In vitro method for determining the stability of compositions comprising soluble Fc gamma receptor(s)

US10866247B2 · kind B2 · utility

Assignee

• SUPPREMOL GMBH · DE

Inventors

• Peter Sondermann · Stockdorf, DE
• Thomas Pohl · Holzgerlingen, DE
• Dominik Ter Meer · Munich, DE

Key dates

• Filing date: Aug 1, 2014
• Grant date: Dec 15, 2020
• Expiry date: Aug 1, 2034

Classification

• Technology area (CPC G): Physics
• CPC primary: G01N33/5047
• WIPO field: Measurement
• WIPO sector: Instruments

Abstract

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 …