Senior Scientist Merck & Co., Inc. Rahway, New Jersey
As Biologics products move into later stages of development, updated methods are often required to monitor product critical quality attributes. bridging studies are performed to understand the differences in the analytical methods and corresponding impact on reportable results. SEC and CE-SDS are two analytical methods used to measure aggregation and fragmentation of large molecules. Here, we discuss the bridging strategy for the transition from the original methods to updated methods for a traditional mAb. Here, the results showed that the new methods improve resolution and quantitation of aggregates (in SEC) and fragmentation (in CE-SDS) to meet the target ATP. These improvements resulted in statistical offsets which required re-evaluation of specifications and a strategy for framing legacy versus new stability for shelf-life indicating attributes. This study will discuss the benefits of introducing new methods while highlighting a strategy to address statistical off-set of the results in later stages of development.
Learning Objectives:
Discuss the benefits of introducing new methods while highlighting a strategy to address statistical off-set of the results and better resolution to quantify new impurities in later stages of development.
Discuss when we need bridging studies for different methods.
Discuss better resolution to quantify new impurities in later stages of development.
