August 1, 2011
Since 2006, Vivalis has operated and maintained a GMP manufacturing facility for the production of monoclonal antibodies, recombinant proteins, and viral-based products. Founded in 1999, Vivalis has developed a series of innovative technologies to address the needs of biopharmaceutical development. These include novel cell substrates, such as our avian EB66® cell line, which has seen wide application in areas from vaccine manufacturing to monoclonal antibody development. Our CMO services not only include those for clients using the EB66® cell line, but also other mammalian cell platforms, such as CHO and HEK-293. As a CMO, we remain platform neutral. Antibody Production Services
The development of single-cell clones, either in CHO or Vivalis’s EB66® cell line, is performed by our scientists located in either our Saint-Herblain or Lyon facilities. These activities are performed under GLP so Vivalis can move a clone into advanced development to ready it for GMP production. Services offered in this area include
Master and working cell banks performed under GMP
Small-scale (shake flasks or 2-L bioreactors), non-GMP expression
Non-GMP production of bulk material up to 20 L
Process development and optimization using DoE methodologies
Fully disposable, single-use systems of 20 L, 200 L, and 500 L for batch, fed-batch, and perfusion production
Downstream purification with column chromatography (fully disposable).
VirusProduction Services
Separate from our antibody production capabilities are our virus production services. Experience across the company includes manufacturing multiple vector types, including influenza, modified vaccinia Ankara, and human adenovirus. A sampling of Vivalis’s virus production services are
Virus plaquing and isolation
Expanding virus plaques to master virus seed stocks (MVSS)
Master and working cell banks and virus banks
Non-GMP production of bulk material up to 20 L
Upstream GMP production of 20 L and 100 L
Downstream purification with column chromatography (fully disposable).
GMP Facilities
The physical infrastructure of the GMP facility has been inspected and approved by the French Medicines Agency (AFSSAPS) for production of materials used in Phase 2 clinical trials. This innovative multiproduct facility includes independent HVAC systems combined with physical separation measures that eliminate potential product crossover. Backup power keeps all critical components — from bioreactors through cold storage — operational in case of breach. Government inspections performed every two years by AFSSAPS continually certify Vivalis’s GMP capabilities, further ensuring a defined level of GMP readiness for client projects. Quality and Regulatory
Overseen by an authorized quality person, the Vivalis quality group monitors and makes certain that all materials received for production — and those resulting from campaigns — meet specifications for release. Assays for product identity and characterization are performed in-house, whereas those for adventitious agents are outsourced to audited suppliers. Assistance with regulatory filings is provided no matter the country.
About the Author
Author Details
Louis J. Cantolupo is a director of business development for Vivalis s.a., 6 rue Alain Bombard, Saint-Herblain, 44821 cedex, France; 33-2-28-07-37-10; [email protected]; www.vivalis.com/cmo.
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