Bioanalytical Testing

At Precision, we have a understand the complexities of immunogenicity testing and other bioanalytical assays, with a leadership team that continues to shape and inform regulatory guidance. Our expertise is evident in the complex studies we have supported, which includes analysis of CAR-T cell immunogenicity, drug-specific IgE assays, antibody detection assays for Gene Therapy, and CLIA-validated companion diagnostics (CDx). In addition, we support the implementation of assays for PEGylated proteins, ADCs, and biospecifics.

Bioanalytical Testing

At Precision, we have a understand the complexities of immunogenicity testing and other bioanalytical assays, with a leadership team that continues to shape and inform regulatory guidance. Our expertise is evident in the complex studies we have supported, which includes analysis of CAR-T cell immunogenicity, drug-specific IgE assays, antibody detection assays for Gene Therapy, and CLIA-validated companion diagnostics (CDx). In addition, we support the implementation of assays for PEGylated proteins, ADCs, and biospecifics.

Areas of bioanalytical expertise

Immunogenicity Testing

Precision specializes in challenging immunogenicity projects, such as the evaluation of multi-domain proteins, PEGylated proteins, complement activation and development of gene therapy anti-drug antibody (ADA) assays in multiple AAV serotypes.

PK Assays

We offer assay development, validation, and implementation using ELISAs and MesoScale Discovery (MSD) assays for biologics: flow cytometry and Droplet Digital™ PCR (ddPCR) for cell-based therapies: and Quanterix SIMOA® for ultrasensitive analyte detection.

ADA Assays

Precision leverages multiple approaches for the development of neutralizing antibody assays (NAb) and total antibody (TAb) assays including ELISA, MesoScale, and Biacore. We have also successfully developed these and other assays into companion diagnostics.

MesoScale Discovery (MSD) Assays

Measure a range of analytes in complex samples matrices consistently and at high sensitivity with our MSD assay capabilities. Applications include ADA, NAb, and TAb assays, PK assays, and more.

Quanterix SIMOA®

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.

ELISA

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.

Immunogenicity of chimeric antigen receptor T‑Cell therapeutics

Boris Gorovits and Eugen Koren
BioDrugs. 2019 Jun;33(3):275-284.

Related specialty lab services

Tissue & Liquid Biopsy

Obtain a detailed molecular view into patient biology with a range of tissue and liquid biopsy technologies, including our proprietary ApoStream platform which can isolate and enrich for circulating tumor cells for downstream analysis.

Flow Cytometry

Acquire detailed insight into cell populations and subpopulations with our multiplex flow cytometry capabilities, which include advanced assays such as tetramer flow, phospho-flow, and receptor occupancy measurement.

Genomics

Find and monitor gene expression signatures, copy number variations, chromosome rearrangements, and other genomic events occurring in patient samples using our NGS, NanoString, qPCR, ddPCR, and FISH/ISH services.

Discover how our bioanalytical testing expertise can advance your development program

Discover how our bioanalytical testing expertise can advance your development program

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