Cell Therapy Processes Utilizing Acoustophoresis

Patent metadata

Field	Value
Publication number	US-2018362918-A1
Application number	US-201816010296-A
Country	US
Kind code	A1
Filing date	Jun 15, 2018
Priority date	May 3, 2016
Publication date	Dec 20, 2018
Grant date	—

Abstract

A closed and modular fluidic system composed of one or more acoustic elements and cell processing reagents. The system employs a cellular manufacturing process for producing cell and gene therapy therapeutics.

First claim

1 . A method for producing a therapeutic by implementing a series of processes, the method comprising:
obtaining cellular material suitable for invoking a therapeutic response; wherein the processes include one or more of a process to concentrate the cellular material, a process to wash the cellular material, or a process for affinity selection of a portion of the cellular material; and at least one of the processes employing an acoustic device to retain the cellular material or a structure to which the cellular material is bound.

2 . The method of claim 1 , further comprising:
fractionating the cellular material or the modified cellular material with an acoustic angled wave device.

3 . The method of claim 2 , wherein the cellular material is included in an apheresis product.

4 . The method of claim 1 , further comprising integrating one or more of the processes into a single device.

5 . The method of claim 1 , wherein the cellular material is housed in a bag.

6 . The method of claim 1 , wherein the series of processes form a closed system.

7 . The method of claim 1 , wherein the process for affinity selection includes negative selection for TCR+ cells.

8 . The method of claim 1 , wherein the series of processes form an end-to-end CAR T production process.

9 . A system for producing a therapeutic by implementing a series of processes, the system comprising:
an acoustic device that includes an ultrasonic transducer configured to generate an acoustic wave to retain cellular material or a structure to which the cellular material is bound; a chamber in the acoustic device for receiving the cellular material or a structure to which the cellular material is bound, the ultrasonic transducer being coupled to the chamber; the acoustic device being configured to implement one or more of a concentration process, a washing process, or an affinity selection process.

10 . The system of claim 9 , further comprising an angled wave acoustic device for fractionating the cellular material.

11 . The system of claim 10 , wherein the cellular material is included in an apheresis product.

12 . The system of claim 9 , wherein the acoustic device is configured to integrate one or more of the concentration process, the washing process, or the affinity selection process.

13 . The system of claim 9 , wherein the cellular material is housed in a bag.

14 . The system of claim 9 , further comprising a closed system.

15 . The system of claim 9 , wherein the affinity selection process includes negative selection for TCR+ cells.

16 . The system of claim 9 , further comprising an end-to-end CART production process.

17 . A cell therapy production system, comprising:
a number of interconnected devices that form a closed system, at least one of the devices being an acoustic device configured to retain cells or structures for supporting cells.

18 . The system of claim 17 , wherein the devices form and end-to-end cell therapy production system.

Assignees

• Flodesign Sonics Inc

Inventors

• Lipkens Bart
• Tostoes Rui
• Dutra Brian
• Gilmanshin Rudolf
• Dionne Jason
• Presz Jr Walter M
• Ross-Johnsrud Benjamin
• Ghoshal Goutam
• Chitale Kedar

Classifications

• A61K35/12

  Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells (vaccines or medicinal preparations containing antigens or antibodies A61K39/00) · CPC title

• B06B1/0607

  using multiple elements (B06B1/064 and B06B1/0688 take precedence) · CPC title

• C12M47/06 Primary

  Hydrolysis; Cell lysis; Extraction of intracellular or cell wall material (lysis of microorganisms C12N1/06; extracting or separating nucleic acids from biological samples C12N15/1003) · CPC title

• A61K35/17

  Lymphocytes; B-cells; T-cells; Natural killer cells; Interferon-activated or cytokine-activated lymphocytes (when activated by a specific antigen A61K39/00) · CPC title

• A61K41/0023

  Aggression treatment or altering · CPC title