Nitrosamine impurities in Sartan drug products by GC-MS/MS

Organic solvent, pH, salt concentration, and gradient mixing rates influence HIC separations. Optimizing these factors allows for effective separation of mAbs and ADCs.

Analytical scientists are faced with the task of finding the right column from an almost unmanageable range of products. This paper focuses on columns that enable protein analysis under native conditions through size exclusion, hydrophobic interaction, and ion exchange chromatography. It will highlight the different column characteristics—pore size, particle size, base matrices, column dimensions, ligands—and which questions will help decide which columns to use.

Not all chromatography resins are created equal. Off-the-shelf chromatography resins might not always meet the rigorous purification requirements of biopharmaceutical manufacturing. Custom bonded silica from Grace can address a wide range of separation challenges, leading to real performance improvements. Discover more about the latest innovations in chromatography silica from Grace, including VYDAC® and DAVISIL®.

Particularly in the pharmaceutical industry, drug purity isn’t just a goal – it’s essential for achieving safety, stability and efficacy. However, purification is easier said than done, especially with challenging molecules like DNA and RNA “oligonucleotides,” due in large part to their diversity and the range of impurities that can be generated during production. Enter DAVISIL® chromatographic silica, with a wide range of pore diameters and particle sizes to meet your specific application, performance and sustainability requirements. Before you choose the chromatography resin for your next purification application, take a look at these 5 considerations.

Recent advancements in automated protein purification stress the importance of efficiency, scalability, and yield consistency. This eBook compares different purification platforms, highlighting their impact on downstream applications and demonstrating how automation enhances throughput and process control.