Descripción del proyecto
Superación de los obstáculos técnicos en la terapia celular
La terapia celular tiene un gran potencial, pero todavía existen obstáculos técnicos que impiden su aplicación generalizada. El empleo de productos de origen animal durante el proceso de cultivo celular «in vitro» plantea un riesgo importante en lo que respecta a las respuestas inmunitarias y la transmisión de zoonosis a los pacientes trasplantados. Para abordar la necesidad de medios de cultivo no animales, PLATELYS, financiado con fondos europeos, propone un producto innovador basado en plaquetas humanas. El lisado de plaquetas es de grado clínico, se ha sometido a pruebas de control de calidad y puede emplearse para diferentes terapias celulares, incluidas las que utilizan células inmunitarias o células madre.
Objetivo
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.
Ámbito científico
Programa(s)
Convocatoria de propuestas
Consulte otros proyectos de esta convocatoriaConvocatoria de subcontratación
H2020-SMEInst-2018-2020-1
Régimen de financiación
SME-1 - SME instrument phase 1Coordinador
220 HAFNARFJORDUR
Islandia
Organización definida por ella misma como pequeña y mediana empresa (pyme) en el momento de la firma del acuerdo de subvención.