The primary function of biopharmaceutical development is to demonstrate that the investigational drug is both safe and efficacious for human use. And aspect of this is to have a comprehensive understanding of both the drug substance and drug product, both from a physiochemical and biological viewpoint. Accordingly, there is a regulatory expectation that any investigational biopharmaceutical will be thoroughly characterized using a wide range of analytical techniques. Due to the highly complex nature of biopharmaceuticals, this is not a trivial exercise, often involving orthogonal analytical techniques to gain deep understanding of the biopharmaceutical product. In this brochure, we outline the regulatory expectations for biopharmaceutical characterization along with the specific requirements for some of the more common modalities that are currently in development.

• Download