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.
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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.
從配方開發到商業配方的進展，皆取決於最終藥物的劑量強度、內在穩定性和蛋白質自結合程度。1 這是因為該藥物的研發已進入最後階段。
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.
藥物開發是個漫長而複雜的過程，從探索開始，一直到讓政府批准上市才算成功。如下所述，藥物開發過程中的每個步驟都有特定的目標，旨在篩選出適合的活性化合物和候選原料，最終得到已核准的原料藥。
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。
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。
基因療法是一種疾病治療方法，它不是使用藥物或手術治療，而是改變病人的基因構造。基因療法是透過激活特定的基因、修復不完善的基因，或是引入新的基因來幫助對抗疾病。
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.