System and methods for use in dispensing biopharmaceutical materials

Patent metadata

Field	Value
Publication number	US-9315281-B2
Application number	US-201213680935-A
Country	US
Kind code	B2
Filing date	Nov 19, 2012
Priority date	Nov 19, 2012
Publication date	Apr 19, 2016
Grant date	Apr 19, 2016

Abstract

A pre-sterilized system for dispensing biopharmaceutical materials includes a reservoir for holding biopharmaceutical materials coupled to a filter and distribution manifold connected to a plurality of receiving containers. The manifold includes a plurality of container conduits and a plurality of distribution conduits. The plurality of container conduits is connected to the plurality of receiving containers and supports the plurality of distribution conduits above the plurality of receiving containers to allow flow of the biopharmaceutical materials from the plurality of distribution conduits by gravity into the plurality of receiving containers. The plurality of receiving containers and the manifold are sealed relative to an ambient environment outside the manifold and the plurality of containers to inhibit contamination of the biopharmaceutical materials when the biopharmaceutical materials are inside at least one of the plurality of receiving containers and the manifold.

First claim

The invention claimed is:

1. A system for dispensing biopharmaceutical materials, the system comprising:
a plurality of receiving containers;
a distribution manifold connected to the plurality of receiving containers;
a pre-sterilized filter;
a reservoir for holding biopharmaceutical materials connected to the pre-sterilized filter and the distribution manifold, the filter located between said reservoir and said manifold;
said manifold comprising a plurality of container conduits and a plurality of distribution conduits, said plurality of distribution conduits connected to each other to form a continuous shape such that interiors of said plurality of distribution conduits are in fluid communication with each other and are at about a same height relative to each other;
said plurality of container conduits connected to said plurality of receiving containers and supporting said plurality of distribution conduits above said plurality of receiving containers to allow flow of the biopharmaceutical materials from said plurality of distribution conduits by gravity into said plurality of receiving containers; and
said plurality of receiving containers and said manifold sealed relative to an ambient environment outside said manifold and said plurality of containers to inhibit contamination of the biopharmaceutical materials when the biopharmaceutical materials are inside at least one of said plurality of receiving containers or said manifold.

2. The system of claim 1 further comprising a sampling container connected to said manifold to allow a flow of the biopharmaceutical materials from said manifold into said sampling container.

3. The system of claim 2 further comprising a sealing connector to allow said sampling container to be sealingly detached from said manifold.

4. The system of claim 2 wherein said sampling container is coupled to said reservoir and said plurality of receiving containers such that the biopharmaceutical materials flows from said reservoir through said sampling container to said plurality of receiving containers.

5. The system of claim 1 further comprising a sampling container in fluid communication with said reservoir and said plurality of receiving containers to allow a flow of the biopharmaceutical materials from said reservoir to said plurality of receiving containers to be received in said sampling container.

6. The system of claim 1 wherein the plurality of container conduits extend into said plurality of receiving containers.

7. The system of claim 6 wherein a first container conduit of the plurality of container conduits comprises an outlet directed against a wall of a first receiving container of the plurality of receiving containers to inhibit foaming of the biopharmaceutical materials when the biopharmaceutical materials flow into the first receiving container.

8. The system of claim 6 wherein a first container conduit of the plurality of container conduits extends into a first container of said plurality of receiving containers, said first container conduit comprising a sealable connector and further comprising an exit port allowing a flow of air from said first container, said exit port comprising a second sealable connector.

9. The system of claim 1 further comprising a plurality of exit ports having filters thereon to allow a flow of air from said plurality of receiving containers when the biopharmaceutical materials flows into the plurality of receiving containers, the filters inhibiting contamination of the biopharmaceutical materials.

10. The system of claim 1 further comprising a pump coupled to said reservoir and said manifold for pumping the biopharmaceutical materials from the reservoir to said manifold.

11. The system of claim 1 wherein said manifold further comprises a plurality of feeder conduits.

12. A system for dispensing biopharmaceutical materials, the system comprising:
a reservoir for holding biopharmaceutical materials;
a distribution manifold coupled to the reservoir;
a plurality of receiving containers;
said manifold connected to the plurality of receiving containers to allow fluid communication between said reservoir and said plurality of receiving containers;
said manifold comprising a plurality of container conduits connected to said plurality of receiving containers such that said manifold is self-supporting and located above said plurality of receiving containers, and a plurality of distribution conduits connected to each other to form a continuous shape such that interiors of said plurality of distribution conduits are in fluid communication with each other and are at about a same height relative to each other, said plurality of distribution conduits are supported by the plurality of container conduits;
a sampling container directly connected to a distribution conduit of the plurality of distribution conduits of said manifold to allow a flow of the biopharmaceutical materials from said reservoir to be received in said sampling container; and
said plurality of receiving containers and said manifold sealed relative to an ambient environment outside said manifold and said plurality of containers to inhibit contamination of the biopharmaceutical materials when the biopharmaceutical materials are inside at least one of said plurality of receiving containers and said manifold.

13. A method for dispensing biopharmaceutical materials comprising:
flowing the biopharmaceutical materials from a reservoir storing the biopharmaceutical materials to a distribution manifold coupled to a plurality of receiving containers;
supporting a plurality of distribution conduits of the manifold by a plurality of container conduits of the manifold connected to the plurality of receiving containers such that the plurality of distribution conduits is located above the plurality of container conduits and the plurality of receiving containers to allow a flow of the biopharmaceutical materials from the plurality of distribution conduits by gravity into the plurality of receiving containers;
the plurality of distribution conduits connected to each other to form a continuous shape such that interiors of the plurality of distribution conduits are in fluid communication with each other and are at about a same height relative to each other; and
sealing the plurality of receiving containers and the manifold relative to an ambient environment outside the manifold and the plurality of receiving containers to inhibit contamination of the biopharmaceutical materials received in at least one of the plurality of receiving containers and the manifold.

14. The method of claim 13 further comprising:
flowing the biopharmaceutical materials from the manifold to a sampling container connected to the manifold and sealing the sampling container relative to the manifold.

15. The method of claim 13 wherein a first container conduit of the plurality of container conduits comprises an outlet directed against a wall of a first-receiving container of the plurality of receiving containers and flowing the biopharmaceutical materials through the outlet to inhibit aggregation of the biopharmaceutical materials flowing into the first-receiving container.

16. The method of claim 13 further comprising flowing the biopharmaceutical material into the plurality of receiving containers by a force of gravity alone.

17. The method of claim 13 further comprising pumping the biopharmaceutical materials from the reservoir to the manifold using a pump.

18. The system of claim 1 wherein said continuous shape comprises a nonlinear, non-terminating shap

Assignees

• Regeneron Pharma

Inventors

• Dissanayake Tikiri Jean

Classifications

• B65B3/22

  Defoaming liquids in connection with filling · CPC title

• B65B3/12

  mechanically, e.g. by pistons or pumps · CPC title

• B65B3/04 Primary

  Methods of, or means for, filling the material into the containers or receptacles · CPC title

• B65B3/003 Primary

  Filling medical containers such as ampoules, vials, syringes or the like · CPC title

• B65B3/06

  by gravity flow · CPC title