Machine learning approaches to root cause analysis, characterization, and monitoring of subvisible particles in monoclonal antibody formulations
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DOI: 10.1002/bit.28239
Abstract: Processing stresses on therapeutic proteins may cause formation of subvisible particles. Different stress mechanisms generate particle populations with characteristic morphological “fingerprints,” and machine learning techniques like convolutional neural networks (CNNs) allow classification of microscopy images… read more here.
Keywords: root cause; machine learning; cause; analysis ... See more keywords
Collaborative Study for Analysis of Subvisible Particles Using Flow Imaging and Light Obscuration: Experiences in Japanese Biopharmaceutical Consortium.
Sign Up to like & getrecommendations! Published in 2019 at "Journal of pharmaceutical sciences"
DOI: 10.1016/j.xphs.2018.08.006
Abstract: The evaluation of subvisible particles, including protein aggregates, in therapeutic protein products has been of great interest for both pharmaceutical manufacturers and regulatory agencies. To date, the flow imaging (FI) method has emerged as a… read more here.
Keywords: biopharmaceutical consortium; flow imaging; light obscuration; collaborative study ... See more keywords
Optimization of Infrared Microscopy to Assess Secondary Structure of Insulin Molecules Within Individual Subvisible Particles in Aqueous Formulations.
Sign Up to like & getrecommendations! Published in 2019 at "Journal of pharmaceutical sciences"
DOI: 10.1016/j.xphs.2018.10.028
Abstract: The analysis of subvisible particles is currently challenging but pivotal to the understanding and control of the quality of protein therapeutics. While a range of characterization methods is available for subvisible particles, information on the… read more here.
Keywords: protein; microscopy; secondary structure; subvisible particles ... See more keywords
Subvisible particles derived by dropping stress enhance anti-PEG antibody production and clearance of PEGylated proteins in mice.
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DOI: 10.1016/j.xphs.2022.01.023
Abstract: Bioconjugation with polyethylene glycol (PEG) is important for protein drug development as it has improved biological stability. In contrast, proteins including PEGylated ones are susceptible to physicochemical stresses. Particularly, protein drugs in solution may form… read more here.
Keywords: peg ova; dropping stress; subvisible particles; antibody production ... See more keywords
Comparative analysis of marketed factor VIII products: recombinant products are not alike vis‐a‐vis soluble protein aggregates and subvisible particles
Sign Up to like & getrecommendations! Published in 2018 at "Journal of Thrombosis and Haemostasis"
DOI: 10.1111/jth.14125
Abstract: Essentials Aggregation is a critical quality attribute of protein therapeutics influencing immunogenicity. Aggregates and subvisible particles in 9 recombinant factor VIII (rFVIII) products were analyzed. Major differences in aggregate and particle concentrations were detected after… read more here.
Keywords: subvisible particles; aggregates subvisible; factor viii; protein ... See more keywords