Methods for continuously inactivating a virus during manufacture of a protein
US-11407981-B2 · Aug 9, 2022 · US
Methods for continuously inactivating a virus during manufacture of a protein
US12018290B2 · US · B2
| Field | Value |
|---|---|
| Publication number | US-12018290-B2 |
| Application number | US-202217854462-A |
| Country | US |
| Kind code | B2 |
| Filing date | Jun 30, 2022 |
| Priority date | Mar 11, 2016 |
| Publication date | Jun 25, 2024 |
| Grant date | Jun 25, 2024 |
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- Title
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Abstract
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Methods for continuously inactivating a virus during manufacture of a protein are provided. Steps include (1) combining, at a single predetermined volumetric ratio, a composition including the protein, and a composition including a virus-inactivation reagent, to obtain a treatment composition having a predetermined property for inactivation of a virus; (2) transferring the treatment composition to a treatment vessel; (3) incubating the treatment composition in the treatment vessel at predetermined conditions; and (4) subjecting the treatment composition to a post-treatment processing operation. The single predetermined volumetric ratio has been selected to ensure that the predetermined property of the treatment composition is maintained across a range of concentrations predicted for the protein in the composition including the protein. Steps (1) to (3) are carried out (a) continuously and (b) without feedback control being exerted by either adjustment of the volumetric ratio or diversion of the treatment composition.
First claim
Opening claim text (preview).
The invention claimed is: 1. A method for inactivating one or more viruses in a sample, wherein the method comprises continuously mixing the sample with one or more virus inactivating reagents as the sample flows from a first unit operation to a second unit operation during a process for purifying a target molecule, wherein the ratio of the one or more virus inactivating reagents to the sample is determined independently of, or without, a feedback control mechanism, wherein the ratio of the one or more virus inactivating reagents to the sample is determined as % v/v by equation 1 and supporting equations 2 and 3: Viral Inactivation pH = Weak Acid pKA + Log ( M [ Sum of Base Species in System ] M [ Sum of Acid Species in System ] ) Equation 1 Sum of Base Species in System = ( Mab mol kg * effective Mab Charge delta ) + Conjugate Base Buffer Species Equation 2 Viral Inactivation pH = Weak Acid pKA + Log ( M [ Initial Weak Acid Conjugate Base + ( Mab mol kg * effective MabCharge delta ) + Background Buffer
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Classifications
Means for after-treatment of the produced biomass or of the fermentation or metabolic products, e.g. storage of biomass (filters in general B01D24/00 - B01D41/00) · CPC title
Specific host cells or culture conditions, e.g. components, pH or temperature · CPC title
- C07K16/00Primary
Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies · CPC title
- C12N7/00Primary
Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof (preparing medicinal viral antigen or antibody compositions, e.g. virus vaccines, A61K39/00) · CPC title
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- What does patent US12018290B2 cover?
- Methods for continuously inactivating a virus during manufacture of a protein are provided. Steps include (1) combining, at a single predetermined volumetric ratio, a composition including the protein, and a composition including a virus-inactivation reagent, to obtain a treatment composition having a predetermined property for inactivation of a virus; (2) transferring the treatment composition…
- Who is the assignee on this patent?
- Boehringer Ingelheim Int
- What technology area does this patent fall under?
- Primary CPC classification C07K16/00. Mapped technology areas include Chemistry & Metallurgy.
- When was this patent published?
- Publication date Tue Jun 25 2024 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).