Assessing developability early in the discovery process for novel biologics
Beyond potency, a good developability profile is a key attribute of a biological drug. Selecting and screening for such attributes early in the drug development process can save resources and avoid costly late-stage failures. Here, we review some of the most important developability properties that...
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2023-12-01
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| Series: | mAbs |
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| Online Access: | https://www.tandfonline.com/doi/10.1080/19420862.2023.2171248 |
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| author | Monica L. Fernández-Quintero Anne Ljungars Franz Waibl Victor Greiff Jan Terje Andersen Torleif T. Gjølberg Timothy P. Jenkins Bjørn Gunnar Voldborg Lise Marie Grav Sandeep Kumar Guy Georges Hubert Kettenberger Klaus R. Liedl Peter M. Tessier John McCafferty Andreas H. Laustsen |
| author_facet | Monica L. Fernández-Quintero Anne Ljungars Franz Waibl Victor Greiff Jan Terje Andersen Torleif T. Gjølberg Timothy P. Jenkins Bjørn Gunnar Voldborg Lise Marie Grav Sandeep Kumar Guy Georges Hubert Kettenberger Klaus R. Liedl Peter M. Tessier John McCafferty Andreas H. Laustsen |
| author_sort | Monica L. Fernández-Quintero |
| collection | DOAJ |
| description | Beyond potency, a good developability profile is a key attribute of a biological drug. Selecting and screening for such attributes early in the drug development process can save resources and avoid costly late-stage failures. Here, we review some of the most important developability properties that can be assessed early on for biologics. These include the influence of the source of the biologic, its biophysical and pharmacokinetic properties, and how well it can be expressed recombinantly. We furthermore present in silico, in vitro, and in vivo methods and techniques that can be exploited at different stages of the discovery process to identify molecules with liabilities and thereby facilitate the selection of the most optimal drug leads. Finally, we reflect on the most relevant developability parameters for injectable versus orally delivered biologics and provide an outlook toward what general trends are expected to rise in the development of biologics. |
| format | Article |
| id | doaj-art-40e1d35a06264ee9a178e72c2e9b24b1 |
| institution | Kabale University |
| issn | 1942-0862 1942-0870 |
| language | English |
| publishDate | 2023-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | mAbs |
| spelling | doaj-art-40e1d35a06264ee9a178e72c2e9b24b12025-08-20T03:25:53ZengTaylor & Francis GroupmAbs1942-08621942-08702023-12-0115110.1080/19420862.2023.2171248Assessing developability early in the discovery process for novel biologicsMonica L. Fernández-Quintero0Anne Ljungars1Franz Waibl2Victor Greiff3Jan Terje Andersen4Torleif T. Gjølberg5Timothy P. Jenkins6Bjørn Gunnar Voldborg7Lise Marie Grav8Sandeep Kumar9Guy Georges10Hubert Kettenberger11Klaus R. Liedl12Peter M. Tessier13John McCafferty14Andreas H. Laustsen15Center for Molecular Biosciences Innsbruck (CMBI), Department of General, Inorganic and Theoretical Chemistry, University of Innsbruck, Innsbruck, AustriaDepartment of Biotechnology and Biomedicine, Technical University of Denmark, Kongens Lyngby, DenmarkCenter for Molecular Biosciences Innsbruck (CMBI), Department of General, Inorganic and Theoretical Chemistry, University of Innsbruck, Innsbruck, AustriaDepartment of Immunology, University of Oslo, Oslo, NorwayDepartment of Immunology, University of Oslo, Oslo University Hospital Rikshospitalet, Oslo, NorwayAuthera AS, Oslo Science Park, Oslo, NorwayDepartment of Biotechnology and Biomedicine, Technical University of Denmark, Kongens Lyngby, DenmarkNational Biologics Facility, Department of Biotechnology and Biomedicine, Technical University of Denmark, Kongens Lyngby, DenmarkDepartment of Biotechnology and Biomedicine, Technical University of Denmark, Kongens Lyngby, DenmarkBiotherapeutics Discovery, Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, CT, USARoche Pharma Research and Early Development, Large Molecule Research, Roche Innovation Center Munich, Penzberg, GermanyRoche Pharma Research and Early Development, Large Molecule Research, Roche Innovation Center Munich, Penzberg, GermanyCenter for Molecular Biosciences Innsbruck (CMBI), Department of General, Inorganic and Theoretical Chemistry, University of Innsbruck, Innsbruck, AustriaDepartment of Chemical Engineering, Pharmaceutical Sciences and Biomedical Engineering, Biointerfaces Institute, University of Michigan, Ann Arbor, Michigan, USADepartment of Medicine, Cambridge Institute of Therapeutic Immunology and Infectious Disease, University of Cambridge, Cambridge, UKDepartment of Biotechnology and Biomedicine, Technical University of Denmark, Kongens Lyngby, DenmarkBeyond potency, a good developability profile is a key attribute of a biological drug. Selecting and screening for such attributes early in the drug development process can save resources and avoid costly late-stage failures. Here, we review some of the most important developability properties that can be assessed early on for biologics. These include the influence of the source of the biologic, its biophysical and pharmacokinetic properties, and how well it can be expressed recombinantly. We furthermore present in silico, in vitro, and in vivo methods and techniques that can be exploited at different stages of the discovery process to identify molecules with liabilities and thereby facilitate the selection of the most optimal drug leads. Finally, we reflect on the most relevant developability parameters for injectable versus orally delivered biologics and provide an outlook toward what general trends are expected to rise in the development of biologics.https://www.tandfonline.com/doi/10.1080/19420862.2023.2171248Biologicsdevelopabilityantibodiesdrug developmentbiotherapeuticsdrug discovery |
| spellingShingle | Monica L. Fernández-Quintero Anne Ljungars Franz Waibl Victor Greiff Jan Terje Andersen Torleif T. Gjølberg Timothy P. Jenkins Bjørn Gunnar Voldborg Lise Marie Grav Sandeep Kumar Guy Georges Hubert Kettenberger Klaus R. Liedl Peter M. Tessier John McCafferty Andreas H. Laustsen Assessing developability early in the discovery process for novel biologics mAbs Biologics developability antibodies drug development biotherapeutics drug discovery |
| title | Assessing developability early in the discovery process for novel biologics |
| title_full | Assessing developability early in the discovery process for novel biologics |
| title_fullStr | Assessing developability early in the discovery process for novel biologics |
| title_full_unstemmed | Assessing developability early in the discovery process for novel biologics |
| title_short | Assessing developability early in the discovery process for novel biologics |
| title_sort | assessing developability early in the discovery process for novel biologics |
| topic | Biologics developability antibodies drug development biotherapeutics drug discovery |
| url | https://www.tandfonline.com/doi/10.1080/19420862.2023.2171248 |
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