Print Email Facebook Twitter Recent advances to accelerate purification process development Title Recent advances to accelerate purification process development: A review with a focus on vaccines Author Keulen, D. (TU Delft BT/Bioprocess Engineering) Geldhof, Geoffroy (GSK Vaccines, Rixensart) Bussy, Olivier Le (GSK Vaccines, Rixensart) Pabst, Martin (TU Delft BT/Environmental Biotechnology) Ottens, M. (TU Delft BT/Design and Engineering Education) Date 2022 Abstract The safety requirements for vaccines are extremely high since they are administered to healthy people. For that reason, vaccine development is time-consuming and very expensive. Reducing time-to-market is key for pharmaceutical companies, saving lives and money. Therefore the need is raised for systematic, general and efficient process development strategies to shorten development times and enhance process understanding. High throughput technologies tremendously increased the volume of process-related data available and, combined with statistical and mechanistic modeling, new high throughput process development (HTPD) approaches evolved. The introduction of model-based HTPD enabled faster and broader screening of conditions, and furthermore increased knowledge. Model-based HTPD has particularly been important for chromatography, which is a crucial separation technique to attain high purities. This review provides an overview of downstream process development strategies and tools used within the (bio)pharmaceutical industry, focusing attention on (protein subunit) vaccine purification processes. Subsequently high throughput process development and other combinatorial approaches are discussed and compared according to their experimental effort and understanding. Within a growing sea of information, novel modeling tools and artificial intelligence (AI) gain importance for finding patterns behind the data and thereby acquiring a deeper process understanding. Subject Artificial intelligenceChromatographyDownstream processingModel-based high throughput process developmentVaccine purification processes To reference this document use: http://resolver.tudelft.nl/uuid:1f7a8bbb-4cfa-4153-8b68-14a953211cda DOI https://doi.org/10.1016/j.chroma.2022.463195 ISSN 0021-9673 Source Journal of Chromatography A, 1676 Part of collection Institutional Repository Document type journal article Rights © 2022 D. Keulen, Geoffroy Geldhof, Olivier Le Bussy, Martin Pabst, M. Ottens Files PDF 1_s2.0_S0021967322003880_main.pdf 1.26 MB Close viewer /islandora/object/uuid:1f7a8bbb-4cfa-4153-8b68-14a953211cda/datastream/OBJ/view