On the brink of commercialisation

Our panel of industry experts discuss the challenges facing developers as more cell and gene therapies progress towards commercialisation, focusing on manufacturing and late-stage fill/finish solutions.

Our expert panel: 

• Dr Alexander Van Hagen Life Sciences Sector Specialist, Watson-Marlow Fluid Technology Solutions (WMFTS)
• James Drinkwater Head of GMP Compliance and Aseptic Process Integration, Franz Ziel GmbH
•  Dr John Milne Training Director, National Institute for Bioprocessing Research & Training (NIBRT)

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The cell and gene therapy (CGT) market is in a period of rapid growth, projected to reach over $34 billion by 2030. Many new therapies, set to change the course of treatment of a range of previously untreatable diseases, are now coming out of the research and development stage, ready for commercialisation.

As developers look to recoup large investments, they hit new challenges. How can these highly complex, technically demanding advanced therapy medicinal products (ATMPs) be rapidly commercialised in an efficient and streamlined way so that they can reach patients faster and deliver the payback needed to drive further research?

Key discussion points include:

• The challenges of commercialising cell and gene therapies
• Key attributes of ATMP platforms for efficient manufacturing
• Developing process design around single-use systems 
• Addressing the skills challenge and training requirements 
• Case studies and future perspectives including the integrated vial fill/finish, containment and No Touch Transfer solution, Cellefill™ 

^{*Panel biographies correct at time of recording, 2022} 

Highlights from panellist discussions:

James Drinkwater:

“We are now looking at smaller batches, and that is a different model in its own right. There is also a paradigm shift in regulations for manufacturing such products, and that is all about managing the contamination risk, the GMP compliance part and its integration into these new platforms. When you look at the process platform attributes, flexibility and scalability are key. Modularity and intensification, automation and digitalisation of control and monitoring are other attributes.”

Dr Alex Van Hagen:

 “There are a number of commercialisation challenges the cell and gene therapy field has to overcome. By building your process design from the ground up with single-use technologies, overcoming these challenges will be less burdensome. The flexibility, modularity, sterility and automation can be facilitated a lot more effectively with single-use technology over static, reusable, legacy equipment.

There are currently 23 FDA approved cell and gene therapy products available and on the market for clinical use but given the near 2,000 products under development we can expect an exponential rise in approved clinical products in the near future. It’s imperative that the biomanufacturing sector accommodates for this expected future demand and changes to GMP practices in their current and future generational production suites.”

Dr John Milne:

“Some of the overt challenges are making sufficient product for commercial-scale production and processes need to scale up manufacturing from infancy, or none at all. There’s a large amount of manual manufacturing in these therapeutics and that presents challenges with respect to competencies of staff involved in manufacturing, and we also can’t underestimate the challenge of supply chains, particularly in regard to viral vector manufacturing.”

Watch now for further insights on addressing the challenges facing CGT commercialisation.

Download now: CGT Commercialisation Industry Report

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