Process and apparatus for the production of sterile filtered...

A - Human Necessities – 23 – J

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A23J 1/06 (2006.01) A61L 2/00 (2006.01) A61L 2/02 (2006.01) C07K 14/755 (2006.01) A61K 38/00 (2006.01)

Patent

CA 1088424

ABSTRACT OF THE DISCLOSURE A process and apparatus are disclosed for producing sterile filtered blood clotting factors, particularly from cryo-precipitate and/or fibrinogen with an enrichment of Factors VIII and/or I. The process involves physically separating plasma from at least one blood extraction obtained from a minimum number of donors until the plasma is almost completely purified of cellular components, deep freezing the highly purified plasma at a temperature lower than the temperature of ca, minus 22°C critical for the preservation of Factor VIII, thawing the plasma, enriching the cold precipitate (cryo-pre- cipitate) in the thawed plasma by physical treatment at this temperature and separating the precipitate from the residual plasma, and dissolving the con- centrated cryo-precipitate in a buffer and then sterile filtering by means of a static filtration with an autoclaved filtration device at a pressure differ- ence of <0.5atm.

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