Abstract:
:Therapeutic antibodies and antibody derivatives comprise the majority of today's biotherapeutics. Routine methods to generate novel antibodies, such as immunization and phage-display, often give rise to several candidates with desired functional properties. On the contrary, resource-intense steps such as the development of a cell line, a manufacturing process, or a formulation, are typically carried out for only one candidate. Therefore, "developability," that is, the likelihood for the successful development of a lead candidate into a stable, manufacturable, safe, and efficacious drug, may be used as an additional selection criterion. Employing a set of small-scale, fast, and predictive tests addressing biochemical and biophysical features, as well as in vivo fate can help to identify a clinical candidate molecule with promising properties at an early stage of drug development. This article gives an overview of existing methods for developability testing and shows how these assays can be interlaced in the lead selection process.
journal_name
J Pharm Scijournal_title
Journal of pharmaceutical sciencesauthors
Jarasch A,Koll H,Regula JT,Bader M,Papadimitriou A,Kettenberger Hdoi
10.1002/jps.24430subject
Has Abstractpub_date
2015-06-01 00:00:00pages
1885-1898issue
6eissn
0022-3549issn
1520-6017pii
S0022-3549(15)30084-8journal_volume
104pub_type
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