Effective Implementation of Phase Appropriate Monoclonal Antibody Analytical Platforms in a cGMP Environment

Characterization of mAbs in a cGMP environment can be a daunting task. The assays are varied and include complex considerations to demonstrate the purity, potency, Identification, and safety profile of the drug candidate. While balancing the variety and specificity associated with mAb analytics, it is important to ensure the following are considered:

·Creation and implementation of platform analytical methods that eliminate the need for extensive development work

·Phase appropriate qualification strategies for phase clinical programs

·The importance of ensuring multiple platforms are available for comprehensive drug candidate characterization

·Selecting (or building) an analytical team and lab capable of supporting your strategy

·Filling in the analytical gaps through partner outsourcing strategies