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.

View Course Outline

Access the Course

	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
15% Group Registration Discount available for 5+ Members / Non-Members from the same institution

Group Registration Discount:

Receive 15% off when registering 5+ ISCT Members / Non-Members from the same company / institution.
Contact ISCT at workforcedevelopment@isctglobal.org to obtain the discounted Group Registration Rate.

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 Reduced Rate:

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 to obtain the Tier 1 and Tier 2 Reduced Rate.

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

UPCOMING COURSE DATES (REGISTRATION NOW OPEN)

2025 Autumn

Dates: September 22–November 28, 2025

Registration deadline: September 29, 2025

Live-Virtual Expert Panel Discussion:

Module 1:
- October 6, 2025: 15:00 GMT/08:00 PT/11:00 ET
Module 2:
- October 20, 2025: 15:00 GMT/08:00 PT/11:00 ET
Module 2b (optional):
- October 30, 2025: 17:00 PT/20:00ET, Oct 31, 2025: 00:00 GMT
Module 3:
- November 3, 2025: 16:00 GMT/08:00 PT/11:00 ET
Module 4:
- November 20: 16:00 GMT/08:00 PT/11:00 ET

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

"In the 8+ years since CMaT was founded, we have only become more aware of the need for a workforce that is well-trained for the needs of the burgeoning cell and gene therapy industry, especially in terms of understanding the unique regulatory and process complexities of manufacturing consistent, high-quality products. Our partnership with ISCT builds on CMaT’s years of experience in developing educational programming and manufacturing research that remains in-sync with the evolving CGT field. Together with ISCT, we deliver critically-needed, on-demand workforce training for CGT manufacturers."

-Johnna Temenoff, Wallace H Coulter Chair, Georgia Tech and Director, CMaT

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