As regenerative medicine products evolve, regulation is clarifying the requirements of platforms to deliver the medicines to the patient and systems for the manufacture and supply of the products. The EPSRC Centre addresses the challenges of the straightforward, consistent, cost effective supply of cellular therapies by developing tools and technologies that will equip the growing industry.
The EPSRC Centre team are investigating alternative manufacturing models that will more appropriately satisfy the ` – where products made at two or more different sites must be shown to be of equivalent quality.
HypoxyCOOL™ was designed to engineer a unique system to mimic components of the physiological niche, increasing stem cell recovery and survival post-transplantation. HypoxyCOOL™ is a rapid and effective means of reducing the dissolved oxygen concentration of cell culture media to minimise oxidative-stress during stem cell recovery.
The team have also worked to test and validate a prototype hydrostatic pressure growth chamber from Instron TGT. Externally applied hydrostatic pressure delivered by the bioreactor can independently stimulate bone growth and also act synergistically with soluble factors added into the cell culture media to enhance bone development in the laboratory.
Researchers have worked with TAP Biosystems and other companies to design manufacturing platforms that minimise the requirement for manual intervention in cell production and provide opportunities for scale-up of manufacturing.
The viability of such manufacturing platforms is further investigated using tools such as cost of goods sold (COGS) analysis.
In conjunction with companies and clinics, researchers are investigating the regulatory and operational logistics of ‘microfactories’ or clinics close to the bedside.
“Collaborating with commercially driven UK researchers is resulting in developing novel automation, which will secure future sustainable production of affordable cell therapies.”
David Newble, CEO, TAP Biosystems
The EPSRC project has provided the essential proof of principle for HypoxyCOOLTM, and through such support has better ensured positive outcomes both in terms of the application of autologous cell production and adding value to the Ruskinn business.”
Huw David Thomas, UK Commercial/Sales Manager, Baker Ruskinn
- Patent application pending for HypoxyCOOL™.
- Demonstration of a range of applications for an advanced micro bioreactor system, the ambr™ from TAP Biosystems.
- PAS 83:2012 – Developing human cells for clinical applications in the European Union and the United States of America (BSI, 2012).
- Recognition of projects and oral evidence from David Williams in House of Lords Science and Technology Committee Report on Regenerative Medicine, July 2013.
Projects within the Manufacturing and Automation theme
- Development and validation of an Instron TGT hydrostatic bioreactor for tissue processing in regenerative medicine
- Efficient manufacturing platform for adherent allogeneic cell therapies
- Hydrogels for treatment of intervertebral disc degeneration
- Modelling thermal performance of a cold chain transportation system
- Near patient cell processing: Enabling manufacturing and supply of cell therapies in hospital settings
- Near patient cell processing: HypoxyCOOLTM for improved autologous cell production
- New regulatory paradigm for manufacturing of autologous therapies
- Red blood cell production from human embryonic stem cells in a scalable suspension format