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Open AccessArticle

Microwave-Assisted Freeze-Drying of Monoclonal Antibodies: Product Quality Aspects and Storage Stability

1
Department of Pharmacy, Pharmaceutical Technology and Biopharmaceutics, Ludwig-Maximilians-Universität München, 81377 Munich, Germany
2
Boehringer Ingelheim Pharma GmbH & Co. KG, Pharmaceutical Development Biologicals, 88397 Biberach an der Riß, Germany
*
Authors to whom correspondence should be addressed.
Pharmaceutics 2019, 11(12), 674; https://doi.org/10.3390/pharmaceutics11120674
Received: 30 October 2019 / Revised: 6 December 2019 / Accepted: 7 December 2019 / Published: 12 December 2019
(This article belongs to the Special Issue Pharmaceutical Freeze Drying and Spray Drying)
In order to overcome the downside of long conventional freeze-drying (CFD) process times for monoclonal antibody formulations, microwave-assisted freeze-drying (MFD) was introduced. Recently, the general applicability and potential shortening of drying times were shown. However, little is known about the storage stability of MFD products compared to CFD references. Additionally, batch homogeneity issues were seen within MFD in the past. In this study, we examined four different formulations of two different monoclonal antibodies using three different glass-forming excipients: sucrose, trehalose, and arginine phosphate. These formulations were freeze-dried with two different drying protocols (CFD and MFD), stored for 24 weeks, and analyzed for solid-state and protein-related quality attributes. Moreover, a new microwave generator setup was investigated for its potential to improve batch homogeneity. In all investigated formulations, comparable stability profiles were found, although the classical magnetron generator led to inferior batch homogeneity with respect to residual moisture distribution. In contrast, the new MFD setup indicated the potential to approximate batch homogeneity to the level of CFD. However, for future applications, there is an unabated need for new machine designs to comply with pharmaceutical manufacturing requirements. View Full-Text
Keywords: freeze-drying; lyophilization; drying; microwave; protein; monoclonal antibody; stability freeze-drying; lyophilization; drying; microwave; protein; monoclonal antibody; stability
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Gitter, J.H.; Geidobler, R.; Presser, I.; Winter, G. Microwave-Assisted Freeze-Drying of Monoclonal Antibodies: Product Quality Aspects and Storage Stability. Pharmaceutics 2019, 11, 674.

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