The Principles and Applications of Cell Therapy Biomanufacturing, Characterization, and Regulatory (Feb 12 - April 19, 2024) v.2023-09
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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 completion of module assessments.
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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
Quiz 1.1
10 Questions | Unlimited attempts | 9/11 points to pass
10 Questions | Unlimited attempts | 9/11 points to pass
The passing score for this quiz is 80%.
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
Quiz 1.2
7 Questions | Unlimited attempts | 7/9 points to pass
7 Questions | Unlimited attempts | 7/9 points to pass
The passing score for this quiz is 80%.
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
Quiz 1.3
10 Questions | Unlimited attempts | 8/10 points to pass
10 Questions | Unlimited attempts | 8/10 points to pass
The passing score for this quiz is 80%.
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.
1.4 LIVE Expert Panel Discussion and Q&A Session
02/29/2024 at 11:00 AM (EST) | 60 minutes
02/29/2024 at 11:00 AM (EST) | 60 minutes
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.
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
Quiz 2.1
5 Questions | Unlimited attempts | 3/5 points to pass
5 Questions | Unlimited attempts | 3/5 points to pass
The passing score for this quiz is 80%.
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
Quiz 2.2
5 Questions | Unlimited attempts | 3/5 points to pass
5 Questions | Unlimited attempts | 3/5 points to pass
The passing score for this quiz is 80%.
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
Quiz 2.3
7 Questions | Unlimited attempts | 5/7 points to pass
7 Questions | Unlimited attempts | 5/7 points to pass
The passing score for this quiz is 80%.
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.
2.4 LIVE Expert Panel Discussion and Q&A Session
03/12/2024 at 12:00 PM (EDT) | 60 minutes
03/12/2024 at 12:00 PM (EDT) | 60 minutes
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.
Lecture 2.1b (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
Lecture 2.1b (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
2.2b LIVE Expert Panel Discussion and Q&A Session
03/11/2024 at 9:00 PM (EDT) | 60 minutes
03/11/2024 at 9:00 PM (EDT) | 60 minutes
This LIVE session provides the opportunity for program participants to ask questions directly to the speakers of Module 2b (Asia Focused). The live discussion is at Tuesday March 12 10AM JST (Monday March 11, 6PM PST)
MODERATOR
Steve Oh, PhD, Independent Cell Therapy Consultant, Singapore
Lecture 2.1b Part 1 Quiz
5 Questions | Unlimited attempts | 3/5 points to pass
5 Questions | Unlimited attempts | 3/5 points to pass
The passing score for this quiz is 80%.
Lecture 2.1b Part 2 Quiz
5 Questions | Unlimited attempts | 3/6 points to pass
5 Questions | Unlimited attempts | 3/6 points to pass
The passing score for this quiz is 80%.
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.
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
Quiz 3.1
8 Questions | Unlimited attempts | 6/8 points to pass
8 Questions | Unlimited attempts | 6/8 points to pass
The passing score for this quiz is 80%.
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
Quiz 3.2
9 Questions | Unlimited attempts | 7/9 points to pass
9 Questions | Unlimited attempts | 7/9 points to pass
The passing score for this quiz is 80%.
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
Quiz 3.3
6 Questions | Unlimited attempts | 4/6 points to pass
6 Questions | Unlimited attempts | 4/6 points to pass
The passing score for this quiz is 80%.
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
APPLICATION
Chris McClain, MBA, Senior Vice President, Business Development, Be the Match BioTherapies, USA
Adrian McKemey, PhD, Managing Director, IQVIA, USA
Quiz 3.4
4 Questions | Unlimited attempts | 3/4 points to pass
4 Questions | Unlimited attempts | 3/4 points to pass
The passing score for this quiz is 80%.
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.
3.5 LIVE Expert Panel Discussion and Q&A Session
03/28/2024 at 12:00 PM (EDT) | 60 minutes
03/28/2024 at 12:00 PM (EDT) | 60 minutes
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.
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
Kara Levine, PhD, Head of Systems and Tools, Cell Therapy Bioprocessing, MilliporeSigma, USA
Quiz 4.1
8 Questions | Unlimited attempts | 7/9 points to pass
8 Questions | Unlimited attempts | 7/9 points to pass
The passing score for this quiz is 80%.
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
Quiz 4.2
7 Questions | Unlimited attempts | 8/10 points to pass
7 Questions | Unlimited attempts | 8/10 points to pass
The passing score for this quiz is 80%.
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.
4.3 LIVE Expert Panel Discussion and Q&A Session
04/09/2024 at 12:00 PM (EDT) | 60 minutes
04/09/2024 at 12:00 PM (EDT) | 60 minutes
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.
