Blog
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...
Selecting a Testing Partner During a Pandemic
While much of the world continues to cancel events and defer projects in light of the COVID-19 pandemic, drug development often doesn't have the luxury of going on hold. Preclinical drug testing and the submissions that follow can't afford potential delays, which...
U.S. FDA Updates to Guidance on Managing Drug-Drug Interactions
The recently updated guidelines on assessing drug-drug interactions will likely improve experimental outcomes, reduce costs and streamline development timelines. The U.S. FDA updated its guidelines for in vitro drug interaction assessment to help drug developers...
Virtual Audits: You Can Now Qualify Testing Sites From Home
Between travel limits and social distancing, in-person visits at testing sites for drug and medical device development are currently not an option. Qualifying testing sites is a standard industry practice, but the resulting restrictions of COVID-19 present new...
The Logistics of Shipping Biological Samples During COVID-19
The novel coronavirus (COVID-19) pandemic has thrown many standard procedures out the window, including how companies approach the logistics of shipping biological samples to China. To prevent the introduction and spread of infectious disease, Chinese Customs...
Keeping Your Molecule’s Timeline on Track During COVID-19
The unforeseen and drastic effects the COVID-19 pandemic has had on the industry have led to unanticipated challenges, including stricter international shipping regulations, travel restrictions, local lockdowns and more. However, industry leaders are still here to...
White Paper: Managing the Increasing Demands for Scientific Resources During the COVID-19 Pandemic
As our partners’ research and development programs begin to ramp up, so does the need for additional resources. At WuXi AppTec, we remain committed to ensuring the availability and integrity of the research models used on our customers’ vital development programs is...