Immunoassay Services
Expert Immunoassay solutions to progress your clinical research pipelines
Immunoassay Services for Clinical Bioanalysis
Immunoassays are a fundamental tool for the development of large-molecule biotherapeutics, enabling sensitive and specific quantification of drug levels in clinical samples. Successful PK assay development begins with selecting the right immunochemically relevant tools to generate a sensitive, robust quantitative bioanalytical method suitable for use in analysis of samples derived from clinical trials.
At Synexa, we develop and validate bespoke immunoassays to support PK analysis of complex biologics, ensuring high-quality data for confident decision-making. All assays are developed adhering to current guidelines, ensuring compliance with GCP/GLP regulatory requirements.
Immunoassay Services Across the Drug Development Pipeline
Clinical Bioanalysis
Custom-developed, GCP-compliant Ligand-binding assays for PK, ADA, and biomarker analysis, fully validated with long-term stability testing.
GLP Bioanalysis
GLP-compliant bioanalysis for preclinical studies, from MTD to pivotal toxicology, supporting seamless transition to clinical development.
Anti Drug Antibody (ADA)
ADA assay development, validation and clinical sample analysis to assess immune responses to biologics and support safety and efficacy evaluations.
Immunoassay Bioanalytical Platforms
Our technology platforms are robust, reliable and reputable in the clinical field and provide comprehensive and detailed data readouts for your application.
VICTOR® Nivo™
Multimode plate reader supporting fluorescence, luminescence and absorbance-based assays
MSD S600
High-throughput electrochemiluminescence reader for sensitive multiplex biomarker detection
MSD SQ 120
Compact MSD reader enabling robust electrochemiluminescent immunoassays
WIZARD2 gammacounter
Gamma counter for sensitive radioisotope detection in ligand binding and PK assays
Gyrolab xPlore
Automated nanolitre-scale immunoassay platform for rapid, low-volume protein biomarker analysis
FAQ
What is an immunoassay?
An immunoassay is a laboratory test that uses antibodies to detect and measure specific molecules (analytes) in biological samples such as blood or urine. Synexa’s immunoassay services help to accurately detect and quantify biomarkers in biological samples, supporting robust bioanalysis for preclinical and clinical drug development.
Which technologies does Synexa utilise for Immunoassays?
Synexa uses Gyrolab automated microfluidic immunoassays, MSD ECL assays (electrochemiluminescence), Delfia TR-FIA (time-resolved fluoroimmunoassays), ELISA (enzyme-linked immunosorbent assays), RIA (radioimmunoassays), AlphaLISA, SPR (surface plasmon resonance) and various cell-based assays.
Which study phases does Synexa's immunoassay services support?
We are capable of supporting a full development programme, from preclinical to clinical Phase III. High throughput assays can be developed by adding automation.
What is the most common study type Synexa undertakes?
We routinely perform PK and ADA assessments for biologics, as well as soluble biomarker PD assessments.
What minimum sample volumes can Synexa accept for immunoassay work?
The lowest sample volume required for the immunoassay is as low as 200 nL, utilising Gyrolab technology.
Has Synexa been inspected by the FDA?
Our GLP/GMP laboratories are regularly inspected by the European Medicines Agency and the MHRA. Additionally, the FDA has conducted inspections of our facilities, with the most recent visit successfully completed in August 2024.
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