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Immunogenicity Testing

Comprehensive and advanced capabilities for immunogenicity testing from pre-clinical through clinical development
Our team includes globally recognized individuals who have led industry and agency working groups tasked with formulating risk-based strategies for therapeutic monitoring. We have helped clients overcome some of their most difficult immunogenicity testing challenges, including the evaluation of multi-domain proteins, PEGylated proteins, complement activation, and the development of gene therapy ADA assays for multiple AAV serotypes.

Precision’s comprehensive immunogenicity solutions:

  • Assay development strategy

    Precision has experience with many different immunogenicity assessment platforms and can develop a plan for assay formats, platforms, and monitoring.
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    • Identify positive control antibodies or assist
    • Select optimal assay formats/platforms (e.g., antigen capture vs bridging, colorimetric vs MSD))
    • Select optimal assay formats for neutralizing antibodies (cell-based or non cell-based)
    • Design appropriate monitoring strategies (selection of optimal time points)

  • Routine implementation

    Precision can collect and analyze samples from locations around the world. We can also run clinical trial assays under CLIA for trial subject enrollment, and can provide support for immunogenicity assay CDx development.
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    • Assay development/validation plans and reports
    • Characterization of anti-drug antibody responses, including NAb assays under CLIA for subject enrollment
    • Test samples under tiered approach: screen, confirm, titer
    • Development of assays to CDx with full regulatory support

  • End-to-end support

    Precision can takes a consultative approach to your project, helping to plan ahead in order to align timelines with your overall project. We can also support all aspects of testing needs from preclinical through phase 3.

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    • Unparalleled scientific leadership
    • Fit for purpose services: design, qualify, validate (GLP, GCLP, CLIA) the right assays at the right time
    • Global scale capabilities: logistics to support global sample collection and storage in a 65,000 square foot state-of-the-art CAP-accredited and ISO-certified facility

Precision develops and performs both standard and unique immunogenicity assays

Product Types
  • Peptides
  • Recombinant proteins
  • Monoclonal antibodies
  • Bi-specific antibodies
  • Antibody-drug conjugates
  • Biosimilars
  • PEGylated proteins
  • Gene therapy (multiple AAV serotypes and transgene proteins)
  • CAR-Ts
Assays
  • ADA screening, confirmatory, and titers
  • Neutralizing ADA assays (functional cell-based and non cell-based)
  • Specialty techniques (acid dissociation, SPEAD)
  • Fully compliant (CLIA) cell-based NAb and TAb assays for AAV for companion diagnostic and commercial use
Unique specialty immunogenicity offerings
  • Functional IgE assays
  • Anti-PEG IgG and IgM assays
  • Detection of ADA-producing circulating B-lymphocytes
  • Detection of drug-specific immune complexes and complement activation
  • Binding of ADA to aggregated drug
  • Clearance of immune complexes

Scientific Poster: Development and validation of a sensitive anti-PEG IgG assay

PEGylated biotherapeutics administered to patients can elicit immune responses and formation of anti-drug antibodies, which may lead to reduction of drug efficacy, and adverse safety consequences. Anti-drug antibodies (ADA) generated against PEGylated biotherapeutics include anti-protein and anti-PEG antibodies. It is recommended by the FDA “Guidance for Industry on Immunogenicity Assessment for Therapeutic Protein Products” that ADA assays for PEGylated therapeutic proteins should be able to detect both anti-protein and anti-PEG antibodies.

So far, efforts to develop methods for detection of anti-PEG IgG and IgM antibodies in human serum failed to demonstrate sufficient assay sensitivity and specificity.

Here we describe development and validation of a sensitive, specific, and robust anti-PEG IgG assay in human serum with the LOD of 234 ng/mL and the LLOQ of 469 ng/mL based on a mouse monoclonal anti-PEG IgG antibody used as a positive control. This assay is applicable to human and non-human sera.

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