Accelerating Biologics PBPK Modelling with Automated Model Building: A Tutorial
Physiologically based pharmacokinetic (PBPK) modelling for biologics, such as monoclonal antibodies and therapeutic proteins, involves capturing complex processes, including target-mediated drug disposition (TMDD), FcRn-mediated recycling, and tissue-specific distribution. The Simcyp Designer Biolog...
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| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
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MDPI AG
2025-05-01
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| Series: | Pharmaceutics |
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| Online Access: | https://www.mdpi.com/1999-4923/17/5/604 |
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| author | Abdallah Derbalah Tariq Abdulla Mailys De Sousa Mendes Qier Wu Felix Stader Masoud Jamei Iain Gardner Armin Sepp |
| author_facet | Abdallah Derbalah Tariq Abdulla Mailys De Sousa Mendes Qier Wu Felix Stader Masoud Jamei Iain Gardner Armin Sepp |
| author_sort | Abdallah Derbalah |
| collection | DOAJ |
| description | Physiologically based pharmacokinetic (PBPK) modelling for biologics, such as monoclonal antibodies and therapeutic proteins, involves capturing complex processes, including target-mediated drug disposition (TMDD), FcRn-mediated recycling, and tissue-specific distribution. The Simcyp Designer Biologics PBPK Platform Model offers an intuitive and efficient platform for constructing mechanistic PBPK models with pre-defined templates and automated model assembly, reducing manual input and improving reproducibility. This tutorial provides a step-by-step guide to using the platform, highlighting features such as cross-species scaling, population variability simulations, and flexibility for model customization. Practical case studies demonstrate the platform’s capability to streamline workflows, enabling rapid, mechanistic model development to address key questions in biologics drug development. By automating critical processes, this tool enhances decision-making in translational research, optimizing the modelling and simulation of large molecules across discovery and clinical stages. |
| format | Article |
| id | doaj-art-44b8cc2f0eaf4b389e8e814d5dbdf3fb |
| institution | DOAJ |
| issn | 1999-4923 |
| language | English |
| publishDate | 2025-05-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Pharmaceutics |
| spelling | doaj-art-44b8cc2f0eaf4b389e8e814d5dbdf3fb2025-08-20T03:14:32ZengMDPI AGPharmaceutics1999-49232025-05-0117560410.3390/pharmaceutics17050604Accelerating Biologics PBPK Modelling with Automated Model Building: A TutorialAbdallah Derbalah0Tariq Abdulla1Mailys De Sousa Mendes2Qier Wu3Felix Stader4Masoud Jamei5Iain Gardner6Armin Sepp7Certara Predictive Technologies Division, Certara UK Ltd., Level 2-Acero, 1 Concourse Way, Sheffield S1 2BJ, UKCertara Predictive Technologies Division, Certara UK Ltd., Level 2-Acero, 1 Concourse Way, Sheffield S1 2BJ, UKCertara Predictive Technologies Division, Certara UK Ltd., Level 2-Acero, 1 Concourse Way, Sheffield S1 2BJ, UKCertara Predictive Technologies Division, Certara UK Ltd., Level 2-Acero, 1 Concourse Way, Sheffield S1 2BJ, UKCertara Predictive Technologies Division, Certara UK Ltd., Level 2-Acero, 1 Concourse Way, Sheffield S1 2BJ, UKCertara Predictive Technologies Division, Certara UK Ltd., Level 2-Acero, 1 Concourse Way, Sheffield S1 2BJ, UKCertara Predictive Technologies Division, Certara UK Ltd., Level 2-Acero, 1 Concourse Way, Sheffield S1 2BJ, UKCertara Predictive Technologies Division, Certara UK Ltd., Level 2-Acero, 1 Concourse Way, Sheffield S1 2BJ, UKPhysiologically based pharmacokinetic (PBPK) modelling for biologics, such as monoclonal antibodies and therapeutic proteins, involves capturing complex processes, including target-mediated drug disposition (TMDD), FcRn-mediated recycling, and tissue-specific distribution. The Simcyp Designer Biologics PBPK Platform Model offers an intuitive and efficient platform for constructing mechanistic PBPK models with pre-defined templates and automated model assembly, reducing manual input and improving reproducibility. This tutorial provides a step-by-step guide to using the platform, highlighting features such as cross-species scaling, population variability simulations, and flexibility for model customization. Practical case studies demonstrate the platform’s capability to streamline workflows, enabling rapid, mechanistic model development to address key questions in biologics drug development. By automating critical processes, this tool enhances decision-making in translational research, optimizing the modelling and simulation of large molecules across discovery and clinical stages.https://www.mdpi.com/1999-4923/17/5/604PBPKbiologicsmAbsoligonucleotidesautomationSimcyp Designer |
| spellingShingle | Abdallah Derbalah Tariq Abdulla Mailys De Sousa Mendes Qier Wu Felix Stader Masoud Jamei Iain Gardner Armin Sepp Accelerating Biologics PBPK Modelling with Automated Model Building: A Tutorial Pharmaceutics PBPK biologics mAbs oligonucleotides automation Simcyp Designer |
| title | Accelerating Biologics PBPK Modelling with Automated Model Building: A Tutorial |
| title_full | Accelerating Biologics PBPK Modelling with Automated Model Building: A Tutorial |
| title_fullStr | Accelerating Biologics PBPK Modelling with Automated Model Building: A Tutorial |
| title_full_unstemmed | Accelerating Biologics PBPK Modelling with Automated Model Building: A Tutorial |
| title_short | Accelerating Biologics PBPK Modelling with Automated Model Building: A Tutorial |
| title_sort | accelerating biologics pbpk modelling with automated model building a tutorial |
| topic | PBPK biologics mAbs oligonucleotides automation Simcyp Designer |
| url | https://www.mdpi.com/1999-4923/17/5/604 |
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