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...
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...
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...
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...
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...
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...
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 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...
As your partner we are taking all the necessary steps to make sure your drug development continues without any disruptions in the process. Moving your molecule forward during COVID-19 doesn’t need to be stressful or difficult. We continue to learn and have found...