Method and apparatus for automated independent parallel batch-processing of cells

A technology of cells and processing stations, applied in the field of automatic independent parallel batch processing and devices for cells, which can solve the problems of increasing the capacity of batch processing systems and unable to solve completely independent processing

Inactive Publication Date: 2019-06-21
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

While the device described in WO 2016 / 012459 addresses the problem of increasing the capacity of a batch processing system, it fails to address the need to process individual samples completely independently in parallel
Therefore, the system of WO 2016 / 012459 cannot provide the flexibility to process samples in a truly independent parallel manner while achieving the same cost savings in terms of reduced capital expenditure and reduced cleanroom space requirements

Method used

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  • Method and apparatus for automated independent parallel batch-processing of cells
  • Method and apparatus for automated independent parallel batch-processing of cells
  • Method and apparatus for automated independent parallel batch-processing of cells

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 3

[0214] A typical method for preparing CAR-T cells is provided in Example 3 as an example of a method that can be suitably performed on a device according to the present invention.

[0215] Automated cell processing methods as described herein generally comprise one or more steps selected from:

[0216] Select and / or enrich for cells of interest

[0217] · Cell activation

[0218] Genetic modification of cells, e.g. by transduction

[0219] · Cell expansion

[0220] · Cell concentration

[0221] Formulation of cells where the formulation is intended for storage (including cryopreservation) and / or direct injection

[0222] Between these steps, the cells are usually washed with an appropriate buffer to remove excess reagent or to change the medium. These various steps are described in more detail below.

[0223] Selection and / or enrichment of cells

[0224] Typically, the cell sample starting material is not a pure population of cells to be processed. Instead, patient m...

Embodiment 1

[0288] Example 1: Cell processing system according to the invention

[0289] Such as figure 1 As best shown in , an embodiment of a cell processing apparatus 100 of the present invention includes a cell processing station 101 with one or more cell processing modules 102 integrated therein. exist Figure 2a , an embodiment of a cell processing facility 100 is shown in which a cell processing module 102 is mounted on a cart such that it can be rotated around a manufacturing facility to collect reagents and other items needed for the process, or to collect samples from patients. In this embodiment, the fluid cassette 103 is estimated to weigh 15 kg and the reagent pack is estimated to weigh 40 kg.

[0290] Mounting the cell processing module on a cart provides a solution to the manual handling required to collect and load disposable components that are too large or heavy to be safely or comfortably carried by hand. The cart is designed to precisely and specifically interface w...

Embodiment 2

[0299] Example 2: Detailed description of the processing workflow in the device according to the invention

[0300] In a specific embodiment of the present invention, there is provided a Figure 7 with 8 The cell processing apparatus 100 operated in the process flow shown in FIG.

[0301]A sample 20 comprising cellular material obtained from a human or animal subject is obtained. Samples may be obtained by apheresis techniques known in the art. Introduction of sample 20 into workflow 10 includes a series of processing steps enabling selection and isolation of specific cell types contained within sample 20 and appropriate processing of this material to produce desired output cell product 90 .

[0302] In one embodiment, apheresis cell sample material 20 is introduced into workflow 10 . This material is subjected to a selection step 30 in which the cellular material is fractionated or otherwise processed to identify desired subtypes of cells - eg T cells. The isolated subty...

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Abstract

A cell processing device is provided that is suitable for performing independent concurrent processing of a plurality of cell preparations, the cell processing device comprising:(I) a cell processingstation; and(II) a plurality of cell processing modules, wherein the plurality of cell processing modules engage and communicate with the cell processing station; wherein each of the plurality of cellprocessing modules comprises discrete processing compartments defined within, the processing compartments comprising:(i) a reagent pack, the reagent pack comprising one or more reagent vessels; and (ii) one or more fluidic cartridges, each fluidic cartridge comprising one or more cell processing compartments and a cell incubation compartment, wherein each of the processing compartments is in fluid communication with each other. A fluidic cartridge is also provided as is a method of use of the cell processing device

Description

technical field [0001] The present application relates to new methods and devices for automated batch processing of cell samples. In particular, it involves parallel batch processing of advanced therapy medicinal products (ATMPs), such as CAR-T cell therapy products. Background technique [0002] In recent years, there has been growing interest in the field of cell therapy. Cell therapy involves the introduction of cellular material, usually whole living cells, into a patient for the treatment of a variety of diseases, including cancer, and for regenerative medicine. [0003] Cell therapy involves the production of cells for treatment, also known as an advanced therapy medicinal product (ATMP). To address the potential risk of systemic immune response and disease transmission, ATMPs are often derived from a patient's own cells in a process known as autologous cell therapy (ACT) or autologous regenerative therapy. [0004] The broadest form of autologous cell therapy invol...

Claims

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Application Information

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IPC IPC(8): C12M3/00C12N5/0783B01D15/00
CPCC12N5/0636C12M23/42C12M23/44C12M23/58C12M41/48C07K2319/03C07K14/7051A61K39/4611A61K39/4631A61K39/464499C12M23/28
InventorD·奥瓦尔斯S·拜拉V·斯蒂文凯尔B·德莫林K·加尔布雷斯R·格兰特M·罗布
Ownerセリアド