Vivante GMP Solutions, Aseptic Technologies Team Up To Address Viral Fill Opportunities

March 25, 2010 (PRLEAP.COM) Business News
HOUSTON, Texas - March 25, 2010—Vivante GMP Solutions, Inc. ("Vivante"; today announced that it has entered into a relationship with Aseptic Technologies ("Aseptic"; whereby Vivante will offer to its clients filling and finishing capabilities using Aseptic's cutting-edge filling technology.

Aseptic Technologies is a company created by GlaxoSmithKline Biologicals to commercialize its novel Crystal® Closed Vial Technology. This technology allows filling operations to be performed in a more controlled environment with higher sterility conditions, reduced particle contamination, and lower vial costs.

"This capability offering is an exciting step for Vivante," said David Enloe, Vivante's founder, President and CEO. "We take pride in remaining ahead of the curve in our approaches to GMP biologics production, and see the use of Aseptic Technologies' fill system to be the next big thing in biologics filling technology. Essentially, with Aseptic's approach, the sterile container closure is never opened and exposed to air, but instead a laser technology seals the rubber stopper after injection of the product into the vial. We are optimistic that several of our clients will value this approach for their products."


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.

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