PK/PD of Biopharmaceuticals
At SNBL Japan, we understand the challenges of development of biopharmaceuticals. Our experience with pharmacokinetics and pharmacodynamics and designing custom solutions will help you get the information you need about your product.
We offer ligand binding assays (LBA), enzyme-linked immunosorbent assay (ELISA), or electrochemiluminescence assay (ECLA) to analyze samples, as well as develop and validate assays to measure blood concentrations of biopharmaceuticals and anti-drug antibodies. In addition, we can also evaluate the pharmacodynamics of biopharmaceuticals by developing analytical methods specific to the characteristics of the drug, such as the receptor occupancy of antibody drugs.
In addition to standard immunotoxicity testing (hematology, serum immunoglobulin, immune system organs weight, histopathology, etc.), we can also perform several types of cytokine analyses and immunophenotyping assays (T cells/B cells/NK cells) of tissues and peripheral blood, measure receptor occupancy in peripheral blood, and evaluate the T-cell dependent antibody response (TDAR) to keyhole limpet hemocyanin (KLH) or tetanus toxoid (TTx).
Many biopharmaceuticals applied to humans are immunogenic in animals, causing anti-drug antibodies (ADA) to be produced. In preclinical safety studies for biopharmaceuticals, we analyze ADA as part of the assessment of drug exposure and evaluation of organ toxicity. We also can provide purified ADA for biopharmaceuticals as a positive control for ADA measurement.
ADA is purified from the serum of immunized animals such as monkeys and rabbits using a protein G column or an antigen-coupled column. We can also prepare labeled antigen for bioanalysis.