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Downstream Late-stage Development

Downstream late-stage development involves various activities aimed at demonstrating process robustness to ensure consistent delivering of intended products at large-scale commercial production. It typically begins after the process is preliminarily locked for pivotal production. A detailed risk assessment is conducted based on potential CQAs and historical process knowledge to identify high-risk parameters and develop mitigation plan. Activities include scale-down model qualification, process characterization, intermediate hold time study, resin lifetime studies, etc.

Scale-down Model Qualification

Qualification of the scale-down model involves qualitative and quantitative comparisons to determine if there are significant differences in column performance between different scales.

Qualitative Comparison

  • UV280nm curves of chromatography A from scale-down model and GMP:

  • Conductivity and pH curves of chromatography A from scale-down model and GMP production scale:

Quantitative Comparison

  • Results of scale down model qualification:

Process Characterization

In process characterization studies, high-risk process parameters are identified and evaluated using OFAT or DOE to determine their effect on product quality attributes and process performance. The % Tolerance is calculated to classify critical process parameters (CPP), key process parameters (KPP) and non-KPP. Acceptance criteria are defined based on contour plots or Monte Carlo simulations.

Lifetime Study

Evaluation for the lifetime of Resin and Membrane


1. PDATR 60-3 Process Validation: A Lifecycle Approach Annex 2: Biopharmaceutical Drug Substances Manufacturing