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The Power Behind LC-MS for Quantifying mAb Therapeutics

Apr 19, 2017 | Biopharma, Blogs | 0 comments

Quantitation of monoclonal antibodies (mAbs) in biological fluids is important during all stages of antibody drug development. First developed in the 1970s, therapeutic mAbs have both research and medicinal impact as they can be used for diagnosis and treatment of a wide variety of diseases, and have a high level of specificity.

Taking upwards of 10 years to bring a therapeutic mAb to market, discovering effective, high-throughput analysis methods is prudent for pharmaceutical companies to help bring these new therapies to market.

Although traditional immunoassays are typically used for biotherapeutic bioanalysis, more recently LC-MS is adopted because of its high selectivity, accuracy, and precision. In this technote, “Improving Sensitivity for an Immunocapture LC-MS Assay of Infliximab in Rat Plasma Using Trap-and-Elute MicroLC-MS,” researchers present results of samples prepared using a generic anti-human IgG immunocapture workflow.

In this method, researchers used the selective extraction of human IgG antibodies from rat plasma and then compared the use of  High Flow LC-MS and Trap-Elute MicroLC-MS methodologies.

Discover how the trap-elute method ensures similar throughput to the conventional high-flow LC-MS workflow, while injecting the same 20 µL of sample, but offers enhanced protection of the MicroLC column and the MS from contamination, thus providing a more robust method.

The utilization of a trap-elute MicroLC-MS method provides a solution for applications where mAbs need to be quantified in small volume samples and at low concentrations.Learn more about micro-LC products can enhance your biologics bioanalysis studies >

As of summer 2016, 30 monoclonal antibodies (mAbs), had been approved for the treatment of certain cancers, autoimmune and infectious diseases, with even more in development.

 

Questions and answers to help improve your mycotoxin analysis

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A 2-fold revolution: MS approaches for the bioanalysis of oligonucleotide therapeutics

In 1998, the US Food and Drug Administration (FDA) approved fomivirsen as the first therapeutic oligonucleotide therapeutic. This approval marked a revolution of mechanism of action discovered decades before finally coming to fruition. Since then, the landscape of chemical modifications of oligonucleotides, conjugations and formulations has evolved tremendously, contributing to improvements in stability, efficacy and safety. Today, more than a dozen antisense oligonucleotides (ASOs) and small interfering RNA (siRNA) drugs are on the market, most of which are designated as orphan drugs for treating rare genetic diseases.

Is “right first time, every time” a pipedream for metabolite identification by LC-MS?

If we lived in an ideal world, it would be possible to unambiguously identify metabolites using a single analytical experiment. This analytical technique would need to be efficient and easily generate the information needed from a routine assay that is also robust, enabling confident decision-making during drug discovery.

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