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Last Updated: November 29, 2021

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Patent: 9,580,506

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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 1997-11-26 ⤷  Try it Free 2039-02-26
Idec Pharmaceuticals Corp. RITUXAN rituximab Injection 103737 2002-02-19 ⤷  Try it Free 2039-02-26
Hoffmann-la Roche Inc. ZENAPAX daclizumab Injection 103749 1997-12-10 ⤷  Try it Free 2039-02-26
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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AstraZeneca
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