Regulatory Affairs & Quality Assurance

Innovations in ATMP: State of the Industry in 2024

Advanced Therapy Medicinal Products are transforming what is possible in healthcare. From CAR T-cell therapy and CRISPR-Cas9 to new approaches in manufacturing and quality, innovation is moving fast. Discover the key developments shaping the ATMP landscape.

About This White Paper

Advanced Therapy Medicinal Products (ATMPs) are opening up entirely new possibilities for treating rare diseases and other conditions that were once considered difficult or impossible to address. But turning these highly personalized therapies into viable treatments comes with equally unique regulatory, manufacturing, quality and commercial challenges.

This white paper takes a closer look at the changing regulatory pathways and GMP requirements surrounding ATMPs, alongside innovations in manufacturing and Quality by Design. It also examines breakthrough technologies such as CAR T-cell therapy and CRISPR-Cas9 gene editing and what they mean for the future of advanced therapies.

Beyond the science, the paper addresses one of the industry's biggest questions: how can developers translate groundbreaking innovation into scalable, commercially viable therapies that ultimately reach patients?

Key Takeaways

• Navigate an evolving regulatory landscape. Explore how risk-based approaches, specialized ATMP frameworks and regulatory support are shaping the path from development to market.
• Understand the innovations reshaping ATMP manufacturing. Discover how modular cleanrooms, closed systems and automation can help address the complexity, cost and contamination risks associated with production.
• Explore breakthrough technologies such as CAR T and CRISPR-Cas9. See how these technologies are advancing personalized medicine while creating new manufacturing, safety and quality challenges.
• Build quality into ATMP development from the start. Learn why Quality by Design, GMP and a structured focus on critical quality attributes and process parameters are particularly important for complex and variable ATMPs.
• Look beyond scientific success to commercial viability. Understand how reimbursement, scalability, manufacturing costs and limited patient populations can affect whether innovative therapies successfully reach the market.
• Prepare for scale-up early. Discover why decisions around technologies, suppliers, manufacturing processes, partnerships and specialized expertise can have a lasting impact on an ATMP's path to patients.

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About the Author

Our whitepapers are created by experts with real-world experience and deep industry knowledge.

Download now to benefit from their valuable insights!

Dr. Julian De Havilland

ATMP Expert

Julian trained as a transplant immunologist and earned his PhD from the University of London, focusing on innate mechanisms of organ transplant rejection. His post-doctoral work included developing recombinant cell-surface targeted complement inhibitors and novel organ perfusion fluids. In 2008, Julian began his role at the Royal Free Hospital in London, where he led the clinical isolation of autologous and allogeneic pancreatic islets of Langerhans in both adult and pediatric patients. Since 2012, Julian has held various positions, including Quality Manager, Production Supervisor, Facilities Manager, Associate Director, and Director of cell and gene therapy production units in Newcastle, London, and Cambridge.

Throughout these roles, Julian gained extensive experience in developing and delivering therapies for diabetes, bone fractures, stroke, blindness, arthritis, myocardial infarction, transplant rejection, viremia, hematological malignancies, and solid organ tumors. His work in cell and gene therapies has included CAR T cells, tumor-infiltrating cells, somatic cells, tissue-engineered products, and stem cell transplantation products, providing him with a comprehensive and technical understanding of advanced therapeutics.

As Director, Julian was responsible for regulatory compliance and inspections in JACIE-accredited and HTA/MHRA-licensed GMP facilities. In 2022, Julian completed a Level 7 Senior Leaders Apprenticeship in Advanced Therapeutics, during which he also earned his MBA. He is currently employed by QbD Group as an ATMP Expert, supporting the development of our clients' ATMP development programs.