Tags

  • Sorting

  • Filters

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.

Overcoming uncertainty in your PFAS analysis

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

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.

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.

FDA’s final rule on LDTs: what does it mean for clinical laboratories?

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.

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.

Screening Food for Allergens Using LC-MS/MS Analysis

Screening Food for Allergens Using LC-MS/MS Analysis

Browse the shelves of any grocery store, and you may get a false sense of security when it comes to ingredient lists. As much as consumers want to trust labels, the truth is, food products could contain mislabelled ingredients, such that they trigger an allergic reaction with serious detrimental effects including discomfort, pain sickness and in some instances, death. Manufacturers, however, do not want to risk their reputation and consumer safety over a false label. As such, there must be some sort of verification to support such an action

Out with the “If it Ain’t Broke, Don’t Fix it” Approach. In with Remote Monitoring.

4 Reasons Why Your Lab Needs Remote Monitoring

You know the drill, lab managers are always seeking new solutions to keep their labs running at peak performance and instrument or system disruptions can be detrimental. Wouldn’t it be nice if there were a way to connect to your lab from anywhere securely and to stay ahead of potential instrument problems? By using remote monitoring, labs are now able to respond to issues quickly and efficiently, productively reducing downtime. 

Testing for a Variety of Bath Salts is a Necessity for Forensic Labs

Testing for a Variety of Bath Salts is a Necessity for Forensic Labs

To date, when it comes to testing urine or oral fluids in the workplace not all psychoactive substances can be detected due to evolving substitutions. As legislation changes, so too do chemical formulations.  Therefore researchers, like the authors of the following publication, A Validated Method for the Detection of 32 Bath Salts in Oral Fluids, published by Oxford Academic, analyze compounds using the best available methods so they can cast a wider net.

Vitamin D Analysis Made Simple

Vitamin D Analysis Made Simple

Last month, Dr. Phil Levy, a clinician, professor, and researcher at Wayne State University, was invited to SCIEX to lecture on ‘Vitamin D Measurement and Implications for Patient Care.’ His message was simple and very clear: Vitamin D testing is here to stay!

Wordpress Social Share Plugin powered by Ultimatelysocial