GEN-MKT-18-7897-A
Jan 30, 2023 | Blogs, Development, Pharma, QA/QC | 0 comments
The pharmaceutical industry is facing an ongoing issue with genotoxic impurities (GTIs). Over the past year, we have witnessed genotoxic impurities affect several drugs, including those used to treat elevated blood pressure, heartburn and acid reflux. Angiotensin II receptor blockers (including valsartan, losartan and irbesartan), along with ranitidine and nizatidine, were recalled to investigate several potentially cancer-causing substances, called nitrosamines. The FDA knows this is an issue that has resulted in regulatory actions and loss of revenue for the manufacturers.
Amid this crisis, companies are realizing they need to address the wider issue of active pharmaceutical ingredient (APIs) quality for drugs currently on the market. Companies must concern themselves with the accurate identification, quantification, and monitoring of impurity levels. They must take a proactive approach to verify the quality of the product and the materials used in the manufacturing.
The regulators currently require this type of quality analysis for those products affected by the nitrosamine crisis. The requirement is not just for the GTIs, but also for the other products and processes in the manufacturer’s portfolio and pipeline. Both the FDA and European Medicines Agency have issued guidance for the impurity detection levels in the angiotensin II receptor blocker based on daily dosage, but the quantitative limit of detection will become even more challenging—going to 0.03 ppm by early 2021. The ability to reach that level of detection will require the highest levels of sensitivity, to help ensure that manufacturers can verify final products before they go to market.
You can learn more about how LC-MS/MS solutions can identify, quantify and monitor the required levels of nitrosamine impurities by accessing technical notes and a webinar addressing the characterization and quantification of the genotoxic impurities. Learn More >
This blog is part 1 of a 3-part series on nitrosamine analysis. Read part 2 (Are we proactively solving the nitrosamine crisis?) and part 3 (Developing a method for nitrosamine analysis in pharmaceutical products).
In a recent webinar, available on demand, scientists Luiza Chrojan and Ryan Hylands from Pharmaron, provided insights into the deployment of capillary gel electrophoresis (CGE) within cell and gene therapy. Luiza and Ryan shared purity data on plasmids used for adeno-associated virus (AAV) manufacturing and data on AAV genome integrity, viral protein (VP) purity and VP ratios using the BioPhase 8800 system.
Last year, Technology Networks hosted two webinars that featured groundbreaking research utilizing SWATH DIA (data-independent acquisition) for exposomics and metabolomics. Researchers Dr. Vinicius Verri Hernandes from the University of Vienna and Dr. Cristina Balcells from Imperial College London (ICL) demonstrated how a DIA approach can be successfully implemented in small molecule analysis using the ZenoTOF 7600 system. Their innovative approaches highlight the potential of SWATH DIA to enhance the detection and analysis of chemical exposures and metabolites, paving the way for new insights into environmental health and disease mechanisms.
For as long as PFAS persist in the environment, there is no doubt they will persist in our conversations as environmental scientists. Globally, PFAS contamination has been detected in water supplies, soil and even in the blood of people and wildlife. Different countries are at various stages of addressing PFAS contamination and many governments have set regulatory limits and are working on assessing the extent of contamination, cleaning up affected sites and researching safer alternatives.
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