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

Omer, Salah Elden LU (2023) KLGM05 20231
Food Technology and Nutrition (M.Sc.)
Abstract
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... (More)
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. (Less)
Popular Abstract
Protein aggregation is a high molecular weight protein content cluster. Their presence in finished therapeutic protein products is considered risky for their significant effects on the quality of the medicine and the safety and health of the patient as it can induce adverse effects. Therefore, it is critical to identify the process that contributes to its formation and address the presence of particles in the development of therapeutic proteins.

From a formulation perspective, having profound knowledge of particle development mechanisms and identifying the causes and factors affecting particle formation is important. Knowing the factors that influence particle formation is advantageous to adopt control measures to mitigate risks... (More)
Protein aggregation is a high molecular weight protein content cluster. Their presence in finished therapeutic protein products is considered risky for their significant effects on the quality of the medicine and the safety and health of the patient as it can induce adverse effects. Therefore, it is critical to identify the process that contributes to its formation and address the presence of particles in the development of therapeutic proteins.

From a formulation perspective, having profound knowledge of particle development mechanisms and identifying the causes and factors affecting particle formation is important. Knowing the factors that influence particle formation is advantageous to adopt control measures to mitigate risks associated with particles beginning from the initial production steps, through storage life duration.

This project was done to investigate the effect of pump tubing, Silicone, and PVC tubing, used for transporting protein during the production process, tubing of a peristaltic pump, on protein particle formation for lipase protein using Silicone and PVC tubing, and characterize the particle formed. Moreover, investigate the effect of using different surfactants on the formation of the particles. The surfactants, a commonly used compound in bio-pharmaceutical formulations to prevent aggregation, used were Polysorbate 20, Poloxamer 188, and Sodium Dodecyl Sulfate (SDS) surfactant. This was done by using a QICPIC instrument for particle analysis and Silicone and PVC tubing for pumped Lipase.

The lipase samples with or without surfactant were pumped in through the tubing for thirty minutes and measurements were taken every minute. Particles were characterized using ferret diameter and Sphericity. The results were compared to see the effect of tubing type and surfactants.

The results obtained from this investigation showed that peristaltic pumps can induce protein aggregation which depends on the tubing type and the presence of the surfactant. It was seen that Silicone tubing in most 7 cases induced the highest number of aggregates and that most surfactants tested except for polysorbate 20, gave protection against aggregation. (Less)
Please use this url to cite or link to this publication:
author
Omer, Salah Elden LU
supervisor
organization
course
KLGM05 20231
year
type
H2 - Master's Degree (Two Years)
subject
keywords
Dynamic Image analysis, Protein aggregation, Peristaltic pump tubing, Particle characterization, PVC tubing, Silicone tubing, Surfactant, QICPIC, Pharmaceutical technology
language
English
id
9123628
date added to LUP
2023-06-13 16:05:40
date last changed
2023-06-13 16:05:40
@misc{9123628,
  abstract     = {{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.}},
  author       = {{Omer, Salah Elden}},
  language     = {{eng}},
  note         = {{Student Paper}},
  title        = {{Influence of Peristaltic Pump Tubes on Protein Particles Formation for Lipase Enzyme Therapeutic Protein}},
  year         = {{2023}},
}