Lonza Launches Xcite AAV Producer Cell Line Platform

Lonza has launched its Xcite adeno-associated virus (AAV) stable producer cell line (PCL) technology, a platform intended to address manufacturing challenges related to scalability, cost of goods and process consistency as gene therapy programs move toward commercialization.

According to Lonza, the Xcite AAV PCL platform is intended to reduce variability, operational complexity and scale-up risks often associated with traditional transient transfection-based AAV manufacturing, particularly as programs advance toward larger patient populations or higher dosing requirements.

Lonza said the platform is based on a proprietary manufacturing approach in which the AAV-producing components are stably integrated into a cell line. In beta testing with a clinically relevant gene of interest and an engineered capsid, the company reported a 10- to 15-fold increase in titer compared with transient transfection methods. The platform is intended for programs targeting larger patient populations or requiring higher dosing levels, including oncology and neurodegenerative diseases.

The platform offers an alternative to multi-plasmid transient transfection and is intended to reduce process variability, support technical transfer and lower cost of goods (COGS). The company also said the Xcite AAV PCL platform can be in-licensed by gene therapy developers for use in their own product development efforts.

Senthil Ramaswamy, Vice President, Research & Development, Specialized Modalities, Lonza, remarked, “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.”

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In March, Lonza entered into a definitive agreement to divest its Capsules & Health Ingredients (CHI) business to Lone Star Funds for an enterprise value of $3 billion.