Leading technological advances for the industry - cell plasticity. Pluripotent stem cells have the capacity to become any type of cell in the human body.
A scalable biotechnological platform
The cell plasticity project aims to develop a scalable biotechnological platform for the consistent and affordable manufacture of human pluripotent stem cells and their derivatives. Current manufacturing processes that use static culture systems are not able to scale-up and use reagents which may not be amenable from a regulatory perspective.
This project utilises areas of expertise from across the organisation but particularly focuses on our bioprocess engineering and analytical development capabilities, as well Good Manufacturing Practice (GMP) knowlegde. The development team is designing a scalable dynamic bioprocess including an analytical framework to monitor and control the quality of the cells throughout the manufacturing process.
The final outcome of the project is to create a predictable, controlled and cost effective bioreactor process.
Leveraging our platform – Asterias
Asterias have developed a novel allogeneic dendritic cell vaccine (AST-VAC2) derived from human embryonic stem cells for the treatment of cancer.
Use of an allogeneic dendritic cell vaccine rather than an autologous (patient specific) vaccine developed from a patient’s own cells, has the potential to improve the feasibility of cancer vaccines. Asterias are currently working with Cancer Research UK to take the vaccine into phase I/II clinical trials in non-small cell lung cancer patients.
“The Cell and Gene Therapy Catapult’s cell plasticity platform is enabling us to tap into new technologies in scalable cell production. It’s helping us accelerate the creation of a scalable industrial manufacturing process for our product.”Katy Spink, Chief Operating Officer Asterias Biotherapeutics
Although there is already a manufacturing process for AST-VAC2, the current process is not able to provide the quantities of cells required for later stage clinical studies and commercialisation of the vaccine.
The investment in the Cell and Gene Therapy Catapult plasticity platform has provided a head start in the scalable production of pluripotent stem cells. We are using this knowledge to establish a scalable manufacturing process for production of human embryonic stem cells for Asterias.
The creation of a scalable manufacturing process will enable conduct of advanced clinical trials of AST-VAC2 in non-small cell lung cancer and other cancers and provide a clear manufacturing pathway to the eventual commercialisation.
“Platform projects are forward facing activities that provide step changes in industrialisation, often absorbing risk for the industry. Our investment in this types of project allows us to tackle industry wide problems head on to provide cost-effective solutions. The Asterias collaboration is a great example of applying the learnings from our platform project in automated scale-up and controlled process.”Dr Stephen Ward, Chief Operating Officer, Cell and Gene Therapy Catapult