Sartorius Stedim Biotech

In one aspect, the present invention relates to a filter module comprising a polymer membrane and at least one anchoring element, wherein a peripheral region of the polymer membrane is embedded in the at least one anchoring element, and wherein the material constituting the at least one anchoring element comprises a polyolefin, at least part of which is modified with a modifying agent having a hydrophilicity higher than that of the unmodified polyolefin. In a further aspect, the present invention relates to a method of manufacturing the filter module. In another aspect, the present invention relates to the use of the filter module.

A filtration device (10), in particular a small-scale filtration device for production of biopharmaceuticals, is shown. The filtration device (10) comprises a housing including a top cover (12) having an unfiltrate inlet (18) and a bottom cover (14) having a filtrate outlet (22), and at least one filter support (32) positioned between the top cover (12) and the bottom cover (16) along a vertical direction (A). Each filter support (32) is equipped with at least one filter (46, 48) having a first membrane (50) and a second membrane (52), wherein each membrane (50, 52) has a filtrate side and an opposite unfiltrate side. Additionally, the first membrane (50) comprises at least one vent opening (54) for releasing gas trapped between the first membrane (50) and the second membrane (52).

The invention relates to a method for purifying a target product, obtained in a bioprocess (1), from an impurity in a process liquid, the method comprising a virus inactivation step (6), a filtration step (7), a first diafiltration step (8) and a first chromatography step (9) as downstream process steps (3). It is proposed that the filtration step (7) is performed after the virus inactivation step (6) and the first diafiltration step (8) is performed after the filtration step (7) and the first chromatography step (9) is performed after the first diafiltration step (8), that the pH value of the process liquid reaches a pH value of smaller than or equal to 4.25 in the downstream process steps (3) before the first diafiltration step (8).

A filtration device (10), in particular a small-scale filtration device for production of biopharmaceuticals, comprises a top cover (12) having an unfiltrate inlet and a bottom cover (16) having a filtrate outlet (20), and one or more filter supports (23) arranged as a stack between the top cover (12) and the bottom cover (16) along a vertical direction (A). Each filter support (22) is configured to support a flat filter (24), especially a membrane. The filter support(s) (23) are provided on the top cover (12) and/or on the bottom cover (16) and or on one or more optional, preferably disc-shaped, filter support plates (22). The top cover (12), the bottom cover (16) and the filter support plates (22) each have an inner portion with at least one inner welding section (26) and an outer portion with at least one outer welding section (28). The inner welding sections (26) have an annular shape fully encircling a vertical filtrate collection channel (30) of the filtration device (10) which leads to the filtrate outlet (20). The outer welding sections (28) have an annular shape fully encircling a filtration area of the filtration device (10). All inner welding sections (26) are substantially congruent and welded in a fluid-tight manner to a corresponding inner welding section (26) of the top cover (12) or bottom cover (16) or a neighboring filter support plate (22), so as to form an inner housing portion (32) of the filtration device (10). All outer welding sections (28) are substantially congruent and welded in a fluid-tight manner to a corresponding outer welding section (28) of the top cover (12) or bottom cover (16) or a neighboring filter support plate (22), so as to form an outer housing portion (34) of the filtration device (10).

The invention relates to a (pre-)filtration unit for (pre-)filtering of a fluid to be filtered, in particular a fluid containing floccules, wherein the (pre-)filtration unit comprises: a first filter stage comprising a first filter body defining an inner volume, the first filter body comprising a first filter mesh for filtering the fluid to be filtered; and a second filter stage comprising a second filter body arranged within the inner volume of the first filter body, the second filter body comprising a second filter mesh for filtering the fluid to be filtered; and wherein a mesh size of the first filter mesh is different than a mesh size of the second filter mesh.

The invention relates to a method of transferring a microbial bioprocess from a multi-use bioreactor (1) to a single-use bioreactor (2), wherein the source bioprocess is a batch or fed-batch microbial bioprocess and the source bioprocess arrangement (3) comprises a source bioreactor (5) with a stirrer and the source bioreactor (5) is the multi-use bioreactor (1) which has at least 1000 L production volume of a microbial culture producing a maximum heat of at least 25,000 W and/or the stirrer of the source bioreactor (5) is driven with a maximum torque of at least 120 Nm, wherein the target bioprocess is a continuous microbial bioprocess and the target bioprocess arrangement (4) comprises a target bioreactor (6) and the target bioreactor (6) is the single-use bioreactor (2) which has a production volume of a microbial culture of at most 50 % of the production volume of the source bioreactor (5) and of at most 800 L, the microbial culture of the target bioreactor (6) produces a maximum heat of at most 20,000 W during the target bioprocess and/or the target bioreactor (6) comprises a stirrer driven with a maximum torque of at most 100 Nm, wherein an average amount of the bioproduct produced per time of performance of the target bioprocess by the target bioreactor (6) is at least 90 %, preferably at least 100 %, of an average amount of the bioproduct produced per time of performance of the source bioprocess by the source bioreactor (5).

Depicted and described is a Filter module (1) for the tangential flow filtration of a feed medium, comprising: a, preferably cassette-shaped, housing (2), one or more hollow fibers (8) for separating a feed medium into a retentate and a permeate, wherein the housing (2) has one or more transverse extension axes (TEA) and/or one or more longitudinal extension axes (LEA), wherein one or more conduits (9) are arranged in the housing (2), wherein the one or more hollow fibers (8) are arranged in the one or more conduits (9). In order to provide a filter module (1) which allows for the use of hollow fibers (8) with a set, preferably standardized, length while allowing for an individual arrangement of inlets and outlets of the filter module (1) it is proposed that the one or more hollow fibers (8) are at least in sections bent around the one or more transverse extension axes (TEA) and/or the one or more hollow fibers (8) are at least in sections bent around the one or more longitudinal extension axes (LEA).

Described and illustrated is a air vent valve (1) for the use in a (bio)pharmaceutical process, comprising: a first housing (2), a first interior chamber (5) arranged within the first housing, a first inlet (3) for conveying air and/or liquid medium to the first interior chamber (5), a first outlet (4) for conveying air away from the first interior chamber (5), and a first floating member (6) for sealing the first outlet (4), wherein the first inlet (3) and the first outlet (3) are respectively connected via a fluidic connection with the first interior chamber (5), and wherein the first floating member (6) is arranged movable within the first interior chamber (5). To improve air vent valves, preferably to provide a less complex air vent valve, the describe air vent valve it is proposed.

A measuring cell unit (16) for a bioprocess system is shown, in particular for a biopharma process, comprising a flow pipe unit (28) with a first connection end (30) having an inlet channel (34), a second connection end (32) having an outlet channel (36) and a measuring chamber (38) between the inlet and the outlet channels (34, 36). The first and second connection ends (30, 32) are configured to connect the measuring cell unit (16) into the bioprocess system. Together, the inlet channel (34), the measuring chamber (38) and the outlet channel (36) define portions of a flow duct (40) through the measuring cell unit (16). Further, the flow pipe unit (16) comprises a sideward sensor insert hole (42) opening into the measuring chamber (38) such that a measuring sensor (26) can be inserted. The flow duct (40) further comprises a transitional portion (44) along which a cross-sectional area of the flow duct (40) increases from the inlet channel (34) towards the measuring chamber (38). Additionally, the measuring cell unit (16) comprises at least one flow deflection arm (46) extending into the transitional portion (44) and deflecting a fluid flowing through the flow duct (40).Further, a bioprocess system and a method for displacing a first fluid by a second fluid are shown.

The invention relates to a method for adjusting the pH of a process liquid in a continuous process, comprising:(a.) providing the process liquid in a first volume flow having a first flow rate (f1),(b.) providing at least one treatment liquid in a second volume flow having a second flow rate (f2),(c.) mixing the at least one treatment liquid with the process liquid to produce a pH-adjusted process liquid,wherein the second flow rate is composed of a predetermined portion (fp) and a variable portion (fv), and wherein the variable portion (fv) is controlled based on at least one liquid parameter (pHa) of the pH-adjusted process liquid.