Opportunities and Limitations of Disposable Technologies in Biopharmaceutical Processes

Brod, Helmut; Vester, Andrea; Kauling, Jörg

doi:10.1002/cite.201100229

Cited by 21 publications

(4 citation statements)

References 4 publications

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“…A wide range of different reactor sizes, starting with disposable screening systems in microliter scale, up to bioreactors with capacities of several cubic meters are on the market [3]. Available cultivation systems and their applications are described in several review articles [2,3,6,7]. …”

Section: Introductionmentioning

confidence: 99%

“…For instance, it is not possible to keep geometric similarity between a stirrer made of stainless steel and a disposable stirrer, due to the reduced strength and rigidity of the disposable polymer material. New agitation concepts for disposable bioreactors are desired to simplify their design and make them more cost-efficient [6]. Surface aerated reactors without complex built-in components fulfil the requirement for a cost-efficient reactor design [9].…”

Section: Introductionmentioning

confidence: 99%

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Correlation between mass transfer coefficient kLa and relevant operating parameters in cylindrical disposable shaken bioreactors on a bench-to-pilot scale

Klöckner

Gacem

Anderlei³

et al. 2013

J Biol Eng

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BackgroundAmong disposable bioreactor systems, cylindrical orbitally shaken bioreactors show important advantages. They provide a well-defined hydrodynamic flow combined with excellent mixing and oxygen transfer for mammalian and plant cell cultivations. Since there is no known universal correlation between the volumetric mass transfer coefficient for oxygen kLa and relevant operating parameters in such bioreactor systems, the aim of this current study is to experimentally determine a universal kLa correlation.ResultsA Respiration Activity Monitoring System (RAMOS) was used to measure kLa values in cylindrical disposable shaken bioreactors and Buckingham’s π-Theorem was applied to define a dimensionless equation for kLa. In this way, a scale- and volume-independent kLa correlation was developed and validated in bioreactors with volumes from 2 L to 200 L. The final correlation was used to calculate cultivation parameters at different scales to allow a sufficient oxygen supply of tobacco BY-2 cell suspension cultures.ConclusionThe resulting equation can be universally applied to calculate the mass transfer coefficient for any of seven relevant cultivation parameters such as the reactor diameter, the shaking frequency, the filling volume, the viscosity, the oxygen diffusion coefficient, the gravitational acceleration or the shaking diameter within an accuracy range of +/− 30%. To our knowledge, this is the first kLa correlation that has been defined and validated for the cited bioreactor system on a bench-to-pilot scale.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Correlation between mass transfer coefficient kLa and relevant operating parameters in cylindrical disposable shaken bioreactors on a bench-to-pilot scale

Klöckner

Gacem

Anderlei³

et al. 2013

J Biol Eng

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“…Of course, more waste is generated by using SU equipment, not only from the SU elements themselves but particularly from the packaging material. Moreover, SU equipment is limited in size, i.e., the maximum size of a commercially available SU fermenter is 2,000 l (Brod et al, 2012).…”

Section: Single-use-technologymentioning

confidence: 99%

Developing the biofacility of the future based on continuous processing and single-use technology

Klutz

Magnus

Lobedann

et al. 2015

Journal of Biotechnology

143

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“…Commercially available bioreactors are limited to 2000 L reactor volume . In addition, disposable downstream equipment is size limited as well (for instance disposable chromatography columns are only commercially available up to 20 L column volume) . A bioreactor harvest of over 2000 L cannot be handled using disposable technology unless continuous operation is employed.…”

Section: Introductionmentioning

confidence: 99%

Continuous cell flocculation for recombinant antibody harvesting

Burgstaller

Krepper

Haas

et al. 2017

J of Chemical Tech & Biotech

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BACKGROUNDIntegrated continuous production technology is of great interest in biopharmaceutical industry. Efficient, flexible and cost effective methods for continuous cell removal have to be developed, before a fully continuous and integrated product train can be realized. The paper describes the development and testing of such an integrated continuous and disposable set‐up for cell separation by flocculation combined with depth filtration.RESULTSScreening of multiple flocculation agents, depth filters, and conditions demonstrated that the best performance was obtained with 0.0375% polydiallyldimethylammonium chloride (pDADMAC; a polycationic flocculation agent) in combination with Clarisolve® depth filters. Using this set‐up, a 4‐fold decrease of filtration area was achieved relative to standard filtration without flocculation, with yields of ≥97% and DNA depletion of up to 99%. Continuous operation was accomplished using a simple tubular reactor design with parallelization of the filtration. The reactor length was selected to allow a 13.2‐min residence time, which was sufficient to complete flocculation in batch experiments. Continuous flocculation performance was monitored on‐line using focused beam reflectance measurement. Filter switch cycles based on upstream pressure were controlled by in‐line pressure sensors, and were stable from one filter to the next.CONCLUSIONIt was demonstrated that stable and efficient continuous flocculation associated with depth filtration can be easily accomplished using tubular reactors and parallelization. Continuous cell separation is essential for the development of fully continuous integrated process trains. This cost‐efficient disposable design run in continuous mode significantly reduces facility foot print, process costs and enables great flexbility. © 2017 The Authors. Journal of Chemical Technology & Biotechnology published by John Wiley & Sons Ltd on behalf of Society of Chemical Industry.

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Opportunities and Limitations of Disposable Technologies in Biopharmaceutical Processes

Cited by 21 publications

References 4 publications

Correlation between mass transfer coefficient kLa and relevant operating parameters in cylindrical disposable shaken bioreactors on a bench-to-pilot scale

Correlation between mass transfer coefficient kLa and relevant operating parameters in cylindrical disposable shaken bioreactors on a bench-to-pilot scale

Developing the biofacility of the future based on continuous processing and single-use technology

Continuous cell flocculation for recombinant antibody harvesting

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