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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 vaccine is available to date. A promising class of vaccines are virus-like particles (VLPs), which were shown to be very effective for the prevention of other diseases. In this study, production of HI-VLPs using different 293F cell lines, followed by a three-step purification of HI-VLPs, was conducted. The quality-by-design-based process development was supported by process analytical technology (PAT). The HI-VLP concentration increased 12.5-fold while >80% purity was achieved. This article reports on the first general process development and optimization up to purification. Further research will focus on process development for polishing and formulation up to lyophilization. In addition, process analytical technology and process modeling for process automation and optimization by digital twins in the context of quality-by-design framework will be developed.
Metadaten
Author:Heribert Helgers, Alina Hengelbrock, Axel Schmidt, Jamila Rosengarten, Jörn Stitz, Jochen Strube
URN:urn:nbn:de:hbz:832-epub4-19573
DOI:https://doi.org/10.3390/pr10020419
ISSN:2227-9717
Parent Title (English):Processes
Publisher:MDPI
Editor:Krist V. Gernaey
Document Type:Article
Language:English
Date of first Publication:2022/02/21
Date of Publication (online):2022/05/10
GND-Keyword:Digitaler Zwilling; HIV; Prozessoptimierung; Virus-like particles
Tag:Digital Twin; Process Analytical Technology (PAT); Process Optimization; Virus-like Particles (VLPs); human immunodeficiency virus (HIV)
Volume:10
Issue:2
Article Number:419
Page Number:22
Institutes:Angewandte Naturwissenschaften (F11)
Dewey Decimal Classification:600 Technik, Medizin, angewandte Wissenschaften
Open Access:Open Access
DeepGreen:DeepGreen
Licence (German):License LogoCreative Commons - CC BY - Namensnennung 4.0 International