Early investment in product characterization helps discover if the molecule developed meets assigned criteria and if that molecule is able to be manufactured on a large scale. Identifying problems as early as possible essentially de-risks the development process and expedites product quality decisions at critical junctures. 

This white paper details:

• Early Development: Establishing a drug’s quality attributes.
• Required: Physical, structural and functional analysis.
• Technical: Case study of mAb product characterization: Adalimumab.