The development of biopharmaceuticals demands precise thermal stability characterization to ensure efficacy, safety, and manufacturability. As the industry shifts toward high concentration biologic formulations and subcutaneous delivery methods, the need for innovative DSC solutions becomes increasingly critical.
Pharmaceutical research and discovery rely on accurate characterization of molecular interactions to develop effective and safe drugs. Isothermal Titration Calorimetry (ITC) is a gold-standard technique that provides critical insights into binding affinity, thermodynamics, and stoichiometry—essential components in Structure-Activity Relationship (SAR) studies.
Isothermal Microcalorimetry (IMC) is a highly sensitive analytical technique that measures the heat flow in chemical and physical processes under constant temperature. IMC enables the precise detection of thermal reactions, including phase transitions, binding events, and metabolic processes, making it invaluable in fields such as pharmaceuticals, materials science, and battery research.
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 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.
The world is driven by battery power, and the various battery testing laboratory applications help to ensure that we get the most out of them.
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.