Vivante GMP Solutions Completes Successful QP Audit of GMP Facility and Quality Systems
March 11, 2010 (PRLEAP.COM) Business NewsVivante GMP Solutions, Inc. ("Vivante"; www.vivante-gmp.com) today announced that it has successfully completed a "QP audit" of its manufacturing facility and quality systems.
The audit was performed by a Qualified Person (QP) on behalf of a Vivante client, in anticipation of that client's use of a biological vaccine product manufactured by Vivante in Phase I clinical trials within the European Union. Importantly, there were no major observations noted during the audit.
"The completion of this audit is a key achievement for Vivante," said David Enloe, Vivante's founder, President and CEO. "While we have had several QP audits conducted in the past, including one related to our performance of a consistency series for a Marketing Authorization Application with the EMA, going through these audits assures us and our clients that we remain compliant with appropriate GMP regulations."
European regulations require a QP audit to be successfully completed prior to use of clinical materials in human clinical studies within the EU.
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.
For more information about Vivante, please visit www.vivante-gmp.com.