Addressing Complexities in Biopharmaceutical Analysis
This eBook discusses various topics about the complexities of biopharmaceutical analysis, including:
- Impurity Testing of Biologic Drug Products - Experts share insights on the various methods used for purity and impurity analysis of therapeutic proteins.
- Expectations for Residual Impurity Analysis Continue to Rise - More complex biologic samples must be evaluated to ever higher levels of specificity and sensitivity.
- 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.
- Laboratory Water Preparation - Optimized - Why process analytical matters to process development R&D.
- 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.