New AAV Quality Control Service from ImmPro

We’re proud to launch our high-throughput AAV empty/full capsid assay—now available to support gene therapy developers.

Using automated Charge Detection Mass Spectrometry (CDMS), ImmPro delivers direct, accurate measurement of individual AAV capsids to quantify empty, full, and partially filled particles. Our platform is:

  • Validated for accuracy, precision, and reproducibility (≤5% RSD)

  • Compatible with minimal sample input (10–20x less than AUC)

  • Scalable to 100+ samples/day with autonomous operation

Standardizing Gene Therapy Quality Control

ImmPro has implemented an automated, robust and high-throughput Charge Detection Mass Spectrometry-based assay for AAV mass analysis to determine the ratio of empty vs full particles. The platform allows for >100 samples a day to be processed in a completely autonomous manner with high levels of reproducibility and accuracy.

Proteoforms are the most direct measure of biology.

Our assay can detect deferentially “filled” AAV capsids through direct detection of the mass of an individual particle and determine the ratio of empty, full, and partially filled capsids. As the full capsid is necessary for the therapeutic efficacy of a gene therapy, control of this distribution is critical to the quality control and process development of this modality.

• The measurement requires >10 fold lower sample amount than analytical ultracentrifugation (~1.00 x1011 cp) and is comparable to anion exchange chromatography (~1.00-2.00 x1010 cp) saving material at release and allowing for inclusion in process development studies

• The measurement enables ratio calculations accurate to <5%, with better than 5% reproducibility.

• Complex DOE experiments can be processed within a day.

Pharma Co-Development Research Program

We are actively seeking partnerships with pharmaceutical companies for co-development

programs. Our focus is on running clinically relevant samples to validate the method and support

process development, QC Release, and Stability.

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