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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.

Candidate selection

候補選択後の調合の最適化

新薬の開発は、薬の候補物質の発見から承認、製品として上市されるまでの、長期にわたる複雑なプロセスです。以下にご説明する医薬品開発プロセスの各ステップには、承認された医薬品成分に適合するヒット候補化合物の選択範囲を絞ることを目指す具体的な目標があります。

マイクロカロリメトリーの歴史

18世紀、多くの科学者が熱の性質について研究を行いました。アイザック・ニュートンは、熱は粒子の振動によって伝達されるものと考え、ロバート・フックは、熱は物体の特性であり、各部位の動きから生じると考えました1 。しかし、熱の測定の歴史に寄与した最初の著名な科学者はスコットランドの物理学者・化学者であるジョン・ブラックでした1 。1761年、彼は正確な測定方法を使って、氷の融点または水の沸点に熱をかけても、温度が変化しないことを発見しました1。 この観察結果により彼は、後の熱力学概念の発端となった、温度と熱とを識別することに成功した最初の科学者となります。

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.

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.