According to the CDC, the exposome is “the measure of all the exposures of an individual in a lifetime and how those exposures relate to health.”
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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.
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.
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?
An overview: LC-MS analysis of targeted protein degraders and their metabolites
Targeted protein degraders (TPD) are a relatively new therapeutic modality that opens the potential to target disease-causing proteins. These disease-causing proteins have been highly challenging for traditional small-molecule therapeutics to treat, making TPDs an exciting new therapeutic modality.
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.
Metabolite identification and peace of mind
Managing metabolite identification (Met ID) studies is challenging, so what is at the top of your priority list as you plan the year ahead? Ensuring you have the data needed to manage product safety, meeting deadlines, staff recruitment and training, maintaining compliance, capital expenses, or something else?
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.
New features in OneOmics suite
I just wanted to thank the readers here, both the OneOmics suite users who’ve shared their time and watched OneOmics grow, and for all the talented developers and scientists who’ve made OneOmics suite what it is today.
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