Lonza, a Switzerland-headquartered contract development and manufacturing organization (CDMO), announced the launch of its Xcite adeno-associated virus (AAV) stable producer cell line platform designed to help gene therapy developers improve scalability, process robustness and cost efficiency as programs move toward commercialization.
The company said the platform uses a manufacturing approach in which all AAV-producing components are stably integrated into a cell line, reducing variability and operational complexity commonly associated with transient transfection methods. During beta testing with a clinically relevant gene of interest and engineered capsid, the platform demonstrated a reported 10- to 15-fold increase in titer compared with transient transfection approaches.
Lonza said the platform is intended to support manufacturing for indications requiring larger patient populations or higher dosing levels, including oncology and neurodegenerative diseases.
According to the company, customers can access the platform through Lonza’s process development laboratories to evaluate manufacturability during early-stage development and support go/no-go decisions. Furthermore developers can in-license the platform for internal product development and commercial manufacturing efforts.
““Xcite® AAV PCL platform represents the culmination of years of Lonza innovation and hands on experience in AAV manufacturing. We’ve embedded this expertise into a robust platform designed to help gene therapy developers who are planning ahead for future commercial demand to overcome manufacturing bottlenecks. The technology has the potential to easily scale up processes to reduce COGS by 80% or more through raw material efficiencies, scalable manufacturing, and productivity gains, ”said Senthil Ramaswamy, vice president of research and development for specialized modalities at Lonza, in a statement.
The launch expands Lonza’s recent investments in advanced biologics and cell and gene therapy manufacturing.
Photo: ©Lonza
Bron: Lonza