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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.

Call for proposal

H2020-NMP-2014-2015

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Sub call

H2020-NMP-PILOTS-2014

Coordinator

MYMETICS BV
Net EU contribution
€ 1 755 073,75
Address
J H Oortweg 21
2333 CH Leiden
Netherlands

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Region
West-Nederland Zuid-Holland Agglomeratie Leiden en Bollenstreek
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 0,00

Participants (5)

MYMETICS SA
Switzerland
Net EU contribution
€ 0,00
Address
Route De La Corniche 4
1066 Epalinges

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
Schweiz/Suisse/Svizzera Région lémanique Vaud
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 1 792 493,75
BACHEM AG
Switzerland
Net EU contribution
€ 0,00
Address
Hauptstrasse 144
4416 Bubendorf

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Region
Schweiz/Suisse/Svizzera Nordwestschweiz Basel-Landschaft
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 1 307 525,00
UPPERTON LIMITED
United Kingdom
Net EU contribution
€ 1 647 777,50
Address
Biocity Nottingham Pennyfoot Street
NG1 1GF Nottingham

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
East Midlands (England) Derbyshire and Nottinghamshire Nottingham
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 0,00
CATALENT U.K. SWINDON ZYDIS LIMITED
United Kingdom
Net EU contribution
€ 1 061 723,13
Address
Frankland Road Blagrove
SN5 8YG Swindon

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Region
South West (England) Gloucestershire, Wiltshire and Bristol/Bath area Swindon
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 0,00
CHIMERA BIOTEC GMBH
Germany
Net EU contribution
€ 874 312,50
Address
Emil-figge-strasse 76a
44227 Dortmund

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
Nordrhein-Westfalen Arnsberg Dortmund, Kreisfreie Stadt
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Other funding
€ 0,00