Expert view: Increasing the efficiency of biologics development: the secret is precise and reliable stability characterisation of candidate molecules

Biologics are becoming increasingly important for the treatment of a wide variety of diseases, with more biologics receiving regulatory approval from the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) and entering the clinic every year.

The combination of therapeutic effectiveness and revenue potential has spurred an increase in investment and the establishment of a healthy pipeline of biologic clinical candidates. However, there is significant pressure relating to the time and cost of biologics development and the need to increase process efficiency.

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