(471g) Engineering-Driven Application of Quality By Design to the Gmma Platform: Enabling the Production of Affordable and Effective Vaccines for Low and Middle Income Countries
- Conference: AIChE Annual Meeting
- Year: 2019
- Proceeding: 2019 AIChE Annual Meeting
- Group: Pharmaceutical Discovery, Development and Manufacturing Forum
- Time: Wednesday, November 13, 2019 - 10:06am-10:27am
GMMA is produced by bacterial fermentation with simple filtration-based downstream processing. Such process has been already scaled-up for producing GMP-quality GMMA at large scale for Shigella sonnei and nontyphoidal Salmonella, pathogens of particular relevance for LMIC. The most advanced GMMA-based vaccine is S. sonnei, already tested in clinical trials showing to be safe and immunogenic in adults (4,5).
In this work we present a techno-economic analysis of the GMMA production process, using SuperPro Designer. We investigate different operating scenarios and scales and monitor their impact on operational and capital costs of the facility. Current efforts are focused on a systematic and quantitative identification of quality attribute-process parameter relationships based on first-principles and data-driven modelling. We will present an illustrative example for such an implementation of Quality by Design principles to the separation unit of tangential flow filtration. The latter is based on independent experimental runs under varying conditions that indicate critical process parameters and allow for a thorough risk assessment. Lastly, we demonstrate a science-driven framework to assist with: (a) identification of the critical quality attributes & critical process parameters and (b) quantification of the impact of the critical processes parameters on the monitored attributes.
Deep process understanding combined to a robust analytical control strategy will support sustainable manufacturing of safe and efficacious GMMA based vaccines, focusing on both product quality and process performance.
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