Vivante GMP Solutions Announces Successful Completion of GMP Manufacture, Lot Release Campaign

May 18, 2010 (PRLEAP.COM) Business News
HOUSTON, Texas-May 18, 2010—Vivante GMP Solutions, Inc. ("Vivante"; today announced that it has successfully completed the GMP manufacture and lot release analysis for a privately-held US biotech company of its virus vector-based gene therapy product for use in Phase I clinical trials.

In addition to performing a variety of other related projects for the client, Vivante completed the process development and scale-up activities for the vector in preparation for the full-scale GMP manufacturing run of both Drug Product for use in clinical studies and a Master Virus Bank. The majority of the product release tests were performed by Vivante staff in-house, while those assays which were outsourced were managed by Vivante for the client.

"The release of a GMP batch of clinical materials is always a significant accomplishment," said David Enloe, Vivante's founder, President and CEO. "The Vivante team continues to build its repertoire of manufactured products and to perfect its production process with each run. The completion of this particular batch marks the first major milestone of what is anticipated to be a long-term, productive relationship with this client. I congratulate both the Vivante staff as well as our client's team on a job very well done."

Vivante provides its clients with flexible, disposable, 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 a 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 of the process and production-related assets of Introgen Therapeutics, Inc., a company that had taken its lead adenovirus-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.