Vivante's Facilities

Vivante operates a fully-validated, state of the art cGMP manufacturing facility in Houston, Texas. From vector design and cell line optimization through product storage and stability testing, our facility has been designed to meet Phase I through Phase III clinical requirements. We offer GMP capability in stainless steel or in the Wave™ system. Our cGMP formulation and aspetic vialing areas allow us to fill viral vectors and viral vaccines up to 5,000 vials per batch.

Regulatory Compliance

The Vivante facility has been designed to meet US and European regulatory requirements. The Vivante team has successfully completed audits with the US FDA and the Irish Medicines Board and has experience producing batches for Phase III clinical trials and consistency batches for Biologics License Applications. Our facility was selected by the Adenovirus Reference Material Working Group (ARMWG) to produce adenoviral vector used by researchers worldwide. Major pharmaceutical and biotechnology companies are using this reference material to aid in the development of their own products.

Technology Transfer and Person-in-Plant

We understand that every product and process is unique and that equipment and process transfers may be required. Our team has experience with process and equipment transfers including equipment procurement and executing the IQ/OQ/PQ protocols for this equipment. Our facility has been designed to accommodate a person-in-plant from the observation windows in all processing areas as well as dedicated client offices with Internet access.