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.
For more than 20 years, the CDCO has supported academic, commercial, and not‑for‑profit drug discovery programs with deep expertise in pharmaceutical lead optimization. Within the bioanalytical group, their role is to enable rapid and reliable decision‑making through quantitative analysis of candidate drugs in biological matrices.
PFAS are increasingly at the center of regulatory change, scientific research, and industry discussion worldwide. As analytical capabilities improve and expectations around environmental responsibility continue to evolve, understanding the role PFAS play, and how they are being addressed, has never been more important. This blog provides an overview of what PFAS are, why they matter, and how responses from regulators and industry are changing.
Pesticides are widely used in agriculture to protect crops and maintain yield, but their presence in food must be carefully monitored. To safeguard consumers, regulatory authorities worldwide set maximum residue limits (MRLs), often at very low concentrations and across a wide range of compound classes.
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