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Drug developers must understand the complex bioanalytical assays for cell- and gene-therapy drug development programs and ensure that partners have the specialized expertise needed for complex therapeutic classes.
Gene and cell-therapy drugs in development require both novel and conventional test methods within the regulated bioanalytical space. Current FDA guidance, however, provides little direction on how to approach assay development and validation for these emerging technologies. In addition, the authors note that there is limited guidance for the application of more familiar technologies to gene-therapy applications.
The authors review key methods and complex assays that developers of gene and cell therpies should undertstand to accurately assess the drugs in development. They also explore the expertise that is need to expedite these highly complex therapeutic classes.
eBook: Outsourcing Resources 2019
When referring to this article, please cite it as C. Satterwhite, et.al., "Emerging Therapies Test Existing Bioanalytical Methods," BioPharm International's Outsourcing Resources eBook (April 2019).