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.
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||Original material||Timeline (month)||Deliverable||Price|
|PK ELISA kit development||
|ADA ELISA kit development||
|Inter batch CV≤10%, Intra batch CV≤15%, Fortified recovery: 80%-120%|