KVAL: BERGENLYS – Preparation of Supplement for Stem Cell Therapies and Regeneration

In regenerative medicine, stem cells are utilized to repair or replace injured cells and tissues, providing new opportunities for treatment of a wide specter of conditions, including cancer, neurological diseases, bone defects, skin diseases, eye diseases and diabetes. BergenLys is an innovation project at Haukeland University Hospital. Outdated platelet concentrates are the source material for production of a cell culture growth medium intended for human therapies. When cells are cultured for application in humans, it is regarded as a great advantage to avoid animal-derived products. Growth factors derived from human platelets induce better cell growth than animal-derived products and there is a lower risk for allergic reactions and transmission of infectious diseases to the recipient. The production is also resource-friendly, as the platelet concentrates otherwise would have been discarded. In addition, the indications for BergenLys can potentially be expanded to a separate medicinal product , as the active ingredient in ointments, eye drops or preparations for orthopedic use. Potential use includes treatment of chronical wounds, eye diseases or various degenerative conditions. In the current project we have established methods for optimized production of BergenLys for research and clinical patient treatments. The BergenLysTM production method is streamlined to ensure that the high quality and safety requirements needed for use in clinical settings are fulfilled. Availability of locally produced high quality platelet lysate is crucial for the successful operation of the newly established Mohn Centre of Regenerative Medicine at Haukeland University Hospital. Furthermore, we have established plans for upscaled production by development of a Norwegian Platelet Lysate Consortium to ensure the supply of raw materials.

In this project we have developed a preliminary plan for supply of raw material. We have discussed a possibilty of a collaboration withina consortium with other Norwegian blood banks and received a list of potentially intersted parteners who could provide he volumes of raw material covering the needs of BergenLys production. We have also updated and improved the SOP for platelet lysat production, which will aloow easy tranfer of the production to GMP facility and providing high level of quality control. Also plan for product validation with local and internatinal protocols has been established. Further, an estimate of the cost of BergenLys for internal and external users has been established, both for clinical-grade and research-grade PL. After we have established a clinical grade production, w will be able to offer BergenLys as it is in direct treatment or supplement for expansion of cells for cell therapies or as an ingredient of ionmtents/gels with regenerative properties.The project resulted also in establishment of three business models and exit startegies which will allow us utilize Research and later clinical grade BergenLys product. The project detailed achievements are as follws: 1. A GMP-compatible SOP for production of BergenLys (including scale-up) has been established. 2. We have established a plan for quality control of the product in line with local and international protocols. 3. Personell resources needed for production has been determined and plans for competence transfer established. 4. Platelet lysate produced from pooled platelet products from multiple donors provides superior homogeneity compared to production from single donor platelets. 5. BergenLys provides economy and environment friendly production providing improved utilization of existing raw materials and reduced need of special hazard material disposal protocols. 6. Opportunities for future development of BergenLys as a separate medicinal product as the active ingredient in ointment, gel or eyedrops have been identified. 7. Clear business model and commercilization path for current research grade and future clinical grade BergenLys products.