ICP-MS and ICP-OES: Tools for Elemental Impurity Analysis
Elemental impurity testing is essential to deliver safe drug products to patients and is a regulatory requirement. It is important to assess the risk of elemental impurities from all sources in the manufacturing process, including process equipment, water, container/packaging, raw materials, drug substances, and the final drug product.
New Strategies for a Better Glycosylation Profile
January 22nd 2025Glycan analysis provides key information on critical quality attributes that could affect stability, safety and efficacy of a protein therapeutic. Specific needs for understanding the glycosylation profiles change throughout the drug development process, but the requirement for high-resolution glycan information remains the same and is essential to help ensure product quality.
