Vivante GMP Solutions Announces Successful Completion of GMP Fill/Finish, Lot Release Campaign for Etubics Corporation
April 07, 2010 (PRLEAP.COM) Business News
HOUSTON, Texas-April 7, 2010—Vivante GMP Solutions, Inc. ("Vivante"; www.vivante-gmp.com) today announced that it has successfully completed the fill/finish and lot release testing for Etubics Corporation's ("Etubics"; www.etubics.com) ETBX-011 adenovirus vector-based gene therapy product for Phase I/II clinical trials. Etubics approached Vivante with an urgent need for fill and finish, and release testing of its bulk drug substance material. Vivante immediately began preparing for the filling activities, performed the filling operations within the specified timeline, and conducted the batch release testing for the vialed Drug Product material. The lot was officially released by Etubics on March 12, 2010.
"During the production of our colon cancer treatment product, which will be used in Phase I/II clinical trials, Vivante provided the Company with outstanding service and a strong commitment for quality," said Dr. Frank Jones, Chairman and CEO of Etubics Corporation. "Vivante's attention to detail, follow through, commitment to deadlines and strong project management skills was instrumental to the completion of the project. We look forward to expanding our relationship with Vivante as we continue to grow our own pipeline of vectored vaccines."
"This achievement is a testament to our ability to execute projects effectively and rapidly, without sacrificing quality," said David Enloe, Vivante's founder, President and CEO. "The relationship that our team has established with Etubics is strong. Etubics has an exciting approach to delivering vaccine antigens, and we look forward to being a key component of advancing those products into the clinic."
ABOUT VIVANTE GMP SOLUTIONS, INC.
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.
ABOUT ETUBICS CORPORATION
Etubics Corporation is a Seattle-based biopharmaceutical company developing "next generation" vector vaccines to immunize or treat large worldwide populations having difficult-to-treat diseases such as select cancers, influenza viruses, HIV, malaria and hepatitis C virus. Etubics' patent-protected pharmaceuticals, called adenovirus vectors, are safer, more effective, more versatile and easier to produce than competing products. They can also be utilized to re-immunize a vaccinee, solving a current challenge in the industry.
For more information on Etubics, please visit www.etubics.com or contact Kimberly R. Jones, Director of Corporate Development and Communications, at 206.838.5110 extension 110.