Influence of pneumatic transportation on the stability of monoclonal antibodies
Abstract 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...
| Main Authors: | , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Nature Portfolio
2023-12-01
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| Series: | Scientific Reports |
| Online Access: | https://doi.org/10.1038/s41598-023-49235-6 |
| _version_ | 1797388393332604928 |
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| author | Pierre Coliat Stéphane Erb Hélène Diemer Dan Karouby Tristan Martin Mainak Banerjee Chen Zhu Martin Demarchi Sarah Cianférani Alexandre Detappe Xavier Pivot |
| author_facet | Pierre Coliat Stéphane Erb Hélène Diemer Dan Karouby Tristan Martin Mainak Banerjee Chen Zhu Martin Demarchi Sarah Cianférani Alexandre Detappe Xavier Pivot |
| author_sort | Pierre Coliat |
| collection | DOAJ |
| description | Abstract 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. |
| first_indexed | 2024-03-08T22:40:10Z |
| format | Article |
| id | doaj.art-2c401a85c3e245a286d2afcfc12de327 |
| institution | Directory Open Access Journal |
| issn | 2045-2322 |
| language | English |
| last_indexed | 2024-03-08T22:40:10Z |
| publishDate | 2023-12-01 |
| publisher | Nature Portfolio |
| record_format | Article |
| series | Scientific Reports |
| spelling | doaj.art-2c401a85c3e245a286d2afcfc12de3272023-12-17T12:12:36ZengNature PortfolioScientific Reports2045-23222023-12-0113111510.1038/s41598-023-49235-6Influence of pneumatic transportation on the stability of monoclonal antibodiesPierre Coliat0Stéphane Erb1Hélène Diemer2Dan Karouby3Tristan Martin4Mainak Banerjee5Chen Zhu6Martin Demarchi7Sarah Cianférani8Alexandre Detappe9Xavier Pivot10Institut de Cancérologie Strasbourg Europe, ICANSInstitut Pluridisciplinaire Hubert Curien, CNRS UMR7178, Université de StrasbourgInstitut Pluridisciplinaire Hubert Curien, CNRS UMR7178, Université de StrasbourgInstitut de Cancérologie Strasbourg Europe, ICANSInstitut de Cancérologie Strasbourg Europe, ICANSInstitut de Cancérologie Strasbourg Europe, ICANSInstitut de Cancérologie Strasbourg Europe, ICANSInstitut de Cancérologie Strasbourg Europe, ICANSInstitut Pluridisciplinaire Hubert Curien, CNRS UMR7178, Université de StrasbourgInstitut de Cancérologie Strasbourg Europe, ICANSInstitut de Cancérologie Strasbourg Europe, ICANSAbstract 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.https://doi.org/10.1038/s41598-023-49235-6 |
| spellingShingle | Pierre Coliat Stéphane Erb Hélène Diemer Dan Karouby Tristan Martin Mainak Banerjee Chen Zhu Martin Demarchi Sarah Cianférani Alexandre Detappe Xavier Pivot Influence of pneumatic transportation on the stability of monoclonal antibodies Scientific Reports |
| title | Influence of pneumatic transportation on the stability of monoclonal antibodies |
| title_full | Influence of pneumatic transportation on the stability of monoclonal antibodies |
| title_fullStr | Influence of pneumatic transportation on the stability of monoclonal antibodies |
| title_full_unstemmed | Influence of pneumatic transportation on the stability of monoclonal antibodies |
| title_short | Influence of pneumatic transportation on the stability of monoclonal antibodies |
| title_sort | influence of pneumatic transportation on the stability of monoclonal antibodies |
| url | https://doi.org/10.1038/s41598-023-49235-6 |
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