Bioanalytical testing platforms are specific analytical tools that analyze and define the amount of drug molecules in biological fluid.
Bioanalysis
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...
ACT Annual Meeting: Managing Roadblocks to Success
One of the largest shares of preclinical testing in any drug development program is toxicology studies, yet bringing together the community supporting this pivotal development stage does not happen often enough. Fortunately, the 2020 American College of Toxicology...
Ramp Up: What Drug Developers Need to Know
Many drug development companies are prepared to move their programs forward and effectively submit preclinical packages to regulatory bodies. In the challenging business of drug development, disruptions and obstacles are elements that must be part of the conversation...
Immunoaffinity Purification using LC-MS/MS: Comparing Two Methods
Protein quantitation by liquid chromatography-tandem mass spectrometry (LC-MS/MS) has become an increasingly popular field for pharmacokinetics study in the drug discovery phase. Traditional method development using a ligand binding assay usually requires 2-3 months....
Webinar: Practical Implications of Recent Changes to Immunogenicity Risk Assessment
Immunogenicity assessment helps drug developers understand the possible immune responses that can occur when humans are exposed to a potential therapeutic protein. Recently, the FDA has updated its guidance for immunogenicity risk assessment for developing and...
Providing Support for Drug Discovery and Non-GLP Bioanalysis
Speed is essential for your in vitro and in vivo screening during drug discovery. Whether you are developing a small or large molecule drug, working with the right bioanalytical team is essential to your success. Look for a partner that provides comprehensive services...
Partnerships that Prioritize the Customers
Around the globe, drug developers are trying to understand how the pandemic will impact the progress of their molecule during preclinical testing. Depending on a testing partner's response to the pandemic, your project's status can look drastically different from one...
Immunogenicity Assessment for Biologics Development: How to Reduce the Risk of a Clinical Hold
In 2019, the U.S. Food and Drug Administration (FDA) revised its guidance for immunogenicity risk assessment (IRA) of biological therapies. IRA is required to help drug developers and regulatory agencies better understand the potential impact an immune response will...
What You Need To Know Planning for an IND Submission
For drug developers ready to progress a molecule to the pivotal clinical trial stage, filing an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) is a significant milestone. Drug developers approach this task with a wide range...