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.
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Pharma perspectives: The influence of LC-MS innovation on drug development outsourcing
It is no secret that (bio)pharmaceutical research and development is complex, both scientific and regulatory processes. Working for a contract research organization and more recently for SCIEX has provided an interesting perspective on trends the market experiences that affect many of us.
Overcoming uncertainty in your PFAS analysis
Just like gum on the bottom of a shoe, the existence of per- and poly-fluorinated alkyl substances (PFAS) in our environment is a sticky one. If you’re in the field of environmental testing, then you’re all too familiar with the threat these substances have on public health. While we have learned a lot about them over the years, there is still much more to understand. With the right detection methods, we can gather the information we need to empower us to make informed decisions on reducing the risks they impose.
6 Signs it’s time for a new vendor
A lab’s success depends on many factors from instrument quality to efficient operations, including being partnered with the right vendor. A vendor is more than just a supplier. They should provide you with a high-level quality of support in maximizing the lifespan and performance of your systems, reducing downtime, enhancing ROI and more. How do you know if you’re partnered with the right one? Here are six signs it might be time to find someone new.
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.
Celebrating customer experience: Insights from SCIEX leaders
Introduction Customer Experience Day (CX Day) is a special occasion for SCIEX, celebrated every first Tuesday in October. It’s a day dedicated to recognizing the incredible value of our customers and the relentless dedication of our associates who strive to make...
PFAS analysis in food: a robustness study in sensitivity and stability
The combination of per- and polyfluoroalkyl substances (PFAS) testing, trace-level regulatory requirements and complex MS applications can be intimidating. In a recent webinar, now available on demand, SCIEX PFAS expert Craig Butt demonstrated how the new SCIEX 7500+ system can help make PFAS testing easier.
Your success and voice go a long way!
At the heart of everything we do is ensuring that your workflows and team are empowered to achieve optimal results with your SCIEX instruments, software, consumables, and services. Every interaction with SCIEX is designed to support your success through the dedication...
FDA’s final rule on LDTs: what does it mean for clinical laboratories?
On April 29, 2024, the U.S. Food and Drug Administration (FDA) announced a final rule regulating laboratory developed tests (LDTs) as in vitro diagnostic devices (IVDs) under the Federal Food, Drug and Cosmetic Act (FD&C Act). This rule amends FDA’s regulations to state that in vitro diagnostic tests “manufactured” by clinical laboratories fall within the scope of the FDA regulatory oversight and is poised to dramatically shift the way clinical diagnostic laboratories in the United States develop and offer LDTs in the future. Read this blog post for a basic overview of the scope, intent and implications of this final rule, including the regulatory requirements, exceptions and timeline for implementation.
LC-MS system replacement: Are you ready?
Meeting deadlines in a bioanalysis laboratory can be a big challenge. Older, less sensitive and less reliable LC-MS systems make it even more difficult. Even the disruption caused by the installation and validation can be disconcerting and delay decisions. Does this sound familiar?
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