Need to assess your therapeutic’s efficacy, safety, and mechanism of action?
Need to develop a specific, sensitive, validated assay for the most informative, predictive, relevant biomarkers for your system? We develop reliable, custom assays to serve customers conducting drug development research.
We are a biologics-focused, global leader in bioanalytical solutions providing over 25 years of industry-leading scientific expertise. We specialise in comprehensive PK/TK, ADA, NAb, biomarker assays and sample analysis for the world’s largest pharmaceutical and biopharmaceutical companies.
Development, Transfer, Validation & Sample Analysis: mAbs, ADCs, fusion proteins, DARPS, bispecifics, enzymes, oligos, PEG products, viral vectors, vaccines, gene therapies, biosimilars, CAR-T
Extensive ADA and NAb method development, validation, and analysis using diverse platforms to ensure drug tolerance and high sensitivity for even the most difficult assays.
We tailor biomarker assay development, validation, and analysis to your needs—using kits, de novo methods, or multiplex solutions to meet regulatory standards.
Support a wide array of cell-based assays for the evaluation of NAbs to immunophenotyping, and cell activation utilizing flow cytometry, cell culture, ELISpot, and other methodologies.
GLP and GCLP assay development, validation and sample analysis for qPCR assays in support of biodistribution, vector shedding, and PK endpoints.
Expertise in PK and ADA assays for biosimilars, with access to select originator assays for starting points for PK and ADA method development.
For over 40 years, we’ve helped our clients advance Phase 1-4 clinical trials with complex/esoteric testing and assay development. Our validated test list includes more than 3,000 assays, with new custom assays developed on a continual basis in response to client needs. We specialise in molecular infectious disease testing, vaccine safety and efficacy assessment, immunogenicity, cell-based assays, allergy/hypersensitivity, and biomarker analysis.
Custom or Kit-based Assays, De Novo Development, Transfer, Qualification/Validation, Tailored Approaches for Context of Use/FFP, Ligand Binding, Multi-plex Capabilities, Cellular, Molecular
Flow Cytometry, ELISpot, Cell-Culture & Isolation, Immunophenotyping, RO, NAb, Cellular Activation, Cytokine Release, Intracellular Markers, Functional Assays, Low Frequency Event, PBMC Processing
Plate-based, Cell-based Testing (ADA/NAb), Clinical Trials (FIH – Ph3) Bridging, Competitive, Acid Dissociation, Traditional, dsDNA, Gene & Cell Therapies, TCID50, Plaque, Live-cell, ELISpot, CMI
Custom qPCR & ddPCR, RCR/RCL PCR safety testing, Next generation sequencing (NGS) & comprehensive genomic profiling w/biostatistics, nanoString, Whole genome (WGS), Whole exome (WES), RNASeq
