Cleaning agent, cleaning liquid, and cleaning method for reverse osmosis membrane
US-2017275571-A1 · Sep 28, 2017 · US
Compositions and methods for reducing bioburden in chromatography
US11369707B2 · US · B2
| Field | Value |
|---|---|
| Publication number | US-11369707-B2 |
| Application number | US-202117153205-A |
| Country | US |
| Kind code | B2 |
| Filing date | Jan 20, 2021 |
| Priority date | Jan 30, 2017 |
| Publication date | Jun 28, 2022 |
| Grant date | Jun 28, 2022 |
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- Title
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Abstract
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The invention provides methods for microbial bioburden reduction of various chromatography matrices, including bioburden reduction in the context of large-scale Protein A-based affinity chromatography columns.
First claim
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The invention claimed is: 1. A method for microbial bioburden reduction of a chromatography matrix comprising a spore forming bacteria, gram positive bacteria, gram negative bacteria, or a combination thereof, wherein the spore forming bacteria are Bacillus pseudofirmus , the gram positive bacteria are Microbacterium spp., and the gram negative bacteria are Stenotrophomonas maltophilia , comprising contacting the chromatography matrix with a composition comprising from about 4.0 M to about 12 M urea and benzyl alcohol for a period of at least about 30 minutes, wherein the contacting step reduces the amount of spore forming bacteria by at least 2 log 10 , reduces the amount of gram positive bacteria by at least 5 log 10 , or reduces the amount of gram negative bacteria by at least 5 log 10 in the chromatography matrix, wherein the composition does not comprise a peroxyacid or a peroxide. 2. The method of claim 1 , wherein the composition further comprises ethanol. 3. The method of claim 2 , wherein the composition comprises about 20% ethanol. 4. The method of claim 1 , wherein the composition comprises from about 1% to about 2% benzyl alcohol. 5. The method of claim 1 , wherein the contacting step reduces the amount of one or more of spore forming bacteria, gram positive bacteria, and gram negative bacteria, in the chromatography matrix, to below the limit of detection as determined by an assay selected from the group consisting of (1) a biofiltration assay, (2) microscopic bacterial staining, (3) IR/FTIR spectroscopy method, (4) a sterility test, and (5) a bacterial identification test. 6. The method of claim 1 , wherein the composition does not comprise acetic acid.
Assignees
Inventors
Classifications
- B01D15/203Primary
Equilibration or regeneration · CPC title
- A61L2/18Primary
Liquid substances · CPC title
of the antigen-antibody type, e.g. protein A, G or L chromatography · CPC title
- G01N30/50Primary
Conditioning of the sorbent material or stationary liquid · CPC title
Devices for testing the effectiveness or completeness of sterilisation or disinfection, e.g. indicators which change colour · CPC title
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Frequently asked questions
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- What does patent US11369707B2 cover?
- The invention provides methods for microbial bioburden reduction of various chromatography matrices, including bioburden reduction in the context of large-scale Protein A-based affinity chromatography columns.
- Who is the assignee on this patent?
- Regeneron Pharma
- What technology area does this patent fall under?
- Primary CPC classification B01D15/203. Mapped technology areas include Operations & Transport.
- When was this patent published?
- Publication date Tue Jun 28 2022 00:00:00 GMT+0000 (Coordinated Universal Time) (B2). Legal status and post-grant events are not shown on this page.
- What related patents are in patentsdb?
- We list 4 related publications on this page (citations in our corpus or others sharing the same primary CPC).