Course Syllabus

The Principles and Applications of Cell Therapy Biomanufacturing, Characterization and Regulatory 

FEBRUARY 12th - APRIL 19th, 2024 session
Time and Dates for the 1-hour Live-Virtual Expert Panel Discussion:
  • Module 1: Thursday, February 29, 08:00 PT/ 11:00 ET
  • Module 2: Tuesday, March 12, 09:00 PT/ 12:00 ET 
  • Module 2b (Optional Asia Focused Content): Tuesday, March 12, 10:00 JST/ 09:00 SGT/ 18:00 PT (UTC-7)
  • Module 3: Thursday, 28 March, 09:00 PT/ 12:00 ET
  • Module 4: Tuesday, 09 April, 09:00 PT/ 12:00 ET
 Use this time zone converter to see the start time in your region.



Module 1: STEM cell & immune cell engineering and therapies
Three 1-hour on-demand modules
one 1-hour live-virtual discussion

This module provides a broad overview of stem and immune cell therapies. More specifically, it will cover different types of therapeutic cells being investigated in the cell and gene-modified cell therapy space, strategies to engineer them and associated challenges, and their manufacturing process.

1.1 Pluripotent and Multipotent Stem Cells - Overview, Engineering, Compare & Contrast of Different Types of Stem 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 

1.2 Cellular Reprograming, Gene-Editing, CRISPR
Theory: Krishanu Saha, PhD, Associate Professor, University of Wisconsin, USA
Application: Robert Deans, PhD, Chief Scientific Officer, Synthego Corp., USA

1.3 Immune Cell Engineering, Adoptive Cell Transfer, CAR-T Therapy, and the Future of Immune Cell Therapies
Theory: Edward Botchwey, PhD, Associate Professor, Georgia Tech, USA
Application: David Kugler, PhD, Scientific Director, Engineered T Cell Biology, Bristol Myers Squibb, USA 


1.4 Expert Panel Discussion and Q&A
A live-virtual session for you to ask Module 2 Speakers questions in real-time
Moderator: Shalu Suri, PhD, Associate Director, NSF ERC Diversity & Inclusion and Engineering Workforce Development, Georgia Tech, USA

Module 2: Quality assurance & regulatory Framework
Three 1-hour on-demand modules
one 1-hour live-virtual discussion


This module begins with a discussion of key Quality by Design (QbD) concepts for therapeutic cell manufacturing including critical quality attributes (CQAs), critical process parameters (CPPs), critical material attributes (CMAs), design space, and process analytical technology (PAT). Emphasis will also be put on the importance of cGMP practices and guidelines, and quality control in cell manufacturing space. In addition, participants will also develop an understanding of ethics and policy guidelines and global regulatory framework for cell therapy and the cell manufacturing industry.

2.1 Quality by Design, Cell Manufacturing Unit Operations, Process Development, Design of Experiments, Critical Quality Attributes (CQAs), and Critical Process Parameters (CPPs)
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

2.2 Good Manufacturing Practices, Manufacturing Quality Control, Quality Assurance, and Stability Testing
Theory: Donald Singer, Senior Microbiology Technical Consultant, North America, Ecolab, USA
Application: Donald Singer, Senior Microbiology Technical Consultant, North America, Ecolab, USA

2.3 Ethics & Policy, FDA, Regulatory Issues, Global Regulatory Framework & Key Differences Across the Globe
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


2.4 Expert Panel Discussion and Q&A
A live-virtual session for you to ask Module 2 Speakers questions in real-time
Moderator: Shalu Suri, PhD, Associate Director, NSF ERC Diversity & Inclusion and Engineering Workforce Development, Georgia Tech, USA

Module 2b: Quality assurance & regulatory Framework (Optional Asia Focused Content)
Two 45 minute on-demand modules
one 1-hour live-virtual discussion

In this module, we will cover the concept of Quality by Design (QbD)-based quality assurance system utilizing in-process monitoring during manufacturing compared with the current “verification” method that requires comprehensive testing at each shipment. Further, participants will learn how the QbD-based approach is useful for the development of products in their life cycle, and linkage of it to supply chain and clinical data for the improvement of clinical outcome and cell products. 

2.1b (Part 1) Introduction to the QbD-based approach using the example of MSC manufacturing 
Theory and Application: Shin Kawamata, PhD, MD, CEO, Cyto-Facto Inc. Japan

2.1b (Part 2) QbD-based manufacturing of iPSC/CART and data integrity of cell products
Theory and Application: Shin Kawamata, PhD, MD, CEO, Cyto-Facto Inc. Japan

2.2b Expert Panel Discussion and Q&A
A live-virtual session for you to ask Module 2b Speakers questions in real-time
Moderator: Steve Oh, PhD, Independent Cell Therapy Consultant, Singapore

Module 3: Cell Bioprocessing & Manufacturing
Four 1-hour on-demand modules
one 1-hour live-virtual discussion


This module will cover various bioprocessing approaches for the effective translation of cell therapies from bench-scale to industrial-scale products. More specifically, various technologies used for therapeutic cell expansion will be discussed. Emphasis will also be put on the discussion of biomaterials and 3D microcarriers employed for adherent cells expansion, and downstream processing approaches including fill and finish, storage of cells, and cryopreservation techniques. Participants will also learn about the importance of supply chain management and distribution strategies in the cell therapy industry.

3.1 Concepts in Scalable Bioprocessing of Cells - Early vs. Late Stage: 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

3.2 3D Microcarriers and Biomaterials, Adherent Cell Expansion, Biocompatible Materials and their Selection Criteria
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

3.3 Downstream Processing - 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

3.4 Supply Chain Management and Distribution, Optimizing Supply Chain & Refining Distribution Strategy
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

3.5 Expert Panel Discussion and Q&A
A live-virtual session for you to ask Module 2 Speakers questions in real-time
Moderator: Shalu Suri, PhD, Associate Director, NSF ERC Diversity & Inclusion and Engineering Workforce Development, Georgia Tech, USA

Module 4: Cell Product Characterization & Importance of Standards
Two 1-hour on-demand modules
one 1-hour live-virtual discussion

In this module, participants will learn about the importance of analytical tools for quality assessment and batch release. Emphasis will also be put on identifying assays for cell characterization to ensure cells potency, viability, and purity, among other attributes. This module will also cover various automation approaches that are being developed and integrated in the overall manufacturing workflow to increase efficiency and reduce cost.

4.1 Analytical Tools in Cell Manufacturing for Quantitative Assessment of CQAs to Ensure Safety and Efficacy - 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

4.2 Automation for Cell Manufacturing, Data Management, and Machine Learning for Predictive Analysis
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

4.3 Expert Panel Discussion and Q&A
A live-virtual session for you to ask Module 2 Speakers questions in real-time
Moderator: Shalu Suri, PhD, Associate Director, NSF ERC Diversity & Inclusion and Engineering Workforce Development, Georgia Tech, USA