PK and ADA Assay Development Services

Applying anti-ID antibodies as critical reagent in IND filing and clinical trials

Pharmacokinetics and Immunogenicity ELISA Kit Development Service

GenScript ProBio guarantees to deliver high-quality PK and ADA assay for measurement of free drugs, binding drugs, total drugs and anti-drug antibody in both discovery and clinical stages.

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

LIST ALCOA+CCEA
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
Record
  • Per protocol
  • Record in notebook/approved forms
Instrument
  • Commission and Report
  • Calibrated
  • Equipment list with Criticality(base on RA)(rules for criticality, follow  SMP)
  • PM program
Document(SMP)
  • Notebook control
  • Forms and logs
  • Review and approval
Facility
  • 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 (month) Deliverable Price
PK ELISA kit development
  • ≥ 0.5mg antibody drug
  • ≥ 1mg detecting antibody
  • ≥ 1mg capture antibody
2-3
  • Report of feasibility analysis
  • Final report of kit development
  • Labelled anti-ID antibody
  • Analytical methods and key reagent instructions
Quote
ADA ELISA kit development
  • ≥ 1mg antibody drug
  • ≥ 1mg Anti-ID antibody
Inter batch CV≤10%, Intra batch CV≤15%, Fortified recovery: 80%-120%