Assessing developability early in the discovery process for novel biologics

ABSTRACTBeyond 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 properti...

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Hauptverfasser: Monica L. Fernández-Quintero (VerfasserIn), Anne Ljungars (VerfasserIn), Franz Waibl (VerfasserIn), Victor Greiff (VerfasserIn), Jan Terje Andersen (VerfasserIn), Torleif T. Gjølberg (VerfasserIn), Timothy P. Jenkins (VerfasserIn), Bjørn Gunnar Voldborg (VerfasserIn), Lise Marie Grav (VerfasserIn), Sandeep Kumar (VerfasserIn), Guy Georges (VerfasserIn), Hubert Kettenberger (VerfasserIn), Klaus R. Liedl (VerfasserIn), Peter M. Tessier (VerfasserIn), John McCafferty (VerfasserIn), Andreas H. Laustsen (VerfasserIn)
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Veröffentlicht: Taylor & Francis Group, 2023-12-01T00:00:00Z.
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100 1 0 |a Monica L. Fernández-Quintero  |e author 
700 1 0 |a Anne Ljungars  |e author 
700 1 0 |a Franz Waibl  |e author 
700 1 0 |a Victor Greiff  |e author 
700 1 0 |a Jan Terje Andersen  |e author 
700 1 0 |a Torleif T. Gjølberg  |e author 
700 1 0 |a Timothy P. Jenkins  |e author 
700 1 0 |a Bjørn Gunnar Voldborg  |e author 
700 1 0 |a Lise Marie Grav  |e author 
700 1 0 |a Sandeep Kumar  |e author 
700 1 0 |a Guy Georges  |e author 
700 1 0 |a Hubert Kettenberger  |e author 
700 1 0 |a Klaus R. Liedl  |e author 
700 1 0 |a Peter M. Tessier  |e author 
700 1 0 |a John McCafferty  |e author 
700 1 0 |a Andreas H. Laustsen  |e author 
245 0 0 |a Assessing developability early in the discovery process for novel biologics 
260 |b Taylor & Francis Group,   |c 2023-12-01T00:00:00Z. 
500 |a 10.1080/19420862.2023.2171248 
500 |a 1942-0870 
500 |a 1942-0862 
520 |a ABSTRACTBeyond 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. 
546 |a EN 
690 |a Biologics 
690 |a developability 
690 |a antibodies 
690 |a drug development 
690 |a biotherapeutics 
690 |a drug discovery 
690 |a Therapeutics. Pharmacology 
690 |a RM1-950 
690 |a Immunologic diseases. Allergy 
690 |a RC581-607 
655 7 |a article  |2 local 
786 0 |n mAbs, Vol 15, Iss 1 (2023) 
787 0 |n https://www.tandfonline.com/doi/10.1080/19420862.2023.2171248 
787 0 |n https://doaj.org/toc/1942-0862 
787 0 |n https://doaj.org/toc/1942-0870 
856 4 1 |u https://doaj.org/article/40e1d35a06264ee9a178e72c2e9b24b1  |z Connect to this object online.