ITC is the most sensitive method for characterizing binding interactions, revealing critical attributes like drug efficacy and stability. But without proper mixing, ITC data is unreliable and unusable. Great ITC experiments start with correct mixing.
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.
在整個 18 世紀，許多科學家都對熱的本質提出了質疑。艾薩克·牛頓 (Isaac Newton) 認為熱能是透過粒子的震動傳遞的，而勞勃·虎克 (Robert Hooke) 則認為熱能是人體各部位運動而產生的一種特性1。然而，在歷史上第一個眾所周知對熱量進行測量的貢獻者是蘇格蘭醫生和化學家約瑟夫·布拉克 (Joseph Black)1。1761 年，他透過精確的測量發現，對達熔點的冰或達沸點的水施加熱量並不會導致溫度變化1。這個觀察結果使他成為第一個區分溫度和熱量的科學家，標誌了熱力學的開端。
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.
過去十年中，電池研究、發展及品質控制已經採用原位與臨場等溫微量熱法 (IMC) 作為評估鋰離子電池循環過程中熱流的主要方法。雖然將電池反覆進行充放電至失效可能耗時數月，但是新興的診斷測試可在數週內預測電池的長期行為。
在治療學中，抗體穩定性對抗體性能有著極重要的影響。創造具有適當半衰期的產品，以及避免抗體生物物理特性惡化的問題，抗體的高度熱穩定性是不可或缺的。
冷凍真空乾燥法 (Lyophilization)，又稱「凍乾」，為移除樣品水分的方法，常作為保存用途。冷凍真空乾燥法中通常透過快速冷凍的過程將樣品中的水分昇華。快速冷凍可避免大冰晶的形成而將樣品的細胞壁受到破壞。