Dr E Neil Lewis, chief technology officer at Malvern Instruments:

Unlike chemical entities, large biological molecules cannot be delivered as powders or tablets and instead, are delivered in suspension via injection. Large biological molecules are heterogeneous in nature, and the therapeutic molecule itself may become misfolded, aggregated or denaturated. Consequently, biological materials bring a level of complexity to the development process that is simply not present for small molecule drugs. Safety and efficacy of the final product are paramount, and have been driving analytical requirements to this point. However, as the industry grows, the analytical expectations throughout the development cycle will mature. Potentially, a suite of analyses will be applied at all stages of development, evolving into the biopharmaceutical analogue to Quality by Design. This includes pre-formulation and formulation stages, where critical decisions must be made as to the likely downstream suitability of a molecule.


In this fast-moving environment, some of the biggest challenges lie in understanding not only what can be measured but what will provide meaningful predictive information as to quality, and finally anticipating what measurements you will be required to make in the future. Such dynamism is pretty exciting and is stimulating some significant scientific advances, but means that we have to keep defining and redefining the metrics, and as analytical instrument providers we have to deliver the necessary tools.