Bioanalysis of Large
Molecules, Complex
Biologics, and
Advanced Therapies
At Precision, we understand the complexities of immunogenicity testing and other bioanalytical methods, with a leadership team that continues to shape and inform regulatory guidance. Our expertise in bioanalysis is evident in the complex preclinical and clinical studies we support, characterized by 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 research 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 sample 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 bioanalysis. 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 and biomarker assay 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.
