CUBRC转发了
CUBRC, Inc.’s President and CEO, Tom McMahon has announced that CUBRC, in collaboration with EpiVax, Inc., was awarded a two-year contract worth $2 million from the Food and Drug Administration (FDA) within the Department of Health and Human Services (HHS). The goal of this research program is to provide information that helps to?‘frame’ the risk for each generic drug?and may assist drug developers and FDA reviewers to differentiate impurities that are potentially riskier from those that are lower risk. The new FDA-funded collaboration builds on research performed by CUBRC and EpiVax during two previous FDA contracts that evaluated the immunogenicity risk of generic drug impurities. Under this newly awarded project, CUBRC and EpiVax will develop standardized controls for T-cell assays performed to?assess the immunogenicity risk?of generic drugs?in support of ANDA applications as outlined in the relevant?FDA guidance. The new contract will?establish new “standards”?that may be used to enhance specificity and sensitivity across industry assay methods for generic drugs, such as such as teriparatide, exenatide, liraglutide and tirzepatide. More information regarding this contract award can be found on our website: https://lnkd.in/gcM2pMHF