Are you considering the purchase of a high-resolution accurate mass (HRAM) instrument for your forensic toxicology lab? To help ensure you invest in a solution that ideally meets your needs, ask yourself the following key questions. 1. How do I ensure my results...
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Managing ADC characterization: The challenge of turning complexity into confidence
Unlike traditional monoclonal antibodies, ADCs combine an antibody backbone with linker chemistry and a cytotoxic payload. This multi-component architecture introduces overlapping layers of heterogeneity, including drug-to-antibody ratio (DAR) distributions, charge variants, post-translational modifications, and structural changes at both the intact and subunit levels. Across ADC development, these characteristics are considered critical quality attributes that must be characterized, understood, and monitored.
ADC analytics FAQs: Answering the most common questions about ADC characterization
Antibody-drug conjugates (ADCs) have emerged as one of the fastest-growing classes of biotherapeutics, combining the targeting specificity of monoclonal antibodies with the potency of cytotoxic payloads. However, this unique architecture also introduces significant analytical complexity. From drug-to-antibody ratio (DAR) distributions and charge variants to conjugation sites and structural modifications, ADCs present multiple, interconnected sources of heterogeneity that must be understood to ensure product quality and performance.
Sterile but toxic: Cereulide detection in food matrices
In a recent webinar, Ming Gao, Ph.D., Senior Research Chemist at Mérieux NutriSciences, explored the growing challenge of cereulide contamination in food products and the analytical strategies needed to detect this heat-stable toxin at trace levels. The session examined how LC-MS/MS can help laboratories overcome the limitations of traditional microbiological screening and meet emerging regulatory requirements.
What do scientists really think about EAD for Met ID?
During an LC-MS/MS experiment, traditional fragmentation techniques like collision-induced dissociation (CID) have long been the gold standard. Electron-activated dissociation (EAD) is emerging as a transformative tool that enhances structural elucidation, particularly for complex or labile metabolites.
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.
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