Vivalis contract manufacturing services offers a full suite
of services that include GMP cell banking, GMP antibody production, and GMP virus production. Our manufacturing facility has been approved by the French Medicines Agency for GMP production up to Phase II clinical trials. A rigorous Quality Management System (QMS) maintains GMP compliance and further ensures adherence to these quality requirements.
GMP production of vaccines and gene therapeutics for clinical trials is offered from 2 – 100 liters. Downstream processing using column chromatography is standard using a fully disposable system.
The production of viruses classically propagated in chicken eggs is also a core specialty of Vivalis through the use of our EB66® cell line.
Production of GMP monoclonal antibodies and recombinant proteins for investigational
use can be performed from 2 – 250 liters in fully disposable, single-use systems. Using our own or customer baseline processes is a client’s choice.
Antibody expressing cell lines can be developed by Vivalis in classical cell lines such as CHO or our proprietary EB66® cell line, which provides enhanced ADCC activity for monoclonal antibodies.
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Vivalis has not received any endorsements.