Differential Scanning Calorimetry is a thermal analysis technique commonly used to characterize materials across a broad array of applications including chemistry, biochemistry, pharmaceuticals, polymers, and more. Differential Scanning Calorimetry (DSC) measures the heat flow in a material as it is heated or cooled over a specified temperature range.
Discover the RS-DSC from TA Instruments, the ultimate high throughput DSC for rapid thermal analysis. Learn more about its precision, speed, and capabilities.
Biologic therapies derived from living organisms have revolutionized the treatment of complex diseases, yet their high development costs are often passed onto patients. Biosimilar drugs offer a promising solution to reduce costs while maintaining therapeutic efficacy. Unlike generic drugs, biosimilars cannot be exact replicas of their reference biologics due to their complex structures, necessitating rigorous testing and regulatory approval.
The stability of high-concentration drugs can change under storage conditions, but until now, thermal testing in the lab using traditional calorimetry methods has been time-consuming and challenging. The new TA Instruments RS-DSC fills a critical antibody formulation development gap by allowing for high-throughput short-term thermal stability testing at formulation strength concentrations. In this blog, we explore why that’s essential.
The method of drug delivery significantly influences the final stages of the manufacturing process. Currently, lyophilization—a widely adopted technique—enables drug developers to stabilize formulations and therapeutic molecules using a validated commercial approach. In this process, precise control of pressure and temperature within a lyophilizer facilitates the removal of liquids from formulations containing thermally sensitive or hydrolytically unstable active pharmaceutical ingredients or formulation components.
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. 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. During this phase, researchers are looking to evaluate the developability of a pool of less than five antibodies.
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.