Cell Therapy Manufacturing Bootcamp

Cell therapies represent an exciting and complex new treatment type with the potential to treat a vast range of conditions. As a medicinal modality, cell therapy is undergoing a major upward inflection in the biopharmaceutical industry. This is evident from large financing deals, exciting clinical trials, and landmark regulatory approvals in the past five years. Rapid development in this high-value modality has created a skills shortage. This course is designed to train scientists, engineers, doctors, and business professionals on cell therapy manufacturing and all the quality assurance, regulatory considerations, and commercialization aspects the process includes.

The Importance of Cell Therapy Manufacturing Best Practices

There are various hurdles that stand in the way of getting life-changing cellular therapies from the lab and into the market. In 2023, the U.S. Food and Drug Administration only approved seven new cell and gene therapies. Approval and regulatory review can be long processes; thus, it’s imperative that cell therapy practitioners and business leaders are well-versed in the best practices that may speed their therapy’s time to market.

Co-developed and co-delivered by industry experts and MIT faculty, this course takes you on a journey to understand the complete life cycle of a cellular therapy, from manufacturing, through clinical trial conduct, regulatory approval, and market launch. This course will teach methods to accelerate development and solve challenges in designing safe, efficacious, durable, scalable, and cost-effective treatments that are accessible to patients in need. This course will cover regulatory frameworks that enable control over product quality, safety, and efficacy. The course will deep dive into a go-to-market model and how to design cell therapies for reimbursement.

With MIT’s motto “Mens et Manus” at the center of course design, this course will use real-world product development case studies and lab tours to focus on application over theory.

• Gain a solid foundation on the product development roadmap for cell therapies.
• Develop an understanding of scientific, medical, and engineering principles required to get cell therapies approved and avoid major delays in manufacturing and clinical and biomarker development.
• Explain all unit operations and manufacturing platforms required to obtain, genetically modify, and produce cell therapy products in a GMP environment.
• Describe the critical quality attributes for cell therapy products and explain how identity, safety, potency, and purity are demonstrated.
• Summarize key industrialization concepts, such as automation, chain of identity and custody, needle-to-needle time, CoGs, and centralized versus distributed manufacturing.
• Explore innovative clinical trial cell therapy models for evidence generation and disease area KOL partnership model.
• Understand the regulatory framework for cell therapies and decode the importance of various acronyms (CBER, OTAT, QbD, CQA, CPP, PPQ, CPV, IND, BLA, RMAT, BTD, PR, AA, ODD).
• Identify the similarities and significant differences between manufacturing molecular therapeutics, such as proteins and monoclonal antibodies, and cellular therapies.
• Adopt best practices demonstrated in real-world case studies, such as product cell therapy product design and optimizing process development.

This course is ideal for biotechnology professionals seeking to transition to cell therapy development and manufacturing. Participants should have some background in biotechnology as well as familiarity with working in an FDA-regulated environment. A bachelor’s degree in a technical area is required.
 

• Professionals with one to three years of pharmaceutical, biotechnology, or healthcare experience in academia or industry
• Scientists, doctors, engineers, or business leaders looking to upskill from protein to cell therapy-based drug development in the US market
• Professionals engaged with the cell therapy product life cycle, such as those in R&D, CMC, product development, clinical design and development, quality control, regulatory review, market access management, and other business decision makers