Aseptic tissue processing method, kit and device

a technology of aseptic tissue and kit, applied in the direction of biomass after-treatment, specific use bioreactor/fermenter, biochemical apparatus and processes, etc., can solve the problems of labour-intensive and labor-intensive manual or semi-automatic solid tissue processing steps, and achieve rapid pre-sterilisation environment, reduce the time required and the risk of operator exposure, the effect of eliminating the risk of contamination

Inactive Publication Date: 2020-01-30
INSTIL BIO UK LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The present invention provides a system for processing solid tissue in a closed and aseptically manner to minimize the risk of contamination and operator exposure. The kit includes interconnected containers that have specific functions to process, stabilize, and store the tissue. The unique design allows for stable, high-quality cellularized tissue products to be produced, with the option to store them for short or long periods of time prior to use. The invention also includes a method for using hydrodynamic filtration to enhance the resolution and fractionation of cells and impurities based on size and shape. Overall, the invention provides a more efficient, safe, and stable process for processing solid tissue for therapeutic applications.

Problems solved by technology

The known manual or semi-automated solid tissue processing steps are labour-intensive and require a knowledge of the art.

Method used

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  • Aseptic tissue processing method, kit and device
  • Aseptic tissue processing method, kit and device
  • Aseptic tissue processing method, kit and device

Examples

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example method

[0191]The method of the invention is exemplified according to the following process. It is clearly stated that other than the essential features of the method, the various optional steps listed herein can be independently combined to achieve the relevant technical advantages associated with the type of sampling and result to be achieved.

[0192]A semi-automatic aseptic tissue processing method comprising: automatically determining aseptic disaggregation tissue processing steps and one or more further tissue processing steps and their associated conditions from a digital tag identifier on an aseptic processing kit, optionally in accordance with the kit described herein; placing a tissue sample into a flexible plastic container of the aseptic processing kit; and processing the tissue sample by automatically executing the one or more tissue processing steps by communicating with and controlling the disaggregation module; the optional enrichment module; and the stabilisation module.

[0193]...

example 1

[0256]Impact of the Length of Disaggregation

[0257]Peripheral blood mononuclear cells were physically disaggregated for 0, 1, 5 & 10 minutes continuously before a being cultured in vitro for 0, 24 & 96 hours to assess cell recovery. The results demonstrate the physical process has negligible impact over 1 or 5 minutes and at 10 minutes the impact was transient where and initial reduction in viable cells at 0 hours was equivalent to non-disaggregated cells at 24 & 96 hours (FIG. 5).

example 2

[0258]Solid Tissue Sample Size, Volume of Digestion Media, Disaggregation and Incubation Times

[0259]Conditions of: Solid tissue size, volume of digestion media, disaggregation time and incubation conditions have been tested and demonstrate full disaggregation of solid tissue (Table 1) except where the volume of digestion media cushioned the solid tissue during the disaggregation process resulting in 30-50% of the solid tissue remaining intact.

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Abstract

The present invention concerns a single use aseptic kit comprising: a disaggregation module for receipt and processing of material comprising solid mammalian tissue; and a stabilisation module for storing disaggregated product material, wherein each of the modules comprises one or more flexible containers connected by one or more conduits adapted to enable flow of the tissue material there between; and wherein each of the modules comprises one or more ports to permit aseptic input of media and / or reagents into the one or more flexible containers. The invention further relates to an automated device for semi-automated aseptic disaggregation and / or enrichment and / or stabilisation of cells or cell aggregates from mammalian solid tissue comprising a programmable processor and the single use aseptic kit. The invention further relates to a semi-automatic aseptic tissue processing method.

Description

[0001]The present invention concerns a kit and a semi-automatic device using that kit for aseptic disaggregation of solid tissue derived eukaryotic cells into either single cells or small cell number aggregates. The invention further relates to a semi-automatic aseptic tissue processing method comprising: a process for aseptic disaggregation of solid tissue derived eukaryotic cells into either single cells or small cell number aggregates and their further processing.BACKGROUND[0002]The conditions during solid tissue disaggregation and time taken to harvest the cells have a substantial impact on the viability and recovery of the final cellularised material. Typically a solid tissue derived cell suspension, that is obtained, comprises a wide variety of different cell types and the disaggregation media and tissue debris or fluids. Often, selective targeting and or isolation of an individual or multiple cell types is prerequisite for the starting material prior to manufacture of regener...

Claims

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Application Information

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IPC IPC(8): C12M1/00C12M1/36C12M1/33
CPCC12M47/04C12M45/02C12M45/09C12M45/22C12M41/48C12M23/28C12M23/14
InventorGUEST, RYAN DOMINICPRICE, NICOLA KAYE
OwnerINSTIL BIO UK LTD