Monitoring Protein Aggregation During Downstream Processing
– Insights Using the NanoFlowSizer –
Protein aggregation is a major concern during downstream processing (DSP) of biopharmaceuticals, affecting both product quality and safety.
This whitepaper explores how the NanoFlowSizer enables real-time monitoring of both submicron and rare subvisible protein aggregates during peristaltic pumping. Using a combination of Spatially Resolved Dynamic Light Scattering (PhaSR-DLS) and Large Particle Detection (LPD), the study reveals how mechanical stresses influence aggregation over time.
The results demonstrate a more efficient, single-instrument approach to aggregation monitoring, supporting better control over critical quality attributes in DSP.
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Key Insights:
- Real-time, non-invasive monitoring of submicron and subvisible aggregates.
- The role of mechanical stress in protein aggregation during peristaltic pumping.
- Benefits of combining PhaSR-DLS and LPD for comprehensive particle analysis.
- Early aggregation detection to optimize process efficiency and product quality.
- How a single instrument can simplify and enhance aggregate monitoring.
“Save time, save money, control production processes.”