Systems and methods for use in dispensing biopharmaceutical materials

Patent metadata

Field	Value
Publication number	US-12570516-B2
Application number	US-202318503948-A
Country	US
Kind code	B2
Filing date	Nov 7, 2023
Priority date	Nov 8, 2022
Publication date	Mar 10, 2026
Grant date	Mar 10, 2026

Abstract

A system for dispensing biopharmaceutical materials, the system including: a plurality of containers, wherein each of the plurality of containers comprises a screw-on cap having a low temperature silicone stopper; a distribution manifold connected to the plurality of containers, wherein the distribution manifold comprises a plurality of distribution conduits and a plurality of discharge conduits and wherein the distribution conduits and the discharge conduits are in fluid communication with each other; a bulk reservoir for holding the biopharmaceutical materials; and a filter assembly positioned between the bulk reservoir and the distribution manifold.

First claim

What is claimed is:

1 . A system for dispensing biopharmaceutical materials, the system comprising:
a plurality of containers, wherein each of the plurality of containers comprises a screw-on cap having a low temperature silicone stopper; a distribution manifold connected to the plurality of containers, wherein the distribution manifold comprises a plurality of distribution conduits and a plurality of discharge conduits, and wherein the distribution conduits and the discharge conduits are in fluid communication with each other; a filter assembly fluidly coupled to the distribution manifold; and an intake conduit positioned downstream of the filter assembly and upstream from the distribution manifold, wherein the filter assembly and the intake conduit are laterally offset from the distribution manifold and the plurality of containers; wherein the distribution manifold is arranged via a plurality of rows that each extends parallel to one another and laterally away from the intake conduit; and wherein each of the plurality of distribution conduits is positioned above the plurality of discharge conduits and aligned along one of the plurality of rows with each of the plurality of rows extending across the plurality of containers that are fluidly coupled to a corresponding distribution conduit of the plurality of distribution conduits.

2 . The system of claim 1 , wherein a top of the screw-on cap comprises two openings to receive: A) an end of one of the plurality of discharge conduits and B) an end of a ventilation tubing shaft.

3 . The system of claim 2 , wherein the low temperature silicone stopper surrounds a circumference of the end of one of the plurality of discharge conduits and the end of the ventilation tubing shaft within the screw-on cap.

4 . The system of claim 1 , wherein each container of the plurality of containers comprises a hydrophobic filter assembly including a quick seal positioned on a ventilation tubing shaft that is connected to an air vent filter.

5 . The system of claim 1 , further comprising a plurality of first clamps positioned on the distribution conduits that are each configured for selectively controlling flow of the biopharmaceutical materials into the plurality of discharge conduits that are fluidly coupled to a corresponding distribution conduit of the plurality of distribution conduits; and
a plurality of second clamps positioned on the discharge conduits that are each configured for selectively controlling flow of the biopharmaceutical materials into a corresponding container of the plurality of containers that is fluidly coupled to a corresponding discharge conduit of the plurality of discharge conduits.

6 . The system of claim 1 , further comprising a sampling container conduit configured to distribute a portion of the biopharmaceutical material to a sampling container.

7 . The system of claim 6 , wherein the sampling container conduit is positioned downstream of the intake conduit and upstream from a plurality of feeder conduits.

8 . The system of claim 7 , wherein the plurality of distribution conduits are positioned adjacent to the plurality of feeder conduits.

9 . The system of claim 1 , wherein the system is configured to receive the biopharmaceutical materials from a bulk reservoir containing the materials.

10 . The system of claim 1 , further comprising a bulk reservoir for holding the biopharmaceutical materials.

11 . The system of claim 1 , further comprising a tube wrap surrounding a perimeter of the plurality of containers.

12 . A plurality of receiving containers for storing biopharmaceutical materials at low temperatures, each of the receiving containers comprising:
a cap configured to screw onto a neck of the receiving container, wherein the cap comprises one or more openings that enable connection of one or more tubes to an interior of the receiving container; a low-temperature silicone stopper positioned in a hollowed out portion of the cap, wherein the low-temperature silicone stopper surrounds the one or more tubes within the interior of the cap; and a sampling container conduit configured to distribute a portion of the biopharmaceutical material to a sampling container, wherein the sampling container conduit is fluidly connected to the intake conduit via a cross connector and wherein the cross connector forms a direct fluid connection with a plurality of feeder conduits and a distribution conduit; wherein the plurality of receiving containers are surrounded by a tube wrap that is configured to collectively contain and support the plurality of receiving containers.

13 . The receiving container of claim 12 , wherein the one or more tubes include: a discharge conduit and/or an air ventilation shaft.

14 . The receiving container of claim 13 , wherein the biopharmaceutical materials are introduced into the receiving container via the discharge conduit.

15 . The receiving container of claim 12 , wherein the low-temperature silicone stopper is hardy to temperatures at least as low as −80° C.

16 . A method for dispensing biopharmaceutical materials, the method comprising:
flowing the biopharmaceutical materials from a bulk reservoir storing the biopharmaceutical materials through a filter assembly and an intake conduit to a manifold coupled to a plurality of receiving containers, wherein the filter assembly and the intake conduit are laterally offset from the manifold and the plurality of receiving containers; and supporting a plurality of distribution conduits of the manifold by a plurality of discharge conduits of the manifold, wherein a terminal end of each of the plurality of discharge conduits is passed through a cap of one of the plurality of receiving containers, and wherein a low temperature silicone stopper is integrated into the cap and surrounds the discharge conduit; wherein the manifold is arranged via a plurality of rows that each extends parallel to one another and laterally away from the intake conduit; and wherein each of the plurality of distribution conduits is positioned above the plurality of discharge conduits and aligned along one of the plurality of rows with each of the plurality of rows extending across the plurality of receiving containers that are fluidly coupled to a corresponding distribution conduit of the plurality of distribution conduits.

17 . The method of claim 16 , wherein the flowing comprises pumping the biopharmaceutical materials from the bulk reservoir to the manifold.

18 . The method of claim 16 , wherein the flowing comprises flowing the biopharmaceutical materials from the bulk reservoir separately into each of the plurality of rows of the plurality of distribution conduits and into the plurality of receiving containers that are arranged along a corresponding row of the plurality of rows, via the plurality of discharge conduits, by a force of gravity alone.

19 . The method of claim 16 , wherein the flowing comprises:
controlling, via manipulation of one or more first clamps positioned on the distribution conduits, an initial flow of the biopharmaceutical materials into the plurality of discharge conduits that are fluidly coupled to a corresponding distribution conduit of the plurality of distribution conduits; and controlling, via manipulation of one or more second clamps positioned on the discharge conduits of the manifold, a subsequent flow of the biopharmaceutical materials into a corresponding receiving container of the plurality of receiving containers that are fluidly coupled to a corresponding dis

Assignees

• Regeneron Pharma

Inventors

• Dissanayake Tikiri Jean

Classifications

• B67D7/76

  Arrangements of devices for purifying liquids to be transferred, e.g. of filters, of air or water separators · CPC title

• A61J1/1418

  Threaded type · CPC title

• B65B3/10

  by application of pressure to material (by screw-type feeders B65B3/08) · CPC title

• B01L2200/0684

  Venting, avoiding backpressure, avoid gas bubbles · CPC title

• B65B3/06

  by gravity flow · CPC title