Systems, devices and methods for engineered tissue construct transport and containment
AssigneeHumacyte Global, Inc.
InventorsRobert Schutte, Dustin Cashman, Heather L. Prichard, Joshua Mccall, William E. Tente, Shannon L.M. Dahl, Laura E. Niklason
Life of this patent
Estimating the term…
Abstract
In some embodiments, an engineered tissue construct (ETC) transport and containment method is provided and includes storing a bioreactor and an ETC contained therein within a transport package via an opening in the package, and sealing the opening. Some embodiments are also directed at methods for sterilizing packaging and bioreactors contained therein.
Claims20
An engineered tissue construct (ETC) transport and containment method comprising:
- aseptically cultivating an ETC within a bioreactor;
- de-cellularizing the ETC within the bioreactor, the de-cellularized ETC comprising extracellular matrix;
- storing the bioreactor within a transport package via an opening in the transport package;
- sealing the opening by applying a sealing membrane across the opening, the sealing membrane including a plurality of pores configured to pass gaseous and/or vaporous molecules of a predetermined size into and out of the interior of the transport package via the opening;
- and
- performing a sterilization process on the transport package, the sterilization process comprising exposing the interior of the transport package and the exterior of the bioreactor to a sterilizing substance comprising the gaseous and/or vaporous molecules.
An engineered tissue construct (ETC) transport containment method comprising:
- aseptically cultivating an ETC within a bioreactor;
- de-cellularizing the ETC within the bioreactor, the de-cellularized ETC comprising extracellular matrix;
- storing the bioreactor within a transport package via an opening in the transport package;
- sealing the opening by applying a sealing membrane across the opening, the sealing membrane including a plurality of pores configured to pass gaseous and/or vaporous molecules of a predetermined size into and out of the interior of the transport package via the opening;
- placing the sealed transport package in a chamber;
- performing a sterilization process on the transport package within the chamber, the sterilization process comprising:
- providing an airflow to the chamber at an airflow rate;
- maintaining the chamber at a chamber pressure below atmospheric pressure;
- dehumidifying the airflow so as to dehumidify the chamber, the dehumidified airflow being provided to the chamber for a dehumidification time;
- after dehumidification, conditioning the airflow by injecting a conditioning amount of a sterilizing substance comprising the gaseous and/or vaporous molecules into the airflow for a conditioning time;
- after injecting the conditioning amount of the sterilizing substance, injecting a decontamination amount of the sterilizing substance into the airflow to establish and/or maintain a decontamination airflow entrained with the sterilizing substance within the chamber;
- and
- exposing, within the chamber, the sealed transport package to the decontamination airflow for a decontamination time so as to decontaminate the interior of the transport package and the exterior of the bioreactor contained therein.
Dependencies are inferred from the claim text.