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Have you ever wished for a compact instrument that delivers expert-level answers to your most complex biotherapeutic characterization challenges faster and easier than what you are doing now? At SCIEX, we recognize that even expert users want easier ways to perform daily characterization tasks and get great results every time. That’s why we set out to develop the X500B QTOF system: a robust and reliable new instrument and software solution that reduces complexity and simplifies biologics characterization workflows so every scientist can get expert-level results

Protein-based biotherapeutics, including monoclonal antibodies (mAbs) and antibody-drug conjugates (ADCs) are a growing component of pharmaceutical companies’ drug pipelines. The growth of ADCs in particular is due to their ability to selectivity target and deliver a potent molecule to a cancer cell based on a specific tumor marker. In order to support this growing class of new drug molecules, robust and reliable bioanalytical methods are required. While ligand binding assays (LBAs) like ELISA have been the most popular platform for biotherapeutic quantitation, bioanalytical scientists have been increasingly adopting hybrid LBA/LC-MS methods in this area.

Throughout all stages of development and manufacture, monoclonal antibodies (mAbs) exhibit a great deal of structural complexity. After translation and folding, proteins undergo post-translational modifications, as well as spontaneous and enzymatic degradation, such that a single preparation of purified mAb exhibits a range of small structural changes, composed of various glycoforms and charge variants, as well as amino acids alterations due to oxidation, deamidation, isomerization, or other chemical reactions. This display of structural heterogeneity can influence the overall stability, efficacy, and safety profile; therefore, understanding the extent of structural modifications has become extremely important to drug manufacturers who continually assess mAb composition throughout bioprocessing to demonstrate stability, batch-to-batch consistency, and long-term shelf life.

A variety of post-translational modifications (PTMs) can impact a biotherapeutic protein’s mass, but none are as common as glycosylation.[1] Hence, the headline for a recent article in Genetic Engineering and Biotechnology News,  “Post-Translational Icing on the Biologics Cake,” featuring comments from Sean McCarthy, Ph.D., Global Market Manager of Biologics at SCIEX.

SelexION® DMS Technology Drives Advancements in Challenging Large Molecule Bioanalysis 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...

In a previous blog outlining the advantages of high-resolution accurate mass measurements for protein quantitation using the TripleTOF 6600, it was noted that although the triple-stage quadrupole demonstrated high sensitivity when operated in multiple reaction monitoring mode (MRM), the relatively low-resolution measurement of m/z failed to discriminate Rituximab response from nominally isobaric interferences given the complexity of the proteolytically digested samples (June 28/2016). While the accurate mass filtering capabilities of the TripleTOF 6600 represents one mechanism for achieving increased selectivity over MRM, the triple quadrupole/linear ion trap (LIT) hybrid platform represented by the QTRAP® 4500, 5500, 6500 and 6500+ systems provides an alternative technique by leveraging a third stage of MS, often referred to as MRM3. In this blog, we outline the MRM3 scan function and survey several large molecule applications which utilize the additional stage of fragmentation in the LIT to yield significant improvements in achievable detection limits when compared to MRM.

Ever wish you had your own team of mass spectrometry experts at your side when working through biologics development and characterization challenges?  With SCIEX 360° Innovations complex biologics characterization is streamlined with a full suite of mass spectrometry (MS), capillary electrophoresis (CE) systems, software, and services from SCIEX experts.

At ASMS this year, the newest version of BioPharmaView Software was released. This software simplifies the processing of biotherapeutic data for characterization and comparability which can dramatically improve your productivity. BioPharmaView 2.0 Software accelerates characterization and comparability studies and simplifies reporting, so you can make better decisions, faster.