Strengthening quality control of biopharmaceutical products through the establishment of structure-function relationships.

Establishing relationships between data from different analytical techniques supports the selection of a suitable set of tests for the characterisation of individual biopharmaceutical preparations. In this case study a portfolio of physicochemical and biological assays was developed that examined batch-to-batch-variability in Interferonalpha preparations produced in a Pichia pastoris expression system, and in samples from external collaborators. Throughout the case study, the NPL material was compared to Chemical Reference Standards supplied by EDQM. A review was undertaken of the industrial and regulatory debate on the application of structure-function relationships for biopharmaceuticals. The selection of key cell-based bioassays and physicochemical methods established a structure-function relationship for the class of model system used within this project.