Sterilizing filtration—Principles and practice for successful scale-up to manufacturing

Rajniak, Pavol; Tsinontides, Stelios; Pham, David; Hunke, W.A.; Reynolds, Steven D.; Chern, R. T.

doi:10.1016/j.memsci.2008.07.049

Cited by 44 publications

(31 citation statements)

References 14 publications

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“…This would lead to an overestimation of 53% if the flat sheet were used to predict the performance of the large-scale cartridge. This level of error is identical to the measured flux reduction of 53% for a pleated polyvinylidene fluoride (PVDF) sterilizing grade membrane compared to a flat sheet (Rajniak et al, 2008), but better than a flux reduction of 70% measured for a pleated glass fibre cartridge (Wakeman et al, 2005). .…”

Section: Pleated Cartridge Clean Water Flux Measurementssupporting

confidence: 73%

“…It has previously been shown that pleating of a flat-sheet membrane before insertion into a cylindrical cartridge format affects performance when compared to the original flat-sheet membrane (Brown et al, 2009;Chandler and Zydney, 2004;Giglia and Yavorsky, 2007;Rajniak et al, 2008). Although the use of pleats leads to higher throughput performance (in terms of permeate flux or filter capacity) the relationship between area and throughput performance is not necessarily directly proportional (Brown et al, 2009).…”

Section: Introductionmentioning

confidence: 99%

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Scale‐down prediction of industrial scale pleated membrane cartridge performance

Brown

Titchener‐Hooker

Lye

2010

Biotech & Bioengineering

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Flat-sheet membrane discs represent the current standard format used for experimental prediction of the scale-up of normal flow filtration processes. Use of this format is problematic, however, since the scale-down results typically show a 40-55% difference in performance compared to large-scale cartridges depending upon the feedstock used. In this work, novel pleated scale-down devices (Am=1.51-15.1×10(-3) m2) have been designed and fabricated. It is shown that these can more accurately predict the performance of industrial scale single-use pleated membrane cartridges (Am=1.06 m2) commonly used within biopharmaceutical manufacture. The single-use scale-down cartridges retain the same pleat characteristics of the larger cartridges, but require a reduced feed volume by virtue of a substantially diminished number of active membrane pleats. In this study, a 1,000-fold reduction in feed volume requirement for the scale-down cartridge with the smallest membrane area was achieved. The scale-down cartridges were tested both with clean water and a pepsin protein solution, showing flux-time relationships within 10% of the large-scale cartridge in both cases. Protein transmission levels were also in close agreement between the different scale cartridges. The similarity in performance of the scale-down and the large-scale cartridges, coupled with the low feed requirement, make such devices an excellent method by which rapid scale-up can be achieved during early stage process development for biopharmaceutical products. This new approach is a significant improvement over using flat-sheet discs as the quantitative similarity in performance with the large-scale leads to reliable scale-up predictions while requiring especially small volumes of feed material.

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Section: Pleated Cartridge Clean Water Flux Measurementssupporting

confidence: 73%

Section: Introductionmentioning

confidence: 99%

Scale‐down prediction of industrial scale pleated membrane cartridge performance

Brown

Titchener‐Hooker

Lye

2010

Biotech & Bioengineering

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“…Membrane fouling manifests itself as a flux decline over time at constant operating conditions (Bottino et al ., 2000;Tolkach & Kulozik, 2006;Rajniak et al ., 2008). The decline in performance due to fouling is irreversible, which marks the transition from concentration polarization and requires cleaning to restore membrane performance (Chen et al ., 1997).…”

Section: Flux Behaviour In Pressure-driven Membrane Operationsmentioning

confidence: 99%

Principles of Membrane Filtration

Hausmann

Duke

Demmer³

2012

Membrane Processing

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“…Proper scale-up techniques using equipment representative to manufacturing is critical. 90 Understanding the need for cost-effective, robust sterile filtration, manufacturers have also developed new classes of composite and asymmetric membranes with higher throughput capacities. 91,92 High performance tangential flow filtration.…”

mentioning

confidence: 99%

Recovery and purification process development for monoclonal antibody production

Liu

Winter

et al. 2010

mAbs

463

411

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Sterilizing filtration—Principles and practice for successful scale-up to manufacturing

Cited by 44 publications

References 14 publications

Scale‐down prediction of industrial scale pleated membrane cartridge performance

Scale‐down prediction of industrial scale pleated membrane cartridge performance

Principles of Membrane Filtration

Recovery and purification process development for monoclonal antibody production

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