eBooK: Addressing Complexities in Biopharmaceutical Analysis

 Last updated: April 2019


This eBook is a vital resource for biopharmaceutical professionals focused on the rigorous analysis of biologic drug products. Sponsored by Sartorius and in partnership with BioPharm International, the eBook offers expert insights into the challenges of impurity testing and the significance of ultrapure water in ensuring accurate results. Industry leaders share their knowledge on advanced methods like mass spectrometry, emphasizing the need for precision in detecting impurities at trace levels.

This concise guide also explores the stringent regulatory standards for viral safety in vaccines and vectors, and the critical role of high-quality laboratory water. Essential for researchers and quality control specialists, this eBook equips readers with the latest strategies to maintain the integrity and efficacy of biopharmaceuticals, making it an indispensable tool for maintaining excellence in biopharmaceutical analysis.

  • Document type: eBook
  • Page count: 45
  • Read time: 58 minutes

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Key Takeaways

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.

This Resource is Designed for:

  • Biopharmaceutical researchers and scientists involved in drug development and analysis
  • Quality control and assurance professionals in the biopharmaceutical industry
  • Regulatory affairs specialists focusing on compliance with industry standards
  • Laboratory technicians working on biologic drug product testing and characterization

Applications Supported:

  • Analytical methods including HPLC, IC, and ICP–MS
  • Life science methods such as DNA analysis and cell culture
  • Buffer and media preparation, reagents, and blanks for laboratory applications
  • Critical applications requiring ultrapure water, like molecular applications

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