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 bio-manufacturing, quality assurance, regulations, bio-processing 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. 

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 

Group Member2 Non-Member Group Non-Member2
Academia1 $795 $675.75 $1,295 $1,100.75
Industry $1,495 $1,270.75 $1,895 $1,610.75
Industry
(Start-up/Small Company3)
$1,195 $1,015.75 $1,595 $1,355.75
Students (Students, Fellows, Post docs)  $250 $212.50 $595 $505.75


1 Please contact ISCT head office at sunny@isctglobal.org to receive a discount code for Academia Member/Non-Member pricing.

Receive a 15% off when registering for five or more people from the same company/institution.

3 Industry Start-Up/Small Company is defined as companies less than 5 years old and has less than 15 employees. Please email ISCT head office at sunny@isctglobal.org to receive a discount code for Industry (Start-up/Small Company) pricing.

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



    UPCOMING COURSE DATES
    • September 23–November 29, 2024
      Deadline to register: September 30, 2024

      (registration open)

    ONGOING COURSE
    • February 12–April 19, 2024
    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.

      “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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