Waisman Biomanufacturing to provide global supply of novel gene therapy product

February 23, 2016

Waisman Biomanufacturing and Agilis Biotherapeutics, LLC, recently announced an exclusive partnership agreement for the production AGIL-FA, a novel gene therapy product for the treatment of Friedreich’s ataxia (FA). FA is an inherited neuromuscular disorder caused by a defect or mutation in the FXN gene. It is the most common inherited ataxia, with 1 in every 100 people being carriers. FA typically arises between the ages of 5 and 15 and manifests as difficulty with balance and coordination. Over time, the disease progresses to an array of neurological symptoms and life-altering changes in mobility, energy, speech, hearing, and other body systems.

Under the terms of the agreement, Waisman Biomanufacturing, located at the Waisman Center at the University of Wisconsin – Madison will utilize its personnel, facilities and proprietary processes to manufacture GLP material for non-clinical studies, cGMP material for non-clinical and clinical studies, and potential future commercial supply should AGIL-FA be successfully developed and approved. Agilis and Waisman will each provide team experts to contribute to the overall execution of the full range of manufacturing, quality and regulatory activities.

“Our partnership with Waisman Biomanufacturing is an important step in advancing our AGIL-FA gene therapy for the potential treatment of the neurological symptoms in Friedreich’s ataxia patients,” said Dr. Mark Pykett, Agilis president and CEO. “Waisman Biomanufacturing is a leading manufacturer of biological products, with extensive experience and a strong track record in the production of innovative medical products. In partnering with them to leverage their proprietary systems, organizational expertise, and extensive infrastructure, Agilis has solidified a key strategic component in the near- and long-term development and commercialization of AGIL-FA. We are pleased to partner with such a reputable organization as Waisman Biomanufacturing to ensure high quality, scalable manufacturing of the product.”

Founded in 2001, Waisman Biomanufacturing operates a 15,000 square foot biologics manufacturing facility with eight cGMP compliant cleanroom areas to accommodate clinical production of mammalian and microbial therapies and aseptic filling of final products. Their quality system and cleanroom facility are designed to maximize regulatory compliance and environmental quality.

“Our partnership with Agilis is reflective of our mission to provide high quality cGMP biologic products to our partners and to assist with the advancement of innovative medicines to enhance the treatment of human diseases,” says Derek Hei, director of Waisman Biomanufacturing. “We are pleased to collaborate with Agilis on its exciting gene therapy product for Friedreich’s ataxia and to facilitate supply of the product for the sequence of development stages required for its approval and ultimate commercialization.”

To learn more about Waisman Biomanufacturing, please visit gmpbio.org.

For more information about Agilis Biotherapeutics, LLC, please visit agilisbio.com.