# US 2016/0243165 A1 · Processing cell therapy products

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- Number: US 2016/0243165 A1
- Document ID: US20160243165A1
- Status: Published application
- Kind: A1
- Application number: 15/030,855
- Filed: 2014-10-21
- Published: 2016-08-25
- Earliest claimed: 2013-10-21
- Applicants: Dana-Farber Cancer Institute
- Inventors: Karl STASKO; Heather GARRITY
- Web page: https://patentgrep.com/patent/US20160243165A1

## CPC

- A61K 35/18: Erythrocytes (haemoglobin A61K38/42)
- A01N 1/162: Temperature processes, e.g. following predefined temperature changes over time
- A61K 35/17: Lymphocytes; B-cells; T-cells; Natural killer cells; Interferon-activated or cytokine-activated lymphocytes (when activated by a specific antigen A61K39/00)
- B01L 3/5021: {Test tubes specially adapted for centrifugation purposes}
- B01L 3/50825: {Closing or opening means, corks, bungs}
- C12N 5/0634: {Cells from the blood or the immune system}
- C12N 5/0641: {Erythrocytes}
- B01L 2200/0647: Handling flowable solids, e.g. microscopic beads, cells, particles
- B01L 2300/041: Connecting closures to device or container
- B01L 2300/046: Function or devices integrated in the closure
- B01L 2300/0627: Sensor or part of a sensor is integrated
- B01L 2300/0672: Integrated piercing tool
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A01N: PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF (preservation of food or foodstuff A23); BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES (preparations for medical, dental or toiletry purposes which kill or prevent the growth or proliferation of unwanted organisms A61K); PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- B01L: CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)

## Abstract

Systems, methods, and apparatus for processing cell therapy products are provided. A closed system can include a container, an expandable seal, a connector, and a needle for aspirating. The container can have an interior configured to hold at least one cellular therapy product. The expandable seal can be coupled to the container and form a barrier between an external environment and the interior of the container. The connector can be coupled to the expandable seal. The needle can be operatively coupled to the connector, and a distal end of the needle can extend from the connector into the interior of the container. The position of the distal end of the needle can be selectively adjusted between a first depth in the interior of the container and a second depth in the interior of the container without exposing the needle to the external environment.

## Claims

### Claim 1

A system comprising:
a container with an interior configured to hold at least one cellular therapy product;
an expandable seal coupled to the container and forming a barrier between an external environment and the interior of the container;
a connector coupled to the expandable seal; and
a needle operatively coupled to the connector, a distal end of the needle extending from the connector into the interior of the container, wherein a position of the distal end of the needle is selectively adjustable between a first depth in the interior of the container and a second depth in the interior of the container without exposing the needle to the external environment, the needle being configured for aspirating one or more of the at least one cellular therapy product.

### Claim 2 (depends on 1)

The system of claim 1, wherein the system is configured for containing cellular therapy products during centrifugation.

### Claim 3 (depends on 1)

The system of claim 1, wherein the container is comprised of a plastic resistant to puncture by the needle when the needle is at least one of repositioned within the interior of the container and used to aspirate a cellular therapy product from the interior of the container.

### Claim 4 (depends on 1)

The system of claim 1, further comprising one or more support elements to support at least a distal portion of the needle during centrifugation.

### Claim 5 (depends on 1)

The system of claim 1, wherein the expandable seal comprises an accordion seal.

### Claim 6 (depends on 1)

The system of claim 1, wherein the connector comprises a mechanically-closed device, the device configured to automatically self-seal when not being accessed.

### Claim 7 (depends on 1)

The system of claim 1, further comprising a plurality of sterile access tubes.

### Claim 8 (depends on 1)

The system of claim 1, further comprising at least one port between the interior of the container and the external environment, the at least one port being at least one of an aspirating needle access port, a vent port, and an infusion port.

### Claim 9

A method comprising:
acquiring a closed system with at least one cellular therapy product, the closed system comprising:
a container with the at least one cellular therapy product disposed within an interior of the container;
an expandable seal coupled to the container and forming a barrier between an external environment and the interior of the container;
a connector coupled to the expandable seal; and
a needle operatively coupled to the connector, a distal end of the needle extending from the connector into the interior of the container, wherein a position of the distal end of the needle is selectively adjustable between a first depth in the interior of the container and a second depth in the interior of the container without exposing the needle to the external environment;
selecting the position of the distal end of the needle to correlate with a location of one or more of the at least one cellular therapy product in the interior of the container; and
aspirating the one or more of the at least one cellular therapy product through the needle.

### Claim 10 (depends on 9)

The method of claim 9, wherein the closed system is configured for containing cellular therapy products during centrifugation.

### Claim 11 (depends on 9)

The method of claim 9, wherein the container is comprised of a plastic resistant to puncture by the needle when the needle is at least one of repositioned within the interior of the container and used to aspirate a cellular therapy product from the interior of the container.

### Claim 12 (depends on 9)

The method of claim 9, wherein the closed system further comprises a one or more support elements to support at least a distal portion of the needle during centrifugation.

### Claim 13 (depends on 9)

The method of claim 9, wherein the expandable seal comprises an accordion seal.

### Claim 14 (depends on 9)

The method of claim 9, wherein the connector comprises a mechanically-closed device, the device configured to automatically self-seal when not being accessed.

### Claim 15 (depends on 9)

The method of claim 9, wherein the closed system further comprises a plurality of access tubes.

### Claim 16 (depends on 15)

The method of claim 15, wherein acquiring the closed system with the at least one cellular therapy product comprises introducing the at least one cellular therapy product into the interior of the container using at least one of the plurality of access tubes.

### Claim 17 (depends on 9)

The method of claim 9, wherein the closed system further comprises at least one port between the interior of the container and the external environment, the at least one port being at least one of an aspirating needle access port, a vent port, and an infusion port.

### Claim 18 (depends on 9)

The method of claim 9, further comprising subjecting the closed system with the at least one cellular therapy product to centrifugation.

### Claim 19 (depends on 9)

The method of claim 9, further comprising repositioning the distal end of the needle to correlate with the location of the one or more of the at least one cellular therapy product in the interior of the container.

### Claim 20 (depends on 9)

The method of claim 9, further comprising distributing the one or more of the at least one cellular therapy product aspirated from the interior of the container into a freeze bag.