SYSTEM AND METHOD FOR THE GENERATION OF HIGH CELL DENSITY SEED CULTURE

    公开(公告)号:US20220372425A1

    公开(公告)日:2022-11-24

    申请号:US17761156

    申请日:2020-09-10

    IPC分类号: C12M1/34 C12M1/00 C12M1/36

    摘要: A system for an automated production of high cell density seed culture, HCDC, preparations, for cryo-preservation comprising a cell expansion device for growing a HCDC in a medium inside a device volume of the cell expansion device, at least one sensor for collecting data by at least temporally monitoring at least one parameter being indicative of the physiological state of the HCDC; and a control unit for processing the collected data to determine whether at least one predetermined criterion is fulfilled by the monitored parameter to control, based on whether the at least one predetermined criterion is fulfilled by the monitored parameter, at least a partial exchange of the medium by a cryo-protective agent, CPA.

    DIGITAL CONTROL UNIT OF A BIOPROCESS ARRANGEMENT

    公开(公告)号:US20230412391A1

    公开(公告)日:2023-12-21

    申请号:US18029225

    申请日:2021-09-16

    IPC分类号: H04L9/32 H04L9/00

    摘要: Various embodiments relate to a digital control unit of a bioprocess arrangement for controlling a bioprocess, wherein the digital control unit comprises a local data storage and a local processor unit, wherein the digital control unit comprises a bioprocess interface for sending and receiving bioprocess control data, wherein the digital control unit is configured to execute a bioprocess control routine via the local processor unit to control the bioprocess, wherein in the bioprocess control routine, the digital control unit generates bioprocess data from the actuator data and/or the sensor data and/or the user control command data. It is proposed that the digital control unit is configured to execute a signing routine via the local processor unit and that in the signing routine, the digital control unit digitally signs documentation data, derived from the bioprocess data, by generating a digital signature.

    METHOD FOR CONDUCTING A BIOPROCESS
    5.
    发明公开

    公开(公告)号:US20230370281A1

    公开(公告)日:2023-11-16

    申请号:US18029327

    申请日:2021-09-16

    IPC分类号: H04L9/32 H04L9/00

    CPC分类号: H04L9/3247 H04L9/50

    摘要: A method for conducting a bioprocess with a digital control unit of a bioprocess arrangement, wherein the digital control unit comprises a local data storage and a local processor unit, wherein bioprocess data are generated by the digital control unit. It is proposed, that in a data safety routine, a documentation routine and a signing routine are executed, that in the documentation routine, documentation data are generated from the bioprocess data and that in the signing routine, a cryptographic private key is extracted from private key data and the documentation data are digitally signed with the cryptographic private key by generating a digital signature and that the documentation routine is executed continuously during the bioprocess and that the signing routine is executed discontinuously during the bioprocess in several signing cycles according to a signing strategy, which defines trigger events for initiating the signing routine.