IN VITRO METHOD FOR DETERMINING THE STABILITY OF COMPOSITIONS COMPRISING SOLUBLE FC GAMMA RECEPTOR(S)

• Main Authors: TER MEER, Dominik, POHL, Thomas, SONDERMANN, Peter
• Format: Patent
• Language: English; French; German
• Published: 18.07.2018
• Subjects: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIRCHEMICAL OR PHYSICAL PROPERTIES; MEASURING; PHYSICS; TESTING

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