Newsletter | August 4, 2022

08.04.22 -- FDA, EMA Accept MS Biosimilar Applications

 
New Podcast Episode
Featured Editorial
Industry Insights
Is Your Biologic At Risk For Protein Aggregation? Part 1

This is the first installment in a three-part series that examines the causes of protein aggregation and practical steps you can take to mitigate the risk.

Container Closure Integrity: A Risk-Based Approach

Container closure integrity is essential to protecting drug product and satisfying regulatory agencies. A risk-based approach enables creation of a robust data file for timely approval of regulatory applications.

Technology Transfers: A Beginner's Guide

You may have questions or knowledge gaps regarding technology transfers. To help your understanding, we’ve compiled a beginner’s guide to technology transfer fundamentals.

Converting From ELISA To Biacore SPR Assays

This article provides general guidance on how to convert an existing ELISA assay to a Biacore SPR assay and, by doing so, shows how you can get results in less than half the time compared with ELISA.

Developing Biosimilars: Challenges And Solutions

Biophysical characterization requires technologies that often require expensive reagents, large quantities of samples, and experimental conditions optimization. Simplified analytical workflows can help.

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