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Change Request - Process Models

As a group, read through the following Change Request and see how it translates to the requirements documented in your shared Google Sheet.

Important

Timing: You have 90 minutes to complete this stage of the project, after which we will debrief as a group.

Note

Build the Perform and Observe Signature Flow before using it in the Xuri Step. Signature Flow requirements are provided at the bottom of this page.

Recipe: CAR T Processing

  1. Create a copy of the CAR T Processing Recipe

    1. Rename the Recipe CAR T Processing and Expansion

    2. Add the Cell Expansion Section to the end

    3. Place this Section in a new swim lane named Expansion

    4. The Batch will transition to this Section when Cell Separation has been completed

  2. Create a new CAR T Product in the MESProduct app

    1. MES Process: CAR T Processing and Expansion

    2. Product Name: CD22 CAR T

Section: Cell Expansion

  1. Add instructions that link to vendor documentation for the CellBag and Cell Expansion System. The formatted Procedures are shown below:

    1. CellBag Instructions - hyperlink to the file with the same name in the Data app

    2. Video Demonstration - https://www.youtube.com/watch?v=39p6IDI39so&ab_channel=Cytiva

    Tip

    What HTML element will create the largest heading and a line break between hyperlinks?

    Review our HTML guide here

  2. Add a data link to pull the Xuri Kit from the CAR T Batch Entity

    1. Do the same for the Sepax Kit and CliniMACS Kit in the Cell Wash and Cell Separation Sections

    Tip

    Commonly used Expressions for Workflow data links.

    Expression

    Description

    {{ cell('Field ID', 'Protocol ID') }}

    Used to link a value from a field in an upstream Protocol.

    {{ cell('Field ID', 'Protocol ID', generation=-1 }}

    Used to link a value from a field in an upstream Protocol, where the parent of the current Entity is the Entity in that upstream Protocol.

    {{ tagged_value(['tag']) }}

    Used to link a value from a tagged field associated with an Entity or Protocol.

    {{ entity_value('Field Name') }}

    Used to link a value from a field associated with the current Entity in the Protocol.

    {{ entity_value('Field Name', generation=-1) }}

    Used to link a value from a field associated with the Parent of the current Entity in the Protocol.

    Important

    Testing: Create a new Batch Record in the MES app to test these changes with the CD22 CAR T Product

Step: Xuri

In the screenshots below, pay special attention to:

  • Sub-Steps and Sub-Step tables

  • Fields that are editable vs. read-only

  • Sample Types collected at Sample Points, and their min and/or max values

  • Min and/or max values for numeric fields and their Units of Measure

  1. Restrict the Xuri Kit field to kits of this type

  2. Add two (2) fields for consumption of the following inventory items:

    1. 2 L CellBag

      1. Position: immediately downstream of the Xuri Kit field

      2. Name: 2 L CellBag

      3. Sub-Step: Xuri Setup

      4. Sub-Step table: Inventory

      5. Valid Item Status: Verified

    2. 500 mL T Cell Expansion Medium

      1. Position: immediately downstream of the 2 L CellBag field

      2. Name: 500 mL T Cell Expansion Medium

      3. Sub-Step: Xuri Setup

      4. Sub-Step table: Inventory

      5. Valid Item Status: Verified

    Tip

    When setting up Sub-Step tables and restricting Items to Kits, consider:

    • How do you add a field to a Sub-Step table using a Var Group?

    • What L7|ESP Expression will restrict Items to the Xuri Kit selected during Batch production?

    Expression

    Description

    {{ [json_loads(entity_value('Field Name'))['uuid']] }}

    Used to reference a Batch Entity Type field.

    {{ [json_loads(cell('Field ID', 'Protocol ID'))['uuid']] }}

    Used to reference a field in a Protocol by ID

    {{ [json_loads(tagged_value(['tag']))['uuid']] }}

    Used to reference a field in a Protocol by tag

    3053881764.png

  3. Add a new Sub-Step named Xuri Sampling with the following Sample Point:

    1. Xuri Process Control Samples

    2. Field position, name, and parameters can be taken from the screenshot below:

    3053881737.png

  4. Add a numeric field named Xuri Total Time to the Final Xuri Sub-Step

    1. This field is a Critical Process Parameter (CPP)

    2. Field position, unit of measure, and a min/max value can be taken from the screenshot below:

    3053881740.png

  5. Create a new Signature Flow named Perform and Observe

    1. Perform and Observe

      1. Accept Reasons: Performed by and Observed by

      2. Reject Reasons: Exception

      3. Signature 1

        1. Signed by members of the Manufacturing Technician Role

        2. Block progress until signed

        3. Signature locks data

      4. Signature 2

        1. Signed by members of the Manufacturing Technician Role

        2. Nominated by the previous signer

    Note

    The observer does not need to sign if the performer signs first. However, if the performer cannot sign in real-time, the observer must sign first and then nominate the performer.

    How does the Signature Flow need to be configured to meet these requirements?

  6. Add a new Sub-Step named Signatures containing the Perform and Observe Signature Flow and Complete field

    3053881743.png

    Important

    Testing: Create a new Batch Record in the MES app to test these changes. Pin the CAR T Processing and Expansion Recipe once testing is complete.

In this section: