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The Principles and Applications of Cell Therapy Biomanufacturing, Characterization, and Regulatory (Feb 24- May 05, 2025) v.2024-10

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Developed by field experts from academia, regulatory, clinical, and commercial domains, this program provides a vital training opportunity to develop the fundamental skillset and knowledge unique to CGT manufacturing and to upskill key personnel for roles within companies and clinical manufacturing centres across the Cell & Gene Therapy (CGT) sector. 

Each module includes a series of asynchronous lectures comprised of Theory and Application components as well as a LIVE Expert Panel Discussion and Q&A Session. Participants will receive a certificate of completion upon completing and passing the module assessments.  Participants will receive a certificate of participation upon completing the course evaluation survey.

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MODULE 1: Stem Cell and Immune Cell Engineering and Therapies
Lecture 1.1 Pluripotent and Multipotent Stem Cells
Open to view video.  |  60 minutes
Open to view video.  |  60 minutes Overview, Engineering, Compare & Contrast of Different Types of Cells and their Manufacturing Process THEORY Johnna Temenoff, PhD, Professor, Georgia Tech and Emory University, USA APPLICATION Fabien Moncaubeig, Chief Development Officer, TreeFrog Therapeutics, France
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Lecture 1.1 Slide Deck
Open to download resource.
Open to download resource.
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Lecture 1.2 Cellular Reprogramming, Gene Editing, CRISPR
Open to view video.  |  60 minutes
Open to view video.  |  60 minutes THEORY Krishanu Saha, PhD, Associate Professor, University of Wisconsin, USA APPLICATION Robert Deans, PhD, Chief Scientific Officer, Synthego Corp., USA
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Lecture 1.2 Slide Deck
Open to download resource.
Open to download resource.
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Lecture 1.3 Immune Cell Engineering, Adoptive Cell Transfer, CAR-T Therapy, and Future of Immune Cell Therapies
Open to view video.  |  60 minutes
Open to view video.  |  60 minutes THEORY Edward Botchwey, PhD, Associate Professor, Georgia Tech, USA APPLICATION David Kugler, PhD, Scientific Director, Engineered T Cell Biology, Bristol Myers Squibb, USA
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Lecture 1.3 Slide Deck
Open to download resource.
Open to download resource.
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Module 1 Discussion Board
Make 1 discussion post to continue.
Make 1 discussion post to continue. With course participants from varying backgrounds, experiences, and areas of expertise, there is a unique opportunity for peer-to-peer knowledge sharing and learning. Participation in the discussion boards is strongly encouraged. 1. Post a thought-provoking question related to a topic (or topics) covered in Module 1 that came to mind while viewing the lectures. 2. Respond to a question posted by another participate to share your experience or opinion. 3. Share a publication from within the past 2-3 years relevant to the topic(s) covered in Module 1.
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1.4 LIVE Expert Panel Discussion and Q&A Session
03/11/2025 at 6:00 PM (EDT)  |  Recorded On: 03/11/2025
03/11/2025 at 6:00 PM (EDT)  |  Recorded On: 03/11/2025 This live-virtual Expert panel discussion Is the opportunity for you to learn from other participants and ask Module 1 speakers questions. You may post your questions in-advanced through the Module 1 discussion board or present your questions through the chat or audio functions in Zoom during the live session. Attendance for all four (4) LIVE Expert Panel & Q&A sessions is mandatory to receive a certificate of course completion. If you are not able to attend, please email Raymond Lam (raymond@isctglobal.org) in advance of the session.
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MODULE 2: Quality Assurance & Regulatory Framework
Lecture 2.1 Quality by Design, Cell Manufacturing Unit Operations, Process Development, Design of Experiments, Critical Quality Attributes (CQAs), and Critical Process Parameters (CPPs)
Open to view video.
Open to view video. THEORY Krishnendu Roy, PhD, Director, NSF Engineering Research Center (ERC) for Cell Manufacturing Technologies (CMaT), USA APPLICATION Gregory Russotti, PhD, Chief Technology Officer, Century Therapeutics, USA
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Lecture 2.1 Slide Deck
Open to download resource.
Open to download resource.
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Lecture 2.2 Good Manufacturing Practices, Manufacturing Quality Control, Quality Assurance, and Sterility Testing
Open to view video.
Open to view video. THEORY & APPLICATION Donald Singer, Senior Microbiology Technical Consultant, North America, Ecolab, USA
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Lecture 2.2 Slide Deck
Open to download resource.
Open to download resource.
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Lecture 2.3 Ethics & Policy, FDA, Regulatory Issues, Global Regulatory Framework & Key Differences Across the Globe
Open to view video.
Open to view video. THEORY Aaron Levine, PhD, Associate Professor, Georgia Tech, USA APPLICATION Bambi Grilley, RPh, RAC, CIP, CCRC, CCRP, Director, Clinical Research & Early Product Development, Center for Cell & Gene Therapy, Baylor College of Medicine, USA
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Lecture 2.3 Slide Deck
Open to download resource.
Open to download resource.
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Module 2 Discussion Board
Make 1 discussion post to continue.
Make 1 discussion post to continue. With course participants from varying backgrounds, experiences, and areas of expertise, there is a unique opportunity for peer-to-peer knowledge sharing and learning. Participation in the discussion boards is strongly encouraged. 1. Post a thought-provoking question related to a topic (or topics) covered in Module 2 that came to mind while viewing the lectures. 2. Respond to a question posted by another participate to share your experience or opinion. 3. Share a publication from within the past 2-3 years relevant to the topic(s) covered in Module 2.
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2.4 LIVE Expert Panel Discussion and Q&A Session
03/27/2025 at 6:00 PM (EDT)  |  Recorded On: 04/02/2025
03/27/2025 at 6:00 PM (EDT)  |  Recorded On: 04/02/2025 This live-virtual Expert panel discussion Is the opportunity for you to learn from other participants and ask Module 2 speakers questions. You may post your questions in-advanced through the Module 2 discussion board or present your questions through the chat or audio functions in Zoom during the live session. Attendance for all four (4) LIVE Expert Panel & Q&A sessions is mandatory to receive a certificate of course completion. If you are not able to attend, please email Raymond Lam (raymond@isctglobal.org) in advance of the session.
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(OPTIONAL CONTENT, ASIA-FOCUSED PERSPECTIVE) MODULE 2B: QUALITY ASSURANCE & REGULATORY FRAMEWORK
Lecture 2b (Part 1) Introduction of Quality by Design (QbD) Based Approach Using MSC Manufacturing As an Example
Open to view video.  |   Closed captions available
Open to view video.  |   Closed captions available Shin Kawamata, PhD, MD, CEO, Cyto-Facto Inc. Japan
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Lecture 2b (part 1) Slide Deck
Open to download resource.
Open to download resource.
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Lecture 2b (Part 2) QbD-based Manufacturing of iPSC/CAR-T and data Integrity of Cell Products
Open to view video.  |   Closed captions available
Open to view video.  |   Closed captions available Shin Kawamata, PhD, MD, CEO, Cyto-Facto Inc. Japan
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Lecture 2b (part 2) Slide Deck
Open to download resource.
Open to download resource.
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2b LIVE Expert Panel Discussion and Q&A Session
04/03/2025 at 8:00 PM (EDT)  |  Recorded On: 04/16/2025
04/03/2025 at 8:00 PM (EDT)  |  Recorded On: 04/16/2025 This live-virtual Expert panel discussion Is the opportunity for you to learn from other participants and ask Module 2 speakers questions. You may post your questions in-advanced through the Module 2 discussion board or present your questions through the chat or audio functions in Zoom during the live session.
You must register to access.
Module 2b Discussion Board
Make 1 discussion post to continue.
Make 1 discussion post to continue. With course participants from varying backgrounds, experiences, and areas of expertise, there is a unique opportunity for peer-to-peer knowledge sharing and learning. Participation in the discussion boards is strongly encouraged. 1. Post a thought-provoking question related to a topic (or topics) covered in Module 2b that came to mind while viewing the lectures. 2. Respond to a question posted by another participate to share your experience or opinion. 3. Share a publication from within the past 2-3 years relevant to the topic(s) covered in Module 2b.
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MODULE 3: Cell Bioprocessing & Manufacturing
Lecture 3.1 Concepts in Scalable Bioprocessing of Cells
Open to view video.
Open to view video. Early vs Late State: Aseptic Techniques, Technologies for Therapeutic Cell Expansion, Bioreactor Design Considerations, Media Formulation, Process Development, CMC, and Introducing New Technologies into Workflow THEORY Carolyn Yeago, PhD, Associate Director – Marcus Center for Therapeutic Cell Characterization and Manufacturing, Georgia Tech, USA APPLICATION Eytan Abraham, PhD, Vice-President, Head of Cell Therapy Franchise, Resilience, USA
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Lecture 3.1 Slide Deck
Open to download resource.
Open to download resource.
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Lecture 3.2 3D Microcarriers and Biomaterials, Adherent Cell Expansion, Biocompatible Materials and their Selection Criteria
Open to view video.
Open to view video. THEORY Shalu Suri, PhD, Associate Director, NSF ERC Diversity & Inclusion and Engineering Workforce Development, Georgia Tech, USA APPLICATION Jon Rowley, PhD, Founder and Chief Technology Officer, RoosterBio, USA
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Lecture 3.2 Slide Deck
Open to download resource.
Open to download resource.
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Lecture 3.3 Downstream Processing
Open to view video.
Open to view video. Cryopreservation Techniques, Fill and Finish, Storage and Distribution, and Inventory Management THEORY Allison Hubel, PhD, Director, Technological Leadership Institute, University of Minnesota , USA APPLICATION Sean Werner, PhD, President, Sexton Biotechnologies, USA
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Lecture 3.3 Slide Deck
Open to download resource.
Open to download resource.
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Lecture 3.4 Supply Chain Management and Distribution, Optimizing Supply Chain & Refining Distribution Strategy
Open to view video.
Open to view video. THEORY Ben Wang, PhD, Professor and Executive Director, Georgia Tech Manufacturing Institute, USA Kan Wang, PhD, Senior Research Engineer, Georgia Tech Manufacturing Institute, USA Chip White, PhD, Professor, Georgia Tech Manufacturing Institute, USA Howard (Chin-Yuan) Tseng, PhD, Simulation Research Scientist, Amazon, United States APPLICATION Chris McClain, MBA, Senior Vice President, Business Development, Be the Match BioTherapies, USA Adrian McKemey, PhD, Managing Director, IQVIA, USA
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Lecture 3.4 Slide Deck
Open to download resource.
Open to download resource.
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Module 3 Discussion Board
Make 1 discussion post to continue.
Make 1 discussion post to continue. With course participants from varying backgrounds, experiences, and areas of expertise, there is a unique opportunity for peer-to-peer knowledge sharing and learning. Participation in the discussion boards is strongly encouraged. 1. Post a thought-provoking question related to a topic (or topics) covered in Module 3 that came to mind while viewing the lectures. 2. Respond to a question posted by another participate to share your experience or opinion. 3. Share a publication from within the past 2-3 years relevant to the topic(s) covered in Module 3.
You must register to access.
3.5 LIVE Expert Panel Discussion and Q&A Session
04/08/2025 at 6:00 PM (EDT)  |  Recorded On: 04/07/2025
04/08/2025 at 6:00 PM (EDT)  |  Recorded On: 04/07/2025 This live-virtual Expert panel discussion is the opportunity for you to learn from other participants and ask Module 3 speakers questions. You may post your questions in-advanced through the module 3 discussion board or present your questions through the chat or audio functions in Zoom during the live session. Attendance for all four (4) LIVE Expert Panel & Q&A sessions is mandatory to receive a certificate of course completion. If you are not able to attend, please email Raymond Lam (raymond@isctglobal.org) in advance of the session.
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MODULE 4: Cell Product Characterization & Importance of Standards
Lecture 4.1 Analytical Tools in Cell Manufacturing for Quantitative Assessment of CQAs to Ensure Safety and Efficacy
Open to view video.
Open to view video. Identifying Assays and their Principles for Cell Characterization THEORY Carolyn Yeago, PhD, Associate Director – Marcus Center for Therapeutic Cell Characterization and Manufacturing, Georgia Tech, USA APPLICATION Aparajita Chatterjee, PhD, Senior Scientist, Bioprocessing, MilliporeSigma, USA
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Lecture 4.1 Slide Deck
Open to download resource.
Open to download resource.
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Lecture 4.2 Automation for Cell Manufacturing, Data Management, and Machine Learning for Predictive Analysis
Open to view video.
Open to view video. THEORY Stephen Balakirsky, PhD, Principal Research Scientist, Georgia Tech Research Institute, USA APPLICATION Ian Johnston, PhD, Senior Project Manager Research and Development, Miltenyi Biotec, Germany
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Lecture 4.2 Slide Deck
Open to download resource.
Open to download resource.
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Module 4 Discussion Board
Make 1 discussion post to continue.
Make 1 discussion post to continue. With course participants from varying backgrounds, experiences, and areas of expertise, there is a unique opportunity for peer-to-peer knowledge sharing and learning. Participation in the discussion boards is strongly encouraged. 1. Post a thought-provoking question related to a topic (or topics) covered in Module 4 that came to mind while viewing the lectures. 2. Respond to a question posted by another participate to share your experience or opinion. 3. Share a publication from within the past 2-3 years relevant to the topic(s) covered in Module 4.
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4.3 LIVE Expert Panel Discussion and Q&A Session
04/22/2025 at 6:00 PM (EDT)  |  Recorded On: 04/24/2025
04/22/2025 at 6:00 PM (EDT)  |  Recorded On: 04/24/2025 This live-virtual Expert panel discussion is the opportunity for you to learn from other participants and ask Module 4 speakers questions. You may post your questions in-advanced through the Module 4 discussion board or present your questions through the chat or audio functions in Zoom during the live session. Attendance for all four (4) LIVE Expert Panel & Q&A sessions is mandatory to receive a certificate of course completion. If you are not able to attend, please email Raymond Lam (raymond@isctglobal.org) in advance of the session.
You must register to access.
Summative Assessment
120 Questions  |  2 attempts  |  93/120 points to pass  |  Graded as Pass/Fail
120 Questions  |  2 attempts  |  93/120 points to pass  |  Graded as Pass/Fail There are a total of 120 questions associated with this exam. You must achieve a total score of 93 out of 120 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.
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Course Evaluation Form
13 Questions
13 Questions
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Course Completion Certificate
No credits available  |  Certificate available
No credits available  |  Certificate available Participants MUST complete all modules, session quizzes and course evaluation form to receive the Course Completion Certificate.
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