Claims for Patent: 9,081,016

Summary for Patent: 9,081,016

Title:	Assay for measurement of antibodies binding to a therapeutic monoclonal antibody
Abstract:	Methods and system for determination of an anti-<therapeutic monoclonal antibody> antibody (anti-<TmAB>AB) in vitro in a sample from a patient treated with a therapeutic monoclonal antibody (TmAB). Also, methods and systems for the determination of antigen specific antibodies of a particular immunoglobulin class and for the identification of a patient who is at risk of developing an adverse drug reaction (ADR) during treatment with a TmAB.
Inventor(s):	Grunert; Veit Peter (Munich, DE), Klause; Ursula (Indianapolis, IN), Kubalec; Pavel (Feldafing, DE), Rothfuss; Matthias (Penzburg, DE), Upmeier; Barbara (Iffeldorf, DE)
Assignee:	Roche Diagnostics Operations, Inc. (Indianapolis, IN)
Application Number:	13/766,130
Patent Claims:	1. A method for determination of an anti-<therapeutic monoclonal antibody> antibody (anti<TmAB>AB) in a whole blood, serum and plasma sample from a patient treated with a therapeutic monoclonal antibody (TmAB), the method comprising: a) providing a F(ab) fragment of the TmAB bound to a solid phase; b) incubating the solid phase provided in (a) with the sample, thereby binding the anti <TmAB>AB to the solid phase via the F(ab) fragment; c) incubating the solid phase obtained in (b) with a monoclonal antibody <h-Agg.-IgG>, whereby said monoclonal antibody binds to the anti<TmAB>AB, wherein said monoclonal antibody is an IgM antibody having a dissociation constant (=K.sub.D) value of about 10.sup.-6 mol/l-10.sup.-8 mol/l; and d) detecting the monoclonal antibody<h-Agg.-IgG> bound in (c) and thereby determining the anti<TmAB>AB in the sample. 2. The method according to claim 1, wherein the TmAB is selected from the group consisting of chimeric antibodies (CA) and humanized antibodies (HA). 3. The method according to claim 1, wherein the TmAB is selected from the group consisting of infliximab, adalimumab, certolizumab and rituximab. 4. The method according to claim 1, wherein the F(ab) fragment is bound to the solid phase by a binding system selected from the group consisting of biotin/steptavidin, biotin/avidin, and biotin/anti-<biotin> antibody. 5. The method according to claim 1, wherein the monoclonal antibody is an antibody having a dissociation constant (K.sub.D) value of between approximately 10.sup.-7 mol/l-10.sup.-8 mol/1. 6. The method according to claim 1, wherein the monoclonal antibody<h-Agg.-IgG> is labeled. 7. The method according to claim 6, wherein the monoclonal antibody<h-Agg.-IgG> is labeled with Dig. 8. The method according to claim 7, wherein the Dig-labeled monoclonal antibody <h-Agg.-IgG> is detected by incubating with an anti-<Dig> antibody conjugated to a detectable label. 9. The method according to claim 8, wherein the detectable label is selected from the group consisting of luminescent labels, chemiluminescent labels, electrochemiluminescent labels, fluorescent labels, and radioactive labels.

Details for Patent 9,081,016

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	RITUXAN	rituximab	Injection	103705	11/26/1997		2030-08-19
Idec Pharmaceuticals Corp.	RITUXAN	rituximab	Injection	103737	02/19/2002		2030-08-19
Janssen Biotech, Inc.	REMICADE	infliximab	For Injection	103772	08/24/1998		2030-08-19