Precision Measurement for the Next Era of Medicine

Don't be Fooled by Your Fulls. Win a Regulatory Advantage
From Your AAV Analytics.

ELISA, ddPCR, and Mass Photometry are falling short of today's regulatory
expectations due to measurement inaccuracies.

NanoMosaic is the only FDA AMT-designated analytics for AAV. Reference your NanoMosaic AMT number for a potential pathway to expedited IND review.

NanoMosaic Tessie instrument

Indirect E/F vs. True E/F

Your Fulls Are Not Full. No More Indirect Estimates. Stop Guessing.

Follow the AAV workflow from construct screening through storage. At every stage, indirect methods dramatically overstate full capsids:

Process Development
Manufacturing
Storage
Construct Screening & Clone Selection
Upstream Vector DoE
Downstream Purification
Scale-up Optimization
Dose Testing
Indirect E/F
ddPCR & ELISA89%
ddPCR & ELISA44%
ddPCR & ELISA & Mass Photometry84%
ddPCR & ELISA93%
Mass Photometry83%
True E/F
Tessie3%
Tessie18%
Tessie26%
Tessie28%
Tessie45%

Each column shows data from a separate top-10 Pharma rAAV program.

Why Indirect Measurements Fail

The two-platform workflow is overdue for retirement

Most AAV teams still rely on separate indirect measurements to estimate what matters most: one system for transgene copies, another for capsids, and additional analysis to force two imperfect numbers into an empty/full ratio. ddPCR measures only a small genomic target region, ELISA estimates capsid quantity, and Mass Photometry infers particle mass. None directly confirms whether an intact, full-length transgene is packaged inside the capsid. NanoMosaic measures what other methods only infer.

That distinction matters in manufacturing. Incomplete characterization can push the wrong constructs, clones, or process conditions forward into costly development steps. By identifying true product quality earlier, NanoMosaic helps teams stop poor candidates sooner, advance the right ones faster, and make process, release, and dosing decisions with greater confidence.

Discuss your AAV workflow
Researcher at the bench

One Platform, One Readout

See inside the capsid:
the Tessie platform

Built on NanoMosaic's NanoNeedle technology, the Tessie platform reads capsid and transgene together in a single run. It resolves empty, partial, and full capsids directly, with no indirect measurements and no cross-instrument math.

  • One chip and one workflow, with no handoffs between systems.
  • A single readout that holds from discovery through release.
  • Ratios you can defend in development and in filings.
  • Less time piecing data together, more time advancing programs.
fg/ml
Sensitivity
2 µL
Sample Volume
7 logs
Dynamic Range
96 or 384
Samples Analyzed/Plate
12 min
Instrument Scan Time
<10%
CV's
Close-up of the Tessie instrument

A Faster Path to IND

A Regulatory Advantage:FDA Advanced Manufacturing Technology (AMT) Designation

Recognized Under the FDA AMT Program

FDA granted NanoMosaic an AMT designation for multiplex testing of vector genome and capsid titers in AAV gene therapy manufacturing.

Reference Your NanoMosaic AMT Number

Cite our AMT reference number to support a faster route to IND review and skip the analytics portion in your CMC submission.

Assistance From FDA

Encourages early engagement with FDA and development support.

Correct Results

Accurate full, partial, and empty calls from one capsid-and-transgene readout.

Researcher handling a microplate

Proven in Practice

Trusted by leading gene therapy teams.

NanoNeedle detection has been put to work across thousands of samples and real AAV programs to date.

  • Demonstrated across a significant number of pharma and biopharma programs
  • Joint white paper with BMS on NanoNeedle technology for AAV manufacturing
  • Featured at ASGCT 2026: "Accelerating AAV development with an FDA/CBER AMT-designated nanoneedle analytics platform"
  • BioRxiv study finds common methods can read rAAV quality differently. NanoMosaic helps close that gap with clarity on accurate transgene integrity quantification.
Read the study summary →

Request the NanoMosaic AAV analytics brief

Share your AAV characterization challenge and the NanoMosaic team will follow up with information relevant to your workflow.