Lonza Houston, Inc. and Benitec Biopharma Ltd. are working together to develop a scalable manufacturing process for DNA-directed RNA interference (ddRNAi) therapeutics.
Benitec has developed a patented “gene silencing” technology and is involved in developing ddRNAi-based therapeutics for chronic and life-threatening conditions.
The two companies said on Wednesday that they have signed a Manufacturing Services Agreement to develop a scalable manufacturing process for Benitec’s ddRNAi-based, Adeno-Associated Virus (AAV)-delivered products intended for therapeutic use in humans.
The firms hope to leverage Lonza’s expertise to facilitate the development of a cost-effective, scalable and robust suspension culture-based manufacturing platform. The aim is to enable the production of sufficient material to meet the potential demand for treating diseases that affect millions of people, such as hepatitis C.
Andreas Weiler, PhD, head of emerging technologies for Lonza’s Pharma & Biotech segment, said: “This agreement with Benitec continues the development of our robust and large-scale AAV platform for the production of AAV-based viral gene therapies. Lonza will utilize our cGMP manufacturing knowledge and world-class quality systems to help Benitec develop these promising novel therapeutics for patients.”
Benitec’s vice president of manufacturing, Dr. Claudia Kloth, added: “As our lead ddRNAi-based hepatitis C therapy TT-034 continues to advance in clinical studies, Lonza is an ideal partner for us to optimize our large-scale production process based on its solid expertise and track record in process development and production of AAV-based gene therapeutics.”
