Enhancing Biologics with CESI-MS Characterization by SCIEX Community | May 18, 2020 | Biopharma, BlogsComprehensive characterization of a biologic requires analysis at both the intact and digest levels, but these analyses can be complex and cumbersome. For example, with conventional liquid chromatography separations, researchers are often left with limited information...
Are we proactively solving the nitrosamine crisis? by Neil Walsh | May 8, 2020 | Blogs, Development, Pharma, QA/QCIn my previous blog, I spoke about the FDA recall of angiotensin II receptor blockers like losartan. This recall was due to the presence of genotoxic nitrosamines. Is a proactive approach the way to mitigate risk? Recently, the FDA has re-issued the 2018 guidance to...
Full, partial and empty capsid ratios for AAV analysis: What’s the big deal? by SCIEX Community | May 7, 2020 | Biopharma, Blogs, PharmaFor many of you working to develop gene therapy drugs, you know that the time to market the drug is critical. Because gene therapeutics cure diseases by targeting specific genes, it is a constant race to see who develops the drug first. Unlike other classes of drugs...