Jun 9 2010
Enavail, LLC, a particle engineering company founded on pioneering drug delivery research from the University of Texas at Austin, announced today the company's plans for the construction of a new state-of-the-art current Good Manufacturing Practices (cGMP) facility in the Abilene Life Sciences Accelerator (ALSA). The Enavail facility will be the first of its kind in the West Texas region.
“The strategic decision to build our new cGMP facility in Abilene was based on a thorough review of our options”
Enavail is an Emergent Technologies, Inc. (ETI) portfolio company, headed by Brian Windsor, Ph.D., President and Breca Tracy, Ph.D., Assistant Managing Director. Enavail's scientific team is led by Chief Scientist Robert O. (Bill) Williams III, Ph.D., Professor of Pharmaceutics in The University of Texas at Austin College of Pharmacy. Enavail's particle engineering technologies allow for tremendous enhancement of drugs with poor water solubility - a condition that can greatly limit a drug's effectiveness.
"The strategic decision to build our new cGMP facility in Abilene was based on a thorough review of our options," said Enavail President Brian Windsor. "The space and the services the Abilene Life Sciences Accelerator have to offer are a perfect fit for us. They will allow for ongoing support for our clients' clinical and commercial GMP needs. We presently offer phase I cGMP clinical batch production for compounds with applications in pulmonary, parenteral, intranasal and oral delivery. The Abilene facility will allow us to support all clinical phases as well as commercial manufacturing."
"Having the GMP facility in the ALSA will better help us to fast-track the growth of our client companies, Abilene and West Texas," David Sougstad, ALSA Executive Director commented. "It represents a substantial new life sciences manufacturing asset in the region."
Richard Burdine, CEO, Development Corporation of Abilene, said, "Enavail's cGMP facility is another first for Abilene in the life sciences industry and a first for the whole West Texas region. It is in keeping with our goal to bring innovative technology to the City of Abilene and this area. It furthers our efforts to provide valuable job and innovation led economic development opportunities for Abilene."
Utilizing its state-of-the-art lab in Austin and the planned cGMP facility in Abilene, Enavail works with collaborative partners in drug development that are interested in improved formulations, product development and clinical scale manufacturing. Co-development projects usually begin with feasibility studies for development of custom-tailored solutions for partners directed to their specific active ingredient. These are followed by cGMP clinical batch production and licensing of the Enavail technologies for commercialization of products. In addition to client services, Enavail is in development of its own proprietary pharmaceutical products.
The planned 1,800 sq. ft. facility will be built in compliance with the current Good Manufacturing Practices (cGMP) set forth in the FDA's code of federal regulations, 21 CFR parts 210 and 211; and will support clinical batch production and commercial scale manufacturing. Facility completion is anticipated by September of this year.