Description du projet
Aplanir les obstacles techniques aux thérapies cellulaires
Malgré les grandes promesses des thérapies cellulaires, des contraintes techniques entravent toujours leur application généralisée. L’utilisation de produits d’origine animale pendant le processus de culture cellulaire in vitro pose un risque considérable en termes de réponses immunitaires et de transmission de maladies transmises par les animaux aux patients transplantés. Afin de répondre au besoin de milieux de culture sans la moindre trace animale, le projet PLATELYS, financé par l’UE, propose un produit innovant qui repose sur les plaquettes humaines. Le lysat de plaquettes ainsi développé est de grade clinique, ayant subi des tests de contrôle de qualité, et peut être utilisé dans le cadre de différentes thérapies cellulaires, notamment celles utilisant des cellules immunitaires ou des cellules souches.
Objectif
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.
Champ scientifique
Programme(s)
Régime de financement
SME-1 - SME instrument phase 1Coordinateur
220 HAFNARFJORDUR
Islande
L’entreprise s’est définie comme une PME (petite et moyenne entreprise) au moment de la signature de la convention de subvention.