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Correlating Differences in the Surface Activity to Interface-Induced Particle Formation in Different Protein
Valerie P Griffin1, Estephanie L N Escobar1, Maria O Ogunyankin2
1Department of Chemical and Petroleum Engineering, The University of Kansas, 1530 W 15th Street, Lawrence, Kansas 66045, United States.
Molecular Pharmaceutics
|October 7, 2024
Summary
Protein particle formation during bioprocessing depends on protein properties and interfacial stress. Polysorbate 80 effectively prevents particle formation for IgG by maintaining a surfactant-dominant interface, but may be less suitable for Fc-fusion proteins.
Area of Science:
- Biopharmaceutical Manufacturing
- Protein Chemistry
- Surface Science
Background:
- Protein-based biologics can form particles at interfaces during bioprocessing.
- Interfacial properties significantly influence protein particle formation.
- Understanding these properties is crucial for stable biologic formulations.
Purpose of the Study:
- To compare interfacial properties of IgG and Fc-fusion biologics.
- To correlate interfacial behavior with interface-induced particle formation.
- To evaluate the efficacy of polysorbate 80 (PS80) in mitigating particle formation.
Main Methods:
- Surface activity and interfacial film properties were measured.
- Interfacial dilatational stresses were applied.
- Protein adsorption kinetics and film compressibility were analyzed.
- Particle formation was monitored using image analysis.
Main Results:
- Interface-induced particle formation is protein-dependent; Fc-fusion showed greater stability.
- Fc-fusion exhibited faster adsorption and formed a less incompressible film.
- PS80 created a surfactant-dominant interface for IgG, mitigating particle formation.
- PS80 was less effective for Fc-fusion, suggesting modality-specific surfactant needs.
Conclusions:
- Interfacial stability and film properties dictate protein particle formation.
- A surfactant-dominant interface is key to preventing interface-induced particles.
- The effectiveness of PS80 is protein-specific, highlighting the need for tailored formulation strategies for different biologics like IgG and Fc-fusion proteins.
