Therapeutic product characterization throughout the Research, Development and pre-commercialization process is an essential part of ensuring comparability against expected criteria, while further enabling risk mitigation associated with any atypical results representing potential product safety/efficacy concerns. In addition to concerns regarding the impact of process scaling or revision/optimization steps on the active biotherapeutic agent, identifying the source of any atypical result can be complicated by an extensive list of necessary hardware and/or consumables revisions. These revisions may include, but are not limited to, changes to the lots of raw materials, storage media and/or cleaning solutions.
This presentation will outline a recent example of an atypical result that occurred during a tech transfer scale-up phase. The work presented will cover all aspects from the original observation following LC-MS peptide mapping, to the identification of the impurity coupled to planned risk management and mitigative activities. Our data will further summarize the source of this atypical result, impacting multiple pilot scale lots, correlated with a third-party consumable revision. The observation was not only important in mitigating risks ahead of production scale up, but further benefitted other products/modalities using the same third-party consumable, highlighting the importance of communication between both internal and external partners.