Search results for "analytical"
Article
Using Multiple Techniques in Biosimilar Analysis
Whether they are called ‘sameness’ for generic drugs, ‘comparability’ for biologics, or ‘analytical similarity’ for biosimilars, these tests are crucial for any regulatory submission, which is vital t…
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Leveraging Data for Better Biopharmaceutical Process Control
For many years, though, extending this approach into true process analytical technology (PAT) and using it to track and control processes was done mainly in the research lab.
Recently, there ha…
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N-Glycan Analysis of Biotherapeutic Proteins
The complex, branched structure of N-glycans present a unique analytical challenge. A variety of approaches exist, each with their own advantages and limitations. In this article, the biological effec…
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Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
Those technologies include more productive cell lines, single use, and powerful analytical methods.
The problem of copying biologics
Biologic drugs have revolutionized the pharmaceutical indus…
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Biosimilars: Making the Switch Comes with Challenges
EMA stresses on analytical data
EMA has been shifting to a policy of giving greater importance to analytical data at the production and preclinical stages when assessing applications for biosimila…
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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…
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Detecting Protein Aggregates and Evaluating their Immunogenicity
The very nature of aggregation is challenging, says St John Skilton, senior global market manager of biologics at SCIEX, a life-science analytical technologies company. The fact that aggregation is “d…
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High-Throughput Process Development in an Historical Environment
The Q&A session was intense and the panel concluded that data management and analytical support are still remaining challenges. The requirement of having a critical mass of robotic users – at differen…
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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 …
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A Closer Look at Affinity Ligands
Affinity ligands play an exciting role in the ever-growing sphere of downstream processing. In speaking with BioPharm International®, Phillip Elliott, PhD, associate director of Process Development,…