Compared to chemical drug production, the production process for protein-based therapeutics is intricate and variable, with a higher risk of product degradation and contamination. The final product is fragile and can be affected by factors like temperature, storage duration, denaturants, solvents, oxygen, and pH changes. As a result, protein biologics require strict controls in manufacturing, transport and storage.
An array of analytical approaches and workflows facilitate comprehensive characterization, allowing for full product understanding which can save significant time and development costs. Throughout process development and manufacturing, these analytical tools are required for reliable monitoring of product microheterogeneity ensuring drug safety and efficacy.
This eBook will provide a comprehensive explanation of the different workflows specifically designed for protein analysis, highlighting the benefits that each workflow offers.
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