Tangential flow filtration device for perfusion applications

a filtration device and perfusion technology, applied in the field of tangential flow filtration devices for perfusion applications, can solve the problems of relatively short lifespan of filter elements used in such conventional systems and processes, and significantly reduced sieving at low harvest throughput, and achieve the effect of improving sieving

Inactive Publication Date: 2020-05-07
MILLIPORE CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0012]Perfusion processes of the present invention can provide for improved sieving over conventional perfusion processes involving open-channel filtration devices. In some embodiments, at least about 80%, at least about 90%, or at least about 95% of the target proteins can be recovered from the liquid feed at a harvest throughput of at least about 500 L / m2 of the filter element. In other embodiments, at least about 80%, at least about 90%, or at least about 95% of the target proteins can be recovered from the liquid feed at a harvest throughput of at least about 1000 L / m2 of the filter element.

Problems solved by technology

However, filter elements used in such conventional systems and processes have relatively short lifespans, exhibiting significantly reduced sieving at low harvest throughputs due to membrane fouling.

Method used

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  • Tangential flow filtration device for perfusion applications
  • Tangential flow filtration device for perfusion applications
  • Tangential flow filtration device for perfusion applications

Examples

Experimental program
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Effect test

example 1

of Feed Spacer Screens

[0088]A modeling study was carried out to evaluate the effects of feed screen parameters on shear rates. The geometry of each of three feed screens was generated for the model using the parametric geometry function in Autodesk Inventor (Autodesk, Inc. Boston, Mass.). The modeled feed screens included: (1) C-screens (Propyltex® screens, Sefar, QC, Canada) having a two-over-one twill pattern, an open area of 32%, a fiber density of 16.2 fibers / cm, fiber diameter of 270 μm, and a thickness of 515 μm; (2) D-screens (Propyltex® screens, Sefar, QC, Canada) having a two-over-one twill pattern, an open area of 36%, a fiber density of 12.2 fibers / cm, fiber diameter of 340 μm, and a thickness of 610 μm; and (3) D3-screens (Propyltex® screens, Sefar, QC, Canada) having a two-over-one twill pattern, an open area of 39%, a fiber density of 10.6 fibers / cm, fiber diameter of 360 μm, and a thickness of 645 μm. FIG. 4A illustrates a simulation of the D3 woven fiber feed spacer ...

example 2

n of Model Results with Experimental Results

[0091]Two prototype filter elements were created, each including a single filter element sheet arranged in Pellicon® 3 micro plate and frame format. Both filter element sheets included a 0.65 micron Durapore® membrane. One filter element sheet contained a D-screen feed spacer and the other contained a D3-screen feed spacer. The filter elements underwent testing in an AKTAcrossflow™ system (GE Healthcare Lifesciences, Marlborough, Mass.) with a cell culture solution containing CHO-S cells in a density of 30-60 million cells per milliliter in CHO Cellvento™ 110 media. Feed, retentate and permeate flow were controlled during the experiments and feed pressure measurements were obtained, as shown in FIG. 6. Obtained experimental feed pressures were compared with those of modeled devices using corresponding retentate and permeate pressure values. As shown in FIG. 6, the results of the modeled devices correlated well with feed pressure values as ...

example 3

f Filter Elements and Pumps

[0092]Six different cell retention systems (i.e., perfusion systems) were evaluated, including four systems having commercially available filter elements, and four systems having prototype filter elements. The systems included:

[0093](1) XCell™ ATF-2 system (Repligen, Waltham, Mass.) with diaphragm pump and a 0.13 m2, 0.2 micron PES hollow fiber filter element. The system was operated in alternating flow mode under recommended cross-flow rates.

[0094](2) XCell™ ATF-2 system with diaphragm pump and a 0.13 m2, 0.5 micron PES hollow fiber filter element. The system was operated in alternating flow mode under recommended cross-flow rates.

[0095](3) Magnetic levitation pump (Levitronix®) and 0.13 m2, 0.5 micron PES hollow fiber filter element. The system was operated in recirculation mode under recommended cross-flow rates.

[0096](4) Peristaltic pump (Watson Marlow) and Prostak™ cassette (MilliporeSigma, Billerica, Mass.) with 0.06 m2, 0.22 micron PVDF membrane. Th...

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Abstract

Filter elements (20, 100) for perfusion systems and methods are provided. A filter element sheet includes a microporous membrane (63, 112) having a mean pore size of at least about 0.65 μm and a feed spacer (25, 120) comprising woven fibers and having an open area of at least about 35%. The filter element sheet can be arranged within a filter element, for example, in a spiral-wound format or in a cassette format. A perfusion system includes at least one filter element and a pump configured to control flow of a liquid feed through the at least one filter element.

Description

RELATED APPLICATION(S)[0001]This application claims the benefit of U.S. Provisional Application No. 62 / 513,793, filed on Jun. 1, 2017. The entire teachings of the above application are incorporated herein by reference.BACKGROUND[0002]Monoclonal antibodies (mAbs) are used as therapeutic agents for a variety of indications, including, for example, cancer, transplant rejections, and cardiovascular disease. Various biopharmaceutical manufacturing techniques exist to produce and harvest mAbs from host cells, including, for example, fed-batch processes and perfusion processes. In fed-batch bioreactor systems, cells are cultured in batches over a set period of time, for example, over about seven to about twenty-one days, after which point media nutrients have been consumed by the host cells and waste products have accumulated. Following the cell culture period, the batch undergoes a harvesting step in which the protein of interest (e.g., a product, such as a monoclonal antibody, or mAb) is...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): B01D63/10C12M1/00
CPCB01D65/08B01D63/103C12M29/04B01D2313/143B01D61/18B01D2311/04B01D2311/06C12M29/10B01D2315/10B01D65/02B01D63/10C07K1/34C12M33/14C12M47/10B01D63/082B01D2311/25B01D2313/243B01D2325/02
Inventor DUPONT, ALISON
Owner MILLIPORE CORP
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