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.
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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.
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?
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.
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.
Optimized rolling collision energy curves for IDA and SWATH DIA for peptides
During data dependent acquisition (DDA or IDA) or SWATH acquisition, the collision energy can be automatically adjusted according to the mass/charge and charge of the peptide. This dependency has been well characterized on our QTOF systems. By selecting rolling...
Excel macro for plate building for transformation of 96-well to 384-well plates with generation of batch lists for SCIEX OS software
This macro-enabled workbook is designed to help with creating a formatted analysis list for the Echo® MS system, using 96-well plate maps or lists
Back to the new basics: Part 1 | Making the leap from GC-MS to LC-MS
Producing accurate results quickly in a demanding environment is no easy feat for analytical scientists. What’s more, many of us are constantly questioning ourselves—I certainly am—about whether we are employing the best technique for the analysis at hand.
It’s an overwhelming thought, considering the wide range of tools that are available to choose from, each of which offers varying levels of capacity, sensitivity, selectivity, specificity and cost. How do you meet the unique needs of your organization without breaking the bank? I get it, and I’m not here to convince you it’s easy. My aim is to guide you through the process to help you make the right decision for you.
How do I check the quality of the Auto Retention Time Calibration used in my Extractor processing?
When using the Auto-Calibration option in Extractor, a set of retention time calibration peptides will be determined automatically from the library and used for RT calibration. To determine how the fit looks for the calibration on each datafile, follow these steps....
MRM method transfer from a SCIEX Triple Quad or QTRAP 6500+ system to the SCIEX 7500 system
General recommendations when beginning method development Objective: The purpose of this document is to provide a quick reference for transferring MRM-based quantification methods from a SCIEX Triple Quad or QTRAP 6500+ system to a SCIEX 7500 system. While the best...
Short-chain PFAS compounds are on the rise- Craig’s PFAS Vodcast Cora Young
Read time: 2 minutes Short-chain per- and polyfluoroalkyl substances (PFAS) are increasing in the Canadian Arctic environment, with the most rapid increases occurring post-2000, according to a recent study in Geophysical Research Letters (April 2020). For example,...
Adapting a SCIEX high flow source for microflow LC
To set up a SCIEX high flow source for microflow LC (Turbo V ion source, DuoSpray source or IonDrive Turbo V ion source), first you must replace the wider bore electrodes with more narrow bore hybrid electrodes. Note with the OptiFlow Turbo V ion sources, there are...
Identifying the unknown PFAS profile in firefighting foams/AFFF
According to a recent study from Harvard University, the US EPA, and NIEHS, traditional targeted analysis techniques poorly characterize the PFAS composition of contemporary PFAS-based firefighting foams, know as aqueous film-forming foams (AFFF). Using the EPA 533 PFAS drinking water method for the analyte list, the researchers found that targeted mass spectrometry methods accounted for <1% of organic fluorine content. This is important because it demonstrates that targeted analysis methods miss nearly all the PFAS compounds in modern AFFF mixtures, thus underestimating the risk to human health and the environment.
Advanced analytics for mAb variants
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High level method optimization considerations for Echo MS system
While an in-depth discussion of method development and optimization for the Echo® MS system is beyond the scope of a community post, here are some points to consider as part of the process: The maximum recommended ion spray voltage for prolonged electrode life is 5000...
Tips to maximize electrode lifetime for Echo MS system
While it’s easy to think of the Echo® MS system as an ultrafast LC system in front of the SCIEX Triple Quad 6500+ mass spectrometer, the system operates on fundamentally different principles. For this reason, it requires different routine maintenance to keep it...
Uploading and using transcriptomics data in the OneOmics suite
RNA experiments can be created in the OneOmics suite for multi-omics analyses, enabling integration of transcriptomics data and proteomics data for biological insight. To build RNA experiments, either CloudConnect for PeakView software 2.2 or BaseSpace (Illumina) can...
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...
What is the difference between MRM3 vs MS/MS/MS (MS3)?
The MRM3 workflow and the MS3 scan are functionally the same QTRAP system scan, but used with different goals in mind. The main difference is how these scans are used in the whole MS workflow. With MS3 scans, you can use these in a data dependent mode for discovery...
Standard addition workflow – for quantification and calculating background levels
The method of standard addition is a quantitative analysis approach used in situations where matrix effects from complex samples contributes to the analytical signal. This makes it impossible to compare the analytical signal between sample and standard using a...
How do I define the experimental design (the metadata) for my SWATH acquisition study within the OneOmics suite? What are the requirement for replicates?
In quantitative Omics research, the goal is to understand which analytes (protein or metabolite) are perturbed between experimental conditions; therefore we carefully design our studies to explore these questions. The algorithms used within the Assembler application...
Controlling the M5 MicroLC system with SCIEX OS software using contact closure
Contact closure can be used to control external devices that are not directly controlled by SCIEX OS software. A sample batch is first created in the SCIEX OS software for MS acquisition, and then a similar batch is created on an external LC device with the required...
What are my normalization options in MarkerView software and when should I use them?
In an LC-MS experiment there are multiple sources of variance that can confound the quality of your results. This variation can be biological e.g. differences between treated and control groups, but can also be non-biological, usually from small variations in...
Intabio acquisition expands SCIEX portfolio of impactful solutions to accelerate biotherapeutic development
Due to the nature of their production, biotherapeutics are difficult to manufacture. Growth conditions, purification protocols and formulation requirements can introduce unintended modifications into the protein structure that may affect its efficacy and safety.
Top questions about the exposome of PFAS revealed
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.”
What’s in your citrus oil?
Craig Butt explains a non-targeted omics approach to characterizing and profiling compounds in citrus oil Read time: 4 minutes There is increasing interest among consumers in the benefits of natural products containing citrus beyond the traditionally known benefits of...