Work on all Work Packages has, in general, proceeded as planned.
WP1, New cultivars, bioactivity, and cultivation scale-up: In-field cultivation of barley cultivars producing human GFs proceeded as planned, bridging the gap until the animal GFs became available in the second half of the project, phasing out ORFs current human GFs. Development of new barley cultivars producing animal GFs proceeded as planned, except that ORF added several new cultivars, with new animal GFs, in addition to those planned in the Grant Agreement. This was done in accordance with expressed interest by CCM companies. Bioactivity of all new GFs was tested by outside lab (SBH Sciences, USA) and cooperating partners among CCM companies. In all cases the bioactivity of the purified growth factors was equivalent or better than industry standard. In-field cultivation trials in Iceland and Canada were successful for both years, resulting in expected amount of high-quality barley grains.
WP2, Optimization of processing: Optimization of seed processing was completed, resulting in a new high-throughput setup of equipment-line for seed cleaning, de-hulling and milling, already tested and in use. Larger extraction vessels were bought and tested; the equipment-line can now easily work with more than 100kg of barley grain in a short timeframe as was the goal. Optimization in extraction and subsequent purification steps for each GF resulted in several fold increases in yield, thereby significantly reducing the cost. A new affinity technology for purification of target proteins was implemented and demonstrated to work efficiently, however, this process took more time and effort than projected to optimize and demonstrated some limitations in economical scale-up due to scale-up problems from supplier of critical component. Therefore, a modified version of the technology was optimized and replaced by a continuous clarification step and high-capacity sieves. This setup has also facilitated the optimization of buffer exchange in the last steps of the purification procedure.
WP3, Industrial product design and optimization: Optimization of the processing reduced the need for raw materials quite significantly and made it possible to switch from pharma grade to food grade for some key ingredients lowered the cost further. The high-capacity sieves are connected to a highly automated feed system, which makes the run semi-automated. At present all customers are receiving the final GF product in a freeze-dried format but a lot of testing has been done indicating that other, simpler, low-cost and more user-friendly formats are just as bioactive. Some customers have received those formats and evaluated the activity. Design and production of packaging for freeze-dried MESOkine GFs portfolio was finalized and is being used for all MESOkine products sold to several CCM companies. All feedback from the customers is positive, the GFs perform as well or better than industry standard.
WP4, Preparation for commercial rollout: ORF has attended a substantial number of conferences and seminars and presented the CCMeat project and the resulting MESOkine products. Most of these events were attended on-line due to covid19 pandemic. The company is in direct contact with the majority of CCM companies in the world, has delivered samples of MESOkine GFs to most of them and initiated sales to many of them, including the leading ones. ORF is now in discussion with several companies and exploring partnership agreements. A website for MESOkine was designed and launched. The company is building up a customer base which is being managed by customer relationship management software linked to the MESOkine website. The business is being continuously monitored through direct contact with CCM companies, key organizations and opinion leaders within the CCM sector as well as through market reports, internet and social media. The business case is continuously re-analyzed in accordance with relevant new information.
WP5, IP, Risk and Project Management: One international (PCT) patent application on the composition of the MESOkine products has been filed and another patent application on the production procedure was planned at the end of the project. However, due to delays in delivery of equipment, resulting in necessary modification of processing and final optimization of the production, the filing will be done in Q1 2023. The brand MESOkine was registered and an application for further worldwide registrations sent to the International Bureau of the World Intellectual Property Organization (WIPO). None of the projected potential risks have materialized. One unexpected new risk appeared; earthquakes and subsequent volcanic eruption in vicinity of ORFs greenhouse in Southwest Iceland. No damage has occurred nor imminent.
