MITx: Making a Cell Therapy: Principles and Practice of Manufacturing course Syllabus

Overview: This course provides a comprehensive introduction to the principles and practices of cell therapy manufacturing, covering biological, engineering, and regulatory aspects. Designed for learners with a foundational understanding of biology or biotechnology, it spans approximately 16–20 weeks of part-time study, with an estimated 8–10 hours per week. The curriculum progresses from foundational concepts to real-world applications, culminating in a final case study project that integrates key learning outcomes.

Module 1: Introduction to Cell Therapy

Estimated time: 24 hours

• Foundations of cell-based medical treatments
• Comparison of cell therapies with traditional pharmaceuticals
• Overview of immune cell therapies, including CAR-T treatments
• Role of biotechnology in regenerative medicine
• Engineering cells to target and treat diseases

Module 2: Cell Collection & Engineering

Estimated time: 32 hours

• Methods for collecting therapeutic cells from patients and donors
• Genetic modification techniques in cell therapy
• Use of viral vectors for gene delivery
• Application of gene-editing tools such as CRISPR/Cas9
• Preparation of engineered cells for manufacturing scale-up

Module 3: Cell Expansion & Biomanufacturing

Estimated time: 32 hours

• Cell culture techniques and growth environments
• Bioreactor systems for large-scale cell production
• Sterile processing and contamination control in manufacturing facilities
• Strategies for maintaining cell viability during expansion
• Ensuring consistency in therapeutic cell products

Module 4: Quality Control & Regulatory Compliance

Estimated time: 28 hours

• Quality control procedures for cellular and biological products
• Regulatory requirements for clinical-grade cell therapies
• Testing methods for safety, purity, and efficacy
• Challenges in ensuring product consistency at scale
• Overview of FDA and international regulatory frameworks

Module 5: Scaling Challenges in Cell Therapy Production

Estimated time: 28 hours

• Barriers to scaling cell therapy manufacturing
• Automation and closed-system technologies
• Supply chain logistics for personalized therapies
• Cost challenges in commercial production
• Facility design and Good Manufacturing Practice (GMP) compliance

Module 6: Final Case Study Project

Estimated time: 30 hours

• Analysis of a real-world cell therapy production pipeline
• Identification of key challenges in scalability and regulatory compliance
• Proposal of process improvements in manufacturing systems

Prerequisites

• Basic knowledge of biology or biotechnology
• Familiarity with cellular and molecular biology concepts
• Some exposure to engineering or manufacturing principles beneficial

What You'll Be Able to Do After

• Explain the end-to-end manufacturing process for advanced cell therapies
• Describe the role of engineering and biotechnology in cell therapy development
• Identify critical quality control and regulatory requirements
• Analyze challenges in scaling production for clinical and commercial use
• Propose improvements to real-world cell therapy manufacturing workflows