Lonza Viral-Based Therapeutics Facilities

Lonza Viral 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 single-use disposable bioreactors or in the Wave™ system. We have significant experience in both adherent and suspension processing systems. Our cGMP formulation and aspetic vialing areas allow us to fill viral vectors and viral vaccines currently up to 9,000 vials per batch . A larger manufacturing suite is scheduled to come online Q1 of 2012. This facility is designed to support the use of 2000L single-use disposable bioreactors and will have an independent filling suite to allow for separate filling activities.

Regulatory Compliance

The Lonza Viral facility has been designed to meet US and European regulatory requirements. The Lonza Viral 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.