Claims for Patent: 8,999,710

Summary for Patent: 8,999,710

Title:	Process for the preparation of disinfected human cell suspensions
Abstract:	In a process for preparing disinfected preparations from mammalian tissues, mammalian tissue is perfused at one step with an enzyme-free liquid antibiotic composition that includes at least one antibiotic and is contained in at least one perfusion buffer. In a step occurring after such one step, enzymatic antibiotic-free treatment of the tissue is carried out to obtain a single-cell suspension. In another step disinfected preparations are obtained.
Inventor(s):	Aleksandrova; Krasimira (Hannover, DE), Barthold; Marc (Hannover, DE), Arseniev; Lubomir (Hannover, DE), Griesel; Carsten (Ladenburg, DE), Priesner; Christoph (Hannover, DE)
Assignee:	Cytonet GmbH & Co. KG (Weinheim, DE)
Application Number:	13/816,909
Patent Claims:	1. A process for preparing disinfected, single-cell suspension preparations from mammalian tissue, comprising: prior to any enzymatic treatment of said mammalian tissue, performing a primary decontamination of a surface of the mammalian tissue comprising rinsing the mammalian tissue to obtain a rinsed mammalian tissue; after said primary decontamination, perfusing said rinsed mammalian tissue with an enzyme-free liquid antibiotic composition that comprises at least one antibiotic and is contained in at least one perfusion buffer, wherein the enzyme-free liquid antibiotic composition is perfused through vascular tissue inherent to the mammalian tissue to obtain an antibiotic-treated mammalian tissue; subsequent to all antibiotic perfusion, carrying out an enzymatic antibiotic-free treatment of the tissue to obtain the disinfected, single-cell suspension preparations comprising contacting said antibiotic-treated mammalian tissue with collagenase I and clostridiopeptidase I to obtain disinfected single-cell suspension preparations; washing the obtained disinfected single-cell suspension preparations with an antibiotic-free washing buffer to obtain a washed disinfected single-cell suspension preparation; subsequent to said washing step, and without an intervening antibiotic treatment, performing a microbiological sterility test of the washed disinfected single-cell suspension preparation; and wherein said washing is adapted to either one of reduce or eliminate said antibiotic from said disinfected single-cell suspension so as not to have a negative effect on said microbiological sterility test. 2. The process according to claim 1, wherein the tissue is liver tissue. 3. The process according to claim 1, wherein a time duration of said perfusing is 30 to 120 min and wherein temperature of the enzyme-free liquid antibiotic composition is increased during the perfusion. 4. The process according to claim 1, wherein the enzyme-free liquid antibiotic composition is contained in at least two perfusion buffers, at least one of the perfusion buffers being an EGTA- or EDTA-containing phosphate/HEPES buffer and at least one other of the buffers being a phosphate/HEPES buffer.

Details for Patent 8,999,710

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Smith & Nephew, Inc.	SANTYL	collagenase	Ointment	101995	06/04/1965		2030-08-14