Granted Patent B2

US 12,710,424 · App. 18/262,316 · Granted Aug 18, 2026

Inventors: Raja Reddy Kuppili (Thane, IN); Chintan Mineshkumar Vaywala (Ahmedabad, IN); Parva Yogeshchandra Purohit (Ahmedabad, IN); Mukesh Mahajan (Ahmedabad, IN); Sanjaykumar Vanrajbhat Talpara (Ahmedabad, IN)

Assignee: Kashiv BioSciences, LLC

G01N33/573G01N2333/92

Abstract

Claims (31)

1 . A process for an extraction of a pancreatic protein from a pancreatic protein sample, the process comprising:

a. treating the pancreatic protein sample with a buffer;

b. dissolving the pancreatic protein sample in the buffer;

c. collecting the extracted pancreatic protein,

wherein the suitable buffer is selected from citrate-phosphate buffer and bicarbonate buffer;

wherein the pancreatic protein sample comprises a pharmaceutical composition comprising:

one or more enzymes selected from lipase, protease, and amylase; and

one or more enzymes selected from Triacylglycerol lipase, Co-lipase, CEL lipase, Phospholipase A2, Trypsin, Chymotrypsin, Elastase, Carboxypeptidase A1, Carboxypeptidase B, Kallikrien glandular, and Alpha amylase.

2 . The process according to claim 1 , wherein the extraction of the pancreatic protein is improved in comparison to an extraction process performed without using a suitable buffer selected from citrate-phosphate buffer and bicarbonate buffer.

3 . The process according to claim 1 , wherein:

the citrate-phosphate buffer concentration is selected from about 10 mM to about 200 mM; or

the bicarbonate buffer concentration is selected from about 10 mM to about 200 mM.

4 . The process according to claim 3 , wherein:

the citrate-phosphate buffer concentration is selected from about 100 mM; or

the bicarbonate buffer concentration is selected from about 100 mM.

5 . The process according to claim 1 , wherein the citrate phosphate buffer has a pH from about 6.0 to about 6.5.

6 . The process according to claim 1 , wherein of the bicarbonate buffer has a pH from about 9.5 to about 10.

7 . The process according to claim 1 , wherein dissolving the pancreatic protein sample in the buffer is performed by stirring or shaking.

8 . The process according to claim 7 , wherein stirring is performed at 200 rpm to 300 rpm.

9 . The process according to claim 8 , wherein stirring is performed for about 20 minutes to about 30 minutes.

10 . The process according to claim 1 , wherein the extracted pancreatic protein is further subjected to estimation of protein performed by using BCA, SDS-PAGE, CE-SDS, SE-HPLC, or RP-HPLC.

11 . The process according to claim 1 , wherein the extracted pancreatic protein is further subjected to quantification of protein performed by using SDS-PAGE, CE-SDS, SE-HPLC, or RP-HPLC.

12 . The process according to claim 1 , wherein the process provides more than about 80% yield of pancreatic protein.

13 . The process according to claim 1 , wherein the process provides more than about 90% yield of pancreatic protein.

14 . The process according to claim 1 , wherein the process provides more than about 98% yield of pancreatic protein.

15 . The process according to claim 1 , wherein the extracted pancreatic protein comprises a protein selected from amylase, lipase and protease.

16 . The process according to claim 1 , wherein the process provides a pharmaceutically acceptable pancreatic protein mixture comprising one or more enzymes selected from amylase, lipase and protease.

17 . The process according to claim 10 , wherein the extracted pancreatic protein is further subjected to estimation of protein based on molecular weight by using CE-SDS.

18 . The process according to claim 10 , wherein the extracted pancreatic protein is further subjected to estimation of purity profile by using RP-HPLC.

19 . The process according to claim 10 , wherein the extracted pancreatic protein is further subjected to estimation of protein based on molecular weight by using SDS-PAGE.

20 . The process according to claim 10 , wherein the extracted pancreatic protein is further subjected to estimation of purity profile by using SE-HPLC.

Assignments (3)

Priority Claims (1)

Continuity (1)

References Cited (180)