Whitepaper: Product characterisation: reveal your molecule earlier, faster and with accuracy

Partnering for product characterisation can streamline drug development and create efficiencies in moving from concept to clinic.

Here, Danny Galbraith, head of product characterisation and new services for MilliporeSigma’s BioReliance^® services, answers key questions relating to product characterisation.

PRODUCT CHARACTERISATION can be challenging throughout drug development because it requires advanced technologies and specialised expertise. Thus, it is vital to start product characterisation early and use it throughout all phases of the drug manufacturing process. It is also essential to capture a biologic’s activity profile from binding, affinity and potency bioassays to have a better understanding of a drug’s critical quality attributes. Outsourcing product characterisation offers greater efficiencies, as well as access to state-of-theart equipment and regulatory expertise.