Search results for " mass spectrometry"
Article
Tackling Analytical Method Development for ADCs
In general, Jacobson notes that most modern chromatographic, electrophoretic, and spectroscopic (ultraviolet-visible [UV-vis] and mass spectrometry [MS]) methods have proven adequate to the task.
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Article
Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing Containers
Quantification of TBPP, oxidized TBPP, and bDtBPP was performed with ultrahigh-performance liquid chromatography (UHPLC) with Exactive Orbitrap high-resolution accurate mass mass spectrometry (HRAM MS…
Article
Predicting Progress in Protein Aggregation
In silico analysis and the evaluation of formulability, aided by new analytical tools such as hydrogen deuterium exchange mass spectrometry (HDX MS), are enabling the improved design, production, and …
Article
Virus-like Particles as Therapeutic Moieties of the Future
Analytical and functional characterization of virus-like particles enables process reproducibility and product consistency.
By Ramesh Kumar, Manidipa Banerjee, Anurag S. Rathore
Virus-like…
Article
N-Glycan Analysis of Biotherapeutic Proteins
This article summarizes the approaches, challenges, and future perspectives for the characterization of N-glycans in biopharmaceutical products.
By Aled Jones
Protein glycosylation, the addi…
Article
Being Thorough When Transferring Technology
Detection of residual cytotoxin at the PPB level on the surface of manufacturing equipment requires expertise in the development and execution of ELISA or tandem mass spectrometry (MS/MS)-based analyt…
Article
Evaluating E&L Studies for Single-Use Systems
Extraction studies demonstrate approaches for evaluating single-use bio-pharmaceutical manufacturing materials.
By Irene Cecchini, Daniele Mastroianni, Silvia Rocchi, Gabriella Angiuoni
Biop…
Article
Host-Cell Protein Measurement and Control
Other technologies, such as 2D-differential in-gel electrophoresis (DIGE), capillary zone electrophoresis-electrospray ionization-tandem mass spectrometry (CZE-ESI-MS/MS) or two-dimensional-liquid chr…
Article
The Importance of Process Intensification and PAT for Achieving Real-Time Release
Creativity and collaboration are required to overcome complex method development challenges.
By Kelvin H. Lee and Mark Lies
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Article
Reimagining Affordable Biosimilars
…ced analytical tools to measure primary, secondary, and tertiary structures (such as mass cytometry, mass spectrometry [MS], cryo-electron microscopy) and computational tools (9,10), there is a need …