Periodic Reporting for period 1 - PLATELYS (PlateLys: The innovative human platelet lysate especially designed to maximize the effectiveness of cell-based therapies)
Reporting period: 2018-08-01 to 2018-11-30
Human Platelet Lysates is a revolutionary bioproduct enabling efficient cell culturing under animal serum-free conditions for research and clinical applications. The list of approved cell therapies for patients has grown spectacularly to 14 since 2012, when the first one was approved. The most advanced ones involve the collection, expansion and engineering of patients' cells before being implanted back. However, the current state of the art for culturing these valuable cells mostly involves the use of serum extracted from calve foetuses (FBS). This is a high-risk practice because of cross-species immune reactions and the transmission of animal borne diseases. PlateLys is the solution to develop and produce a remarkable human-based serum substitute fulfilling all the requirements to culture cells. It is the only hPL combining: a viral-inactivated hPL ensuring the highest safety profile; a clinical-grade lysate with standardized quality control and GMP certified amenable for research and clinical set-ups; a powder formulation providing maximal flexibility. The objectives of the project are optimizing and validating the automatic hPL production instrument using our innovative and validated protocol for commercialization.
Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far
Our Feasibility Study has guaranteed the viability of the project: 1) In the technical plan, we defined the strategy to optimize and validate hPL instrument according to a detailed work plan with cost analysis for Phase 2 and a complete evaluation of technical risks. 2) Our commercial plan and a Freedom to Operate Analysis show that PlateLys is freely exploitable. We have assessed the existing and new-targeted markets, our target segments, sizing of our addressable markets, competitor’s analysis, commercial risk analysis, and regulatory environment to consolidate our marketing strategy. We have also built our business, revenue models as well as the value chain. 3) We have prepared a financial plan, in which we conclude that PlateLys will allow us to generate €42.14M cumulative profit with a ROI of 4.84 in 2026.
Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)
PlateLys addresses the challenges faced by the growing field of cellular therapy. Being a human-derived product (avoiding the cross-species related immune responses), it allows the expansion and proliferation of both immune cells and MSCs used for human clinical trials and cell therapy treatments. Furthermore, hPL automation minimizes the potential for human errors, thus enhance cell therapy manufacturing and cut costs.