The Principles and Applications of Cell Therapy Biomanufacturing, Characterization, and Regulatory

ABOUT THE COURSE

ISCT and CMaT have jointly created this nine-week, part-time, virtual training course to train you on the fundamentals and best practices of CGT biomanufacturing, quality assurance, regulations, bioprocessing requirements, product characterization and assessments.

This course consists of a total of 12 hours of on-demand modules and four hours of live-virtual discussions with Subject Matter Experts working in leading academic institutes, regulatory agencies, clinical manufacturing laboratories, and industries.

Learn fundamentals and best practices on CGT biomanufacturing, product characterizations, and regulatory-quality framework through on-demand modules and live-virtual discussions. 

Click here to view the course outline
COURSE CONTENT
  • Stem Cell and Immune Cell Engineering and Therapies
    • Reprogramming iPSCs, gene editing CRISPR.
    • Immune cell engineering and CAR-T therapy.
  • Quality Assurance and Global Regulatory Framework
    • Quality by Design, Cell Manufacturing Unit Operations, Process Development, Design of Experiments, Critical Quality Attributes (CQAs), and Critical Process Parameters (CPPs).
    • Ethics and policies, global regulatory framework.
  • Cell Bioprocessing and Manufacturing
    • Concepts in Scalable Bioprocessing of Cells - Early vs. Late Stage.
    • Downstream Processing.
    • Supply Chain Management and Distribution.
  • Cell Product Characterization and Importance of Standards
    • Analytical Tools in Cell Manufacturing.
    • Automation for Cell Manufacturing, Data Management, and Machine Learning.

LEARNING OUTCOMES

  • Understand the therapeutic cell manufacturing approach and applications.
  • Develop knowledge in cell-based therapies and biomanufacturing.
  • Understand the current landscape and gaps in the CGT industry.
  • Learn from CGT experts in academic, clinical, regulatory and industry sectors.

PRICE (USD)

Category

ISCT or CMaT Member 

 Non-Member
Academia1 $795 $1,295
Industry $1,495 $1,895
Industry
(Start-up/Small Company3)		 $1,195 $1,595
Students (Students, Fellows, Post docs)  $250 $595
Tier 1 and Tier 2 Reduced Rate4 $557 N/A

Click here for more information 

For full details on our course policies, including cancellations, complaints and appeals processes and our privacy policy, click here.

Register Now

UPCOMING COURSE DATES

September 23–November 29, 2024
Deadline to register: September 30, 2024
(registration open)

Time and Dates for the 1-Hour
Live-Virtual Expert Panel Discussion:

  • Module 1: 
    8 October, 2024 - 08:00 PDT / 11:00 ET
  • Module 2:
    21 October, 2024 - 08:00 PDT / 11:00 ET
  • Module 2b
    (Optional Asia Focused Content): 
    28 October, 2024 - 17.00 PDT /
    09:00 JST (29 October, 2024)
  • Module 3: 
    5 November, 2024 - 08:00 PDT / 11:00 ET 
  • Module 4: 
    20 November, 2024 - 09:00 PDT / 12:00 ET

2025 Spring
February 24–May 2, 2025
Live-Virtual Expert Panel Discussion:

  • Module 1: Week of March 10
  • Module 2: Week of March 24
  • Module 3: Week of April 7
  • Module 4: Week of April 21

2025 Autumn
September 22–November 28, 2025
Live-Virtual Expert Panel Discussion: 

  • Module 1: Week of Oct 6 
  • Module 2: Week of Oct 20
  • Module 3: Week of Nov 3 
  • Module 4: Week of Nov 17
DESIGNED FOR:
  • Graduate students
  • Professional looking to learn the fundamentals of CGT manufacturing
 
STRUCTURE:

Nine weeks, 16 total hours:

  • 12 hours of on-demand modules
  • Four hours of live-virtual discussions

ELIGIBILITY REQUIREMENTS:
  • None
UPON COMPLETION1, YOU WILL RECEIVE:

  • An electronic copy of the course materials.
  • Certificates of course completion from ISCT-CMaT and CMLE.

1Completing all training modules and quizzes is mandatory to receive a course completion certificate. 

*This course has been accepted by the ANSI National Accreditation Board's Certificate Accreditation Program (CAP)

**ISCT is an ASCP Continuing Medical Laboratory Education (CMLE)-approved provider. This course consists of 16 CMLE credits.

    CONTACT US

    If you need help with registration or have questions, please contact us.

    Contact

    “ISCT has long identified and taken measures to alleviate the skills shortages across the cell and gene therapy sector. ISCT has run a range of courses across the CGT sector, including forming our ISCT Early-Stage Professionals (ESP) Committee, responsible for our extensive Mentoring Program. Despite these efforts, growth in the CGT sector continues to outpace the professionals entering. This is a major issue for the sector that could become critical in the near future."
    -Bruce Levine, Immediate-Past President, ISCT
    “A well-trained, readily available, diverse workforce is crucial to the success of the emerging cell and gene therapy industry, especially given its highly specialized skill sets, GMP and regulatory requirements, and complex manufacturing and supply chain infrastructure.

    Our partnership with ISCT brings the largest cell manufacturing research and education consortium together with the largest global cell & gene therapy society to deliver critically needed workforce training for CGT. Together, we hope to develop a robust, on-demand, client-centric training platform for industry and clinical manufacturers.”
    -Krishnendu Roy, Robert A. Milton Chair, CMaT

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