In this project we have;
1. identified our position in the market by analysing our competitors and new players in the market, and current patents by, together with a leading RTO (Research and Technology Organization);SINTEF, reading company reports, analysing press releases and articles and searching through proprietary databases.
2. acquired consultation from an expert team of SINTEF and together developed an optimal proof of concept project plan as a development strategy. This maximizes the chance of achieving success in development. In this plan we have considered the techno-economic aspect to assure a commercially feasible result. This setup also matched with the requirements from regulatory experts regarding regulatory approval.
3. investigated the necessary regulatory roadmap and build a schedule for when to begin interactions with the regulatory authorities. As the CEO Roy Abraham has over a decade of experience in pharmaceutical process development, and aware of which regulatory bodies to contact in order to develop the correct roadmap to market entry.
Results achieved so far:
1. Findings from our market study are very promising as it showed that our technology is not yet on the market for producing paclitaxel (not patented either). There is a shift towards plant cell fermentation (10-20% of the market), but this technique provides low quantity with high associated production costs.
2. Our technical analysis concluded the following;
(1) After re-evaluating the ideal production platform (plant cell, bacteria, fungi, algae), we concluded to stick to our initial plan by using microalgae as production platform, potentially being the most stable and cost-efficient method.
(2) A techno-economic analysis concluded a specific concentration requirement out of kg dry algae mass, which would make the production profitable (confidential)
(3) For next technical development steps 0.4 – 0.6 M is needed (2-year framework)
3. To set up the quality management system the ICH Q7 document will be followed as well as appropriate Good Manufacturing practices at all stages of the API supply chain, including distribution. Following regulatory procedures to enter the market, we have decided to use the CEP procedure for registration in Europe and we will submit a DMF file to register in the U.S.A.
