| 摘要 |
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 1MB, said method comprising the steps of contacting a surface comprising human Fc gamma receptor IIA, MB, IIIA and/or 1MB with a set amount of aggregated human IgG; contacting said surface comprising human Fc gamma receptor IIA, MB, IIIA and/or 1MB with a set amount of said composition of soluble human Fc gamma receptor IIA, MB, IIIA and/or 1MB; determining the amount of aggregated human IgG which is bound to said surface comprising said human Fc gamma receptor IIA, MB, IIIA and/or 1MB, 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 1MB. 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. |
