Influence of Peristaltic Pump Tubes on Protein Particles Formation for Lipase Enzyme Therapeutic Protein

Sammanfattning: Introduction: In Bio-pharmaceutical production, peristaltic pump tubing is considered one of the factors that influence protein aggregation. Background: Protein particles present challenges for the control and analysis of various manufacturing processes in the biopharmaceutical industry for their significant effects on safety and quality. Aim(s): This research aims to study the effect of different peristaltic pump tubing on particle formation as well as the Characterization of the particles and investigate the effect of surfactants on particle formation. Methods: The study was conducted using a dynamic image analysis instrument (QICPIC) to characterize particles formed by Lipase protein samples while pumping through Silicone and PVC tubing using a peristaltic pump. Lipase samples concentration of 1mg/ml were investigated with and without polysorbate 20, Poloxamer 188, and SDS surfactants, while Lipase 10 mg/ml samples were investigated without using the surfactants. Results: Pumped of all Lipase protein samples resulted in particle formation with varying degrees between Silicone and PVC tubing. The presence of Poloxamer 188 and Sodium Dodecyl Sulfate (SDS) surfactants reduced pumping-induced particles except for Polysorbate 20. Conclusion: Silicone and PVC tubing generate particles even in the presence of surfactants and a great level of reduction the particle formation was achieved with Poloxamer 188 and SDS surfactants.