Influence of pneumatic transportation on the stability of monoclonal antibodies

Pneumatic transportation systems (PTS) were recently proposed as a method to carry ready-for-injection diluted monoclonal antibodies (mAbs) from the pharmacy to the bedside of patients. This method reduces transportation time and improves the efficiency of drug distribution process. However, mAbs ar...

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Veröffentlicht in:Scientific reports Jg. 13; H. 1; S. 21875 - 15
Hauptverfasser: Coliat, Pierre, Erb, Stéphane, Diemer, Hélène, Karouby, Dan, Martin, Tristan, Banerjee, Mainak, Zhu, Chen, Demarchi, Martin, Cianférani, Sarah, Detappe, Alexandre, Pivot, Xavier
Format: Journal Article
Sprache:Englisch
Veröffentlicht: London Nature Publishing Group UK 10.12.2023
Nature Publishing Group
Nature Portfolio
Schlagworte:
631/67/1059
639/925
692/308/153
Antibodies, Monoclonal - chemistry
Bioengineering
Humanities and Social Sciences
Humans
Immunology
Immunotherapy
Life Sciences
Mass spectrometry
Mass spectroscopy
Mechanical Phenomena
Monoclonal antibodies
multidisciplinary
Pharmacy
Post-translation
Science
Science (multidisciplinary)
Transportation - methods
ISSN:2045-2322, 2045-2322
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Zusammenfassung:Pneumatic transportation systems (PTS) were recently proposed as a method to carry ready-for-injection diluted monoclonal antibodies (mAbs) from the pharmacy to the bedside of patients. This method reduces transportation time and improves the efficiency of drug distribution process. However, mAbs are highly sensitive molecules for which subtle alterations may lead to deleterious clinical effects. These alterations can be caused by various external factors such as temperature, pH, pressure, and mechanical forces that may occur during transportation. Hence, it is essential to ensure that the mAbs transported by PTS remain stable and active throughout the transportation process. This study aims to determine the safety profile of PTS to transport 11 routinely used mAbs in a clinical setting through assessment of critical quality attributes (CQA) and orthogonal analysis. Hence, we performed aggregation/degradation profiling, post-translational modifications identification using complementary mass spectrometry-based methods, along with visible and subvisible particle formation determination by light absorbance and light obscuration analysis. Altogether, these results highlight that PTS can be safely used for this purpose when air is removed from the bags during preparation.
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ISSN:2045-2322
2045-2322
DOI:10.1038/s41598-023-49235-6