Chromatography equipment characterization

US9047438B2 · US · B2

Patent metadata
FieldValue
Publication numberUS-9047438-B2
Application numberUS-201313922101-A
CountryUS
Kind codeB2
Filing dateJun 19, 2013
Priority dateDec 21, 2010
Publication dateJun 2, 2015
Grant dateJun 2, 2015

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  1. Title

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  2. Abstract

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  3. Assignees and inventors

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  4. Key dates

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  5. First independent claim

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  6. CPC / IPC classifications

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Abstract

Official abstract text for this publication.

Herein is reported a method for determining whether a re-usable chromatography column packing, which is used at least for the second time in a purification step of a purification of a polypeptide, has reduced separation efficacy in said purification step of said purification of said polypeptide, comprising the following steps: a) identifying and determining the experimental data of an inert change of at least one physicochemical parameter of a mobile phase passing through said re-usable chromatography column packing, b) determining the parameters of a function of formula I by fitting the experimental data of the inert change of the physicochemical parameter of the at least second use, c) determining the difference between the experimental data of the inert change of the physicochemical parameter of the at least second use and the function of formula I with the parameters determined in step b), d) calculating the difference between the maximum value and the minimum value of the difference determined in step c) and normalizing said difference, e) determining reduced separation efficacy of said re-usable chromatography column packing when the absolute value of the difference calculated in step d) is more than 0.1.

First claim

Opening claim text (preview).

The invention claimed is: 1. A method for determining whether a re-useable chromatography column packing, which is used at least for the second time in a purification step of a purification of a polypeptide, has reduced separation efficacy in said purification step of said purification of said polypeptide, characterized in that said method comprises the following steps: a) identifying and determining the experimental data of an inert change of at least one physicochemical parameter of a mobile phase passing through said re-useable chromatography column packing of the at least second use, b) determining the parameters of a function of formula I by fitting the experimental data of the inert change of the physicochemical parameter of the at least second use, c) determining the difference between the experimental data of the inert change of the physicochemical parameter of the at least second use and the function of formula I with the parameters determined in step b), d) calculating the difference between the maximum value and the minimum value of the difference determined in step c) and normalizing said difference, e) determining reduced separation efficacy of said re-useable chromatography column packing when the absolute value of the difference calculated in step d) is more than 0.1, wherein the function of formula I is yI = - 1 2 ⁢ A · exp ⁡ ( - x t 0 ) ⁢ ( exp ⁡ ( 2 ⁢ x c ⁢ t 0 + w 2 2 ⁢ t 0 2 ) ⁢ ( erf ( ( x - x c w - w t 0 ) 2 ) + 1 ) - exp ⁡ ( x t 0 ) · erf ⁡ ( x -

Assignees

Inventors

Classifications

  • Signal analysis · CPC title

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

  • G06F19/70Primary

    Physics · mapped topic

  • for calibrating the measuring apparatus · CPC title

  • Conditioning of the sorbent material or stationary liquid · CPC title

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What does patent US9047438B2 cover?
Herein is reported a method for determining whether a re-usable chromatography column packing, which is used at least for the second time in a purification step of a purification of a polypeptide, has reduced separation efficacy in said purification step of said purification of said polypeptide, comprising the following steps: a) identifying and determining the experimental data of an inert cha…
Who is the assignee on this patent?
Hoffmann La Roche, Hoffmann La Roche
What technology area does this patent fall under?
Primary CPC classification G06F19/70. Mapped technology areas include Physics.
When was this patent published?
Publication date Tue Jun 02 2015 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 8 related publications on this page (citations in our corpus or others sharing the same primary CPC).