Overview

Bioanalytical method is used for quantitative determination of drugs and/or metabolites in biological matrices such as blood, serum, plasma, or urine… tissue and skin samples. The applications of such methods are pharmacology, bioavailability, bioequivalence, pharmacokinetic, and toxicology studies conducted in humans and animals. Immunogenicity tests are also considered bioanalytical methods, in that their target analytes are antiproduct antibodies in serum or plasma. Bioanalytical methods are not intended for elucidating quality parameters (e.g., identity, purity) of a biotech product; they’re intended to determine the quantity of a drug (or the presence of induced antibodies) in biological samples. For that reason, technologies used to perform bioanalytical methods vary according to the molecular entity’s nature. With chemical products, the biological components of test samples can be removed by precipitation or extraction, allowing remaining small molecule(s) to be analyzed with technologies such as LC–MS or GC–MS. With biomolecular products (or antiproduct antibodies), processing away the biological components of a sample can equally remove the target analyte, making accurate quantitation technically impossible. So for biotech products and antiproduct antibodies, bioanalytical methods require technologies that can specifically measure one biological moiety in the presence of a biological milieu. Immunological methods that use specific antigen–antibody recognition are usually chosen for bioanalytical assays applied to biopharmaceutical products because they can find the one protein of interest out of the protein mixture. Similarly, immunogenicity screening assays use ELISA-like methods to capture reactive immunoglobulins. Bioanalytical laboratory services include development, qualification and validation of biological assays such as bioassays, cell-based potency assays and binding assays. Range of bioanalytical testing services supports the characterization of biologic products from pre-clinical development through to commercialization. Physicochemical and Structural Analyses Development and testing services include: Cell Line Development, Cell Bank Manufacturing, Biosafety Testing, Cell Bank Characterization, GMP Lot Release The bioanalytical lab has significant experience working with small molecules, biologics, vaccines and biomarkers across a wide variety of technologies and therapeutic areas.