With QbD (Quality by Design) as concept, stable and high yield process is achieved by identifying critical process parameters (CPP) based on CQA (critical quality attribute) using DoE experimental process design.
With QbD (Quality by Design) as concept, stable and high yield process is achieved by identifying critical process parameters (CPP) based on CQA (critical quality attribute) using DoE experimental process design.
Purity ≥ 95%; endotoxin <50 EU/mg of protein.
Affinity chromatography: after affinity with A3, purity reached 94.1%
Anion exchange chromatography: after the use of 50HQ, yield reached 73.9% and purity reached 98.1%
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