Article in American Pharmaceutical Review October 2017

November 7, 2017 Article in American Pharmaceutical Review October 2017

"Strategies to Predict the Developability of Biopharmaceuticals"

Stefan R. Schmidt

Over the last decades drug development expertise for biologicals has constantly increased. Nevertheless, failures still happen and are mostly related to intolerable toxicity, low efficacy and undesired physicochemical and biopharmaceutical attributes. The attrition rate could be reduced by a more systematic approach, assessing the "developability" of new biological entities (NBE) at an early stage.

Therefore, developability assessment is introduced to enable a ranking of several potential product candidates not only based on their biological activity. This article describes typical strategies to predict the behavior of molecules in terms of aggregation, stability, potency, pharmacokinetics and -dynamics (PK/PD), solubility, viscosity, immunogenicity and safety, taking into account sample consumption, duration of the assays and amenability to high throughput.

You will find the full article here.

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