Q&A with Sean McCarthy Global Market Manager, Biologics, SCIEX MAM is an acronym for Multiple Attribute Method. In short, MAM is a method which may be applied for characterization of a biotherapeutic to understand its sequence, identify liabilities, identify...
Tags
Selecting an LC-MS system for quantitation of pharmaceutical drug development
We understand you are busy, needing to prioritize running instruments, reporting results and managing your laboratory to meet deadlines. We created a solution guide to explain how SCIEX systems fit in the drug development pipeline to save you time evaluating options.
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
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.
High complexity of the lipidome
The complexity of the lipidome is diverse in the structure and there are many combinatorial isoforms that are available within nature. Currently, many different techniques are required to fully characterize a lipid molecule. What if you could do it in a single...
Breaking down the SCIEX Triple Quad™ 7500 LC-MS/MS System – QTRAP® Ready
Sensitivity and robustness carry different meanings in the world of mass spectrometry. Generally, sensitivity refers to an instrument’s ability to achieve lower limits of detection (LOD). Robustness, on the other hand, refers to an instrument’s ability to consistently...
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...
Innovation that’s blasting through limitations in explosive detection
Mass spectrometry’s important role in identifying explosives The need for rapid explosive detection is now an unfortunate reality. The remit is multifaceted. The first is for preventative purposes, to protect us from any threat to life. The second is in the...
A new generation of therapeutic modalities
There are over 7,000 genetic diseases that could potentially be cured using gene therapy. Rare metabolic diseases, autoimmune disorders, cardiovascular disease and cancers are some of the top disease classes that can be addressed with gene therapies. With over 1,000...
Enhancing Biologics with CESI-MS Characterization
Comprehensive characterization of a biologic requires analysis at both the intact and digest levels, but these analyses can be complex and cumbersome. For example, with conventional liquid chromatography separations, researchers are often left with limited information...
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.
Perfluoroalkyl Acids in Drinking Water – EPA Method 537
The United States Environmental Protection Agency (EPA), under the 1996 Safe Drinking Water Act (SDWA), requires a new list of no more than 30 unregulated contaminants to be monitored by public drinking water systems. Known as the Unregulated Contaminant Monitoring Rule (UCMR), a new list is published every five years. The last rule, UCMR3, was published May 2, 2012, and is the focus of the following application note, “Analysis of Perfluoroalkyl (PFFA) Acids Specified under the UCMR3 Using the QTRAP® 6500 LC-MS/MS system,” which can be found in the Food and Environmental Compendium.
SCIEX helps set food standards in China
One of the biggest concerns of Chinese citizens is food safety1. Even though China ranks second in global economies2, crowding, industrial pollution, labor and certain agriculture practices have contributed to this. In October 2015, however, we began to see a turnaround as the Chinese government revised its 2009 Food Safety Law in an attempt to strengthen its food supply oversight and quality.
Discover the new and accurate SCIEX way to enhance your routine food allergen testing
Food allergy is an immune-mediated, adverse reaction to an antigenic protein. Even limited exposure to an antigen can provoke a significant reaction in sensitive individuals, causing rashes, itching and swelling in the mouth, nausea, vomiting, and asthma. Additionally, food allergies are the leading cause of anaphylaxis, an acute, potentially deadly allergic reaction. The prevalence and severity of food allergies are rising, with approximately 150 million people suffering from food allergies worldwide.1, 2 Presently, there is no cure for food allergies, and sufferers must rely on the correct labeling of foods to avoid consuming allergens. Hence, the development of sensitive and accurate analytical methods to screen for the presence of allergens in food products is necessary for the prevention of potentially life-threatening health problems for allergy sufferers.
Three Infographics to Show You How to Overcome Challenges in Transitioning to Biologics Bioanalysis
The move to large molecules in Pharma is accelerating, offering unprecedented opportunities to improve human health and expand into new markets. But for those with extensive experience with small molecule bioanalysis, the shift to biologics can be challenging, from Sample Prep to Instrumentation and Software, to Methods and Training:
Rapid Characterization of Biologics using CESI-MS
Today, 30 monoclonal antibodies (mAbs), have been approved for the treatment of certain cancers, autoimmune and infectious diseases. Even more are in development, and perhaps you and your team of scientists are working on one now. Keeping pace with fast development timelines while performing comprehensive characterization of biologic candidates can be challenging. However, more and more, scientists are tackling these challenges with new techniques to speed and simplify their characterization workflows. Read more in the application note, “Rapid Characterization of Biologics using a CESI 8000 – SCIEX TripleTOF® System,” found in the Biologics Analytical Characterization Compendium, which highlights how CESI separation coupled with high-resolution mass spectrometry can provide a comprehensive characterization of biotherapeutics.
The Not So Hidden Truth about Climate Change How It’s Poisoning Your Food
Did you know climate change could be poisoning your food? According to the United Nations Environmental Program (UNEP) report on Emerging Issues of Environmental Concern, rising temperatures are making crops more toxic.
Guardians of Antibiotics
This second is a blog series on the global war: Rise of Superbugs! Part 1 took a critical look at the antibiotic threat we face in today’s battlefield. The waning effectiveness of antibiotics as we head into what may seem like a post-antibiotic era has impelled new reformation to at the very least control antibiotic usage to ensure food safety.
Protein Quantitation Workflows using the TripleTOF 6600: A Case Study for Rituximab
Although the triple-stage quadrupole (QQQ) mass spectrometer remains the pillar for quantitative LC-MS/MS bioanalytical assays, due in part to the platforms’ high duty cycle when operated in multiple-reaction monitoring (MRM) mode, the applicability of high-resolution mass spectrometry (HRMS) has become of increasing importance for protein quantitation given the complexity of proteolytically digested samples in the surrogate peptide approach. While the QQQ demonstrates high sensitivity and specificity, the relatively low-resolution measurement of m/z may fail to differentiate analyte response from nominally isobaric background interference. In contrast, HRMS with accurate mass assignment of product ion allows interference to be resolved through judicious selection of a post-acquisition mass extraction window whose tolerance is largely dictated by the effective resolution and stability of mass calibration.
Rise of the Super Bugs
The term “antibiotic-free” is becoming more and more popular in food advertising these days. Take Subway for example; in March the company elevated their antibiotic-free policy and introduced a new antibiotic-free rotisserie-style chicken sub, and they plan to, “Nix antibiotics in all its meat by 2025.”
Glyphosate, a Polar Pest Put to Test
No other pesticide has courted more media attention and controversy in recent months than glyphosate, with governments and national agencies debating its use and health effects.
Using Mass Spec to Detect Trace Explosives
The importance of protecting a country’s border is a very topical issue. The war on drugs and terror is a 24/7 task 366 days a year (2016 is a leap year). The government agencies in charge must be vigilant and maintain instrumentation to prevent terrorism, drug trafficking, and other illegal activities. Mass Spectrometry is rapidly becoming the instrument of choice for border agencies throughout the world when it comes to explosive trace detection and forensic drug compounds.
Routine Food Testing Using Mass Spectrometry
These days, it is not uncommon to hear about the overzealous application of pesticides to crops or the injection of antibiotics into animals. From grocery stores to restaurants, our food is at risk. How then, can consumers be assured that chemical contaminants like these , not to mention the risk of mycotoxin compounds are not making their way to your dinner table?
Quantify and Identify Pesticides in Complex Food Samples Using the QTRAP 6500 LC-MS/MS System
Recent regulations on food analysis require screening for pesticides using confirmatory techniques, such as GC-MS and LC-MS/MS. More than 1000 pesticides are used worldwide and, along with their metabolites and degradation products, are present in food. There is a demand for powerful and rapid analytical methods that can identify pesticides with high confidence in a broad range of food matrices and quantify at low concentrations with good accuracy and reproducibility. Challenges for pesticide residue laboratories at the moment are the request to test for more compounds, in a wider range of samples, all without sacrificing data quality.
Fast, Efficient, Disulfide Bond Mapping Using BioPharmaView™ Software
Fast LC-MS acquisition and automated data processing will help you speed up peptide mapping of your biotherapeutic, including critical disulfide bond and post-translational modification characterization. SCIEX helps you untangle the complexity of disulfide bonds, speeding up your characterization process.
Bottom-Up Proteomics: A Discussion with Christie Hunter
Biocompare recently featured an article on Bottom-Up Proteomics. I had a chance to follow up with Christie Hunter and expand on some of the questions featured in the article:
Characterize and Monitor Host Cell Proteins (HCPs) Using SWATH Acquisition Technology
During drug development, the removal of impurities and purification of a final drug product is absolutely essential in order to ensure the safety and efficacy of a therapeutic drug. Of particular concern for biologics are impurities that can stem from host cell proteins. Because biologics are developed through cell culture and fermentation within a host cell, proteins from this host cell can be co-purified with the final biologic. These host cell proteins or HCPs can cause the final product to have undesired side-effects such as eliciting an immune response in patients taking the drug, or affecting the drug’s stability or efficacy. As a result, regulating agencies require drug companies to monitor levels of HCPs during the development and purification of a biologic and to remove HCPs to an acceptable level in the final biotherapeutic product.
Simplifying Biologics Bioanalysis Sample Prep
These days, everyone seems to be furiously scratching tickets to become instant winners, but I’ll bet you didn’t expect to find sample prep tips that way. For large molecule bioanalysis, preparing your samples can be one of the biggest challenges. It’s a whole different world from traditional small molecule bioanalysis. SCIEX has developed techniques and automation that make biologics sample prep simpler and faster, with reproducible results.
The Connection Between Mass Spectrometry and Space Exploration
Mass spectrometry has been used for some pretty fascinating applications in our world – like testing for steroid use in athletes1, measuring pesticides in grapes2, assessing the efficiency of a psoriasis drug3, and whether that expensive bottle of 100% olive oil is, well, really 100% olive oil.4 But did you know mass spec is also used out of this world? Like… in space?
The Future of Biologics Drug Development is Today
Since the 1982 approval of Eli Lilly’s recombinant human insulin, Humulin, biotherapeutic drug development has steadily grown into a global market valued at $140 billion in 2013, increased from $25 billion in 2001
A Hybrid LBA/LC-MS Assay – Your Questions Answered
Last week we posted a blog on Biologics Bioanalysis Key Challenges, where we presented a webinar on those key challenges.