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Hollow fiber countercurrent dialysis for continuous buffer exchange of high‐value biotherapeutics
Author(s) -
Yehl Christopher J.,
Jabra Mario G.,
Zydney Andrew L.
Publication year - 2018
Publication title -
biotechnology progress
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.572
H-Index - 129
eISSN - 1520-6033
pISSN - 8756-7938
DOI - 10.1002/btpr.2763
Subject(s) - buffer (optical fiber) , countercurrent exchange , chromatography , diafiltration , chemistry , biomanufacturing , dialysis , batch processing , filtration (mathematics) , process engineering , membrane , computer science , mathematics , medicine , telecommunications , biochemistry , physics , statistics , biology , engineering , thermodynamics , programming language , microfiltration , genetics
Buffer exchange, desalting, and formulation of high‐value biotherapeutics are currently performed using batch diafiltration (DF); however, this type of tangential flow filtration process may be difficult to implement as part of a fully continuous biomanufacturing process. The objective of this study was to explore the potential of using countercurrent dialysis for continuous protein formulation and buffer exchange. Experiments were performed using concentrated solutions of immunoglobuin G (IgG) with commercially available hollow fiber dialyzers having 1.5 and 1.8 m 2 membrane surface area. More than 99.9% buffer exchange was obtained over a range of conditions, as determined from the removal of a model impurity (vitamin B 12 ). The dialyzers were able to process more than 0.5 kg of IgG per day in an easily scalable low‐cost process. In addition, buffer requirements were less than 0.02 L of buffer per gram IgG, which is several times less than that used in current batch DF processes. These results clearly demonstrate the potential of using low‐cost hollow fiber dialyzers for buffer exchange and product formulation in continuous bioprocessing. © 2018 American Institute of Chemical Engineers Biotechnol. Prog ., 35: e2763, 2019.