In vitro method for determining the stability of compositions comprising soluble Fc gamma receptor(s)
The present invention relates in essence to an in vitro method for determining the stability, such as the shelf stability; stability over time; shelf life of a composition which comprises or essentially consists of soluble human Fc gamma receptor IIA, MB, IIIA and/or 1 MB, said method comprising the...
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Main Authors | , , |
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Format | Patent |
Language | English |
Published |
07.07.2016
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Subjects | |
Online Access | Get full text |
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Summary: | The present invention relates in essence to an in vitro method for determining the stability, such as the shelf stability; stability over time; shelf life of a composition which comprises or essentially consists of soluble human Fc gamma receptor IIA, MB, IIIA and/or 1 MB, said method comprising the steps of contacting a surface comprising human Fc gamma receptor IIA, MB, IIIA and/or 1 MB with a set amount of aggregated human IgG; contacting said surface comprising human Fc gamma receptor IIA, MB, IIIA and/or 1 MB with a set amount of said composition of soluble human Fc gamma receptor IIA, MB, IIIA and/or 1 MB; determining the amount of aggregated human IgG which is bound to said surface comprising said human Fc gamma receptor IIA, MB, IIIA and/or 1 MB, and comparing the amount of aggregated human IgG which is bound to said surface as determined in step (c) with a reference value and (thereby) determining the stability [shelf stability; stability over time; shelf life] of said composition which comprises or essentially consists of soluble human Fc gamma receptor IIA, MB, IIIA and/or 1 MB. The present invention also relates to aggregated human IgG obtainable by a method as defined herein, as well as to the use of the mentioned aggregated human IgG in the methods of the invention. |
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Bibliography: | Application Number: US201414909009 |