Patent application EP20171946A (EP), filed 2020-04-28
Publication number: EP3733267A1
Title: DEVICE AND PROCESS FOR TREATMENT OF BIOLOGICAL MATERIAL
Abstract: The present invention relates to a device (1) for the treatment of biological material (2) comprising a concentration circuit (3) having at least one concentration filter (20), at least one supply conduit (30) of the biological material (2), and a concentration section (40) interposed between separation filter (10) and concentration filter (20) and defining an inner volume configured to accommodate a fraction of interest (2a) of the biological material (2). A discharge conduit (50) is connected to the second access (22) of the concentration filter (20) downstream of the concentration section (40), and an infusion line (60) is connected to the concentration circuit (3). The concentrated fraction of interest (2a) of biological material (2) may be withdrawn from a collection channel (70) or by removing the entire concentration section (40) from the rest of the circuit.
IPC codes: B01D  61/    14            A I
B01D  65/    02            A I
C07K   1/    34            A I
C12N  15/    10            A I
Claims: number: 1
text: Device (1) for treatment of biological material (2) comprising:
number: 2
text: Device according to claim 1, wherein the concentration circuit (3) also comprises at least one separation filter (10) comprising a respective first and a respective second access (11, 12), and a filtering membrane (13) interposed between said first and second access (11, 12); wherein a second end (32) of the at least one supply conduit (30) is connected to the first access (11) of the at least one separation filter (10) and said concentration section (40) is interposed between the at least one separation filter (10) and the first and second concentration filters (20a, 20b); further wherein the filtering membrane (23) of the first and second concentration filters (20a, 20b) has a cut-off threshold different from a cut-off threshold of the filtering membrane (13) of the separation filter (10).
number: 3
text: Device of claim 2, wherein the concentration section (40) is on one side connected or connectable to the second access (12) of the at least one separation filter (10) and on the other side connected or connectable to the first access (21a, 21b) of the first and second concentration filters (20a, 20b),
and/or
wherein the concentration circuit has a delivery channel (90) which connects the second access (12) of the at least one separation filter (10) to an intake port (41) of the concentration section (40), each of the first accesses (21a, 21b) of the first and second concentration filters (20a, 20b) being connected respectively to a first and a second connection port (42a, 42b) of the concentration section (40), said intake port (41) being optionally equidistant from said first and second connection ports (42a, 42b).
number: 4
text: Device of claim 2 or 3, wherein the filtering membrane (23) of the first and second concentration filters (20a, 20b) has lower cut-off threshold with respect to the cut-off threshold of the filtering membrane (13) of the separation filter (10);
optionally wherein the filtering membrane (13) of the separation filter (10) has cut-off threshold of between 50 and 200 µm, and the filtering membrane (23; 23a, 23b) of the first and second concentration filters (20; 20a, 20b) has cut-off threshold of between 3 and 10 µm.
number: 5
text: Device according to any one of the preceding claims comprising:
number: 6
text: Device according to any one of the preceding claims, wherein the at least one infusion line (60) comprises:
number: 7
text: Device according to claims 5 and 6, wherein each of said first and second secondary sections (66a, 66b) of the infusion line (60) comprises at least one respective interception member (80a, 80b) which is part of the infusion flow regulator and which is configurable at least in an open position and in a closed position, respectively to allow or prevent flow of the auxiliary fluid (8) through the first and second secondary sections (66a, 66b) of the infusion line (60) respectively into the first and second concentration filter; and/or
wherein each first and second secondary section (56a, 56b) of the discharge conduit (50) comprises at least one respective interception member (81a, 81b) which is part of the discharge flow regulator and which is configurable at least in an open position and in a closed position, respectively to allow and prevent flow of the waste fluid (7) out of the first and second concentration filters (20a, 20b) through said first and second secondary section (56a, 56b) of the discharge conduit (50).
number: 8
text: Device according to any one of claims from 5 to 7, wherein the control unit (110) during execution of said concentration cycle is configured to arrange the circuit (3) alternatively in:
number: 9
text: Device according to claims 7 and 8, wherein the control unit is configured to:
number: 10
text: Device according to any one of claims from 2 to 9, wherein the inner volume of the concentration section (40) is of between 10 and 100 cm<3> and communicates with the rest of the concentration circuit (3) exclusively through the membranes (13, 23) of the at least one separation filer (10) and of the first and second concentration filters (20a, 20b); optionally wherein the concentration circuit is a single plastic disposable component, more optionally a single plastic sterile disposable component.
number: 11
text: Device according to any one of the preceding claims, wherein the at least one infusion line (60) is also configured to be selectively placed in fluid communication with a first chamber (10') of the separation filter (10) to define, at least in one operative condition, a tangential flow with respect to the surface of the filtering membrane (13), the separation filter further comprising a second chamber (10") separated from the first chamber (10') by the filtering membrane (13) of the same separation filter (10);
wherein the infusion line (60) has a section (66e) having a second end (62) connected to the first chamber (10') of the separation filter (10) and wherein an additional discharge line (66f) is also connected to the first chamber (10') of the separation filter, the or a control unit (110) being active on a wash flow regulator, optionally including a washing pump (88), active on the section (66e) for causing a tangential wash through the first chamber (10') of the separation filter and out of the additional discharge line (66f), the control unit operating the wash flow regulator either continuously or at regular intervals or at intervals determined by detection of a triggering event which is either a user command received by the control unit, or expiration of set timeout period, or a detection of reaching a specific transmembrane pressure across the separation filter (10) as detected based on pressure signals from sensors (p1 and p2) positioned upstream and downstream the separation filter and communicatively connected to the control unit (110).
number: 12
text: Device according to any one of the preceding claims from 5 to 11, further comprising a withdrawal conduit (70) connected with the concentration circuit (3) and configured for collecting the fraction of interest of the biological material, and a withdrawal flow regulator (82) operative on the withdrawal conduit and configured to control flow of the fraction of interest (2a) of the biological material (2) through said withdrawal conduit (70), optionally the withdrawal flow regulator comprising at least one respective interception member (82) which is configurable at least in an open position and in a closed position, respectively to allow or prevent flow of the fraction of interest (2a) of the biological material (2) through said withdrawal conduit (70),
and wherein the control unit is connected to the withdrawal flow regulator (82) and is further configured to:
number: 13
text: Device according to any one of the preceding claims comprising a supply flow regulator, in particular operative on the supply conduit (30) or the delivery channel (90), configured to control flow of biological material to the concentration section (40),
wherein the control unit (110) is also configured to put the device in a withdrawal condition in which the control unit controls the infusion flow regulator to deliver auxiliary fluid into the concentration section (40) through one of said first and second filters (20a, 20b), controls the supply flow regulator to stop flow of biological material through the delivery channel or supply conduit, controls the withdrawal flow regulator to collect the concentrated fraction of interest through the withdrawal conduit (70),
optionally wherein:
number: 14
text: Device according to any one of claims 8 to 13, wherein the control unit is configured to switch the device (1) from the first to the second filtering condition either at predetermined time intervals or upon detection of a transmembrane pressure threshold across the membrane of the second concentration filter, and to switch the device (1) from the second to the first filtering condition either at predetermined time intervals or upon detection of a transmembrane pressure threshold across the membrane of the first concentration filter;
in particular wherein first pressure sensors (p3 and p4) are provided, respectively located upstream and downstream of the first concentration filter (20a) and second pressure sensors (p5 and p6) respectively located upstream and downstream of the second concentration filter (20b), the control unit 110 being configured for cyclically repeating the following steps:
number: 15
text: Process for the treatment of biological material (2) using the treatment device according to any one of the preceding claims, said process comprising at least the following steps:
Office action: search_report, dated 2020-11-04
Prior art cited: ref_id: WO2010130303A1
ref_type: patent
severity: background
ref_id: US4420398A
ref_type: patent
severity: background
ref_id: US2015183815A1
ref_type: patent
severity: background
ref_id: US2006246544A1
ref_type: patent
severity: background
ref_id: ITMI20111282A1
ref_type: patent
severity: background
ref_id: - SCHNABEL R ET AL: "STRUCTURAL AND CHEMICAL PROPERTIES OF GLASS CAPILLARY MEMBRANES AND THEIR USE IN PROTEIN SEPARATION", GLASTECHNISCHE BERICHTE, VERLAG DER DEUTSCHEN GLASTECHNISCHEN GESELLSCHAFT, FRANKFURT, DE, vol. 62, no. 2, 1 February 1989 (1989-02-01), pages 56 - 62, XP000025684, ISSN: 0017-1085
ref_type: npl
severity: background
ref_id: US2006246544
ref_type: patent
severity: background
ref_id: ITMI20111282
ref_type: patent
severity: background
ref_id: US2015183815
ref_type: patent
severity: background
ref_id: - SCHNABEL R ET AL, "STRUCTURAL AND CHEMICAL PROPERTIES OF GLASS CAPILLARY MEMBRANES AND THEIR USE IN PROTEIN SEPARATION", GLASTECHNISCHE BERICHTE, VERLAG DER DEUTSCHEN GLASTECHNISCHEN GESELLSCHAFT, FRANKFURT, DE, (19890201), vol. 62, no. 2, ISSN 0017-1085, pages 56 - 62, XP000025684 [A] 1-15 * figures 6-8 *
ref_type: npl
severity: background
Final disposition: pending (2020-11-04)