Scaling Clinical Grade Stem Cells for Therapeutic Applications FHCC 2026

Introduction

The translation of stem cell therapies from research laboratories to clinical practice requires robust, scalable, and regulatory-compliant manufacturing processes. This workshop focuses on the production of clinical-grade stem cells for therapeutic applications, highlighting the key principles of Good Manufacturing Practice (GMP), quality management systems, donor screening, cell sourcing, and large-scale cell expansion. Participants will gain insights into process optimization, scaling technologies, cell banking, cryopreservation, and quality control measures essential for ensuring product safety, potency, and consistency.

The workshop will also address critical aspects of product characterization, potency testing, sterility assurance, regulatory requirements, and release criteria for clinical use. Case studies on mesenchymal stem cells (MSCs), induced pluripotent stem cells (iPSCs), and emerging cell-derived products such as extracellular vesicles and exosomes will be discussed for protecting and restoring vision. By bridging manufacturing science with clinical translation, this workshop aims to equip participants with the knowledge needed to develop scalable, high-quality stem cell products for regenerative medicine and advanced therapeutic applications.

Objectives

• To provide participants with a comprehensive understanding of the isolation, expansion, characterization, and quality assessment of human mesenchymal stem cells (MSCs) under clinical-grade manufacturing standards.
• To demonstrate strategies for scaling stem cell production, including process optimization, quality control, and GMP-compliant practices required to achieve therapeutically relevant cell doses.
• To explore the translational and therapeutic applications of stem cells and their derivatives, including extracellular vesicles and exosomes, with a focus on their potential in safeguarding eyesight and vision restoration.

Target Audience

This workshop addresses this critical need by providing participants with practical and theoretical knowledge of clinical-grade stem cell production, scale-up strategies, quality assurance, and regulatory requirements. It will expose researchers, clinicians, and industry professionals to current best practices in Good Manufacturing Practice (GMP)-compliant cell manufacturing and translational research. By strengthening local expertise in stem cell bioprocessing and therapeutic development, the workshop will contribute to advancing regenerative medicine, promoting innovation, and enhancing the capacity to develop safe, effective, and accessible stem cell-based therapies for future healthcare needs.

Workshop Structure

Upon completion of the workshop, participants will be able to:

• Understand the fundamental principles of clinical-grade stem cell manufacturing and their role in regenerative medicine and advanced therapeutic applications.
• Demonstrate knowledge of the isolation, expansion, characterization, and quality assessment of human mesenchymal stem cells (MSCs).
• Recognize the requirements of Good Manufacturing Practice (GMP), quality management systems, and regulatory frameworks governing the production of clinical-grade stem cell products.
• Apply strategies for scaling stem cell cultures to achieve therapeutically relevant cell doses while maintaining product quality, safety, and consistency.
• Evaluate critical quality attributes, potency assays, sterility testing, and release criteria necessary for clinical translation.
• Understand the principles of cell banking, cryopreservation, and long-term storage of clinical-grade stem cells.
• Appreciate the therapeutic potential of stem cells and their derivatives, including extracellular vesicles and exosomes, in regenerative medicine.
• Identify key challenges and opportunities in translating stem cell-based products from laboratory research to clinical application and commercialization.
• Strengthen technical and translational competencies required for developing safe, effective, and scalable stem cell therapies.