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J Pharm Sci. 2015 Jun;104(6):1885-1898. doi: 10.1002/jps.24430. Epub 2015 Mar 26.

Developability assessment during the selection of novel therapeutic antibodies.

Author information

1
Roche Pharma Research and Early Development, Roche Innovation Center Penzberg, Nonnenwald 2, 82377 Penzberg, Germany.
2
Roche Pharma Research and Early Development, Roche Innovation Center Penzberg, Nonnenwald 2, 82377 Penzberg, Germany. Electronic address: hubert.kettenberger@roche.com.

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.

KEYWORDS:

analytical biochemistry; bioinformatics; biotechnology; deamidation; degradation products; immune response; in silico modeling; monoclonal antibody; oxidation; pharmacokinetics

PMID:
25821140
DOI:
10.1002/jps.24430
[Indexed for MEDLINE]

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