YOUR REFERENCE GUIDE TO THE ANALYSIS OF BIOPHARMACEUTICALS AND BIOMOLECULES
Biotherapeutics have enormous potential to improve human health. The number of approved
protein and antibody therapeutics continues to grow around the world as this important
therapeutic class addresses unmet medical needs. But discovery and development of
biopharmaceuticals is difficult. You face a variety of challenges and must not only stay abreast of
advances in knowledge and improvements in technology, but also navigate the maze of shifting
government regulations. Making good decisions fast is critical. At every stage in the process,
from disease research to QA/QC and manufacturing, Agilent can help you make the right
choices for moving therapeutics successfully to market. And it’s not just because we build
reliable instruments and consumables that provide accurate, reproducible results. We
understand the biopharmaceutical workflow and provide families of products that work
together seamlessly – as engines of research, discovery, and development – to move
candidate biopharmaceuticals forward.
Given that protein biopharmaceuticals are very heterogeneous, they will require a number of
chromatographic methods to accurately characterize the active pharmaceutical ingredient (API).
Methods include size exclusion chromatography for the quantitation of dimers and aggregates,
and ion-exchange chromatography for charge variant analysis. As part of the full characterization,
it will be necessary to look at primary amino acid sequence and any post-translational
modification to the sequence that may occur during purification or formulation steps. To enable
complete, reproducible, and high-quality analysis for key characterization workflows, Agilent
provides a broad range of columns and supplies.
This comprehensive guide will help you find the right column for your characterization workflow.
We have also included advice and tips on method development, solvent choice, mobile phase
modification, optimization, and many example separations, all to assist you in column selection
and method development.
Agilent has complete solutions for your needs. These include the Agilent 1260 Infinity Bio-inert
Quaternary LC with a metal-free sample path and the Agilent 1290 Infinity LC, designed to
provide highest speed, resolution, and ultra-sensitivity for UHPLC applications, including those
using Agilent wide-pore ZORBAX 300Å StableBond columns. Biomolecules may be complex in
structure, but their analysis is simplified by using Agilent HPLC columns, systems, and supplies
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