Artis BioSolutions has launched a Genetic Medicines Center of Excellence in Bilbao, Spain, adding mRNA and lipid nanoparticle development and manufacturing capabilities to its platform for genetic medicines.
The new center integrates synthetic DNA production, mRNA drug-substance manufacturing, lipid nanoparticle formulation and manufacturing, and good manufacturing practice drug-product manufacturing. Artis said the capabilities are intended to support programs from early development through clinical trials and commercial supply.
The company said the integrated model is designed to reduce the need for technology transfers among multiple suppliers, which can add time, cost and operational risk to genetic-medicine development. By offering starting materials, RNA production, delivery technologies, formulation, analytics and scalable drug-product manufacturing within one organization, Artis aims to provide customers with a more coordinated development path.
The Bilbao site expands Artis’ services for developers of genetic medicines, including therapeutic and vaccine programs requiring mRNA and lipid nanoparticle technologies. Lipid nanoparticles are used as delivery systems for genetic medicine payloads.
Brian Neel, Artis BioSolutions’ chief executive officer, described the expansion as a defining milestone for the company. He said the integrated platform combines synthetic DNA, mRNA, lipid nanoparticle technologies and GMP manufacturing to help customers move programs more quickly, reduce complexity and lower costs.
Peter Stolba, chief business officer, said developers often coordinate multiple suppliers as they progress a genetic-medicine program, adding time and risk. He said the Bilbao center is intended to give customers a single development and manufacturing partner from starting materials through commercialization.
The company said the facility supports product design, manufacturing-process development and therapeutic delivery in a coordinated manner. It also creates multiple entry points for customers seeking CDMO services, ranging from initial materials and development work to manufacturing support.
The Bilbao operation complements Artis BioSolutions’ Boston BioSolutions site in Watertown, Massachusetts. The company said its global manufacturing footprint allows it to provide process development and GMP manufacturing capabilities across modalities and locations, from technology transfer through clinical and commercial manufacturing.
Artis BioSolutions is a San Diego-based advanced-therapies platform built around a DNA-first model for genetic medicines. The company said it combines proprietary technologies and specialized expertise to support biotechnology and pharmaceutical innovators developing emerging therapeutic modalities.