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Carbonell, Ruben G.

Fan, Jinxin

Linova, Marina Y.

Menegatti,, Stefano

Pham, Dan N.

Sripada, Sobhana A.

Tiago Gomes Martins, Edite M.

Woodley, John M.

English

Engineering Conferences International

 Poster Number 34 TOWARDS IMPLEMENTATION OF NOVEL SINGLE-USE DEVICES IN INTEGRATED PROCESSES FOR BIOPHARMACEUTICALS   Marina Y. Linova, Department of Chemical and Biochemical Engineering, Technical University of Denmark  marlin@kt.dtu.dk Edite M. Tiago Gomes Martins, Department of Chemical and Biochemical Engineering, Technical University of Denmark Dan N. Pham, Department of Chemical and Biochemical Engineering, Technical University of Denmark Jinxin Fan, Department of Chemical and Biomolecular Engineering, North Carolina State University Sobhana A. Sripada, Department of Chemical and Biomolecular Engineering, North Carolina State University Stefano Menegatti, Department of Chemical and Biomolecular Engineering, North Carolina State University Ruben G. Carbonell, Department of Chemical and Biomolecular Engineering, North Carolina State University and Biomanufacturing Training and Education Center (BTEC), North Carolina State University  John M. Woodley, Department of Chemical and Biochemical Engineering, Technical University of Denmark   Key Words: protein recovery, protein removal, protein capture, single-use devices, process development, in-situ product removal  Depending on how labile therapeutic proteins are they can be difficult to manufacture in traditional fed-batch processes due to their unstable nature, unfavorable upstream conditions, and degradation by host cell proteases1,2. Integration of the protein capture step with the upstream process, in a continuous or semi-continuous operation, could offer a solution by rapidly recovering the target product or removing unwanted impurities in a flow-through mode. In this context, single-use devices for protein capture, such as membrane chromatography devices and functionalized chromatography resins, are attractive tools suitable for such processes3,4. We investigate new strategies for the evaluation of novel single-use devices for their implementation in an integrated process, bridging the gap between the device development and process development.   We evaluate to what degree membrane chromatography devices and functionalized chromatography resins could accommodate different upstream processes with respect to media composition, the presence of compounds interfering with protein binding, as well as the lifetime of the devices. A key element of the ongoing work is to establish new feasible process development approaches, which do not require the production of a large number of single-use devices but still provide an insight into the integration of protein recovery and impurities removal directly from the fermentation process. Therefore, scale-down fermentation systems have been used in the experimental work, as well as microcultivations for holistically optimizing fermentation and binding conditions specifically for resin-based capture technologies.        1. Vázquez-Rey, M. & Lang, D. A. Aggregates in monoclonal antibody manufacturing processes. Biotechnology and Bioengineering vol. 108 1494–1508 (2011). 2. Sinha, J., Plantz, B. A., Inan, M. & Meagher, M. M. Causes of proteolytic degradation of secreted recombinant proteins produced in methylotrophic yeast Pichia pastoris: Case study with recombinant ovine interferon-τ. Biotechnology and Bioengineering 89, 102–112 (2005). 3. Jungbauer, A. Continuous downstream processing of biopharmaceuticals. Trends in Biotechnology vol. 31 479–492 (2013). 4. Zydney, A. L. Continuous downstream processing for high value biological products: A Review; Continuous downstream processing for high value biological products: A Review. Biotechnol. Bioeng 113, 465–475 (2016).  

Towards implementation of novel single-use devices in integrated processes for biopharmaceuticals

https://dc.engconfintl.org/cgi/viewcontent.cgi?filename=0&article=1067&context=biomanufact_v&type=additional

Towards implementation of novel single-use devices in integrated processes for biopharmaceuticals

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Engineering Conferences International