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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.

Loss the contact closure signal

Loss the contact closure signal

our 7600 couple with nanoLC Ultimate 3000 via contact closure. it has run without any loss connection during the batch. Just yesterday, the last injection keep equilibrating system until the LC finished the gradient run. We closed the software and power off LC and MS then started again but it did not help. The Dionex engineer also checked their LC and triggerring cable found both are ok.

The honey sting

The honey sting

As a consumer it’s hard for me not to feel inundated with claims that our food is “all-natural” or “chemical-free” or that we should buy certain “superfoods” for their health benefits.  We read labels and trust that the product we are buying is what we are truly...

Full, partial and empty capsid ratios for AAV analysis: What’s the big deal?

Full, partial and empty capsid ratios for AAV analysis: What’s the big deal?

For many of you working to develop gene therapy drugs, you know that the time to market the drug is critical. Because gene therapeutics cure diseases by targeting specific genes, it is a constant race to see who develops the drug first. Unlike other classes of drugs where multiple medications can be used to treat a disease, whoever is first to develop a gene therapy drug wins.

A rising star in food allergen research: proteomics of shellfish allergen

A rising star in food allergen research: proteomics of shellfish allergen

It’s important to know what you’re eating, especially if you suffer from a food allergy.

About 220 million people worldwide live with a food allergy.1 These numbers, along with the complexity and severity of conditions, continue to rise. In America, there are about 32 million food allergy sufferers—5.6 million of those are children under the age of 18.2.2 That’s 1 out of every 13 children, or about 2 in every classroom. From a financial perspective, the cost of food allergy childcare for US families is up to $25 billion

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