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Infographic: Simplifying the Screening Workflow for Extractables Testing

Reading Time: 3 minutes

How to design an analytical workflow to screen for extractables and leachables The safety of pharmaceuticals, cosmetics, and foodstuffs may be compromised by chemical compounds in the various types of packaging and food contact materials (FCMs) that are in direct contact with the consumer product. Due to continuously increasing global regulations, the characterization of extractables...

Analytical Tools for Developing Biosimilars: Part 3, Glycosylation, Aggregation, and Charge Variants

Reading Time: 8 minutes

In biotherapeutics, the state of glycosylation has a direct and pronounced effect of the structure, stability, serum half-life, immunogeneicity and bioactivity of the molecule, and constitutes a critical quality attribute (CQA). In our study, characterizing and comparing the glycosylation profile of infliximab began by examining the glycosylation profiles from intact and reduced subunit mass data.

How Analytical Technologies Support the Development of Biosimilar Drugs

Reading Time: 10 minutes

Advancements in High-Resolution Analytics for the Characterization of Innovator and Biosimilar Therapeutics As the pharmaceutical industry continues to evolve its focus from small-molecule drugs to balanced product portfolios that include protein therapeutics, analytical chemists are increasingly challenged to produce routine and automated characterization workflows that move innovator and biosimilar biopharmaceutical products forward through development and...