Descrizione del progetto
Superare gli ostacoli tecnici nelle terapie cellulari
Nonostante la grande promessa delle terapie basate sulle cellule, permangono ancora dei limiti tecnici che ne vietano l’applicazione diffusa. L’uso di prodotti di origine animale durante il processo di coltura cellulare in vitro pone un rischio significativo per le risposte immunitarie e per la trasmissione di malattie trasmesse dagli animali ai pazienti trapiantati. Per soddisfare le esigenze di mezzi di coltura senza impiego di animali, il progetto PLATELYS, finanziato dall’UE, propone un prodotto innovativo a base di piastrine umane. Il lisato piastrinico è di grado clinico, essendo stato sottoposto a test di controllo qualità, e può essere impiegato per diverse terapie cellulari, comprese quelle che utilizzano cellule immunitarie o cellule staminali.
Obiettivo
Cellular therapies making use of stem cells, engineered immune cells or engineered tissue represent an unprecedented and fast-growing therapeutic area. To date, 14 cell therapies have been approved by the FDA. However, the cells being implanted to the patient need to be cultured in vitro at some point under highly specific and controlled conditions. One of these conditions –indispensable to culture any type of isolated cell in vitro– involves using animal-derived serum as a source of hormones and growth factors to mimic cells' native environment. It is estimated 1.5 million calf fetuses are inhumanely sacrificed to collect serum. This leads (among other negatives) to endanger patient's safety, because of cross-species immune reactions (which may be lethal) and the transmission of animal borne diseases (e.g. the mad cow disease). PlateLys is PLATOME´s solution to develop and produce a remarkable human-based serum substitute fulfilling all the requirements to culture cells. PLATOME is an award-winning Icelandic start-up created in 2016 to leverage the substantial know-how on human platelet lysates (hPL) production from its founders. PlateLys is the only hPL combining: a viral-inactivated hPL ensuring the highest safety profile for patients and operators; a clinical-grade lysate with standardized quality control and GMP certified amenable for research and clinical set-ups; a powder formulation providing maximal flexibility, especially on applications that were nonviable previously. The market of sera supplements will be worth €1.14 billion by 2025 (CAGR of 8%, period 2017-2025) with a large shift to hPL use ongoing. Through the PlateLys project we seek to complete the optimization and scale-up production, starting commercialization activities in Europe by 2021. By 2025, we will have generated €5.52 million in turnover and increase our staff by 300%. PlateLys will allow us to expand our portfolio of cell-oriented products, thanks to our patented production technology.
Campo scientifico
Programma(i)
Argomento(i)
Invito a presentare proposte
Vedi altri progetti per questo bandoBando secondario
H2020-SMEInst-2018-2020-1
Meccanismo di finanziamento
SME-1 - SME instrument phase 1Coordinatore
220 HAFNARFJORDUR
Islanda
L’organizzazione si è definita una PMI (piccola e media impresa) al momento della firma dell’accordo di sovvenzione.