Claims for Patent: 9,638,696

Summary for Patent: 9,638,696

Title:	Process for detection and optional quantification of an analyte
Abstract:	The present disclosure relates to a process for detecting and optionally quantifying an analyte in a sample in the presence of a soluble target of the analyte. The soluble target forms a complex with the analyte and thus may interfere in determining the total analyte concentration. The process of the present invention utilizes a unique modified citrate buffer for diluting the sample containing the analyte and the soluble target which in turn helps in dissociating the analyte-soluble target complex, thereby enabling the process of the disclosure to detect and optionally quantify measure the analyte accurately.
Inventor(s):	Sengupta; Nilanjan (Bangalore, IN), Udiavar; Anita Rao (Bangalore, IN), Thangamuthu; Senthil (Tamil Nadu, IN), Nayak; Vivek Gopal (Bangalore, IN), Pillai; Ranjit Ravindran (Bangalore, IN), Vashishta; Laxmikant (Bangalore, IN), Ramaswamy; Shilpa Govinda (Krishnagiri, IN), Hegde; Vishika (Bangalore, IN), Melarkode; Ramakrishnan (Bangalore, IN)
Assignee:	Biocon Limited (Bangalore, IN)
Application Number:	14/379,186
Patent Claims:	1. A process for detection and quantification of trastuzumab in a biological sample, said process comprising: (a) diluting the biological sample with a modified citrate buffer comprising citrate-HCl at a concentration of about 125 mM and polysorbate-20 at a concentration of about 0.1% w/v, the modified citrate buffer having a pH of 3.5, and (b) performing an assay to detect and quantify trastuzumab in the biological sample, wherein the biological sample comprises at least one interfering substance that binds trastuzumab, wherein the at least one interfering substance is an extracellular domain of HER-2 (HER-2-ECD) and wherein said interfering substance and trastuzumab combine to form a complex in the biological sample. 2. The process of claim 1, wherein the modified citrate buffer dissociates the complex to enable accurate detection and quantification of trastuzumab. 3. The process of claim 1, wherein the biological sample is selected from the group consisting of blood, plasma, serum or a combination thereof. 4. The process of claim 1, wherein the assay is an enzyme linked immunosorbent assay (ELISA). 5. The process of claim 4, wherein the ELISA is a sandwich ELISA and is carried out in presence of components selected from the group consisting of capture antibody, detection antibody, reagent for reacting with the detection antibody, microtitre plate, coating buffer, washing solution and stopping solution. 6. The process of claim 5, wherein the capture antibody is an antibody that binds to trastuzumab. 7. The process of claim 5, wherein the detection antibody is labelled with a label selected from the group consisting of horseradish peroxidase, alkaline phosphatase, or ruthenium. 8. The process of claim 5, wherein the reagent for reacting with the detection antibody is a chromogenic substrate selected from the group consisting of ABTS (2,2'-Azinobis[3-ethylbenzothiazoline-6-sulfonic acid]-diammonium salt) and TMB (3,3',5,5'-tetramethylbenzidine). 9. The process of claim 5, wherein the reagent for reacting with the detection antibody is an electrochemiluminescent substrate. 10. The process of claim 5, wherein the coating buffer is phosphate buffered saline. 11. The process of claim 5, wherein the washing solution comprises phosphate buffered saline and polysorbate-20. 12. The process of claim 5, wherein the stopping solution is 0.1 N sulphuric acid.

Details for Patent 9,638,696

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	09/25/1998		2032-02-15
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	02/10/2017		2032-02-15
Genentech, Inc.	HERCEPTIN HYLECTA	trastuzumab and hyaluronidase-oysk	Injection	761106	02/28/2019		2032-02-15