Algi-SCALEUP: Fermentation Scaleup for Manufacturing of Pharmaceutical Alginate Oligosaccharides

The Algi-SCALEUP aims to establish a scaled up fermentation process for the production of alginate oligomers that can be used for therapeutic applications in a variety of diseases. Earlier projects have shown that it is possible to produce alginates of good quality from a medium-sized fermentation process of 750L. To produce sufficient material for use in multiple therapeutic applications, this process needs to be expanded to industrial scale (> 30 000 L). The first tasks of the project will include optimizing the cost and scalability of specific production steps, and identifying a commercial partner for this production. Once the process is established the alginate oligomers will be compared for structural and functional identity with material isolated from existing seaweed sources. It is expected that the new scaled up process will provide a valuable alternative commercial source of high quality alginate oligomers for therapeutic use. AlgiPharma will collaborate extensively with long-time partners NTNU and Sintef in addition to other CMOs and CROs in this project. In 2021, AlgiPharma and partners have been working with planning scale up activities and new formulations.

The Algi-SCALEUP project will develop a microbial process for manufacturing of alginate oligosaccharides that have several potential applications within medicine. This project builds on previous research projects where a bacterial process for producing alginate oligosaccharides have been succesfully demonstrated at 750L scale. Value will be created through significant reduction of production costs of oligosaccharides thereby improving margins, and by significantly increased manufacturing volume that will allow exploitation of large disease indications that cannot be addressed using the current seaweed source. In order for AlgiPharma to produce enough medicine for high-volume indications s the process needs to be scaled up to industrial scale (>30 000 L). The realization of a full process will be an innovation with world-wide impact, since all commercial production of alginate polymers and oligomers today is based upon harvested seaweeds. The project will scale up and improve an existing process for producing epimerase, a vital and cost-driving step in our current 750L process. The fermentation process for producing alginate oligomers will be scaled up, the purification and isolation of material will be scaled up and optimized and the whole process will be transferred to an industriall producer. Analytical and quality control methods will be employed to test the new material and assure safety for potential patients. Two new formulations of AlgiPharmas API, OligoG, will be developed which will be used in clinical trials after this project. AlgiPharma and the partners have competence and experience in bacterial fermentation, chemical processing, physical/chemical and biological characterisation of alginate oligomers, and market knowledge, and thus have the required skills to reach the project objectives.