Blog
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...
In the News: The IND Application, Timelines & Advice for Small Drug Developers
Recently our WuXi AppTec subject matter experts contributed to notable publications. Below is a quick recap of where to find them sharing their knowledge, advice and passion for drug development. Pharma Manufacturing Keys to Submitting a Successful IND Application to...
Alliances for Innovation: Insight from Steve Yang
In the face of a wide-spread pandemic, something extraordinary is happening in the drug development industry – competitors are becoming collaborators and collaborations are accelerating results. WuXi AppTec’s Co-CEO, Head of RSD, Head of WuXi Testing, Steve Yang,...
In Vivo PK/ADME Studies — Positioning, Planning and Best Practices
In vivo studies, such as pharmacokinetics (PK) and absorption, distribution, metabolism and excretion (ADME), are critical to your compound’s vitality as you prepare for regulatory submission. Knowing when these studies should be completed can often be a pressure...
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...
Tracking Your Molecule: Technology Advancements in the Industry
Molecule tracking via preclinical testing is a significant yet necessary investment for drug developers. The stakes are high, and it's critical to stay apprised of your program's progress from start to finish. You need to monitor how your compound is progressing and...
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...