Process for the preparation of disinfected human cell suspensions

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.