TY - JOUR
T1 - Recent advances to accelerate purification process development
T2 - A review with a focus on vaccines
AU - Keulen, Daphne
AU - Geldhof, Geoffroy
AU - Bussy, Olivier Le
AU - Pabst, Martin
AU - Ottens, Marcel
PY - 2022
Y1 - 2022
N2 - 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.
AB - 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.
KW - Artificial intelligence
KW - Chromatography
KW - Downstream processing
KW - Model-based high throughput process development
KW - Vaccine purification processes
UR - http://www.scopus.com/inward/record.url?scp=85132737473&partnerID=8YFLogxK
U2 - 10.1016/j.chroma.2022.463195
DO - 10.1016/j.chroma.2022.463195
M3 - Article
AN - SCOPUS:85132737473
SN - 0021-9673
VL - 1676
JO - Journal of Chromatography A
JF - Journal of Chromatography A
M1 - 463195
ER -