Publication type: Conference other
Type of review: Peer review (abstract)
Title: Comparison of stirred single-use bioreactors : case study of an IgG production process
Authors: Schirmer, Cedric
Kienle, Klaus
et. al: No
Conference details: BioTech 2019 : Biopharmaceutical Manufacturing and Single-Use Technologies, Wädenswil, 2-4 July 2019
Issue Date: Jul-2019
Language: English
Subject (DDC): 660: Chemical engineering
Abstract: Today, the benefits of single-use (SU) technologies for upstream processing are much more prevalent and heavily adopted within the biopharmaceutical industry. Pall has developed the Allegro™ STR stirred single-use bioreactor family which is currently available in 4 sizes: STR 50, STR 200, STR 1000, and STR 2000 (Figure 1). The direct-bottom mechanically driven impeller allows a large range of power inputs from 0.002 W/kg up to 0.3 W/kg, while the macro sparger seated below the three 45-degree elephant ear blades results in high oxygen transfer rates (kLa up to 40 h-1) and short mixing times (minimum tM~10 s). Previous studies highlighted that the critical parameters to be kept constant from one scale to another are the volumetric power input (P/V) for agitation and the superficial gas velocity (vs) for aeration. This will successfully scale up a process at a constant kLa, keeping equivalent mixing time and shear stress environment in the bioreactor. In this case study the stirred SU bioreactor Allegro STR 200 from PALL has been tested and compared against a conventional, cylindrically shaped SU 200 L bioreactor regarding the growth and the monoclonal antibody production (mAb) of a Chinese hamster ovary (CHO) cell line in a chemically defined, animal‐derived component-free (ADCF) medium optimized for high‐yield protein production with a fed‐batch process intended for use in combination with specific feed supplements. Comparable results could be achieved in both stirred bioreactors. The average peak cell density at the end of the growth phase was 2.15·107 cells·mL-1, which correlated with a decrease in viability. The specific growth rate during the exponential growth phase was 0.028 h-1. As expected, the mAb titer increased to an average level of 2.18 g·L-1 at the culture harvest and only small amounts of aggregates or low molecular weight species were found. This allows to conclude, that the shear stress acting on the cells under the selected process parameters does not impair the mAb quality in the AllegroTM STR 200.
Fulltext version: Published version
License (according to publishing contract): Not specified
Departement: Life Sciences and Facility Management
Organisational Unit: Institute of Chemistry and Biotechnology (ICBT)
Appears in Collections:Publikationen Life Sciences und Facility Management

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