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Enhancing In Vitro ADME Screening

LC-MS technology is helping contract research organization Cyprotex Discovery Ltd. perform bioanalysis of small molecules, peptides, and other pharmaceuticals, enabling quantification to be performed in complex matrices during in vitro ADME studies.

Host Cell Protein Analysis – Mass Spec’s Edge Over ELISA

The number of protein based drugs coming onto the market is at an all-time high, particularly those produced with a host cell system. With host cells come their own proteins. These host cell proteins (HCPs) constitute a major part of process-related impurities and can adversely affect drug safety, so it is critical that they are identified and quantified accurately.

Fipronil Tainted Eggs Detected in Several European Countries

News agencies all over the world are reporting a new food contamination issue regarding eggs which have been found to contain residues of Fipronil. According to Nieuwsuur, a Dutch news, and current affairs program, “The Fipronil scandal is a huge blow to the poultry sector. Millions of eggs are destroyed and 138 companies remain tentatively closed. But supermarkets also face great damage. In recent days all contaminated eggs have been taken out of the shelves.” CBS news has reported that contaminated eggs have been discovered in Belgium and in the Netherlands with other European countries now on alert.

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.

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