Vivante GMP

Vivante GMP Overview

Our unparalleled industry expertise represents a competitive advantage for our partners. Let us show you how.

The Vivante team has a unique perspective in that its scientific and regulatory team has both CMO and relevant product development experience through BLA. We are the only CMO team with experience producing products and processes suitable for commercial use. Our scientific and regulatory expertise paired with a strong customer focus, makes Vivante the leader for outsourced gene therapy product development.

We offer services for a wide range of product types including adenovrial vectors, AAV vectors, lentiviral vectors and plasmid DNA. Our services range from cell line optimization and vector development to process development and cGMP manufacturing through product release testing. We produce batches and perform release testing for preclinical through Phase III clinical batches.
Manufacturing Solutions:

* Process Development and Validation
* Cell Line Optimization
* Vector Design
* Assay Development and Validation
* Regulatory Services (IND, CMC and BLA submissions)
* Process Development in Adherent and Suspension Cell Culture Systems
* Downstream Process Development Large Scale Ultrafiltration and Diafiltration
* cGMP Bulk Production
* Chromatographic Purification
* Formulation and Lyophilization
* Aseptic Fill and Finish
* Stability Testing and Product Storage
* Clinical Production Distribution