An Automated Tool for Glycosimilarity Assessment of mAb Therapeutic Biosimilars: Trastuzumab and Bevacizumab as Case Studies

BioDrugs, Год журнала: 2025, Номер unknown

Опубликована: Янв. 28, 2025

Язык: Английский

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Advancements in Electrochemical Biosensors for Comprehensive Glycosylation Assessment of Biotherapeutics

Sensors, Год журнала: 2025, Номер 25(7), С. 2064 - 2064

Опубликована: Март 26, 2025

Proteins represent a significant portion of the global therapeutics market, surpassing hundreds billions dollars annually. Among various post-translational modifications, glycosylation plays crucial role in influencing protein structure, stability, and function. This modification is especially important biotherapeutics, where precise characterization glycans vital for ensuring product efficacy safety. Although mass spectrometry-based techniques have become essential tools glycomic analysis due to their high sensitivity resolution, complexity lengthy processing times limit practical application. In contrast, electrochemical methods provide rapid, cost-effective, sensitive alternative assessment, enabling real-time glycan structures on biotherapeutic proteins. These techniques, often used conjunction with complementary methods, offer valuable insights into profiles both isolated glycoproteins intact cells. review examines latest advancements biosensors analysis, highlighting potential enhancing biotherapeutics advancing field precision medicine.

Язык: Английский

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Leveraging bioanalytical characterization of fractionated monoclonal antibody pools to identify aggregation‐prone and less filterable proteoforms during virus filtration

Biotechnology Progress, Год журнала: 2024, Номер 40(4)

Опубликована: Март 7, 2024

Abstract Monoclonal antibodies (mAbs) are an essential class of biotherapeutics. A platform process is used for mAb development to ensure clinically safe and stable molecules. Regulatory authorities that production processes include sufficient viral clearance steps achieve less than one virus particle per million doses product. Virus filtration size‐based removal enveloped nonenveloped viruses during downstream processing mAbs. Process in purification relies on empirical approaches often includes adsorptive prefiltration mitigate filter fouling. Opportunities molecular‐level prediction filterability needed plug the existing knowledge gap processing. approach understanding factors influencing may reduce time, material loss, costs due oversized filters. In this work, pH step gradient fractionation was applied polished bulk feed obtain concentrated pools fractionated variants. Biophysical properties quality attributes pools, including oligomeric state (size), isoelectric point profile, diffusion interaction parameters, glycoform were determined using bioanalytical methods. Filterability (loading throughput) evaluated. Statistical methods correlations between fractions Viresolve Pro filter.

Язык: Английский

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Machine learning tool as an enabler for rapid quantification of monoclonal antibodies N-glycans using fluorescence detection

International Journal of Biological Macromolecules, Год журнала: 2024, Номер 271, С. 132694 - 132694

Опубликована: Май 28, 2024

Язык: Английский

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