Pharmacokinetics (PK) / Pharmacodynamics (PD)
Assessments

Our scientists are experienced in supporting PK assessments in a variety of species including rodents, humans, and non-human primates, and in multiple matrices such as serum, plasma, urine, and saliva. We are well-versed in the factors that could influence the validity of the data generated by these assays, and take those complexities into account during method validation to ensure optimal results. Our team has a clear understanding of the ability of the assay to detect the drug in the sample matrix.

In addition to their use for the detection of monoclonal antibodies using anti-idiotypic antibodies, BioAgilytix establishes and validates PK assays for therapeutic proteins with endogenous counterparts. PK assays are also required for comparative analysis of originator and biosimilar products, which our team is well-versed in performing.

We conduct our high-quality PK assay procedures and results strictly in compliance with GLP / GMP regulations and in accordance with international regulatory standards (FDA, EMEA, ICH).

For pharmacodynamic studies, our team brings extensive experience in developing receptor occupancy assays in soluble proteins, such as Bruton’s tyrosine kinase (Btk). Btk regulates the proliferation and survival of cancer cells in various B-cell lymphoid malignancies, and we have successfully developed, optimized, and validated various ELISA-based, GLP-compliant assays to determine the Btk occupancy in PBMC lysates.

In fact, our Boston lab is capable of acting as a central laboratory for Phase I/II studies, from sample collection kit preparation to whole blood PBMC isolation and processing and lysate sample preparation to receptor occupancy testing.