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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.

Syringe and needle with glass medical ampoule vials for injection. Medicine is dry white drug penicillin powder or liquid with of aqueous solution in ampulla

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.

微量熱法的歷史

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。

什麼是等溫滴定量熱法(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.

适于大分子生物物理表征的微热量测定法

生物大分子是每个细胞的基本成分 ,因此对所有生命来说都是必不可少的。 这些重要分子被分为四大类:碳水化合物、脂质、蛋白质和核酸。表征生物大分子对于了解它们的功能和关系非常重要,从而助力开发新型治疗方法。在高分子研究领域中,生物治疗药物疗法侧重于可导致疾病和/或细胞死亡的高分子相互作用。