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

Compliance Requirements for Anti-idiotype Antibodies

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	2-3		Quote
Inter batch CV≤10%, Intra batch CV≤15%, Fortified recovery: 80%-120%