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抗体制剂的稳定性收敛。

Stability Convergence in Antibody Coformulations.

机构信息

Department of Biochemical Engineering, UCL, WC1E 6BTLondon, U.K.

EPSRC Future Targeted Healthcare Manufacturing Hub, UCL, WC1E 6BTLondon, U.K.

出版信息

Mol Pharm. 2022 Nov 7;19(11):4098-4110. doi: 10.1021/acs.molpharmaceut.2c00534. Epub 2022 Oct 20.

Abstract

Combined administration of antibody therapeutics has proven to be beneficial for patients with cancer or infectious diseases. As a result, there is a growing trend toward multiple antibodies premixed into a single product form and delivered to patients as a fixed-dose coformulation. However, combining antibodies into a single coformulation could be challenging as proteins have the potential to interact and alter their stability and degradation profiles in the mixture, compared to that in isolation. We show that in two specific antibody-antibody coformulations, the more stable antibody component increased the stability of the less stable component, which in return destabilized the more stable component, hence exhibiting an overall convergence of stability in the coformulation.

摘要

联合使用抗体疗法已被证明对癌症或传染病患者有益。因此,越来越多的趋势是将多种抗体预先混合到单一产品形式中,并以固定剂量的复方制剂形式输送给患者。然而,将抗体组合到单一的复方制剂中可能具有挑战性,因为与单独存在相比,蛋白质有可能相互作用并改变其在混合物中的稳定性和降解特性。我们表明,在两种特定的抗体-抗体复方制剂中,较稳定的抗体成分增加了较不稳定成分的稳定性,而反过来又使较稳定的成分不稳定,因此在复方制剂中表现出整体稳定性的收敛。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ef09/9644375/a2e00043303c/mp2c00534_0002.jpg

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