Emerging Therapies Test Existing Bioanalytical Methods

April 15, 2019
Valerie Theobald, Jenifer Vija, Jessica St. Charles, Christina Satterwhite, PhD
Volume 2019 eBook, Issue 1
Page Number: 22–26

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.

Read this article in BioPharm International's Outsourcing Resources 2019 eBook.

Article Details

BioPharm International
eBook: Outsourcing Resources 2019
April 2019
Pages: 22–26


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).