Quality Consistency of Critical Reagents

For ligand binding assays (LBA), the critical reagents are the reagents/molecules (usually produced by biological processes) involved in binding and staining reactions, which can affect the assay results. Therefore, these reagents can affect the validity of the LBA assay.

As a critical reagent used in IND filing and clinical trials, the batch variation of anti-idiotype antibodies significantly affects the performance of following PK/ADA assay. Particularly in long-term clinical use, it is critical to ensure batch-to-batch consistency.

GenScript ProBio provides the best practice and compliance in anti-ID antibody manufacturing and PK/ADA kit development.

Service Highlights

  • GenScript ProBio Anti-idiotype Antibody Service Scope

  • Service Highlights

    • 14-year experience and 400+ projects delivered

    • Targeting multiple biological drug modalities:mAb, bsAb, scFv/sdAb, CAR-T, ADC and viral vector

    • One-stop service from anti-ID Ab discovery to PK and ADA kit development and manufacturing, covering preclinical PK and ADA testing needs once for all.

    • Guarantee to deliver ready-to-use kits

    • Good compliance for experiments and record, suitable for clinical sample testing

Data integrity
  • Paper:
  • SOP Controlled
  • DI Program (Non-submission appr.)
  • Record, Technical Review
  • QA samples to review
  • Electronic:
  • Controlled
  • Access Control (logbook+ mitigation plan is needed for client audit)
  • Audit Trail (logbook+ needed for client audit)
  • Data Back-up & Archive
  • Per protocol
  • Record in notebook/approved forms
  • Commission and Report
  • Calibrated
  • Equipment list with Criticality(base on RA)(rules for criticality, follow  SMP)
  • PM program
  • Notebook control
  • Forms and logs
  • Review and approval
  • Calibrated
  • Preventive Maintenance (PM program)
  • Certified
  • Monitor (e.g. Temperature, Humidity, when required)
  • HVAC: IO/Q (Focus on Micro)
  • GAS (Shared with GMP Plant): Routine Monitor

Service Details

Service Original material Timeline Deliverable Price
PK ELISA kit development
  • ≥ 0.5mg antibody drug
  • ≥ 1mg detecting antibody
  • ≥ 1mg capture antibody
2-3 month
  • Report of feasibility analysis
  • Final report of kit development
  • Labelled anti-ID antibody
  • Analytical methods and key reagent instructions
ADA ELISA kit development
  • ≥ 1mg antibody drug
  • ≥ 1mg Anti-ID antibody
Kit manufacturing 100 PK kit manufacturing /150 ADA kit manufacturing 1-2 weeks 100/150 kits
Manufacturing method transfer (optional) / Analytical methods and key reagent instructions
Inter batch CV≤10%, Intra batch CV≤15%, Fortified recovery: 80%-120%