The progression from formulation development to commercial formulation is dependent on the dose strength, intrinsic stability, and extent of protein self-association in the final drug.1 This is because the drug is reaching the final stage of development.
Candidate selection is the third phase of the drug development process.1 The main purpose of candidate selection is to continue screening and filtering down to the most promising antibodies, ideally having one or two progress forward.
The most popular tool used to characterize binding in the late-discovery phase of drug development is isothermal titration calorimetry (ITC). ITC is a high-resolution method for complete characterization of the basic chemical details of a binding interaction. The calorimeters accomplish this by measuring the heat that is released or absorbed when molecules interact with each other.
Drug development is a long and complex process that starts with discovery and, if successful, ends with government approval for marketing. Each step in the drug development process, outlined below, has specific goals with the aim of down-selecting appropriate hits and candidates to an approved drug substance.
Throughout the 18th century, many scientists questioned the nature of heat. Isaac Newton thought that heat was transferred by the vibrations of particles, while Robert Hooke believed heat was a property of the body that arose from the motion of its parts.
Antibody stability is crucial for antibody performance in therapeutics. High antibody thermostabilities are essential for creating products with a reasonable shelf life and avoiding problems with deterioration of the biophysical properties of the antibody.
Gene therapy is an approach to disease treatment where a patient’s genetic makeup is altered rather than using drugs or surgery. Gene therapy treatment is accomplished through the activation of a particular gene, repairing faulty genes, or introducing new genes to help fight disease.
Isothermal Titration Calorimetry (ITC) is an experimental method used to measure the amount of heat released or consumed during a bimolecular chemical reaction. Chemical reactions can be either exothermic or endothermic, depending on the relative energetic stabilities of the reactants. Isothermal titration calorimetry can be used to quantify the magnitude of the heat change during the reaction.
Biological macromolecules are fundamental components of every cell and are therefore essential for all life. These vital molecules are categorized into four major classes: carbohydrates, lipids, proteins, and nucleic acids. Characterizing biological macromolecules is important for understanding their functions and relationships, which empowers the development of new therapies and treatments. Under this branch of macromolecule research, biotherapeutic drug therapy focuses on macromolecular interactions which can lead to disease and/or cell death.