PK and ADA Assay Reagent Development
ADA (Anti-Drug Antibody) assay is important in the evaluation of immunogenicity, which is the ability of a therapeutic protein/antibody to induce an immune response in a patient. Pharmacokinetic (PK) analysis is a key component of the evaluation of antibody drugs to provide information about how the drug is absorbed, distributed, metabolized, and eliminated in the body. Both assays are critical tools in the development and optimization of antibody drugs and help ensure that patients receive safe and effective treatments.
An anti-idiotypic antibody (anti-ID Ab) binds to the idiotype of another therapeutic protein or antibody, usually an antibody drug, which are commonly used in preclinical setting for Pharmacokinetic analysis of antibodies (PK) and pharmacodynamics (PD). Due to the similarity between anti-ID Abs and anti-drug Abs (ADA), anti-ID Abs can be used in ADA assay as a reference standard for antibody drug immunogenicity, anti-drug antibody (ADA) studies and neutralization antibody measurement.
Yurogen leverages extensive first-hand experience to highly sensitive and specific rabbit polyclonal and monoclonal anti-ID Abs for your PK and ADA Assay during antibody drug development. We are offering:

1.Anti-ID pAb development service
2.Anti-ID monoclonal antibody pair development service
3.Anti-ID antibody development and PK/ADA assay development combo service.

All the services Yurogen provides can be tailored to client’s specific downstream application, helping to accurately determine the immunogenic profile, safety, and efficacy of your therapeutic candidate.
Service Features
Proprietary SMab™ Platform

First commercial Single B cell based platform for rabbit mAb discovery; able to rapidly identify blocking and non-blocking antibodies

Great Experience in Anti-ID Antibody Discovery

Developed nearly 800 anti-ID antibodies, against various targets including ADC, Bi- and Tri- specific antibodies

One Immunization for pAb and mAb Discovery

Only need to do one batch of rabbit immunization to get both anti-drug polyclonal antibodies (pAb) and anti-ID monoclonal antibodies

Fast Turnaround Time

4 months to deliver anti-drug polyclonal antibodies and anti-ID monoclonal antibodies for most targets

Great Diversity

Ensured to get similar percentage of blocking and non-blocking anti-ID antibodies after 1st round of screen

Professional Project Design

Tailoring the immunization, sorting and screening strategy for each project

  • Phase I: Immunization
  • Phase II: SMab™ platform Screening
  • Phase III: Rabbit mAb expression and purification
Phase IImmunization

  • Standard Package: Immunize two NZW rabbits fo 6-9 weeks with 4 injections and 2 bleed collections.
  • Bleed titer and blocking measured with ELISA.
  • (Optional) Additional Assays: ELISA counter screen & FACS etc.
  • Client selects one (or more) rabbit for splenocytes isolation.
  • (Optional) Antigen affinity purification of terminal bleed from immunized rabbits.
  • Phase I report

6-9 weeks
Phase IIaSingle B cell Sorting

  • Antigen specific B cell sorting (by FACS) and culture.
  • High throughput ELISA screening for cultured cell supernatant.
  • Cherry pick ELISA positive clones and freeze cell pallets in RNAshield.
  • Additional high throughput screening of blocking ELISA with remaining cell supernatant for neutralized clone screen.
  • (Optional) Additional high throughput screening with remaining cells supernatant: ELISA counter screen & FACS etc.

2 weeks
Phase IIb VH/VL Amplification & LEM Construction

  • VH/VL gene amplification from selected positive B cells.
  • Linear Expression Module (LEM) construction & transfer into HEK293T cells.
  • Regular ELISA & blocking ELISA screen for transfected HEK293T cell supernatant.
  • (Optional) Additional Assays: affinity ranking & FACS etc.

2 weeks *
Phase IIIExpression Plasmid Construction & Antibody Expression

  • Subclone VH/VL gene into mammalian expression vector (pcDNA3.4) from selected LEM clones.
  • Small scale expression and protein A/G purification of rabbit monoclonal antibodies.
  • QC for purified rabbit mAbs: SDS-PAGE and/or Mass-spec, SEC-HPLC (optional)
  • Validation of purified rabbit mAbs with regular ELISA and blocking ELISA, or (optional) FACS, WB & IHC etc.
  • Final project report.

3 weeks *
* This timeline is based on the construction of 20 LEM clones and 5 final rabbit antibodies.