Potency is a key quality attribute in biotherapeutics, reflecting the biological activity of a drug. It is assessed through various methods, including Cell-Based Bioassays, which measure the drug’s ability to elicit biological responses in living cells, and Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) assays, used to evaluate the effectiveness of antibodies in mediating immune cell destruction of target cells. Additionally, ELISA (Antigen Binding) quantifies the binding strength of antibodies to their antigens, critical for confirming the drug's mechanism of action. These methods ensure the therapeutic efficacy and consistency of biopharmaceuticals.
A bioassay is a type of test that measures the biological activity of a biotherapeutic drug. The purpose of a bioassay is to determine the potency of the drug and to ensure that it is safe and effective for use in humans. An activity bioassay is a type of bioassay that measures the quantity of a substance, such as a protein or enzyme. On the other hand, a functional bioassay is a type of bioassay that measures the quality of a substance, such as its biological activity, and is used to determine the potency of the substance.
Bioassay for
Biotherapeutics
A Cytotoxicity assay is a type of test that measures the ability of a substance to cause cell damage or cell death.
An ADCC (Antibody Directed Cell-Mediated Cytotoxicity) bioassay is a type of bioassay that measures the ability of an antibody to induce cell-mediated cytotoxicity. The assay is based on the ability of the antibody to bind to a target cell and recruit immune cells to destroy the target cell.
Cytotoxicity and
ADCC Bioassays
Developing a cytotoxicity bioassay involves several steps. Here are ten steps that can be followed to develop a cytotoxicity bioassay: Cell line(s) selection, Culture conditions, Seeding parameters, Incubation conditions, Assay reagent, Detection, Analysis, and Validation
Valentia Analytical’s expertise can help with antibodies, antibody drug conjugates, natural killer cell engagers, gene therapy.