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MAnufacturing process for Cold-chain Independent VIrosome-based VAccines

Objective

MACIVIVA is a highly interdisciplinary consortium among well established and innovative SMEs with scientific excellence and complementary industrial world-leading experts with unique expertise and know-how in virosome technology, spray and freeze drying, large scale manufacturing and packaging. MACIVIVA will pave the path to other large scale thermostable nanopharmaceuticals products for therapeutic and prophylactic vaccines and other potential applications for direct application by non-invasive routes.
Liquid products are inherently prone to physical and/or chemical modifications and degradations. Solid vaccine dosage formats (e.g. powder) may prevent molecular motion and shear-induced degradation, and slow down degradation involving water and oxygen radicals, resulting in improved stability and enhanced shelf-life of vaccines. The cold chain storage is still fundamental for preserving the bioactivity of most liquid and freeze-dried vaccines, and a reconstitution step prior to administration is required for freeze dried vaccines that are usually administered intramuscularly or subcutaneously. These reconstituted freeze dried vaccines harbor important instability and must be used within hours and kept refrigerated. Because most liquid and reconstituted freeze-dried vaccines are susceptible to degradations, it may affect the immunological properties of the immunogens, with unwanted immune responses or insufficient immune protection.
For addressing liquid virosome-based vaccine instability and improving their shelf-life outside the cold chain, MACIVIVA will explore new galenic vaccine formulations through careful screening of excipients, stabilization and drying methods for generating new vaccine solid forms that can be easily self-administered. Robust “universal” manufacturing processes for upscale production of virosome dried powder for the non-invasive intranasal, oral and sublingual routes should be achieved by month 42.

Field of science

  • /medical and health sciences/basic medicine/pharmacology and pharmacy/pharmaceutical drug/vaccines

Call for proposal

H2020-NMP-PILOTS-2014
See other projects for this call

Funding Scheme

RIA - Research and Innovation action

Coordinator

MYMETICS BV
Address
J H Oortweg 21
2333 CH Leiden
Netherlands
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
EU contribution
€ 1 755 073,75

Participants (5)

MYMETICS SA
Switzerland
EU contribution
€ 0
Address
Route De La Corniche 4
1066 Epalinges
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
BACHEM AG
Switzerland
EU contribution
€ 0
Address
Hauptstrasse 144
4416 Bubendorf
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
UPPERTON LIMITED
United Kingdom
EU contribution
€ 1 647 777,50
Address
Biocity Nottingham Pennyfoot Street
NG1 1GF Nottingham
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
CATALENT U.K. SWINDON ZYDIS LIMITED
United Kingdom
EU contribution
€ 1 061 723,13
Address
Frankland Road Blagrove
SN5 8YG Swindon
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
CHIMERA BIOTEC GMBH
Germany
EU contribution
€ 874 312,50
Address
Emil-figge-strasse 76A
44227 Dortmund
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)