The aims of this action were to identify suitable strategies to scale up the manufacturing of protein nanosheet-stabilised bioemulsions, the production of adherent stem cells and their use for the production of biotherapeutics by adherent cells cultured on bioemulsions. In addition, it aimed to identify strategies for GMP/GDP, to strengthen a path to market for protein nanosheet technologies and to enable the diversification of end users.
Rapid progress was made on the scale up of protein nanosheet manufacturing. The production of bioemulsions stabilised by affordable/scalable protein nanosheets based on a range of scaffold proteins enabling cell adhesion. The scale up was developed using microfluidic technologies as well as membrane emulsification, with a range of different oils relevant to the biomedical and biotechnology industry. The resulting materials were characterised using a range of techniques, including interfacial rheology, fluorescence microscopy and master sizing.
The action then focused on developing strategies for the culture of a range of stem cells and adherent cells relevant to therapeutics production. This included the culture of keratinocytes, MSCs, iPSCs, HSCs, fibroblasts and HEK293 cells. Scale up was carried out in conical flasks comparable to those used for the culture of E. coli or yeast, suitable for validation prior to moving to larger industrial scales.
Based on the cell manufacture scale up platform developed, the production of selected therapeutics was validated. This included exosomes and matrix proteins. The resulting biotherapeutics yields was studied and their characterisation using fluorescence microscopy, PCR and western blotting was carried out.
To develop a strategy to GMP/GDP, compounds entering into the formulation of protein nanosheets and bioemulsions, and approved by regulatory bodies such as the FDA were selected. Methods of production and transportation of emulsions were identified and preliminary tests conducted.
The action also identified a path to market. A long term market and business plan was identified, but de-risking and intermediate business plans were also identified to facilitate fund raising.
Finally, a broad range of end users has been identified. A start up (Liquibio Limited) was registered in the UK in order to exploit the technology and three partners were identified for early evaluation of the technology (de-risking).
