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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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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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Why DSC Testing is a Critical Step in Developing Biosimilar Drugs

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.

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