Precision provides 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 testing solutions
In addition to working with you to generate a strategic assessment, our services include method development or transfer, validation, and routine sample testing.
Assay development strategy
- 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)
- 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
Precision can address your immunogenicity testing needs from preclinical through phase 3.
- 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 for a number of product types
- Recombinant protein
- Monoclonal antibody
- Bi-specific antibody
- Antibody-drug conjugate
- PEGylated protein
- Gene therapy (multiple AAV serotypes)
- Screening ADA assay
- Confirmatory ADA assay
- Neutralizing ADA assay (functional cell-based and non cell-based)
- Specialty assays (e.g., complement)
- Specialty techniques (acid dissociation, SPEAD)
- Fully compliant (CLIA) cell-based NAb assays for AAV for companion diagnostic and commercial use
Unique specialty immunogenicity offerings
- Specialty assays-eg, functional IgE assay, anti-PEG IgG and IgM
- Detection of circulating B-lymphocytes producing ADA
- 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.
Integrating biomarker and clinical trial data
To help researchers understand and interpret biomarker assay data in the context of other assays as well as clinical trial data, Precision provides the option to manage and analyze assay data using our proprietary QuartzBio Translational Informatics platform.
Global Reach, Multi-site Support
Our immunongenicity testing services support pre-clinical and clinical research, including multi-site and global studies.
Working with Precision
Precision’s specialty lab scientists take a collaborative and consultative approach to projects and can provide recommendations on biomarker assay strategies and implementation, including comprehensive plans for immunogenicity testing.
Services can be provided individually or as part of a comprehensive therapeutic development package including biomarker assays and clinical trials.
Precision leverages multiple approaches for the development of neutralizing antibody assays (NAb) and total antibody (TAb) assays including ELISA, MesoScale, and Biacore. These assays can be co-developed as a CDx.
ELISA is generally recognized as a gold standard for quantitative, antibody-based analysis. Precision’s ELISA services include assay development or transfer, validation, and implementation.
Quanterix SIMOA provides precise quantification of analytes in multiple matrices at ultra-high sensitivity. This platform can measure targets present at femtomolar (fM) levels, enabling analysis of analytes that may have been previously undetectable.