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1. WO2020117610 - APPARATUS FOR MANUFACTURING CELL THERAPY PRODUCT

Note: Text based on automatic Optical Character Recognition processes. Please use the PDF version for legal matters

[ EN ]

AMENDED CLAIMS

received by the International Bureau on 31 March 2020 (31.03.2020)

CLAIMS

1 . A system for processing a pharmaceutical suspension , comprising:

a process container comprising a substantially cylindrically shaped container body and a movable plunger rod having a first and second end, wherein the container body contains the pharmaceutical suspension and the movable plunger rod is configured to have a mixing blade at the first end of the movable plunger rod contacting the pharmaceutical suspension in the container body, wherein the mixing blade generates mixing force applied to the pharmaceutical suspension when the movable plunger rod is rotated around axis of the container body, wherein the second end of the movable plunger extends out of the container body; and

a rotor generating centrifugal field that extends to the process container.

2. The system of claim 1 , wherein the end of the movable plunger rod contacting the pharmaceutical suspension is movable in the container body along longitudinal direction of the container body.

3. The system of claim 2, wherein the pharmaceutical suspension is kept sterile in the process container.

4. The system of claim 2, further comprising a centrifugation chamber assembly, having an upper body and a lower body, to host the process container, wherein the upper body is stationary relative to the container body and the lower body is free to move relative to the container body.

5. The system of claim 4, further comprising a linear actuator to move the lower body of the centrifugation chamber assembly along the longitudinal direction of the container body.

6. The system of claim 5, further comprising a control mechanism to control the distance of movement of the lower body of the centrifugation chamber assembly.

7. The system of claim 4, further comprising a rotation motor to rotate the lower body of the centrifugation chamber assembly around the axis of the container body.

8. The system of claim 7, further comprising a control mechanism to control the rotational movement of the lower body of the centrifugation chamber assembly.

9. The system of claim 1 , further comprising a first container component to contain the pharmaceutical suspension, wherein the first container component is bag, bottle, vial or syringe.

10. The system of claim 9, wherein the pharmaceutical suspension in the first container component is in plasma, culture media, washing media, cryopreservation media or infusion media.

1 1. The system of claim 9, further comprising a temperature control adjacent to the first container component.

12. The system of claim 1 , further comprising a second container component to contain process fluid, wherein the second container component is bag, bottle, vial or syringe.

13. A process container for processing a pharmaceutical suspension, comprising:

a substantially cylindrically shaped container body; and

a movable plunger rod having a first and second end, wherein the container body contains the pharmaceutical suspension and the movable

plunger rod is configured to have a mixing blade at the first end of the movable plunger rod contacting the pharmaceutical suspension in the container body, wherein the mixing blade generates mixing force applied to the pharmaceutical suspension when the movable plunger rod is rotated around axis of the container body, wherein the second end of the movable plunger extends out of the container body.

14. A method of changing media in pharmaceutical suspension, comprising:

providing a process container having a substantially cylindrically shaped container body and a movable plunger rod having a first and second end, wherein the container body contains the pharmaceutical suspension and the movable plunger rod is configured to have a mixing blade at the first end of the movable plunger rod contacting the pharmaceutical suspension in the container body, wherein the mixing blade generates mixing force applied to the pharmaceutical suspension when the movable plunger rod is rotated around axis of the container body, wherein the second end of the movable plunger extends out of the container body;

withdrawing the pharmaceutical suspension in a first liquid media into the process container by moving the movable plunger rod along longitudinal direction of the container body;

generating centrifugal field that extends to the process container to separate the first liquid media;

expelling the first liquid media out of the process container by moving the movable plunger rod along the longitudinal direction of the container body;

withdrawing a second liquid media into the process container by moving the movable plunger rod along the longitudinal direction of the container body; and

re-suspending in the second liquid media by rotating the movable plunger rod around the axis of the container body.