Vivante GMP Solutions, Inc. formed through purchase of GMP assets from Introgen Therapeutics; Formally launches business
September 18, 2009 (PRLEAP.COM) Business NewsHOUSTON, Texas – September 18, 2009 – Vivante GMP Solutions, Inc. ("Vivante") today announced that it has commenced operations as a high quality provider of contract process development and GMP manufacturing of cutting edge biologics. Vivante was created on June 1, 2009, as a result of the purchase of the process and production equipment, GMP facilities, quality systems, and all other related assets from bankrupt Introgen Therapeutics, Inc. For almost 15 years, Introgen was a leader in the development and GMP production of adenoviral-based delivery systems.
Importantly, Vivante commences its operations with an intact team of management, GMP production, process development, quality control, facilities and engineering, quality assurance, and project management professionals, all of whom joined the company from now-defunct Introgen. Vivante was founded by President and CEO J. David Enloe Jr., who was Introgen's first employee and who oversaw operations of that company's growth from a virtual company to a publicly-traded company with multiple products developed, manufactured, and put into phase 1-3 clinical studies. When Introgen's lead product met with regulatory challenges, the company elected to file Chapter 11 bankruptcy.
Enloe and the Vivante team's experience includes the management of construction, commissioning, and validation of three separate GMP production facilities and related supporting quality labs and systems, as well as the production and release of over 60 GMP-grade batches used in clinical trials across the world. This manufacturing expertise includes the production and release of the Adenoviral Reference Material ("ARM"), which is now the gold standard of adenoviral materials used by academicians and industry.
"We are very excited about the opportunity we have with Vivante GMP Solutions," said Enloe. "Our team brings with it a legacy of being the recognized leaders in the production of adenoviral vectors. Our aggressive approach of the use of disposable systems – which we have been doing for over 14 years – allows multiple types of biologics to be produced in a very cost-effective way. The Vivante team already has contracts in place and we are optimistic about our future."
The company was capitalized by Houston-based private equity investors.
ABOUT VIVANTE GMP SOLUTIONS, INC.
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.
For more information about Vivante, please visit www.vivante-gmp.com.