Syringe and needle with glass medical ampoule vials for injection. Medicine is dry white drug penicillin powder or liquid with of aqueous solution in ampulla

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.

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.

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.