What Is The Best Way To Manufacture Lentiviral Vectors For Cell And Gene Therapies?

In the field of cell and gene therapy, there are two main types of viral vectors: adeno associated virus (AAV) and Lentivirus (LV). The manufacture of these vectors is dependent on the regulatory requirements dictated by its end use. AAVs are most commonly used to deliver gene therapies – meaning they will be administered directly to a patient. In contrast, LV is typically used as an input material to genetically modify cells used for cell therapies (e.g. CAR-Ts) and is not included in the final product delivered to the patient.

In this post we will focus on LV because of its importance in the manufacture of cellular immunotherapies (e.g. CAR-Ts). However, many of the same considerations will apply to AAV manufacturing as well.

Today, clinical and commercial-scale processes for the manufacture of LV remain based on methods adapted from the basic research laboratory. Each of step requires optimization to allow for process scale-up and maximal recovery of functional virus, free of contaminants. The main challenge for optimization is how to effectively translate protocols that are reliable and reproducible at small scale to a scale compatible with commercial product manufacture.

This blog outlines the challenges for optimization of scaled-up LV manufacturing processes and new technologies being used to solve these challenges.