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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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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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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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Solving Problems for the Next Generation

The recent release of our 2022 Environmental, Social, and Governance (ESG) report demonstrates a continued commitment to leaving the world better than we found it. The pursuit of the goals outlined in this report remains a top priority for our company and this year’s edition reflects both our current focus areas and future ambitions.

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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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Lithium-ion Battery Quality and Performance Testing with Isothermal Microcalorimetry

Over the past decade, battery research, development, and quality control have adopted in-situ and in-operando isothermal microcalorimetry (IMC) as the leading method to evaluate heat flow during lithium-ion battery cycling. While cycling a cell to failure can take many months, emerging diagnostic tests are able to predict long-term behavior in a matter of weeks.

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How To Optimize Lyophilization with Thermal Analysis

Lyophilization, also called freeze-drying, is the process of removing water from a sample, often for preservation. Lyophilization involves the sublimation of a sample’s water content, usually through a rapid freezing process. Freezing materials quickly helps avoid the destruction of the cell walls in the sample from the formation of large ice crystals.

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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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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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