Correlating Differences in the Surface Activity to Interface-Induced Particle Formation in Different Protein Modalities: IgG mAb Versus Fc-Fusion Protein.

The propensity of protein-based biologics to form protein particles during bioprocessing can be related to their interfacial properties. In this study, we compare the surface activity and interfacial film properties of two structurally different biologics, an IgG and Fc-fusion, in the absence and presence of interfacial dilatational stresses, and correlate these differences to their tendency to form interface-induced protein particles. Our results show that interface-induced particle formation is protein-dependent, with the Fc-fusion demonstrating greater interfacial stability.

Understanding the Impact of Combined Hydrodynamic Shear and Interfacial Dilatational Stress, on Interface-Mediated Particle Formation for Monoclonal Antibody Formulations.

During biomanufacturing, several unit operations expose solutions of biologics to multiple stresses, such as hydrodynamic shear forces due to fluid flow and interfacial dilatational stresses due to mechanical agitation or bubble collapse. When these stresses individually act on proteins adsorbed to interfaces, it results in an increase in protein particles in the bulk solution, a phenomenon referred to as interface-induced protein particle formation. However, an understanding of the dominant cause, when multiple stresses are acting simultaneously or sequentially, on interface-induced protein particle formation is limited.

Telehealth Virtual Simulation Across the Family Nurse Practitioner Curriculum.

The American Association of Colleges of Nursing recognizes telehealth education as an essential aspect of nurse practitioner (NP) education because it increases accessibility to health care. Studies reported in the literature have focused on NP telehealth simulation, but findings for the inclusion of simulation in multiple courses throughout the curriculum are scarce. This pre- and post-survey design study aimed to evaluate family nurse practitioner students' perceptions of knowledge, confidence, and attitudes regarding telehealth before and after engaging in telehealth virtual simulations in six courses.

Correlating Surface Activity with Interface-Induced Aggregation in a High-Concentration mAb Solution.

Interface-induced aggregation resulting in protein particle formation is an issue during the manufacturing and storage of protein-based therapeutics. High-concentration formulations of therapeutic proteins are even more prone to protein particle formation due to increased protein-protein interactions. However, the dependence of interface-induced protein particle formation on bulk protein concentration is not understood.

Comparison of Protein Particle Formation in IgG1 mAbs Formulated with PS20 Vs. PS80 When Subjected to Interfacial Dilatational Stress.

Polysorbates (PS) are nonionic surfactants that are commonly included in protein formulations to mitigate the formation of interfacial stress-induced protein particles and thus increase their long-term storage stability. Nonetheless, factors that dictate the efficiency of different polysorbates in mitigating protein particle formation, especially during the application of interfacial stresses, are often ill defined. Here, we used a Langmuir trough to determine the surface activity of two IgG1 monoclonal antibodies formulated with two different polysorbates (PS20 and PS80) when subjected to interfacial dilatational stress.