Viral Vector gene therapy has been the focus of intense research driven by the safety profile and several clinical breakthroughs. As of March 2022, there are two viral vector gene therapies approved and many are in active clinical trials. The expected increase in demand for specific viral vectors still poses many challenges. The current talk tries to summarize the key aspects related to Research and development needs and Chemistry, Manufacturing and Control (CMC) efforts to help this growing demand. We will primarily discuss applying the different orthogonal bioanalytics to identify, monitor and control Critical Quality Attributes (CQAs) during the process development activity.

Learning Objectives:

1. Discuss different next generation bioanalytics applications.

2. Discuss unique challenges in implementing the new generation bioanalytics application.

3. Discuss and determining different Critical Quality Attributes (CQAs) for process development.