Characterization assays are part of every drug development and manufacturing process to inform a level of safety and efficacy while meeting regulatory requirements before patient administration. However, the development and production of cell and gene therapies (CGTs) is highly variable and presents unique challenges in characterization. We wanted to understand how current CGT developers are grappling with these new hurdles for this newer class of drugs. This included understanding their current workflows, focus areas of therapeutic development, what attributes they measure, how it is measured, and their satisfaction with their current tools.
Mission Bio developed a survey targeting CGT developers and consisted of questions around their current drug programs. The survey specifically focused on their analytical characterization strategies, motivations, and satisfaction level. Highlights include:
- 40% admit their analytical characterization assays are not sufficient for determining CQAs
- 56% feel dissatisfied with their characterization approach
- 81% agree better characterization would reduce risk of holds
Download The cell and gene therapy characterization survey report to learn more.
