Besides the required stability studies, a change in drug substance container needs a re-assessment of the freezing and thawing steps, as well as the possible impact of the shipping configuration on the product quality. This poster focuses on the process development studies necessary to de-risk a change in drug substance container. First, a small-scale model using a Blast Freezer to evaluate the effect of controlled freezing and thawing rates on product quality is presented. The experimental approach is illustrated for a monoclonal antibody. Second, the effect on the solution pH of possible CO2 ingress during shipping on dry ice is investigated to determine if a gas impermeable barrier such as a mylar bag is necessary. The results show that even though the presence of CO2 can create a pH shift, it does not occur during shipping if container closure integrity is maintained. These results illustrate a process development framework where appropriate studies performed to focus on the freezing/shipping conditions, and to guide the necessary QbD risk assessments in order to build a robust control strategy.

Process development methodology to assess a new drug substance container: Freezing and thawing small scale model considerations and effect of CO2 ingress during shipping

Macromolecular Chemistry: The Second Century

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ACS Spring 2020 National Meeting & Expo

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.