IMI2-2014-02-02 - Manufacturing capability
In view of the current epidemic, the WHO has identified the progression of vaccine candidates currently in development as an urgent public health need. Because Ebola vaccines are recombinant adenovirus or other viral-based vaccines and need to be produced in facilities meeting an appropriate biosafety level, manufacturing the quantity of vaccine doses necessary for large-scale clinical testing and that can be thereafter urgently deployed represents a major challenge.
The project(s) will work on scaling up the currently available production techniques to the necessary scale and will be fully compliant with good manufacturing practices (GMP) and biological safety level requirements.
a. Costs and milestones are requested for manufacturing activities at volumes in the range of:
- 100,000 – 250,000 vaccine courses
- 250,000 – 2M vaccine courses
- 2M – 20M vaccine courses
Consideration to Drug Substance manufacture (formulated vaccine bulk) and finished Drug Product (vialed vaccine doses) should be given. Alternative manufacturing platforms to those currently utilised, or process improvement activities to increase vaccine manufacturing yields, may also be proposed.
b. Production and release of finished Drug Product is currently foreseen as a key bottleneck. Based on current regulatory requirements, non-replicating viral vaccine vectors need to be filled in BSL-2 compliant manufacturing facilities. This limits the number of manufacturers (CMOs and pharmaceutical companies) that are able to offer their services for fill and finish of an Ebola vaccine. Proposals are sought to generate additional data to help provide the necessary scientific, technical and regulatory justifications to seek a reclassification of such vectors such that they require BSL-1 containment, thereby opening up the potential for more manufacturers to assist in responding to the current outbreak.
It is considered that an IMI2 JU financial contribution of 10-20 million and an EFPIA in-kind contribution of EUR 70-110 million would allow this specific challenge to be addressed appropriately. Nevertheless, this does not preclude submission and selection of proposals requesting other amounts.
The project will deliver a manufacturing platform to provide the capacity for producing the required number of vaccine doses in GMP quality. Getting this type of production capacity online will have impact more generally for European competitiveness in the area of biological production under appropriate biological safety level conditions.
Special informationSince the implementation of Phase I, II, and III clinical trials is linked to manufacturing capability, projects funded under Topics 1 and 2 of this Call are expected to work in collaboration to ensure maximal impact.