PlateLys: The innovative human platelet lysate especially designed to maximize the effectiveness of cell-based therapies

Informazioni relative al progetto

PLATELYS

ID dell’accordo di sovvenzione: 824138

DOI

10.3030/824138

Progetto chiuso

Data della firma CE 17 Luglio 2018

Data di avvio 1 Agosto 2018

Data di completamento 30 Novembre 2018

Finanziato da

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Costo totale

€ 71 429,00

Contributo UE

€ 50 000,00

Coordinato da

PLATOME LIFTAEKNI EHF
Iceland

Periodic Reporting for period 1 - PLATELYS (PlateLys: The innovative human platelet lysate especially designed to maximize the effectiveness of cell-based therapies)

Periodo di rendicontazione: 2018-08-01 al 2018-11-30

Sintesi del contesto e degli obiettivi generali del progetto

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.

Lavoro eseguito dall’inizio del progetto fino alla fine del periodo coperto dalla relazione e principali risultati finora ottenuti

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.

Progressi oltre lo stato dell’arte e potenziale impatto previsto (incluso l’impatto socioeconomico e le implicazioni sociali più ampie del progetto fino ad ora)

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.

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