Pharmacokinetic/toxicokinetic analysis of biopharmaceutical drugs require some different analytical solutions to those traditionally employed in analysis of small-molecule compounds.
BioAnalab's capabilities include a range of ligand-binding formats (EIA, ELISA, RIA), flow cytometry (FACS), surface plasmon resonance (BIAcore) and electrochemiluminescence (ECL).
We have many years of experience in the development/ transfer and validation of PK/TK assays for large molecule analysis. We have the capacity to perform large scale sample analysis for pre-clinical (GLP compliant) and clinical (GCP compliant) studies. Studies not claiming GLP/GCP compliance are still performed to the same high standards under our comprehensive quality system. For large scale studies we have the equipment to automate assay handling where appropriate.
It is particularly important to develop and validate an assay that has an analytical range appropriate for what is expected in the study samples. Development of assays that are both specific and sensitive presents an analytical challenge that BioAnaLab welcomes.