Addressing Complexities in Biopharmaceutical Analysis

This eBook discusses various topics about the complexities of biopharmaceutical analysis, including: 

  1. Impurity Testing of Biologic Drug Products - Experts share insights on the various methods used for purity and impurity analysis of therapeutic proteins.
  2. Expectations for Residual Impurity Analysis Continue to Rise - More complex biologic samples must be evaluated to ever higher levels of specificity and sensitivity.
  3. Ensuring Viral Safety of Viral Vaccines and Vectors - Viral vaccines and viral vectors used in biotherapeutic applications carry the risk of microbial contamination, which must be addressed.
  4. Laboratory Water Preparation - Optimized - Why process analytical matters to process development R&D.
  5. Ultrapure Water for Trace Analysis - The purity of the solvents used, primarily that of water, is a decisive criterion for interference-free and reproducible analysis by liquid chromatography.

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