Efficient Ultrafiltration/Diafiltration Process Development
Inline Particle Monitoring in Downstream mAb Purification
Program události
- Case study applying in-situ particle monitoring and IR/Raman spectroscopy to UF/DF process development in downstream mAb purification
- Real-time visibility into particle formation (turbidity/particle counts) and protein/buffer concentration during UF1–DF–UF2
- Correlate pH and protein concentration with turbidity/particle formation to guide operating conditions and accelerate development
This presentation reviews GSK’s case study using in-situ particle monitoring (ParticleTrack™ and EasyViewer™) alongside ReactIR™ and ReactRaman™ spectroscopy during ultrafiltration/diafiltration (UF/DF) process development for monoclonal antibody purification. The combined monitoring strategy provided real-time insight into particle formation and turbidity trends, while simultaneously tracking protein concentration and buffer exchange through UF1, DF, and UF2.
Key learnings showed that particle formation can be monitored in real time, and that IR and Raman spectroscopy enable monitoring of excipient/buffer composition and protein concentration to confirm process targets and detect deviations. The data also highlighted how pH conditions and protein concentration during diafiltration influence turbidity and particle formation, helping teams converge on operating conditions with fewer experimental iterations.
