Therapeutic grade thrombin produced by chromatography

Overview

Information

Number
5506127
Application
08/309583
Filing date
09/21/1994
Issue date
04/09/1996
Inventor(s)
Zbigniew Proba, Teresa Brodniewicz
US Classification
435/214; 435/815
View at USPTO

Citations

Pfizer (4)
Yoshitomi Pharmaceutical Industries, (1)
Medtronic (1)
Baxter International (1)
basf beauty care solutions france sas (1)
Mochida Pharmaceutical Co. (1)
Leuven Research & Development V.Z.W. (1)
The Green Cross (1)
Omrix Biopharmaceuticals (1)
NA (1)
SEROLOGICALS ROYALTTY (1)
New York Blood Center (1)

Abstract

Abstract

A process for the large-scale production of therapeutic grade thrombin of excellent viral safety and storage-stability is carried out by purification of viricide treated crude thrombin by ion-exchange chromatography on a single column using a sulfalkyl-activated polysaccharide, particularly a non-compressible composite medium of sulfoalkyl-activated dextran and silica particles, as the ion exchange medium and using increasing concentrations of phosphate buffer for elution. After recovery of thrombin in the final eluate, the phosphate buffer is exchanged for a stabilizing formulation buffer, and the stabilized thrombin is subjected to viral filtration and optional dry heat treatment for further viral inactivation. The final product has high specific activity and is obtained in good yield.

Assignees with Similar Patents

Referenced by

Asahi Kasei Medical Co. (3)
Omrix Biopharmaceuticals (3)
Bristol-Myers Squibb (2)
Grifols, (2)
Arteriocyte Medical Systems (1)
Mitsubishi Pharma (1)
CSL Behring (1)
Drying Technology (1)
Angiotech International (1)

Tech Analysis

Class Subclass Type Reference Factor Citation Factor Strength Grant time Early grant (%)
435 214 Stable Sustaining Seminal Medium Rapid 14.5
435 815 Declining Sustaining Average Medium Rapid 23.4