SAFETY & EFFICACY TESTING
Biotherapeutic agents can elicit an adverse immune response when administered in humans. Unintended immune responses can impact both safety and efficacy. Immunogenicity screening early in the preclinical phase will save time and money by reducing the likelihood of unwanted immune responses cropping up during the development process.
Benefit From Our Extensive Bioassay Capabilities
IBT Bioservices offers a range of services for preclinical evaluation of innate immune system activation, cytokine release and biomarker analysis. We offer fit-for-purpose services from method development all the way through validation and analysis.
Whether you are bringing your assay to us for validation or looking for de novo assay development, our design and development strategy includes:
- Gathering your assay requirements and objectives
- Selecting optimal assay format/platform
- Identifying & coordinating components and optimal time point selection
- Documentation of procedures, specifications, and results
- Assay optimization & validation for sensitivity and detection
Immunogenicity Testing Services
Immunogenicity is defined by the FDA as the propensity of a therapeutic protein to induce an immune response with potential for adverse clinical effect. Whether it is for pharmacokinetics, immunogenicity or biomarker analysis we develop our assays using the best practices and with QC for all assays so they can be adapted for future GLP use and progress toward IND. IBT Bioservices will source or develop the necessary reagents for your assays.
- Positive control identification
- Assay format selection
- Assay design and validation
- Cell-based neutralization assays
- Cytokine Assays (ICS)
- Flow Cytometry
- In vivo PK assessment
- Dose response assessment
- Non-clinical bioanalysis