Process Design and Optimization towards Digital Twins for HIV-Gag VLP Production in HEK293 Cells, including Purification

Despite great efforts to develop a vaccine against human immunodeficiency virus (HIV), which causes AIDS if untreated, no approved HIV is available date. A promising class of vaccines are virus-like particles (VLPs), were shown be very effective for the prevention other diseases. In this study, production HI-VLPs using different 293F cell lines, followed by three-step purification HI-VLPs, was conducted. The quality-by-design-based process development supported analytical technology (PAT). HI-VLP concentration increased 12.5-fold while >80% purity achieved. This article reports on first general and optimization up purification. Further research will focus polishing formulation lyophilization. addition, modeling automation digital twins in context quality-by-design framework developed.