Valneva SE

Vivalis was founded in 1999 with the aim to better understand the extraordinary biological properties of embryonic stem (ES) cells and to use this knowledge for practical applications in human and animal health.   The company’s distinctive expertise in the field of avian ES cells has led to the development and successful commercialization of its proprietary EB66® platform, derived from duck embryonic stem cells, which has shown high utility in the production of human vaccines and monoclonal antibodies requiring enhanced ADCC. 

Vivalis also performs CMO services for the GMP manufacture of vaccines and antibodies/non-antibody proteins.  Our facility has been inspected by l'AFSSAPS for up to Phase II production of materials used in human clinical trials.  Whether produced in Vivalis's EB66 platform or another cell line, the GMP facility is platform-neutral so products and cell lines of multiple origin can be utilized.


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Locations


France
Building A
6, rue Alain Bombard
Saint-Herblain,   44821
France, Europe

GMP Experience
Two independent production trains that have been inspected and authorized by l'AFSSAPS, the French Medicines Agency for the production of Investigational Medicinal Products.

Contacts


Louis J. Cantolupo
Director, Business Development

Production Lines

Building A   ZPL-1
Location: Saint-Herblain, France
Main Details
Specialization:  Drug Substance (API)Drug Substance (API)
Platform:  Cell CultureCell Culture
BioReactor Process:  BatchBatch
BioReactor Process:  Fed-BatchFed-Batch
BioReactor Scale:  1L-100L100L Bioreactor
GMP Level:  Phase I/IIPhase I/II
Biosafety Level:  Biosafety Level 2Biosafety Level 2
Single Use:  NoneNone
Additional Services
Analytical Services are Not AvailableAnalytical Services
Cell Banking is AvailableCell Banking
Cell Line Development is AvailableCell Line Development
Preclinical Manufacturing is AvailablePreclinical Manufacturing
Process Development is AvailableProcess Development
Viral Manufacturing is AvailableViral Manufacturing
Availability: Available

Last Update: 02SEP11

Send Inquiry about this Production Line
Building A   ZPL-3
Location: Saint-Herblain, France
Main Details
Specialization:  Drug Substance (API)Drug Substance (API)
Platform:  Cell CultureCell Culture
BioReactor Process:  BatchBatch
BioReactor Process:  Fed-BatchFed-Batch
BioReactor Scale:  100L-2000L250L Bioreactor
GMP Level:  Phase I/IIPhase I/II
Biosafety Level:  Biosafety Level 2Biosafety Level 2
Single Use:  NoneNone
Additional Services
Analytical Services are Not AvailableAnalytical Services
Cell Banking is AvailableCell Banking
Cell Line Development is AvailableCell Line Development
Preclinical Manufacturing is AvailablePreclinical Manufacturing
Process Development is AvailableProcess Development
Viral Manufacturing is Not AvailableViral Manufacturing
Availability: Available

Last Update: 02SEP11

Send Inquiry about this Production Line

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