Patent: 9,580,506

Summary for Patent: 9,580,506

Title:	Potency assays for antibody drug substance binding to an Fc receptor
Abstract:	The invention relates to a method of characterizing an antibody, which method is suitable as a potency assay for batch release of a pharmaceutical composition comprising an antibody, specifically for use when applying for marketing authorization for said pharmaceutical composition. The assay provided is a method for determining the potency of a drug product comprising an FcR binding peptide, wherein at least one mechanism of action of the FcR binding peptide of the drug product is mediated through the binding of the FcR binding peptide of the drug product to a Fc receptor, wherein said method comprises determining the binding of the FcR binding peptide of the drug product to an Fc receptor.
Inventor(s):	Gerarda Havenith; Catharina Emanuele (Bodegraven, NL), Vink; Tom (Alphen aan den Rijn, NL), Berkel; Patrick Van (Utrecht, NL), Parren; Paul (Odijk, NL)
Assignee:	GENMAB A/S (Copenhagen, DK)
Application Number:	11/989,064
Patent Claims:	see list of patent claims

Details for Patent 9,580,506

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	RITUXAN	rituximab	Injection	103705	11/26/1997		2039-02-26
Idec Pharmaceuticals Corp.	RITUXAN	rituximab	Injection	103737	02/19/2002		2039-02-26
Hoffmann-la Roche Inc.	ZENAPAX	daclizumab	Injection	103749	12/10/1997		2039-02-26
Novartis Pharmaceuticals Corporation	SIMULECT	basiliximab	For Injection	103764	05/12/1998		2039-02-26
Novartis Pharmaceuticals Corporation	SIMULECT	basiliximab	For Injection	103764	01/02/2003		2039-02-26
Swedish Orphan Biovitrum Ab (publ)	SYNAGIS	palivizumab	For Injection	103770	06/19/1998		2039-02-26
Swedish Orphan Biovitrum Ab (publ)	SYNAGIS	palivizumab	Injection	103770	07/23/2004		2039-02-26