapy.
We do cell line development
We do cell line development and process development at our site.
We share progress
We share progress and data with you using our software.
We ship you producer cell banks
We ship you clonal cell banks and transfer the process to your site.
LV Edge Packaging System
Best for: Speed
We develop a cell line for you
Using our platform, we will design a custom cell line specifically for your needs and ship it to you.
We transfer our system to your lab
We ship you our host cells and grant access to our software, which you use to design and request DNA. You use our system to perform lentivirus manufacture at your facility.
Transient
Packaging
Batch-to-batch consistency
Low manufacturing complexity
Low supply chain risk
Scalability
Rapid development timeline
Low cost
You request producer cells
You request a producer cell line for a biologic or gene therapy.
We do cell line development
We do cell line development and process development at our site.
We share progress
We share progress and data with you using our software.
We ship you producer cell banks
We ship you clonal cell banks and transfer theprocess to your site.
LV Edge Producer System
Best for: Scale and reproducibility
We provide tools for you to develop a cell line
We will ship the software, cells, and genes you need to design your cell line in-house.
You design DNA
You use our software to design and optimize genetic constructs using best-in-class parts and models.
We build DNA
We will ship the software, cells, and genes you need to design your cell line in-house.
You transfect cells
You transfect and generate stable cell lines and use our software for data analysis.
We perform services in our lab
Using the LV Edge Producer System, we develop a stable cell line containing your gene of interest and ship it to you to perform lentivirus manufacture at your facility.
Transient
Producer
Batch-to-batch consistency
Low manufacturing complexity
Low supply chain risk
Scalability
Rapid development timeline
Low cost
System performance
Achieving >E8 TU/mL titers for clinically relevant CAR
Production of lentivirus was assessed in transient, packaging, and producer cell lines for the CAR Kymriah.
Speak to a member of our team
In lentiviral manufacturing, GMP plasmids account for a significant proportion of raw material costs. The procurement of these plasmids also introduces additional supply chain complexity, which can impact both timelines and product variability.
The LV Edge Packaging System combines an engineered HEK293T cell line containing inducible viral genes, software for DNA design, and robust, ready-to-transfer processes. It routinely achieves E8 TU/mL titers for multiple therapeutic transgenes and enables tuneable viral potency in the transduced cell.
Why choose LV Edge?
High performance
- Routinely achieve E8 TU/mL titers for multiple therapeutic transgenes and enables tuneable expression in the transduced cell.
Lower cost of goods
- Reduce the number of GMP plasmids, leading to cost savings for every batch.
Lower supply chain risk
- Decrease supply chain risk for GMP plasmids without compromising speed to market.
System performance
High performance across multiple CAR transgenes
The LV Edge Packaging System consistently achieves E8 TU/mL titers across clinically relevant transgenes.
High performance across multiple CAR transgenes
The LV Edge Packaging System consistently achieves E8 TU/mL titers across clinically relevant transgenes.
anti-BCMA Car LV
8.3E7 TU/mL
Yescarta CAR LV
1.1E8 TU/mL
Kymriah CAR LV
1.5E8 TU/mL
Kymriah case study:
LV Edge Packaging System vs transient
The LV Edge Packaging outperforms commercially-available systems.
Titers: Codon optimization of the CDS results in a 5-fold improvement in functional titer and 10-fold improvement of the infectivity ratio. As expected, both LV Edge Packaging and standard four-plasmid systems both show increased titers from sequence optimization.
Variability: Lentiviral production from a single-plasmid transfection results in reduced inter-batch variability versus the standard four-plasmid process. Importantly, the observed reduction in variability is maintained across the different sequence-optimized transfer plasmids.
Improved productivity and potency
LV Edge sequence optimization of GOI results in a 1.3-fold increase in the % of transduced cells coupled with a 6-fold increase in the amount of transgene expressed in these cells.
Flow cytometry histogram of HEK293T cells transduced with lentivirus harboring a chimeric antigen receptor (CAR). Expression level is visualized with an anti-CAR fluorescent antibody. Area under the orange curve is transduced population. Area under the grey curve is un-transduced population. Mean expression calculated as average intensity.
System components
Packaging cell line
Engineered HEK293T cell line ready for your gene of interest
- Clonal derivative with stable integration of viral genes – VSV-G, Gag-pol, & Rev under inducible control.
- Full traceability and documentation.
- Adapted to suspension growth in animal component-free, chemically-defined media.
- Rapid, <30 hour doubling time.
DNA optimization
Computer-aided optimization of your gene of interest
Sequence optimization using our computer-aided design (CAD) software, Kernel, shows up to 17x improvement in productivity for clinically relevant CAR, with consistent highest performance across multiple molecules versus competitors.
Platform process
Robust, scaleable and ready-to-transfer
- Tested in 4 different scales
Shake flask, AMBR15, AMBR250, 2L.
- Compatible with off-the-shelf materials
Easily procured from 3rd party vendors.
- No media dilution step required
Simply grow, transfect/induce, harvest.
We optimized our process in 3 phases
250+
Runs performed
8
Parameters calibrated
4
Scales tested
Well documented process
Ready to transfer with ease
Supported by our experts
How it works
1
We transfer the LV Edge Packaging System to your lab
We ship you vials of the suspension clonal packaging cell line along with the associated documentation.
2
Design DNA
Access our advanced computational models to optimize the DNA sequence of your Gene of Interest (GOI).
3
We ship your DNA
We construct, prepare, sequence, QC, and ship your GOI transfer plasmid direct to your facility.
4
You manufacture your lentivirus
You transfect the plasmid containing your GOI and induce the packaging cell line, receiving technical support from our team.
Speak to a member of our team
The LV Edge Producer System entirely eliminates GMP plasmids from lentiviral production, enabling greater bioreactor scalability, product consistency, and cost savings, while generating clones that achieve E9 TU/mL.
This system is available through a fully-stable cell line development service that incorporates your gene of interest into a final cell line, from transfection to RCB in 4 months.
Why choose LV Edge Producer?
High performance
- Unconcentrated lentiviral titers of 1E9 TU/mL for therapeutic transgenes.
Significant cost and risk reduction
- Eliminate GMP plasmid from lentivirus manufacturing process.
Enhanced scalability
- Suspension adapted, fully stable cell lines facilitate scalability and ensure consistent batch quality.
System performance
High performance across multiple CAR transgenes
The LV Edge Producer System achieves E9 TU/mL titers for clinically relevant transgenes. Functional titer calculated by transducing cells with crude supernatant and measuring expression of GOI via flow cytometry.
High performance across multiple CAR transgenes
The LV Edge Packaging System consistently achieves E8 TU/mL titers across clinically relevant transgenes.
anti-BCMA Car LV
8.3E7 TU/mL
Yescarta CAR LV
1.1E8 TU/mL
Kymriah CAR LV
1.5E8 TU/mL
Kymriah case study:
LV Edge Packaging System vs transient
The LV Edge Packaging outperforms commercially-available systems.
Titers: Codon optimization of the CDS results in a 5-fold improvement in functional titer and 10-fold improvement of the infectivity ratio. As expected, both LV Edge Packaging and standard four-plasmid systems both show increased titers from sequence optimization.
Variability: Lentiviral production from a single-plasmid transfection results in reduced inter-batch variability versus the standard four-plasmid process. Importantly, the observed reduction in variability is maintained across the different sequence-optimized transfer plasmids.
Clones exhibit high expression stability
Functional titer shows stable results across 5 clones for both Kymriah and anti-BCMA producer cell lines.
Demonstrated performance in primary cells
Lentivirus containing different CAR payloads efficiently transduce primary T-cells from multiple donors, exhibiting high correlation with HEK293T transduction titer.
How it works
Sequence transfer
You request a cell line development campaign for a specific GOI and provide us with its sequence. Optionally, we use our design software, Kernel, to optimize the GOI sequence.
CLD start
Suspension-adapted stable pool generation
We generate stable pools by simultaneously transfecting all 4 plasmids and selecting for integrants.
1 month
Suspension adaptation
Adherent stable pools are suspension adapted into chemically-defined media.
2 months
Single cell printing and clone screening
Suspension-adapted pool is cloned out with monoclonality verification via pre and post deposition imaging using the Cytena F-sight™ and Solentim Cell Metric®. We use a proprietary screening method to enrich for high-performance clones
3 months
Scale-up and AMBR15® run
Optionally, Asimov process development capabilities can be use to further improve performance.
4 months
Research Cell Bank (RCB) release
What you get
Top 5 clones
- RCB supplied for top 5 clones producing your lentivirus
Stability >70 generations
- >80% functional titer stability over 70 generations
CMC-compliant documentation
- Plus a robust platform process for bioreactor scale-up