Learning Center

Essentials of Cell Therapy Product Manufacturing, Qualification and Validation v.2023-09

  • Register
    • Non-member - $450
    • Advanced Practice Professional Member - $100
    • Emeritus Member - $125
    • Industry Community - $200
    • Industry Community Sub Account - $200
    • Laboratory Member - $100
    • Laboratory Technologist Sub Account - $100
    • Laboratory Regular Member Sub Account - $100
    • Laboratory Resident and Fellow Sub Account - $100
    • Regular Member - $200
    • Resident or Fellow Member - $85
    • Student Member - $85
    • Technologist Member - $100

    Continue

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

Key:

Complete
Failed
Available
Locked
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
11 Questions
11 Questions Participants must complete this feedback survey to receive a Certificate of Participation
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
17 Questions  |  3 attempts  |  13/17 points to pass  |  Graded as Pass/Fail
17 Questions  |  3 attempts  |  13/17 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.