A vaccine for Ebola virus - approaches and results of accelerated process development and characterization studies

摘要

Several approaches were used to expedite process development and characterization of the V920 vaccine candidate and develop a robust process: 1. Work in parallel 2. Use a risk-based approach to prioritize development studies 3. Create and use a scale-down model to increase experiment throughput 4. Robust Process Results from experiments 1. A1000x MOI range produces acceptable potencies 2. Enzyme addition is critical for achieving expected potency increase during purification 3. TFF robustly clears process residuals 5. Consider single-use solutions.