title: Rational and systematic protein purification process development: the next generation.
abstract: Current biopharmaceutical manufacturing strongly relies on using purification platform processes, offering harmonization of practices and speed-to-market. However, the ability of such processes to respond quickly to anticipated higher quality and capacity demands is under question. Here, we describe novel approaches for purification process development that incorporate biothermodynamics, modern high throughput experimentation and simulation tools. Such development leads to production platform-specific databases containing thermodynamic protein descriptors of major host cell proteins over a range of experimental conditions. This will pave the way for in silico purification process development, providing better process understanding and the potential to respond quickly to product quality and market demands. Future efforts will focus on improving this field further and enabling more rationale in process development.
authors.affiliation: Department of Biotechnology, Delft University of Technology, 2628 BC Delft, the Netherlands.
authors.forename: Beckley K
authors.initials: BK
authors.lastname: Nfor
authors.forename: Peter D E M
authors.initials: PD
authors.lastname: Verhaert
authors.forename: Luuk A M
authors.initials: LA
authors.lastname: van der Wielen
authors.forename: Jürgen
authors.initials: J
authors.lastname: Hubbuch
authors.forename: Marcel
authors.initials: M
authors.lastname: Ottens
mesh_terms: D001688:Biological Products / Q000302:isolation & purification*; D001709:Biotechnology / Q000379:methods*; D011506:Proteins / Q000302:isolation & purification*; D013678:Technology, Pharmaceutical / Q000379:methods*
chemical_list: D001688:Biological Products; D011506:Proteins