Particles in Biopharmaceutical Formulations, Part 2: An Update on Analytical Techniques and Applications for Therapeutic Proteins, Viruses, Vaccines and Cells
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Miniaturized Forced Degradation of Therapeutic Proteins and ADCs by Agitation-Induced Aggregation using Orbital Shaking of Microplates
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Analysis of Aggregates and Particles
Cheng Y, Saggu M, and Thomas JC, Protein Instability at Interfaces During Drug Product Development, 2021 Feb, pp 199-266
Surfactant Impact on Interfacial Protein Aggregation and Utilization of Surface Tension To Predict Surfactant Requirements for Biological Formulations
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Developability Assessment for Monoclonal Antibody Drug Candidates: A Case Study
Garripelli VK, et al., Pharm Dev Technol, 2021 Jan, 26(1):11-20
A Rapid, Small-Volume Approach To Evaluate Protein Aggregation at Air-Water Interfaces
Wood CV, et al., J Pharm Sci, 2020 Nov, doi: 10.1016/j.xphs.2020.11.024
A Comparison of Background Membrane Imaging Versus Flow Technologies for Subvisible Particle Analysis of Biologics
Vargas SK, et al, Int J Pharm, 2020 Mar, 578:119072
Backgrounded Membrane Imaging (BMI) for High-Throughput Characterization of Subvisible Particles During Biopharmaceutical Drug Product Development
Helbig C, et al., J Pharm Sci, 2020 Jan, 109(1):264-276
What Makes Polysorbate Functional? Impact of Polysorbate 80 Grade and Quality on IgG Stability During Mechanical Stress
Grabarek AD, et al., J Pharm Sci, 2020 Jan, 109(1):871-880