Learning Center

Cell Therapy Manufacturing: Strategy & Optimization

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    • Non-member - $450
    • Advanced Practice Professional Member - $100
    • Industry Community - $200
    • Industry Community Sub Account - $200
    • Laboratory Member - $100
    • Laboratory Technologist Sub Account - $100
    • Laboratory Regular Member Sub Account - $99.99
    • Laboratory Resident and Fellow Sub Account - $85
    • Non-member Advanced Practice Professional - $450
    • Non-member Regular - $449.99
    • Non-member Resident or Fellow - $450
    • Non-member Technologist - $449.99
    • Regular Member - $200
    • Resident or Fellow Member - $85
    • Student Member - $85
    • Technologist Member - $100

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Cell Therapy Manufacturing: Strategy & Optimization

This 1-day, in-person training course aims to provide you with advanced knowledge to optimize and standardize cell manufacturing processes.

The course addresses critical areas within the cell manufacturing workflow where inconsistencies and challenges arise, with real-world case studies presented by leading academic and industry experts. Participants will gain advanced knowledge in standardizing processes essential to cell product quality, including cryopreservation, product characterization, safety testing and knowledge to integrate new technologies into their current workflows. Interactive Q&A sessions and panel discussions led by SMEs will offer participants the chance to deepen their understanding and ask targeted questions. 

WHAT YOU WILL LEARN
  • Effective strategies for product storage, cryopreservation, stability, and tracking of cell and gene therapy product tracking
  • Methods for standardizing and enhancing product safety testing and characterization assays for cell and gene therapy products
  • Insights into best-fit strategies for scaling up manufacturing processes
  • Approaches to evaluate and incorporate new technologies into workflows, ensuring proper validation and training
  • Acquire actionable insights through dynamic panel discussions and interactive
    Q&A sessions
DESIGNED FOR:


Key:

Complete
Failed
Available
Locked
Acknowledgement
Agree to terms to continue.
Agree to terms to continue. Non-Distribution Statement for Content and Exam Materials
You must register to access.
Cell Product Manufacturing Considerations
Lecture 1 Recording: Cell Product Manufacturing Considerations: Characterization and Safety Testing (361 vs 351 products)
Open to view video.
Open to view video. Instructor: Olive Sturtevant, MHP, MT(ASCP)SBB, SLS, CQA(ASQ), Senior Administrative Director of the Connell & O'Reilly Families, Cell Manipulation Core Facility, Dana-Farber Cancer Institute, United States
You must register to access.
Lecture 1 Slide: Cell Product Manufacturing Considerations: Characterization and Safety Testing (361 vs 351 products)
Open to download resource.
Open to download resource. Instructor: Olive Sturtevant, MHP, MT(ASCP)SBB, SLS, CQA(ASQ), Senior Administrative Director of the Connell & O'Reilly Families, Cell Manipulation Core Facility, Dana-Farber Cancer Institute, United States
You must register to access.
Cell Product Manufacturing Considerations
Lecture 2 Recording: Cell Product Manufacturing Considerations: Cryopreservation, Stability, Storage, and Product Tracking (361 vs 351 products)
Open to view video.
Open to view video. Instructors: Steve Oh, PhD, Independent Cell Therapy Leader, Singapore and Sita Somara, PhD, MBA, Drug Development and Regulatory Program, Soma Life Science Solutions, United States
You must register to access.
Lecture 2 Slide: Cell Product Manufacturing Considerations: Cryopreservation, Stability, Storage, and Product Tracking (361 vs 351 products)
Open to download resource.
Open to download resource. Instructors: Steve Oh, PhD, Independent Cell Therapy Leader, Singapore and Sita Somara, PhD, MBA, Drug Development and Regulatory Program, Soma Life Science Solutions, United States
You must register to access.
Adapting to Emerging Technologies
Lecture 3 Recording: Key Considerations, Scalability, and Limitations in Manufacturing
Open to view video.
Open to view video. Instructor: Darin Sumstad, MLS(ASCP), Technical Lead of Cell Therapy Clinical Laboratory, M Health Fairview University of Minnesota Medical Center, United States
You must register to access.
Lecture 3 Slide: Key Considerations, Scalability, and Limitations in Manufacturing
Open to download resource.
Open to download resource. Instructor: Darin Sumstad, MLS(ASCP), Technical Lead of Cell Therapy Clinical Laboratory, M Health Fairview University of Minnesota Medical Center, United States
You must register to access.
Identifying Common Issues
Lecture 4 Recording: Identifying and Mitigating Common Issues when Bringing on Industry-Sponsored Technologies
Open to view video.
Open to view video. Instructors: Wade Atkins, MS, MT (ASCP) SBB, CQA (ASQ), Quality Assurance and Regulatory Affairs Supervisor, Department of Transfusion Medicine at the Clinical Center of the National Institutes of Health, United States Diane Kadidlo, BSc, MT (ASCP) SBB, Director of Molecular and Cellular Therapeutics, University of Minnesota, United States
You must register to access.
Lecture 4 Slide: Identifying and Mitigating Common Issues when Bringing on Industry-Sponsored Technologies
Open to download resource.
Open to download resource. Instructors: Wade Atkins, MS, MT (ASCP) SBB, CQA (ASQ), Quality Assurance and Regulatory Affairs Supervisor, Department of Transfusion Medicine at the Clinical Center of the National Institutes of Health, United States Diane Kadidlo, BSc, MT (ASCP) SBB, Director of Molecular and Cellular Therapeutics, University of Minnesota, United States
You must register to access.
Designing a Sustainable and Robust Training Program
Lecture 5 Recording: Designing a Sustainable and Robust Training Program: Approach and Competency Assessment
Open to view video.
Open to view video. Instructors: Cheryl Cox, MHA, MT(ASCP), CSSMBB, Director of Cell Therapy Core Operations, Moffitt Cancer Center, United States Christina J Vaughan, MS, CABP, Manager of Cell Immunotherapy and Transduction (CIT) Facility, Indiana University School of Medicine, United States
You must register to access.
Lecture 5 Slide: Designing a Sustainable and Robust Training Program: Approach and Competency Assessment
Open to download resource.
Open to download resource. Instructors: Cheryl Cox, MHA, MT(ASCP), CSSMBB, Director of Cell Therapy Core Operations, Moffitt Cancer Center, United States Christina J Vaughan, MS, CABP, Manager of Cell Immunotherapy and Transduction (CIT) Facility, Indiana University School of Medicine, United States
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
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Summative Assessment
15 Questions  |  2 attempts  |  12/15 points to pass  |  Graded as Pass/Fail
15 Questions  |  2 attempts  |  12/15 points to pass  |  Graded as Pass/Fail There are a total of 15 questions associated with this exam. You must achieve a total score of 80% in order to pass. You have two attempts to complete the exam. Any of the course resources made available to you in the course modules may be used during this examination.
You must register to access.
Certificate of Completion
No credits available  |  Certificate available
No credits available  |  Certificate available
You must register to access.