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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...

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.

Unlock the benefits of nominal mass spectrometry for NPS analysis

Unlock the benefits of nominal mass spectrometry for NPS analysis

The development of analytical methods for the detection and quantitation of drugs and metabolites in a range of biological matrices is a challenging process. Forensic toxicology labs need a reproducible and reliable methodology to ensure the robustness of the data and the quality of the results. They also need robust and sensitive instrumentation that can detect drugs at trace levels with high specificity, especially when it comes to novel psychoactive substances (NPS), which can be difficult to monitor and control.

Why Quant?

Why Quant?

Every decision you make requires a number As a pharmaceutical scientist, you understand the challenges in getting a new drug through the discovery and development pipeline. As an innovation partner in mass spectrometry, SCIEX works continuously with you, our...

Uncovering the Links Between Childhood Growth, Body Size, and a Woman’s Risk of Breast Cancer

Uncovering the Links Between Childhood Growth, Body Size, and a Woman’s Risk of Breast Cancer

Welcome to the second in a series of posts marking International Women’s Day, and our ongoing support of World Cancer Research Fund. This installment is a review by Dr. Jennifer Baker, of her work, that, with the help of a WCRF grant, is studying body size and its links to breast cancer. Dr. Baker, Lead Investigator at Denmark’s Frederiksberg Hospital, has a Ph.D. in Human Nutrition from Cornell University. Her research focuses on clinical epidemiology.

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