Search results for "analytical" in Articles / App Notes
Article
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…
Article
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…
Article
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…
Article
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 …
Article
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,…
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Report from the 6th International HTPD Conference
Many of the challenges are the same with analytical technologies and data handling. However, when working in a cGMP environment, these challenges become even more important to tackle.
Analytics…
Article
Maximum Output Starts with Optimized Upstream Processing
Developing and scaling up manufacturing operations and analytical testing capabilities are, however, requiring major innovation and the courage to move away from conventional constructs, asserts Botto…