Targeted metabolite assays that measure tens or hundreds of pre-selected metabolites, typically using liquid chromatography–mass spectrometry, are increasingly being developed and applied to metabolic ...
Human Epidermal Growth Factor Receptor 2 Quantification Using Computational Pathology to Identify Novel Biomarkers for Trastuzumab Deruxtecan–Treated Human Epidermal Growth Factor Receptor 2–Positive ...
Most of the previous methods for BMH determination are based on high performance liquid chromatography which utilizes a huge amount of highly pure organic solvents. Such methods have low environmental ...
Flow cytometry assay validation requires different analytical approaches in preclinical and clinical settings. A fit-for-purpose (FFP) strategy allows researchers to customize the validation to ...
The last two decades have witnessed the steady growth of the protein drug market. As original recombinant products come off patent, generics/ biosimilars are also beginning to be manufactured. The ...
Analytical validation of NeXT Personal®, an ultra-sensitive personalized circulating tumor DNA assay
Figure 8: Major analytical performance measurements of the NeXT Personal assay. “NeXT Personal uses whole genome sequencing of tumor and matched normal samples combined with advanced analytics to ...
Although phosphorylated tau at threonine 231 (pTau 231) is a promising blood-based biomarker for incipient Alzheimer's disease (AD), existing assays such as Simoa ® are not sensitive enough to ...
Laboratory-based design verification testing (DVT) of combination products and medical devices must be performed to demonstrate that the device meets the performance requirements that were set in the ...
JCO Precision Oncology Conversations podcasts feature discussions with leading authors of JCO Precision Oncology articles, hosted by Dr. Abdul Rafeh Naqash. Join our experts in engaging conversations ...
The safety and quality control of parenteral pharmaceuticals, biologics, and medical devices depend heavily on the Bacterial Endotoxin Test (BET). Historically, Limulus Amebocyte Lysate (LAL), derived ...
Advanced analytical services support partners from product characterization and assay development to GMP readiness and clinical manufacturingIntravacc offers state-of-the-art analytical methods for ...
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