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Article An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
Viral testing/detection level As the name indicates, the main purpose of this level is to detect adventitious viruses. Early detection is essential in order to deploy an adequate respo…

Article Changing the Culture of Cell Culture: Applying Best Practices and Authentication to Ensure Scientific Reproducibility
By Leonard P. Freedman, Mark C. Gibson, Richard M. Neve Irreproducible preclinical research is a global, expensive, and well-recognized problem that contributes to delays and increased costs of …

Article Continuous Chromatography: Trends, Definitions and Approaches
As this movement is seen periodically, one could argue that the name Periodic Counter Current (PCC) is the most appropriate to describe what is really happening in a multicolumn system. However, for t…

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Article Moving Biosimilars Forward in a Hesitant Market
“Pricing pressure can come from lower priced, brand name biologics when they come off patent, it can come from competing biosimilars, but that’s the market. It’s not exactly like the generics market, …

Article BetaLife Wins Cytiva's First BioChallenge Competition in Southeast Asia
BetaLife was named as the winner of the first BioChallenge in Southeast Asia on May 19, 2023. Read full article

Article Reimagining Affordable Biosimilars
It is a resourceful tool at different stages of biosimilar development, namely, clone selection (e.g., clonal proteome variations, product confirmation, sequence, glycosylation, residue modifications)…

Article Emerging Therapies Test Existing Bioanalytical Methods
This leaves investigators asking questions about how to demonstrate the key bioanalytical attributes specified in the guidance, namely demonstrating that the method measures the intended analyte, eval…

Article Advances in Engineering of Protein-Based APIs
But to effectively combat disease, many future drugs will require multiple proteins being agonized or antagonized to achieve efficacy, namely in the immune-oncology and inflammation space,” Stevens ex…

Article Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
The result was a new web utility named GlycanAnalyzer, developed in a collaboration between New England Biolabs and the Bioprocessing Technology Institute (A*STAR, Singapore). The program automates an…

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