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A Diagnosis And A “Difficult Waiting Game”

We are thrilled to mark International Women’s Day 2019 by making our fourth annual donation to World Cancer Research Fund, a global not-for-profit organization and leading authority on the links between diet, nutrition, physical activity, and cancer. In fact, our...

Nitrosamines: Where are we now?

Nitrosamines: Where are we now?

Nitrosamines are a large group of N-nitroso compounds that share a common functional N-N=O group. They are produced by a chemical reaction between a nitrosating agent and a secondary or tertiary amine. Back in 2018, nitrosamines suddenly found themselves in the spotlight when they were unexpectedly detected in medications for high blood pressure. Since then, they have been found in several other prescription medications, including those for heartburn, acid reflux and diabetes, resulting in manufacturers recalling some common medications.

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.

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.

How to Achieve Higher Sensitivity with Hybrid Immunoaffinity LC-MS Assays

How to Achieve Higher Sensitivity with Hybrid Immunoaffinity LC-MS Assays

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.

Top Five Misconceptions about Mass Spectrometry

Top Five Misconceptions about Mass Spectrometry

Do you work in a lab handling precious samples yet, hesitant to make the move to mass spectrometry? Many laboratories just like yours continue to conduct sample analysis using ELISA assays, PCR scans, and amino acid tests because of their effectiveness. These processes work, so why change? Well, these type of analytical experiments can report false positive and negative results. You have trained your staff, know the process, and fingers crossed, not too many user errors have compromised analysis.

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

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

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.

Harnessing the Power of MRM3 for Large Molecule Quantitative Bioanalysis

Harnessing the Power of MRM3 for Large Molecule Quantitative Bioanalysis

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.

You’ve Seen It… Now Try It! BioPharmaView Software 2.0

You’ve Seen It… Now Try It! BioPharmaView Software 2.0

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.

Quantitation of Antibiotics and Insecticides in Poultry Feed using LC-MS/MS

Quantitation of Antibiotics and Insecticides in Poultry Feed using LC-MS/MS

Quantitating antibiotics and insecticides in poultry is serious business. Overuse can lead to antibiotic resistance while insecticide residuals can cause harmful side effects in humans. In the United States, for example, the Federal Drug Administration (FDA), has offered up a plan to limit common antibiotics in feed, which are used to encourage growth. However, this is a voluntary plan, and as the following application note, “Quantitation of Antibiotics and Insecticides in Poultry Feed using LC-MS/MS,” points out, antibiotics have been shown to accumulate in poultry feathers, which are in turn used for nutritional elements in the feed.

Screening Novel Psychoactive Substances with Confidence

Screening Novel Psychoactive Substances with Confidence

How do you know what you can’t see? This is the challenge many a lab faces as they relentlessly test for novel psychoactive substances (NPS) as unknown samples with an ever-changing ingredient list make discovery difficult work at best. There are many reasons for the complexities of which you can discover in this application note, “Accurate Mass Screening Workflows for the Analysis of Novel Psychoactive Substances.”  However, the biggest of which is that non-targeted findings can turn up thousands of molecular features in a single sample. Sifting through the peaks is laborious, and many are normal besides.

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