Principles & Applications of Cell Therapy Biomanufacturing, Characterization, Regulatory

Principles & Applications of Cell Therapy Biomanufacturing, Characterization, Regulatory

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. 

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12 hours
Self-paced, on-demand modules
4 hours
Live-virtual expert panel discussions
Course Access Duration: 
9 weeks of structured learning
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
Academia 1 $795 $1,295
Industry $1,495 $1,895
Industry
(Start-up/Small Company 2)		 $1,195 $1,595
Students (Students, Fellows, Post docs)  $250 $595
Tier 1 and Tier 2 Reduced Rate 3 $557 N/A
Re-examination fee 4 (valid within one month after failing the course assessment.) $250 $250

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

1 Please contact ISCT Head Office at workforcedevelopment@isctglobal.org to receive a discount code for Academia Member / Non-Member pricing.

2 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 workforcedevelopment@isctglobal.org to receive a discount code for Industry (Start-up/Small Company) pricing.

3 Tier 1 and Tier 2 countries are listed here. Reduced rates are available only for Academic / Government / Non-Profit / Technologist / Pharmacist / Nurse. Contact ISCT at workforcedevelopment@isctglobal.org for special pricing.

4 For re-examination, please contact workforcedevelopment@isctglobal.org.

CURRENT COURSE SCHEDULE

2025 Spring

  • Dates: February 24–May 2, 2025
  • Registration deadline: March 1, 2025

Live-Virtual Expert Panel Discussion:

  • Module 1: March 11, 2025: 15:00 PST/18:00 EST/07:00 JST 
  • Module 2: March 27, 2025: 15:00 PST/18:00 EST/07:00 JST
  • Module 2b (optional): April 7, 2025: 17:00 PST/20:00 EST/09:00 JST 
  • Module 3: April 8, 2025: 15:00 PST/18:00 EST/07:00 JST  
  • Module 4: April 22, 2025: 15:00 PST/18:00 EST/07:00 JST 

UPCOMING COURSE DATES (REGISTRATION NOW OPEN)

2025 Autumn

  • Dates: September 22–November 28, 2025

Live-Virtual Expert Panel Discussion: 

  • Module 1: Week of October 6 
  • Module 2: Week of October 20
  • Module 3: Week of November 3 
  • Module 4: Week of November 17
DESIGNED FOR:

Undergraduate students with a Science degree interested in entering the CGT field, as well as professionals seeking to expand their knowledge of CGT bioprocessing and best practices. 

16 CMLE Hours

  • This course is accepted by the ANSI National Accreditation Board’s Certificate Accreditation Program (CAP)
UPON COMPLETION, YOU WILL RECEIVE:
  • 16 CMLE Credits
  • Electronic copy of the course materials
  • Certificate of Course Completion from ISCT-CMaT and CMLE

Note: Completing all training modules and passing the quizzes is mandatory to receive a course completion certificate.

“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

COURSES YOU MAY ALSO BE INTERESTED IN:

Essentials of Cell Therapy Product Manufacturing, Qualification, and Validation

Format: Self-paced virtual course
Length: 3 hours of targeted learning

A concise on-demand course covering the foundational knowledge of cell product development, including manufacturing, qualification, validation, stability, and regulatory submission processes.

Cell Therapy Manufacturing: Strategy & Optimization

Format: In-person interactive course
Length:  1-day training

This in-person, case-study-focused training course features real-world case studies from top academic and industry experts. It provides advanced knowledge to optimize and standardize cell manufacturing processes, addressing critical challenges and inconsistencies in cell therapy manufacturing workflows.