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How to Accelerate Thermal Stability Testing for High-Concentration Drugs

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.

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Unlocking Stability: The Crucial Role of Thermal Analysis in Lyophilization Temperature Optimization

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.

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How to Assess Binding in Drug Discovery

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.

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What is Isothermal Titration Calorimetry (ITC)?

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.

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Microcalorimetry for the Biophysical Characterization of Macromolecules

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.

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