High throughput screening for membrane process development

Chandler, Martin; Zydney, Andrew L.

doi:10.1016/j.memsci.2004.03.011

Cited by 44 publications

(19 citation statements)

References 16 publications

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“…However, screening optimal process conditions can be time-consuming and tedious (as mentioned in Part I). Miniaturization and automation are bringing new tools and strategies to biotech process development for production of therapeutic proteins [10][11][12]. This protocol describes creation of a high-throughput process development (HTPD) approach using membrane chromatography.…”

Section: Introductionmentioning

confidence: 99%

High-Throughput Process Development: II. Membrane Chromatography

Rathore

Muthukumar

2014

Methods in Molecular Biology

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Membrane chromatography is gradually emerging as an alternative to conventional column chromatography. It alleviates some of the major disadvantages associated with the latter including high pressure drop across the column bed and dependence on intra-particle diffusion for the transport of solute molecules to their binding sites within the pores of separation media. In the last decade, it has emerged as a method of choice for final polishing of biopharmaceuticals, in particular monoclonal antibody products. The relevance of such a platform is high in view of the constraints with respect to time and resources that the biopharma industry faces today. This protocol describes the steps involved in performing HTPD of a membrane chromatography step. It describes operation of a commercially available device (AcroPrep™ Advance filter plate with Mustang S membrane from Pall Corporation). This device is available in 96-well format with 7 μL membrane in each well. We discuss the challenges that one faces when performing such experiments as well as possible solutions to alleviate them. Besides describing the operation of the device, the protocol also presents an approach for statistical analysis of the data that is gathered from such a platform. A case study involving use of the protocol for examining ion exchange chromatography of Granulocyte Colony Stimulating Factor (GCSF), a therapeutic product, is briefly discussed. This is intended to demonstrate the usefulness of this protocol in generating data that is representative of the data obtained at the traditional lab scale. The agreement in the data is indeed very significant (regression coefficient 0.99). We think that this protocol will be of significant value to those involved in performing high-throughput process development of membrane chromatography.

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Section: Introductionmentioning

confidence: 99%

High-Throughput Process Development: II. Membrane Chromatography

Rathore

Muthukumar

2014

Methods in Molecular Biology

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“…Recently, Chandler and Zydney have described one approach to this problem [23]. They used a custom manifold designed to connect individual wells of a standard 96-well filter plate to a sealed and pressurised solution reservoir.…”

Section: Introductionmentioning

confidence: 99%

An automated microscale technique for the quantitative and parallel analysis of microfiltration operations

Jackson

Liddell

Lye

2006

Journal of Membrane Science

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“…It can be seen that the 1 00 UEAV A cartridge performance is within 10% of the 10 00 UEAV cartridge, compared with 41% for the flat-sheet disc. Whilst the 25 mm diameter flat-sheet discs used in these experiments were smaller than the standard 47 mm discs, it was not anticipated that the smaller area would lead to an increase in the degree of variability in performance that have been reported with other small diameter discs (Chandler and Zydney, 2004;Jackson et al, 2006). This was indeed seen to be the case, as the variability in performance was relatively low and did not impact upon the performance prediction that could be made with the flat-sheet disc.…”

Section: Volume Throughput Predictions For Protein Solution Filtrationmentioning

confidence: 87%

“…Other studies (Chandler and Zydney, 2004;Jackson et al, 2006) have previously shown measurable differences in the performance of membrane taken from different locations within a manufactured roll. Thus it may be expected that reduced pleat levels lead to an increase in experimental variation.…”

Section: Effect Of Number and Distribution Of Membrane Pleats On Perfmentioning

confidence: 94%

“…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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High throughput screening for membrane process development

Cited by 44 publications

References 16 publications

High-Throughput Process Development: II. Membrane Chromatography

High-Throughput Process Development: II. Membrane Chromatography

An automated microscale technique for the quantitative and parallel analysis of microfiltration operations

Scale‐down prediction of industrial scale pleated membrane cartridge performance

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