Reconciling predicted and measured viscosity parameters in high concentration therapeutic antibody solutions
Monoclonal antibody (mAb) solution viscosity in ultra-high concentration formulations is a key developability consideration in mAb development risk mitigation strategies that has implications for downstream processing and patient safety. Predicting viscosity at therapeutically relevant concentration...
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2024-12-01
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| Series: | mAbs |
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| Online Access: | https://www.tandfonline.com/doi/10.1080/19420862.2024.2438172 |
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| _version_ | 1832576559740878848 |
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| author | Georgina Bethany Armstrong Aisling Roche William Lewis Zahra Rattray |
| author_facet | Georgina Bethany Armstrong Aisling Roche William Lewis Zahra Rattray |
| author_sort | Georgina Bethany Armstrong |
| collection | DOAJ |
| description | Monoclonal antibody (mAb) solution viscosity in ultra-high concentration formulations is a key developability consideration in mAb development risk mitigation strategies that has implications for downstream processing and patient safety. Predicting viscosity at therapeutically relevant concentrations remains critical, despite the need for large mAb quantities for viscosity measurement being prohibitive. Using a panel of IgG1s, we examined the suitability of viscosity prediction and fitting models at different mAb test concentration regimes. Our findings caution against extrapolation from low concentration measurements, as they lack predictive ability for ultra-high concentration regimes. For the first time, we demonstrate the importance of analyte concentration range selection, and the need for bespoke viscosity model development. |
| format | Article |
| id | doaj-art-9107f30c2c614a5b919e214e74629f03 |
| institution | Kabale University |
| issn | 1942-0862 1942-0870 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | mAbs |
| spelling | doaj-art-9107f30c2c614a5b919e214e74629f032025-01-31T04:19:38ZengTaylor & Francis GroupmAbs1942-08621942-08702024-12-0116110.1080/19420862.2024.2438172Reconciling predicted and measured viscosity parameters in high concentration therapeutic antibody solutionsGeorgina Bethany Armstrong0Aisling Roche1William Lewis2Zahra Rattray3Drug Substance Development, GlaxoSmithKline, Stevenage, UKLarge Molecule Discovery, GlaxoSmithKline, Stevenage, UKDrug Substance Development, GlaxoSmithKline, Stevenage, UKStrathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow, UKMonoclonal antibody (mAb) solution viscosity in ultra-high concentration formulations is a key developability consideration in mAb development risk mitigation strategies that has implications for downstream processing and patient safety. Predicting viscosity at therapeutically relevant concentrations remains critical, despite the need for large mAb quantities for viscosity measurement being prohibitive. Using a panel of IgG1s, we examined the suitability of viscosity prediction and fitting models at different mAb test concentration regimes. Our findings caution against extrapolation from low concentration measurements, as they lack predictive ability for ultra-high concentration regimes. For the first time, we demonstrate the importance of analyte concentration range selection, and the need for bespoke viscosity model development.https://www.tandfonline.com/doi/10.1080/19420862.2024.2438172Antibodyformulationphysicochemical descriptorspredictionviscosity |
| spellingShingle | Georgina Bethany Armstrong Aisling Roche William Lewis Zahra Rattray Reconciling predicted and measured viscosity parameters in high concentration therapeutic antibody solutions mAbs Antibody formulation physicochemical descriptors prediction viscosity |
| title | Reconciling predicted and measured viscosity parameters in high concentration therapeutic antibody solutions |
| title_full | Reconciling predicted and measured viscosity parameters in high concentration therapeutic antibody solutions |
| title_fullStr | Reconciling predicted and measured viscosity parameters in high concentration therapeutic antibody solutions |
| title_full_unstemmed | Reconciling predicted and measured viscosity parameters in high concentration therapeutic antibody solutions |
| title_short | Reconciling predicted and measured viscosity parameters in high concentration therapeutic antibody solutions |
| title_sort | reconciling predicted and measured viscosity parameters in high concentration therapeutic antibody solutions |
| topic | Antibody formulation physicochemical descriptors prediction viscosity |
| url | https://www.tandfonline.com/doi/10.1080/19420862.2024.2438172 |
| work_keys_str_mv | AT georginabethanyarmstrong reconcilingpredictedandmeasuredviscosityparametersinhighconcentrationtherapeuticantibodysolutions AT aislingroche reconcilingpredictedandmeasuredviscosityparametersinhighconcentrationtherapeuticantibodysolutions AT williamlewis reconcilingpredictedandmeasuredviscosityparametersinhighconcentrationtherapeuticantibodysolutions AT zahrarattray reconcilingpredictedandmeasuredviscosityparametersinhighconcentrationtherapeuticantibodysolutions |