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Essentials of Cell Therapy Product Manufacturing, Qualification and Validation v2.0 2024-10

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Essentials of Cell Therapy Product Manufacturing, Qualification and Validation

Designed for experienced CGT staff and lab managers to learn topics related to process validation and manufacturing.

  • Developing a CAR-T Program
    • Does terminology matter?
    • Practical FDA recommendations
    • Test method qualification requirements
    • Has the goalpost been moved?
    • Starting materials for IND-type products (tissues, cell lines) and manufacturing
  • Developing a Validated Assay That Will Please the FDA
    • Assay qualification or validation
    • Potency assay
    • Stability testing
  • Role of Manufacturing in Regulatory Submissions
    • CMC preparation and expectations
    • Considerations in filing an IND, FDA pathways, and designations
    • FDA interactions
  • Cryopreservation and Stability
    • Cryopreservation
    • Thawing methods
    • Stability studies

Participants will receive a certificate of completion upon completing and passing the module assessments.  Participants will receive a certificate of participation upon completing the course evaluation survey.

Key:

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Acknowledgement
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Agree to terms to continue. Non-Distribution Statement for Content and Exam Materials
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Developing a CAR-T Program
Session 1 Recording: Developing a CAR-T Program
Open to view video.
Open to view video. F. Enrique Alvarez, BS, MLS (ASCP)CM, CQA (ASQ) & Indresh Kaur, PhD
You must register to access.
Session 1 Slides: Developing a CAR-T Program
Open to download resource.
Open to download resource. F. Enrique Alvarez, BS, MLS (ASCP)CM, CQA (ASQ) & Indresh Kaur, PhD
You must register to access.
Developing an Assay That Will Please the FDA
Session 2 Recording: Developing an Assay That Will Please the FDA
Open to view video.
Open to view video. Emily Hopewell, PhD
You must register to access.
Session 2 Slides: Developing an Assay That Will Please the FDA
Open to download resource.
Open to download resource. Emily Hopewell, PhD
You must register to access.
Role of Manufacturing in Regulatory Submissions
Session 3 Recording: Role of Manufacturing in Regulatory Submissions
Open to view video.
Open to view video. Kevin Bosse, PhD, RAC-US
You must register to access.
Session 3 Slides: Role of Manufacturing in Regulatory Submissions
Open to download resource.
Open to download resource. Kevin Bosse, PhD, RAC-US
You must register to access.
Cryopreservation, Stability, and Thawing
Session 4 Recording: Cryopreservation, Stability, and Thawing
Open to view video.
Open to view video. Natasha Lapteva, MS, PhD
You must register to access.
Session 4 Slides: Cryopreservation, Stability, and Thawing
Open to download resource.
Open to download resource. Natasha Lapteva, MS, PhD
You must register to access.
Course Assessment
Course Evaluation Form
10 Questions
10 Questions For detailed information on how your data is retained, please refer to our program policies and guidelines using the below link in relation to Request for Record and Data Retrieval Policy and Our Privacy Policy: https://lms.isctglobal.org/Policies
You must register to access.
Certificate of Participation
No credits available  |  Certificate available
No credits available  |  Certificate available
You must register to access.
Course Quiz
20 Questions  |  2 attempts  |  16/20 points to pass  |  Graded as Pass/Fail
20 Questions  |  2 attempts  |  16/20 points to pass  |  Graded as Pass/Fail Participants must complete this quiz to receive a Certificate of Completion for CE hours. The passing score for this quiz is 80%.
You must register to access.
Certificate of Completion
No credits available  |  Certificate available
No credits available  |  Certificate available
You must register to access.