Immunogenicity Testing & Immunoassays

A full range of services for the development and validation of traditional and custom-designed PK, immunogenicity testing, and biomarker projects.

Immungenicity testing and immunoassays can be a crucial component of your product's development and success. Q2 Solutions services can meet your immunogenicity and immunoassay needs from method development and validation, through sample analysis and customized reporting. Our scientists have extensive experience developing and validating variety of assays that support drug development including ELISA, Electrochemiluminescence (ECL), and cell-based immunoassays. At Q2 Solutions we can develop and validate custom-designed assays as well as ensure the transfer of existing bioanalytical methods. 

Tailored solutions

  • Ligand Binding assays for PK
  • Immunogenecity Assays (screen, confirm, titer)
  • Macromolecule pharmacokinetic assays
  • Isotyping assays
  • Cell based NAb
  • Fit for purpose biomarker assays (including in a regulated environment) 
  • ELISA assays
Additional solutions
  • Technical transfer for developed assays
  • Assay development
  • Assay validation
  • Preclinical/Clinical
  • Sample analysis sample management and storage

Delivery excellence 

As with all of our bioanalytical services, we have a team of client focused scientists who understand the importance of not only delivering your project in accordance with all relevant SOPs and regulations but also delivering your project on time and within budget. Our project management team has significant lab experience and is responsible for project planning, client communication, ensuring timelines are met, and coordinating with internal support groups.  

We utilize a wide array of technology to deliver trusted results, including:
  • Molecular Devices (colorimetric, chemiluminescence, fluorescence; 384 SpectraMax, i3)
  • Meso Scale Discovery (electrochemiluminescence; 2400, 6000, SQ120)
  • Luminex (100, 200 and FlexMap 3D)
  • Automated workstations (Biomek NxP, Selma, Tecan EVO)
  • GE AKTA Pure FPLC system

Shaping outcomes

Through our experience and expertise we can help you build the right assay to get the data you need.  Our method development approach emphasizes robust and rugged assays, minimal failed validations, minimal failed runs in production, and minimal failed incurred sample reanalysis. Our method development experience includes:

  • PK assays, immunogenicity assays, biomarker, cell based assays
  • Plasma and serum from multiple species
    • Human, monkey, mouse, pig, rabbit, rat, etc.
  • Wide assortment of compound types
    • Peptides
    • Human molecules
    • PEG-therapeutics
    • Recombinant proteins
    • Natural proteins
    • Biosimilars

 Learn more about our bioanalytical capabilities including our biomarker development  and ADME services.
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