Bioanalytical testing platforms are specific analytical tools that analyze and define the amount of drug molecules in biological fluid.
Bioanalytical
Simoa Joint Laboratory Delivering Greater Speed, Sensitivity and Customization in Biomarker Validation
For more than 20 years, WuXi AppTec has been a leader in developing and validating biomarker methods to support drug development and clinical research. It has used cutting-edge technology to validate hundreds of biomarkers on most major platforms with the aim of...
How Bioanalytical Laboratory Automation Improves Timelines and Accuracy
It is challenging to find a fully automated bioanalytical laboratory, but doing so can help drug developers stay competitive in today’s market. A fully automated laboratory can perform controlled and error-free assays, dramatically improving the accuracy and...
Understanding Oligonucleotides and Their Bioanalytical Considerations
As new modalities in drug development gain popularity, we are in an exciting place to treat and prevent complex disease states. Researchers have been making great strides in the development of oligonucleotides, otherwise known as “oligos.” Though these therapies...
Join WuXi AppTec at the 2021 American Association of Pharmaceutical Scientists PharmSci 360
WuXi AppTec is looking forward to this year's American Association of Pharmaceutical Scientists (AAPS) annual meeting—known as "PharmSci 360"—on Oct. 17-20. PharmSci 360 is being held at the Pennsylvania Convention Center located in Philadelphia's Center City...
In The News: WuXi AppTec Experts In The Drug Development Community (Jan-July 2021)
WuXi AppTec Laboratory Testing Division experts continually weigh in on emerging trends and stay updated on salient drug development topics. These experts routinely contribute to industry publications. Here’s where they’ve been featured in the first half of 2021....
Testing Toxicity to Advance to Phase I Clinical Trials
Preclinical research teams enter each drug testing project with the same hope – that the drug will meet all the safety requirements in order to advance to phase I clinical trials in humans. In laboratory experiments, scientists will test their ideas for new...
Managing Critical Reagents: An Essential Part of Your Bioanalytical Strategy
Critical reagents are an essential part of bioanalytical testing for large molecule preclinical and clinical studies. These essential components help determine the accuracy of the analyte, precision and performance of ligand binding assays (LBAs), which are key to...
ICH M10: Preview New Bioanalytical Method Validation Guidance
The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) is in the process of revising M10, a multidisciplinary guideline that governs bioanalytical method validation. Drugs need to contain the correct...
Pathologists Can Move Your Drug Development Program Forward
Pathologists examine the causes and mechanisms of diseases and, in the world of drug development, that means collecting, processing and analyzing tissue for toxicity. Histotechnologists fix tissue samples onto slides, stain them to distinguish types of cells and cell...
5 Questions When Planning a Nonclinical Toxicology Program for Biotherapeutics
Encountering challenges while developing a new drug is expected, but drug developers who understand the pitfalls are often better prepared to navigate them and emerge successfully. Nonclinical safety assessment is a highly complex and molecule-specific process, but...
Internal Standard Variation Case Studies: A Look into the Latest Whitepaper
The use of Internal Standards (IS) is essential to Liquid Chromatography-tandem Mass Spectrometric (LC-MS/MS) quantitative bioanalytical methods. Yet, there are no set methodologies or widely adopted criteria among laboratories for establishing and assessing Internal...