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Article

Minimizing Oxidation of Freeze-Dried Monoclonal Antibodies in Polymeric Vials Using a Smart Packaging Approach

1
Department of Pharmacy, Pharmaceutical Technology and Biopharmaceutics, Ludwig-Maximilians-Universität München, 81377 Munich, Germany
2
Coriolis Pharma, Fraunhoferstr. 18 b, 82152 Munich, Germany
*
Author to whom correspondence should be addressed.
Academic Editor: Anna Angela Barba
Pharmaceutics 2021, 13(10), 1695; https://doi.org/10.3390/pharmaceutics13101695
Received: 20 August 2021 / Revised: 17 September 2021 / Accepted: 28 September 2021 / Published: 15 October 2021
(This article belongs to the Special Issue New Trends in Freeze-Drying of Pharmaceutical Products)
Primary containers made of cyclic olefin polymer (COP) have recently gained attention since they may overcome several risks and shortcomings of glass containers as they exhibit a high break resistance, biocompatibility, and homogeneous heat transfer during lyophilization. On the downside, COP is more permeable for gases, which can lead to an ingress of oxygen into the container over time. Since oxidation is an important degradation pathway for monoclonal antibodies (mAbs), the continuous migration of oxygen into drug product containers should be avoided overall. To date, no long-term stability studies regarding lyophilizates in polymer vials have been published, potentially because of the unbearable gas permeability. In this study, we demonstrate that after lyophilization in COP vials and storage of these vials in aluminum pouches together with combined oxygen and moisture absorbers (“smart packaging”), oxidation of two lyophilized therapeutic antibodies was as low as in glass vials due to the deoxygenated environment in the pouch. Nevertheless, active removal of oxygen from the primary container below the initial level over time during storage in such “smart” secondary packaging was not achieved. Furthermore, residual moisture was controlled. Overall, the smart packaging reveals a promising approach for long-term stability of biopharmaceuticals; in addition to COP’s known benefits, stable, low oxygen and moisture levels as well as the protection from light and cushioning against mechanical shock by the secondary packaging preserve the sensitive products very well. View Full-Text
Keywords: COP; polymer; absorber; freeze-drying; lyophilization; oxidation; oxygen permeation; monoclonal antibody; stability COP; polymer; absorber; freeze-drying; lyophilization; oxidation; oxygen permeation; monoclonal antibody; stability
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MDPI and ACS Style

Härdter, N.; Menzen, T.; Winter, G. Minimizing Oxidation of Freeze-Dried Monoclonal Antibodies in Polymeric Vials Using a Smart Packaging Approach. Pharmaceutics 2021, 13, 1695. https://doi.org/10.3390/pharmaceutics13101695

AMA Style

Härdter N, Menzen T, Winter G. Minimizing Oxidation of Freeze-Dried Monoclonal Antibodies in Polymeric Vials Using a Smart Packaging Approach. Pharmaceutics. 2021; 13(10):1695. https://doi.org/10.3390/pharmaceutics13101695

Chicago/Turabian Style

Härdter, Nicole, Tim Menzen, and Gerhard Winter. 2021. "Minimizing Oxidation of Freeze-Dried Monoclonal Antibodies in Polymeric Vials Using a Smart Packaging Approach" Pharmaceutics 13, no. 10: 1695. https://doi.org/10.3390/pharmaceutics13101695

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