Vivante GMP Solutions, Inc. Completes Process Optimization Contract for Oxford University Malaria Vaccine

October 09, 2009 (PRLEAP.COM) Business News
HOUSTON, Texas October 9, 2009 Vivante GMP Solutions, Inc. ("Vivante") today formally announced that it has completed the performance of process optimization activities related to the upcoming production of a GMP clinical lot of an Oxford University adenovirus-based malaria vaccine.

David Enloe, Vivante's President and CEO, said, "We are very pleased to be working with Oxford on this important project. Oxford has multiple vaccine initiatives which represent the next generation of addressing many serious public health threats. The work Vivante has done thus far to optimize this product's GMP production process is something our team is very proud of."

"Vivante has been important to the Jenner Institute in our development of new approaches to vaccinating against malaria," said Professor Adrian Hill, Director of the Jenner Institute and Chairman of the Centre for Clinical Vaccinology and Tropical Medicine at Oxford University. Professor Hill added, "We are a major early-stage developer of vectored vaccine approaches for malaria, TB, influenza and other infections and I look forward to a growing relationship with Vivante as these programs progress through clinical trials."

The Jenner Institute at Oxford University is involved in multiple vaccine projects for various infectious diseases. These programs are funded in part by the European Malaria Vaccine Initiative and the Grand Challenges in Global Health (GCGH) initiative. The GCGH is jointly funded by the Bill and Melinda Gates Foundation, the Wellcome Trust, and the Canadian Institute of Health Research.


Vivante provides its clients with flexible, disposable technology-dependent, scalable Good Manufacturing Practices (GMP) production capabilities, including the skills needed to convert early stage, lab-grade production into robust and scalable therapeutic product classes, suitable for clinical studies and commercial use. Vivante offers its clients access to its intellectual property portfolio, which includes patents, proprietary quality and validation systems, and broad GMP knowledge systems. Vivante operates a state-of-the-art GMP clean room facility which includes production and fill/finish capabilities, as well as facilities for research and development and Quality Control. In addition to its GMP manufacturing service, Vivante offers process development and optimization, Quality Control analytical testing, and on- and off-site GMP product storage and distribution to clinical trial sites. Notably, through its predecessor company, Vivante created the adenoviral reference material (ARM) that serves as the industry gold standard against which all other U.S. adenovirus-based materials are compared.

Vivante was created in 2009 as a result of the purchase out of Chapter 11 proceedings all the process and production-related assets of Introgen Therapeutics, Inc., a company that took its lead adenoviral-based product from inception in 1993 through BLA and MAA filings in 2008. Concurrent with the asset purchase, the management and technical team joined Vivante, thus assembling the critical pieces of a new CMO focused on viral development and GMP production.

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