We develop anti-idiotypic (anti-ID) reagents to innovator and biosimilar therapeutic antibodies for use in bioanalytical assays. Our high quality, highly specific Affimer reagents can be rapidly identified from the Affimer phage library and developed to meet specific assay requirements. With a 100% success rate our reagents can advance drug development timelines and guarantee a consistent, secured supply throughout the preclinical research and clinical trials process.
Anti-ID reagents are molecules that specifically bind the idiotype of an antibody. An idiotype is the unique set of variable residues, typically found in the complementarity determining regions (CDRs), that defines a particular antibody. Anti-ID reagents are powerful tools that can detect a specific antibody within a complex IgG background. During the process of therapeutic antibody development, anti-ID reagents are used in pharmacokinetic (PK) assays to monitor drug levels in preclinical and clinical samples.
ANTI-ID REAGENTS CAN BIND THEIR SPECIFIC TARGET ANTIBODY IN THREE DIFFERENT MODES:
- Competing: Binding to the paratope of the monoclonal antibody and competing with its target antigen – used to measure free drug.
- Non-competing: Binding near the paratope but still allowing the antibody to bind its target antigen – used to measure total drug.
- Complex specific: Binding specifically the antibody-target complex but not the unbound antibody or the unbound target – used to measure target bound drug.
Each of these binding modes have a different utility in designing and developing therapeutic monoclonal antibody drug monitoring assays.
BENEFITS OF AFFIMER REAGENTS IN THE DESIGN OF PK ASSAYS
- Rapid development: Our proven anti-ID Affimer binder process takes under 3 months, helping you to meet tight product development timelines.
- High target specificity: Enables accurate and reproducible detection of therapeutic antibodies in complex matrices using a simple universal capture assay.
- Reproducibility: Recombinant bacterial production process allows for batch to batch consistency and secure supply of critical reagents throughout the drug development process.
- Fully validated: Validation of Affimer reagents by leading CRO, Covance, shows that they meet regulatory requirements for critical reagent in PK assays. The calibration curves for our anti-ID Affimer reagents are validated in accordance with FDA regulatory guidelines.
- Proven track record: 100% success rate.
We are developing an expanding catalogue of anti-ID reagents against commercial therapeutic antibodies to allow pharma and biotech customers to quickly develop PK assays for monitoring combination therapies or for CROs to support their customers developing biosimilars.
- See how anti-ID Affimer reagents can address the challenges in drug development PK assays.
- All our Affimers can be validated in accordance with the FDA's Bioanalytical Method Validation Guidance for Industry.