Developability assessment during the selection of novel therapeutic antibodies.

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 Sci

authors

Jarasch A,Koll H,Regula JT,Bader M,Papadimitriou A,Kettenberger H

doi

10.1002/jps.24430

subject

Has Abstract

pub_date

2015-06-01 00:00:00

pages

1885-1898

issue

6

eissn

0022-3549

issn

1520-6017

pii

S0022-3549(15)30084-8

journal_volume

104

pub_type

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