The Food and Drug Administration (FDA) recently issued a final guidance document, Validation and Verification of Analytical Testing Methods Used for Tobacco Products. This nonbinding guidance provides ...
Client programs using CHOMax follow platform-defined workflows and phase-appropriate practices across the development lifecycle.
Given the multifaceted nature of ADCs, developers should have an integrated analytical toolkit. Three complementary approaches dominate the current landscape: Ligand Binding Assays (LBA): Ideal for ...
Southwest Research Institute has upgraded its nuclear magnetic resonance (NMR) laboratory to offer robust chemical analysis ...
DS InPharmatics Head of Analytical Services, Colman Byrne joins the show to share his experience in analytical method development and validation. Colman is the most senior analytical services expert ...
In a landmark decision poised to revolutionize drug development, the U.S. Food and Drug Administration (FDA) has announced a new initiative to significantly reduce, refine, and replace animal testing ...
Gene therapy represents one of the fastest growing biotherapeutics worldwide, with AAV at the forefront. This rapid growth is constantly challenging CMC approaches, from manufacturing through release ...
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