Cell and Gene Therapy: Meeting Regulatory Requirements for Lentiviral Vectors

Lentiviral vectors are important gene delivery tools for cell and gene therapies, notably chimeric antigen receptor T-cell (CAR-T cell) therapies which have proven successful in treating a growing list of blood cancers. However, using Lentiviral vectors requires comprehensive drug substance and product testing to ensure potency, stability, identity, and purity. Furthermore, multiple safety assays are required to meet regulatory requirements, such as testing for the replication-competent virus. In addition, the testing requirements for cell and gene therapies evolve as regulators, testing organizations, and drug developers apply recent learnings to guide future strategies. Therefore, it can be advantageous to work with a testing organization that can provide a comprehensive service from the early stages of drug development through to clinical trials, supporting research, clinical, and commercial GMP material.

In this GEN webinar, our distinguished presenter, Patricia McDuffie, will discuss the regulatory requirements and challenges of bringing new Lentiviral vector-based cell and gene therapies to market. Additionally, we will learn about a unique Lentiviral vector testing panel that supports customers through their therapeutic development journey and the benefits of working with a single service for the manufacturing and testing process.

A live Q&A session followed the presentation, offering a chance to pose questions to our expert panelist.