Course

Module 1

(8 Hrs)

Fundamentals of Stem Cell Manufacturing: Introduction to stem cell-based therapeutic products; Classification of stem cells: autologous vs. allogeneic; Overview of stem cell manufacturing workflows; GLP (Good Laboratory Practice), requirements in stem cell research; Principles of current Good Manufacturing Practices (cGMP); Design and layout of cGMP-compliant manufacturing facilities; Clean room operations and contamination control strategies.

Module 2

(10 Hrs)

Bioprocessing and Quality Control of Clinical-Grade Stem Cells, Stem cell expansion techniques: 2D vs. 3D systems; Bioreactors: design, operation, and scale- up strategies; Large-scale production of clinical-grade stem cells; Cell banking and preservation strategies; Quality control testing: identity, purity, potency, and viability; Sterility, endotoxin, and mycoplasma testing; Regulatory expectations for quality assurance and release criteria.

Module 3

(10 Hrs)

Storage, Transport, and Regulatory Frameworks: Cryopreservation techniques and cryoprotectants; Batch labelling, tracking, and documentation; Storage conditions and stability requirements for stem cells; Cold chain management and transport logistics; Overview of global regulatory frameworks: CDSCO, FDA, EMA; Regulatory submissions: IND applications, quality dossiers; Ethical and legal aspects in stem cell product development.

Module 4

(10 Hrs)

Clinical Translation and Commercialization: Clinical indications for stem cell therapy: hematological, neurological, cardiovascular, and musculoskeletal disorders; Clinical trial phases and design considerations; Challenges in translation: immunogenicity, tumorigenicity, scalability, and cost; Case studies of successful and failed clinical applications; Commercialization strategies: start-ups, biotech partnerships, and licensing; Regulatory intelligence and market access strategies; Role of health economics in stem cell therapy adoption.

Module 5

(7 Hrs)

Case Studies and Clinical Trial Insights:
In-depth analysis of landmark stem cell clinical trials (Phase I–III); Case studies highlighting success stories and failures; Trial design elements specific to cell-based therapies; Regulatory decision-making based on trial outcomes; Lessons learned and future outlook.

Pre-requisites: Undergraduate level basic biology

Total number of classes: 45

Preample: Stem cell technologies are at the forefront of regenerative medicine, offering significant potential to repair, replace, or regenerate damaged tissues and organs. With their unique abilities for self-renewal and differentiation, stem cells are key tools for understanding disease and advancing therapeutic strategies. This course provides an integrated overview of the scientific, technological, and regulatory aspects of stem cell-based product development from manufacturing to clinical translation, linking laboratory innovation with patient-focused therapies and global compliance.

Course Outcomes (COs)

CO1: Explain the classification, manufacturing process, and regulatory (GLP, cGMP) requirements for stem cell-based therapeutics.

CO2: Apply bioprocessing methods—including 2D/3D cultures and bioreactors—for clinical-grade stem cell production and quality assurance.

CO3: Assess preservation, storage, and transport strategies, and interpret regulatory and documentation requirements for global compliance.

CO4: Analyze the clinical translation of stem cell therapies, covering trial design, commercialization, risk, ethics, and economic factors.

CO5: Critically evaluate case studies and clinical trial outcomes to understand success factors, failures, and regulatory decision-making in stem cell therapeutics.

PO1: Bioscience Knowledge

PO2: Problem Analysis

PO3: Design/Development of Solutions

PO4: Conduct Investigations of complex problems

PO5: Modern tools usage

PO6: Bioscientist and Society

PO7: Environment and Sustainability

PO8: Ethics

PO9: Individual & Team work

PO10: Communication

PO11: Project management & Finance

PO12: Lifelong learning

0 – No affinity; 1 – low affinity; 2 – Medium affinity; 3 – High affinity

Program Specific Outcomes. (PSO)

PSO1. Demonstrate comprehensive knowledge of stem cell biology and their clinical and research relevance.

PSO2. Apply core laboratory techniques for stem cell isolation, characterization, and manipulation.

PSO3. Integrate principles of tissue engineering and biomaterials for regenerative applications.

PSO4. Analyze drug delivery, pharmacokinetics, and bioinformatics relevant to stem cell-based therapies.

PSO5. Evaluate ethical, regulatory, and translational aspects of stem cell product development.

PSO6. Bridge basic science with translational approaches in regenerative medicine and gene therapy.

PSO7. Design and interpret experimental strategies for stem cell-based disease

modeling and preclinical studies.

Evaluation Pattern: 50+50 = 100

• Stem Cell Production Processes, Practices and Regulation, Edited by Firdos Alam Khan, Springer 2022 
• Lanza, R., Langer, R., Vacanti, J. P.,  Atala, A. (Eds.). (2013). Principles of Tissue Engineering (4th ed.). Academic Press. ISBN 978-0-12-398370-1
• Cabral, J. M. S., Lobato da Silva, C., Diogo, M. M. (Eds.). (2020). Stem Cell Bioprocessing and Manufacturing (Reprint of Bioengineering Special Issue). MDPI Books. ISBN 978-3- 03943-038-3; DOI:10.3390/books978-3-03943-039-0
• Karimi-Busheri, F. Weinfeld, M. (Eds.). (2016). Biobanking and Cryopreservation of Stem Cells (Advances in Experimental Medicine and Biology, Vol. 1016). Springer. ISBN 978-3-319- 45455-9; DOI:10.1007/978-3-319-45457-3
• Lanza, R. Atala, A. (Eds.). (2013). Essentials of Stem Cell Biology (3rd ed.). Academic Press. ISBN 978-0-12-409503-8