FIELD: biotechnology.
SUBSTANCE: invention relates to the field of biotechnology. Disclosed is a method for continuous microorganism-reducing production and/or treatment of a biopharmaceutical biological macromolecular product from a heterogeneous mixture of cell culture and fluid medium. Method comprises providing a particle-free fluid medium from a heterogeneous mixture of a cell culture and containing a product in form of a fluid medium product stream, filtering to obtain a filtrate, two or more chromatography stages for product purification, virus exhaustion, ultrafiltration or product flow diafiltration. Chromatography steps include purification by chromatographic columns and/or membrane adsorbers, and elements used at stages are subjected to reduction of microorganisms. Filtration step is performed between said stages and/or after them, where the filter is automatically replaced in conditions of microorganisms reduction. Method is carried out in a closed and modular way.
EFFECT: invention provides reduced growth of microorganisms with continuous purification of the product for several hours to several weeks.
1 cl, 4 dwg, 1 tbl, 1 ex
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Authors
Dates
2020-05-19—Published
2016-04-29—Filed