Activated carbon for the removal of leachables and/or extractables

Patent metadata

Field	Value
Publication number	US-10793592-B2
Application number	US-201515524824-A
Country	US
Kind code	B2
Filing date	Oct 20, 2015
Priority date	Nov 6, 2014
Publication date	Oct 6, 2020
Grant date	Oct 6, 2020

Abstract

The present invention relates to the purification of target molecules like recombinant and/or biotherapeutic proteins. Activated carbon can be used to remove leachables and/or extractables resulting from disposable equipment employed in the process.

First claim

The invention claimed is:

1. A method for purifying a target molecule comprising:
separating a target molecule from leachables and/or extractables by contacting a liquid comprising the target molecule and leachables and/or extractables with activated carbon, wherein said leachables and/or extractables are removed from said liquid by said activated carbon,
wherein said target molecule is a protein with a molecular weight of 10,000 or more, and
wherein the activated carbon is an activated carbon obtained by pyrolysis of a synthetic, chemically defined organic polymeric material.

2. The method according to claim 1 , wherein said target molecule is a glycoprotein.

3. The method according to claim 1 , wherein said target molecule is an antibody.

4. The method according to claim 1 , wherein the leachables and/or extractables are one or more of the following components: Acetaldehyde, Toluene, 2-Hexanone, Acetone, 2-Butanone, Ethyl Acetate, Bisphenol A, Benzyl alcohol, Trimethyl Silanol, Formaldehyde, Bis (2-ethylhexyl) phthalate, 1-Methylethyl ester acetic acid, 2,4-di-t-butyl Phenol, 2-Octanone, 2-Pentanone, 3,3-dimethyl-2-Butanone, 3-ethoxy-Propane, 3-Hexanone, 3-Methoxy-1-butanol, Butanal, Cyclohexanone, Ethanol, formic acid, Heptaethylene glycol, Hexanal, Methyl isobutyl ketone, Pentanal, t-Butanol, Tetrahydrofuran, Methyl formate.

5. The method according to claim 1 , wherein the contact of the target molecule with the activated carbon is carried out at a pH between 3 to 9.

6. The method according to claim 1 , wherein the activated carbon has a medium particle size between 5 and 40 μm.

7. The method according to claim 1 , wherein the target molecule is separated from leachables and/or extractables by filtration through one or more filters comprising said activated carbon.

8. The method according to claim 1 , wherein said method is used hit a production and/or purification process comprising one or more of the following steps:
Cell culture in a bioreactor,
Clarification,
Chromatographic purification, and
Filtration.

9. The method according to claim 1 , wherein the target molecule is contacted with the activated carbon after a process step in which disposable equipment is used in combination with a temperature above 25° C. and/or mechanical deformation of the disposable equipment and/or in which the residence time of the target molecule in the disposable equipment is more than 1 hour.

10. The method according to claim 1 , wherein the liquid is contacted with the activated carbon in a filtration device.

11. The method according to claim 1 , wherein the activated carbon has a surface area of 10 to 10 000 m 2 /g.

12. The method according to claim 1 , wherein the activated carbon has a surface area of 100 to 5000 m 2 /g.

13. The method according to claim 1 , wherein the activated carbon has a surface area of 1000 to 2000 m 2 /g.

14. The method according to claim 1 , wherein the proportion of activated carbon having a particle size range of 5 to 40 μm is at least 90% by weight.

15. The method according to claim 1 , wherein the proportion of activated carbon having a particle size range of 5 to 40 μm is at least 95% by weight.

16. The method according to claim 1 , wherein the proportion of activated carbon having a particle size range of 5 to 40 μm is at least 98% by weight.

17. The method according to claim 1 , wherein the organic polymeric material is polystyrene, polyamide, polycarbonate, polymethylpentene, polyethylene, polyester, polyvinyl or polypropylene.

18. The method according to claim 1 , wherein the organic polymeric material is polystyrene.

19. A method for purifying a target molecule comprising:
separating a target molecule from leachables and/or extractables by contacting a liquid comprising the target molecule and leachables and/or extractables with activated carbon, wherein said leachables and/or extractables are removed from said liquid by said activated carbon,
wherein said leachables and/or extractables are impurities within said liquid that result from equipment employed in a production or purification process,
wherein said target molecule is a protein with a molecular weight of 10,000 or more, and
wherein the activated carbon is an activated carbon obtained by pyrolysis of a synthetic, chemically defined organic polymeric material.

20. The method according to claim 19 , wherein said leachables and/or extractables result from use of disposable equipment in a production or purification process.

Assignees

• Merck Patent Gmbh

Inventors

• Skudas Romas
• Adrian Klaus
• EDLEMANN Bianca
• Andrecht Sven
• Moya Wilson

Classifications

• B01D39/2055

  Carbonaceous material (solid sorbent compositions comprising free carbon B01J20/20) · CPC title

• B01D15/00 Primary

  Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor · CPC title

• C07K1/34

  by filtration, ultrafiltration or reverse osmosis · CPC title

• C07K1/22 Primary

  Affinity chromatography or related techniques based upon selective absorption processes · CPC title

• B01J20/20

  comprising free carbon; comprising carbon obtained by carbonising processes · CPC title