Pharmaceutical Biotechnology Pharmaceutical biotechnology is a relatively new and growing field in which the principles of biotechnology are applied to the development of drugs. A majority of therapeutic drugs in the current market are bioformulations, such as antibodies, nucleic acid products and vaccines. Such bioformulations are developed through several stages that include: understanding the principles underlying health and disease; the fundamental molecular mechanisms governing the function of related biomolecules; synthesis and purification of the molecules; determining the product shelf life, stability, toxicity and immunogenicity; drug delivery systems; patenting; and clinical trials.
Bioactivity & Potency Testing
Knowing potency assays are critical for product development and manufacturing, are you concerned about your assays being reliable, standardized, and relevant to reflect the product’s mechanism of action. Our experts have extensive experience in establishing, validating, and conducting routine bioassays.
Bioactivity & Potency Assays Potency testing is necessary to ensure the quality, safety, and efficacy of biopharmaceutical products, as well as the confirmation of biocomparability between an innovator and bio similar product. Our full range of potency testing services for a variety of biologics includes both in vivo and in vitro bioassays. Potency testing and bioassay development services:
Pharmacology is the science dealing with biochemical and physiologic aspects of drug effects, including absorption, distribution, metabolism, elimination, toxicity doses, and specific mechanisms of drug action.
