Search results for " techniques"
Article
Tackling Analytical Method Development for ADCs
Expertise in both chemical and biological analysis is required, and techniques for both types of molecules must be used. In addition to performing typical characterization studies, the linker chemistr…
Article
Elucidating Biosimilars Characterization
Glycans are traditionally analyzed using either liquid-phase separation techniques such as liquid chromatography or capillary electrophoresis with optical or fluorescence detection or mass spectrometr…
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Nurturing Knowledge from Disparate Data Streams
For many of these techniques, however, the inevitable evolution from paper-based data collection procedures to electronic systems has not been without difficulties. “It may be argued, for example, tha…
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Impurity Testing of Biologic Drug Products
Physicochemical methods can be largely based on compendial procedures and require little development, and parameters for platform techniques such as size-exclusion high-performance liquid chromatograp…
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Downstream Processing for Cell-Based Therapies
Equally, DSP techniques adapted from protein production for CGTs have the capacity to handle the scales required for allogeneic therapies but are hindered by the lack of specificity and sensitivity to…
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Defining Risk Assessment of Aseptic Processes
Schniepp
Q: I work in the quality group for a manufacturer who makes intravenous (IV) injectable drugs using aseptic processing techniques. Recently, the facility has experienced an increase in the…
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Implications of Cell Culture Conditions on Protein Glycosylation
Richard Easton
This article reviews the implications of cell-culture conditions on biologic product quality, focusing on glycosylation and analytical techniques for its accurate assessment. Glyco…
Article
Genetic Vaccine Platforms Demonstrate Their Potential
Subsequent engineered viral production is performed using well-established manufacturing techniques.
As an example, Christy notes that Moderna went from sequence selection to ship…
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Virus-like Particles as Therapeutic Moieties of the Future
The structural characteristics of VLPs can be mapped by various techniques including transmission electron microscopy, cryo-EM, atomic force microscopy (AFM), and x-ray crystallography, the latter bei…
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Reimagining Affordable Biosimilars
Multi-attribute methodology (MAM), liquid chromatography (LC), and capillary electrophoresis coupling techniques allow simultaneous measurement of multiple product and process impurities in an automat…