GEN-MKT-18-7897-A
Feb 29, 2016 | Biopharma, Blogs | 0 comments
Traditionally, the pharmacokinetic profile of biotherapeutics such as insulin glargine, adalimumab, trastuzumab and others, used gold standard LBAs to assess dose-response during drug discovery and development. However, LBAs require a specific antibody reagent to be developed for each mAb variant, a process that is often incompatible with the compressed timeframes encountered during the initial stages of drug development. More recently, LC-MS/MS-based methods have come to the forefront as a feasible approach for the quantification of biotherapeutics in biological matrices, with many of these methods relying on proteolytic digestion of the target mAb and quantification of multiple unique signature peptides, which are equivalent to levels of the whole protein. But, to drive the real biological need, we have to quantify the pharmacologically active or free form of the drug to assess safety, efficacy and proper dosing regimen. Here we present a solution to get the best of both technologies: an LBA strategy to capture the active form of the drug; and an LC-MS assay to selectively quantify the free and circulating drug.
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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