GEN-MKT-18-7897-A
Oct 10, 2016 | Biopharma, Blogs | 0 comments
By the End of 2024, the peptide therapeutics market value is expected to reach US$46.6 billion1. However, peptide therapeutics present some of the toughest analytical challenges for bioanalytical quantification. Large molecule therapeutics often may not fragment well for MS/MS analysis and often the case upon digestion in a complex biologic matrix this leads to an even higher background and potential for interferences.
To keep up with the pace of developmental therapies, Novartis Pharmaceuticals, along with SCIEX application specialists, recently developed a validated method to quantify pasireotide, a therapeutic peptide used to treat Cushing’s disease, in human plasma samples. The complete article was published in Analytical Chemistry and highlights how SelexION Technology on a QTRAP system can be used to increase selectivity for the accurate and sensitive quantitation of the difficult peptide therapeutic. To summarize the article, pasireotide, a therapeutic cyclic peptide exhibits poor fragmentation efficiency for multiple reaction monitoring (MRM) detections. Therefore, to increase the overall sensitivity of the assay, a DMS multiple ion monitoring (MIM) approach was explored. This method, utilizing the SelexION DMS cell on a QTRAP 6500, overcomes the sensitivity challenge in the typical MRM method due to the poor fragmentation of the analyte. What is great about this is the Pasireotide Method was developed and validated for bioanalytical analysis in human plasma down to 0.01 ng/mL, approximately 5-fold better than an MRM based method without using DMS separation – talk about improvements!
Over the past few years, researchers have needed to overcome the challenges associated with peptide bioanalysis in order to keep up with market demands. One way to do this according to Evgueni Fedorov, Executive Director, R&D, BIOTRIAL Bioanalytical ServicesOne, is to increase separation power. This was demonstrated in his webinar with SCIEX, where he showed how SelexION DMS technology on a QTRAP system can be used to enhance the selectivity of another challenging large therapeutic peptide, exenatide.
The Take-Away
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Regulated laboratories are evolving faster than ever. New analytical modalities, higher sample throughput, increasing regulatory scrutiny, and leaner teams are reshaping how work gets done. At the same time, expectations for data integrity, standardization, and operational efficiency continue to increase complexity and/or scope. In this environment, LC-MS software is no longer simply an instrument control platform—it has become a critical part of a laboratory’s quality management system. The question is no longer whether your lab has changed, but whether your software has evolved to support the way regulated labs operate today, and if they are ready and able to meet the demands, they will face tomorrow.
Analyst software has long been a trusted foundation in regulated LC-MS laboratories—and for many, it still performs reliably today. But regulated environments are evolving faster than ever. As labs transition to Windows 11, strengthen cybersecurity policies, modernize IT infrastructure, and prepare for future compliance expectations, software decisions are no longer just about what works today—they’re about managing tomorrow’s risk. Analyst will not be supported on Windows 11. While some labs may continue operating in unsupported environments temporarily, the bigger question is: when that risk becomes reality, will your lab be reacting under pressure—or executing a planned mitigation strategy with confidence?
As regulatory scrutiny increases and detection requirements tighten, laboratories are facing a new question: How can TFA be measured reliably, sensitively, and at scale?
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