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Rapid Separation Method for Intact Monoclonal Antibodies (Mab) Merges Charge Variant, Impurity, and Glycoform Analyses into a Single Assay

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.

Glycosylation Analysis Designed for the (Protein) Masses

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.

The History of Isotopic Labels for Quantitative Proteomics

Proteomics has become a vital tool for biological scientists performing research on the healthy and diseased states of living things. It involves the large scale and systematic analysis of all proteins within a given cell, tissue, or organism. Because proteins are regulated by many different internal and external stimuli, the proteome is dynamic and quantities of proteins can change from one state to the next. Therefore, in order to be of the highest utility, proteomics experiments need to both identify and quantify proteins so that comparative studies can be done, such as between healthy cells and tumor cells, or the comparison of different treatment regimens.

Detecting low levels of drugs and their metabolites in hair and nail samples using LC-MS/MS

Detecting low levels of drugs and their metabolites in hair and nail samples using LC-MS/MS

You probably have heard of testing blood and urine samples for the presence of drugs and their metabolites. But do you know about the benefits of hair and nail analysis? In a recent webinar, Tina Binz, Deputy Head of the Center for Forensic Hair Analysis, University of Zurich, discussed the benefits of developing comprehensive and sensitive LC-MS/MS for the detection of low-level drugs and metabolites in keratinized matrices.

Guide decisions during cell line development with more information at the intact level

Guide decisions during cell line development with more information at the intact level

Monitoring product quality attributes (PQAs) throughout monoclonal antibody (mAb) development is vital to ensuring drug safety and efficacy. By adopting orthogonal analytical techniques and integrating new technologies that have the potential to provide more information, it is possible to improve product quality and manufacturing efficiency and make more informed decisions.

Maximize NPS analysis with accurate mass spectrometry

Maximize NPS analysis with accurate mass spectrometry

LC-MS/MS is a powerful analytical tool in forensic toxicology testing that can support a variety of testing regimes such as screening, confirmation and quantitative workflows. More specifically, analysis of NPS using LC-MS/MS provides many advantages, including the ability to reliably detect new drugs and their metabolites from a variety of biological matrices.

What has the Echo® MS system done for the pharma industry? (And don’t just take our word for it!)

What has the Echo® MS system done for the pharma industry? (And don’t just take our word for it!)

SCIEX was very proud to have an illustration of the Acoustic Ejection Mass Spectrometry (AEMS) technology that powers the Echo® MS system on the front cover of the Journal of the American Society for Mass Spectrometry in January 2023. The associated article—Ultrahigh-Throughput Intact Protein Analysis with Acoustic Ejection Mass Spectrometry—was co-authored by scientists from SCIEX and Merck.

Rescheduling a Schedule I substance, and the Delta-8 controversy

Rescheduling a Schedule I substance, and the Delta-8 controversy

Did you know that in the US, drugs and other chemicals are classified into 5 distinct categories depending on the drug’s acceptable medical use and its potential for abuse or dependency?  Drugs federally classified as Schedule I substances by the US Drug Enforcement Administration (DEA) are considered to have the highest potential for abuse and for creating severe psychological and/or physical dependence. In addition to heroin, LSD and MDMA (ecstasy), cannabis is classified as a Schedule I substance in the Controlled Substance Act of 1970, which means it has no approved medical usage.

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