System and method of applied radial technology chromatography
Assigneeemp Biotech GmbH
InventorsAlistair J. Hurst, Derek W. K. Levison
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Abstract
A system and method of applied radial technology chromatography using a plurality of beads is disclosed, with each bead comprising one or more pores therein having a diameter of about 250 Å to about 5000 Å, and each bead having an average radius between about 100 μm to about 250 μm. Also disclosed are processes for selecting beads for use in a radial flow chromatography column, and for purifying an unclarified feed stream using a radial flow chromatography column.
Claims44
A radial flow chromatography column system for purification of a particle of interest, wherein the particle is a virus or VLP, comprising:
- a radial flow chromatography column having a bed length of about 3 cm to about 50 cm,
- a plurality of beads packed in the radial flow chromatography column, and
- unclogged interstitial channels formed between the beads,
- wherein each bead comprises one or more pores, and each pore has a diameter of about 250 Å to about 5000 Å,
- wherein at least about 80% of the plurality of beads have a diameter of about 200 μm to about 500 μm,
- wherein the beads have an average radius R of about 100 μm to about 250 μm, and
- wherein the beads maintain their size and morphology under flow rates to 10 column volumes per minute,
- wherein the beads are monodisperse wherein all beads have a radius of ±about 10% of a targeted or labeled radius and smaller beads having a radius r<0.225 R have been removed prior to packing the column, and
- wherein the system provides for purifying a virus or VLP by direct filtration from an unclarified feed stream or crude biological feed stream.
A radial flow chromatography column system for purification of a particle of interest, wherein the particle is an IgG or IgM, comprising:
- a radial flow chromatography column having a bed length of about 3 cm to about 50 cm,
- a plurality of beads packed in the radial flow chromatography column, and
- unclogged interstitial channels formed between the beads,
- wherein each bead comprises one or more pores, and each pore has a diameter of about 250 Å to about 5000 Å,
- wherein at least about 80% of the plurality of beads have a diameter of about 200 μm to about 500 μm,
- wherein the beads have an average radius R of about 100 μm to about 250 μm, and
- wherein the beads maintain their size and morphology under flow rates to 10 column volumes per minute,
- wherein the beads are monodisperse wherein all beads have a radius of ±about 10% of a targeted or labeled radius and smaller beads having a radius r<0.225 R have been removed prior to packing the column, and
- wherein the system provides for purifying an IgG or IgM by direct filtration from an unclarified feed stream or crude biological feed stream.
A radial flow chromatography filtration system for isolating one or more particle of interest, wherein the particle of interest is a virus or VLP, comprising:
- a radial flow chromatography column having a bed length of about 3 cm to about 50 cm,
- a plurality of beads packed in the radial flow chromatography column,
- unclogged interstitial channels formed between the beads, and
- an unclarified feed stream comprising a plurality of particles;
- wherein each bead comprises one or more pores therein, and each pore has a diameter of about 250 Å to about 5000 Å,
- wherein at least about 80% of the plurality of beads have a diameter of about 200 μm to about 500 μm,
- wherein the beads have an average radius R of about 100 μm to about 250 μm,
- wherein the beads maintain their size and morphology under flow rates to 10 column volumes per minute,
- wherein the beads are monodisperse wherein all beads have a radius of ±about 10% of a targeted or labeled radius and smaller beads having a radius r<0.225 R have been removed prior to packing the column, and
- wherein the diameter of each of the interstitial channels is about 3 to about 10-fold larger than the largest particle in the unclarified feed stream.
A radial flow chromatography filtration system for isolating one or more particle of interest, wherein the particle of interest is an IgG or IgM, comprising:
- a radial flow chromatography column having a bed length of about 3 cm to about 50 cm,
- a plurality of beads packed in the radial flow chromatography column,
- unclogged interstitial channels formed between the beads, and
- an unclarified feed stream comprising a plurality of particles;
- wherein each bead comprises one or more pores therein, and each pore has a diameter of about 250 Å to about 5000 Å,
- wherein at least about 80% of the plurality of beads have a diameter of about 200 μm to about 500 μm,
- wherein the beads have an average radius R of about 100 μm to about 250 μm,
- wherein the beads maintain their size and morphology under flow rates to 10 column volumes per minute,
- wherein the beads are monodisperse wherein all beads have a radius of ±about 10% of a targeted or labeled radius and smaller beads having a radius r<0.225 R have been removed prior to packing the column, and
- wherein the diameter of each of the interstitial channels is about 3 to about 10-fold larger than the largest particle in the unclarified feed stream.
Dependencies are inferred from the claim text.