Functional testing, such as cell based assays and receptor binding, is important because small changes to the structure of a biopharmaceutical can have significant effects on the method of action. These changes include structural aspects such as post translational modifications and glycosylation. For example, glycan structures can control the half-life of a biopharmaceutical in the blood stream, receptor binding or other biological effects. Function can also be effected by higher order structure. If the overall 3D shape is wrong, receptor binding can be inhibited, immunogenic epitopes can be exposed and aggregation can occur.
For these reasons, it is crucial to consider structural and functional data together throughout the development process and correlate any findings.
Custom Biologics is BioPharmaSpec’s strategic partner in providing functional testing such as cell based assays and receptor binding to our clients. Based in Toronto, Canada, Custom Biologics provide a comprehensive range of functional characterization and comparability methods including: