For gene therapy laboratories

Analyze AAV capsids & transgenes with one method

With our newest assay, gene therapy bioprocessing and manufacturing scientists run in-process testing for capsids and transgenes at the required depth of analysis, in a single workflow and on a single platform.

Challenges with AAV gene therapy QC

Optimizing amount of controls versus quality of controls

In traditional gene therapy workflows, scientists typically choose between

Capsid ELISA + dPCR

Lower quality, higher frequency

Requires manufacturers to develop complex assays, run two separate workflows and reconcile data from two analytical methods (compounding errors1).

AUC / CD-MS

Lower frequency, higher quality

Requires highly specialized training and expensive equipment that is hard to roll out in a (c)GMP environment. Typically only possible at a couple of samples per day.

Introducing

Characterize capsid and gene quality in one workflow

We have unified the most essential steps in an AAV-based gene therapy QC into a workflow that’s as simple as running an ELISA. Our workflow works from crude samples and can be executed in under 3 hours and requires a minimal amount of training. Our generated data is a single quantified value and easy to interpret.

Register for our AAV product launch

Analyze directly from crude samples

No purification steps, no DNA isolation, no complex sample prep. Our platform works from sample volumes as little as 2µL and works directly on crude samples.

Full/empty/partial characterization

With 3 different assay variants, you can accurately determine viral capsid titer, transgene titer (and transgene at the desired level of granularity).

One workflow, one training

Single workflow combining capsid and transgene titration assays. The platform features a familiar ELISA-like setup that deploys seamlessly in manual and automated workflows

How it works

Add sample to nanoplate

For capsids: After having conjugated the capture antibody overnight, add 2 to 10 uL of crude sample to your nanoplate and let it incubate at room temperature for 30 minutes. 
For transgenes: same as above, only lyse your capsids and add in affinity-tagged probes to your sample.

Add detection antibody

Once incubated simply add the detection antibody to your plate and let it incubate for another 30 minutes.

Add Nano amplifier and read

Add our proprietary Nano amplifier, incubate for 5 minutes, wash and dry and perform a 10-minute plate read on Tessie. Interpolate the data on your standard curve and use the quantified values to calculate your ratios.

How it works

Add sample to nanoplate

For capsids: After having conjugated the capture antibody overnight, add 2 to 10 uL of crude sample to your nanoplate and let it incubate at room temperature for 30 minutes. 
For transgenes: same as above, only lyse your capsids and add in affinity-tagged probes to your sample.

Add detection antibody

Once incubated simply add the detection antibody to your plate and let it incubate for another 30 minutes.

Add Nano amplifier and read

Add our proprietary Nano amplifier, incubate for 5 minutes, wash and dry and perform a 10-minute plate read on Tessie. Interpolate the data on your standard curve and use the quantified values to calculate your ratios.

How it works

Add sample to nanoplate

Add detection antibody

Add Nano amplifier and read

Testing for capsids and genes have always been part of either one complex workflow or two separate ones. With NanoMosaic’s process, we’re seeing great results in bringing these two together, at high throughput, with the full/ empty/ partial resolution of lower throughput methods.

Tal Raz

Vice-President of Biology at NanoMosaic

Production grade platform

Tessie and our Nanoplates are designed to work in cGMP environments, with 21 CFR Part 11 support in our software and excellent CVs and reproducibility across technicians.

Wide dynamic range

Excellent dynamic range between 1.0E+08 to 1.0E+10.

Low cross-user CV

Highly repeatable with CV’s <10% across multiple runs, assays, technicians and instruments.

Start simplifying your AAV production quality control

Learn more about NanoMosaic’s platform.

Join our AAV launch event

We’re formally launching our AAV capsid & transgene titer assay on the 26th of March, 2024. We’ll be joined by early users from University of Massachussets to discuss their experience.

Register for our AAV product launch

26th of March

45

Days

12

Hours

44

Mins

29

Secs