Expert view: Early product characterisation mitigates risks in biologics development

These tests fulfilled the regulatory requirements of the pharmacopoeia and are carried out in a standardised method. With small molecule drugs the testing of the final product is relied upon. In today’s complex world of biologics, it is recognised that success demands a different approach, where the process as well as the product is combined to define the drug and a more orthogonal approach on analytics is required.

What makes biologics different? The intricacies of biological manufacturing, the large size of the molecules and the final product heterogeneity introduced by cellular expression systems present significant challenges to measuring the quality of a biologic drug. During the early phase of drug development, much about the drug’s quality attributes is unknown and must be established empirically by physical, structural and functional analysis.