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• Ryan, B
• McCarthy, C
• Ramtoola, Z
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• Ryan, B
• McCarthy, C
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• Ryan, B
• McCarthy, C
• Ramtoola, Z

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Pharmaceutics 2011, 3(3), 510-524; doi:10.3390/pharmaceutics3030510

Article

Effect of Microencapsulation Shear Stress on the Structural Integrity and Biological Activity of a Model Monoclonal Antibody, Trastuzumab

Ritesh M. Pabari, Benedict Ryan, Catherine McCarthy and Zebunnissa Ramtoola*

School of Pharmacy, Royal College of Surgeons in Ireland, 123 St. Stephens Green, Dublin 2, Ireland

* Author to whom correspondence should be addressed.

Received: 4 July 2011; in revised form: 16 August 2011 / Accepted: 19 August 2011 / Published: 24 August 2011

(This article belongs to the Special Issue Microencapsulation Technology Applied to Pharmaceutics)

Download PDF Full-Text [402 KB, uploaded 24 August 2011 12:52 CEST]

Abstract: The aim of the present study was to investigate the influence of process shear stressors on the stability of a model monoclonal antibody, trastuzumab. Trastuzumab, at concentrations of 0.4–4.0 mg/mL, was subjected to sonication, freeze-thaw, lyophilisation, spray drying and was encapsulated into micro- and nanoparticles. The stressed samples were analysed for structural integrity by gel electrophoresis, SDS-PAGE, and size exclusion chromatography (SEC), while the conformational integrity was analysed by circular dichroism (CD). Biological activity of the stressed trastuzumab was investigated by measuring the inhibition of cell proliferation of HER-2 expressing cell lines. Results show that trastuzumab was resistant to the process shear stresses applied and to microencapsulation processes. At the lowest concentration of 0.4 mg/mL, a low percent ( 0.05). The results of this study conclude that trastuzumab may be resistant to various processing stresses. These findings have important implications with respect to pharmaceutical processing of monoclonal antibodies.

Keywords: trastuzumab; shear stress; stability; size exclusion chromatography; circular dichroism; biological activity

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