Commercial-scale manufacture of lentivirus for ex vivo and in vivo therapies

Cell & Gene Therapy Insights 2024; 10(5), 551–563

DOI: 10.18609/cgti.2024.067

Published: 4 June
Innovator Insight
Rachel Legmann, Michelle Yen Tran

As the field of lentivirus progresses toward large-scale manufacturing to generate sufficient and affordable functional lentiviruses for treating patients, scalability and consistency are important aspects to consider. A KrosFlo® Tangential Flow Depth Filtration (TFDF®) perfusion system that is adapted to the fragility of envelope viruses can be scaled to industrial-size production bioreactors where the lentiviruses are harvested continuously and passed onto the capture step of downstream purification, greatly reducing process hold time and rendering less loss of functionality. This article presents case study data to show how TFDF enables a functional titer entrancement and scalable perfusion process that can provide sufficient lentivirus doses for large patient populations at affordable cost.