Cel This topic response (Topic 2: Manufacturing Capability) forms part of an integrated proposal to address the urgent unmet needs of accelerating the development of an Ebola vaccine. To help facilitate this main goal additional activities will be performed; the generation of sufficient vaccine and the capacity increase for generating more vaccine by means of process scale up and improvements.The main objectives of this proposal are to manufacture sufficient supplies (and overages) for the clinical studies described in topic 1 and to prepare for a rapid access to large quantities of Ad26.ZEBOV (prime) and MVA-BN®-Filo (boost) vaccine in case of further escalation of the Ebola outbreak (The clinical development may change requiring an alternative vaccine combination; vaccination strategy. Any changes will be subsequently reflected in the manufacturing of clinical supplies). In conjunction with topic 3 (Transport and Rapid Access Ebola Vaccine) we should be able to respond quickly to future emergency needs of the vaccine.The program therefore covers immediate manufacturing of clinical material and creation of additional capacity (by scale up, process improvements) and product understanding (BSL classification downgrading, process and product characterisation) to cope with increased need for the vaccine. The program includes:Manufacturing, release and supply of Ad26.ZEBOV and MVA-BN®-Filo vaccine candidate for clinical studies (outcome: released clinical material)Process Development activities required to ensure scale up of Ad26.ZEBOV manufacturing to 50L and fully define the 300L scale MVA BN®-Filo production.Execute process development activities to ensure scale up of Ad26.ZEBOV and MVA-BN®-Filo to support potential manufacturing of up to 4M dosesProcess Development and further scale up to support potential manufacturing of 10-20M dosesGenerate material for further stability investigations towards late phase Dziedzina nauki engineering and technologymechanical engineeringmanufacturing engineeringmedical and health scienceshealth sciencesinfectious diseasesRNA virusesebolamedical and health sciencesbasic medicinepharmacology and pharmacypharmaceutical drugsvaccines Słowa kluczowe Ebola vaccine manufacturing development capability Ad26.ZEBOV MVA-BN®-Filo EBOMAN Program(-y) H2020-EU.3.1. - SOCIETAL CHALLENGES - Health, demographic change and well-being Main Programme H2020-EU.3.1.7. - Innovative Medicines Initiative 2 (IMI2) Temat(-y) IMI2-2014-02-02 - Manufacturing capability Zaproszenie do składania wniosków H2020-JTI-IMI2-2014-02-single-stage Zobacz inne projekty w ramach tego zaproszenia System finansowania RIA - Research and Innovation action Koordynator VIBALOGICS GMBH Wkład UE netto € 1 023 325,00 Adres ZEPPELINSTRASSE 2 27472 Cuxhaven Niemcy Zobacz na mapie MŚP Organizacja określiła się jako MŚP (firma z sektora małych i średnich przedsiębiorstw) w czasie podpisania umowy o grant. Tak Region Niedersachsen Lüneburg Cuxhaven Rodzaj działalności Private for-profit entities (excluding Higher or Secondary Education Establishments) Linki Kontakt z organizacją Opens in new window Uczestnictwo w unijnych programach w zakresie badań i innowacji Opens in new window sieć współpracy HORIZON Opens in new window Koszt całkowity € 1 023 325,00 Uczestnicy (2) Sortuj alfabetycznie Sortuj według wkładu UE netto Rozwiń wszystko Zwiń wszystko JANSSEN VACCINES & PREVENTION BV Niderlandy Wkład UE netto € 0,00 Adres ARCHIMEDESWEG 4 2333 CN Leiden Zobacz na mapie Region West-Nederland Zuid-Holland Agglomeratie Leiden en Bollenstreek Rodzaj działalności Private for-profit entities (excluding Higher or Secondary Education Establishments) Linki Kontakt z organizacją Opens in new window Strona internetowa Opens in new window Uczestnictwo w unijnych programach w zakresie badań i innowacji Opens in new window sieć współpracy HORIZON Opens in new window Koszt całkowity € 23 287 849,00 BAVARIAN NORDIC AS Dania Wkład UE netto € 0,00 Adres HEJRESKOVVEJ 10 A 3490 Kvistgard Zobacz na mapie Region Danmark Hovedstaden Nordsjælland Rodzaj działalności Private for-profit entities (excluding Higher or Secondary Education Establishments) Linki Kontakt z organizacją Opens in new window Uczestnictwo w unijnych programach w zakresie badań i innowacji Opens in new window sieć współpracy HORIZON Opens in new window Koszt całkowity € 15 877 055,00
