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.

The functionality and stability of the candidate molecule must be demonstrated for biologics to be approved by regulatory bodies. Both attributes are equally important and must be characterised at all stages of discovery and development to ensure a successful development process. As biologics are structurally complex molecules, stability becomes a complicated matrix of multiple molecular properties and failure to precisely characterise them can potentially doom
the successful development of a candidate molecule. Ensuring a clear understanding of each of the properties that define stability is where efficiency is needed the most. Equally important is that information is trustworthy and offers actionable insights.

It is therefore critical that research groups select a technology that provides precise characterisation of the stability attributes, with the highest resolution and sensitivity to ensure changes in the properties of the candidate molecules are detected early in the development process. With high-quality data, researchers can predict biologics developability profiles through early-stage screening and perform comparability studies to validate that changes to manufacturing processes or sites do not affect the drug product.

By choosing the right technology to characterise stability, researchers can successfully introduce efficiency in the development of biologics and answer the demands for faster times to get the drug to the clinic while keeping costs under control.