AIFA GMP Approval of Non-Viral Vector LNPs for ATMPs & Gene Therapy

As of 28 March 2025, CordenPharma is pleased to announce that our Caponago, Italy facility received Good Manufacturing Practice (GMP) certification from the Italian Medicines Agency (AIFA), that operates on behalf of the EMA, to produce non-viral vectors, including Lipid NanoParticles (LNPs) and polymeric nanoparticles. This milestone enhances our position as a full-service CDMO partner supporting innovators with the complex modalities they need for advanced therapeutics such as mRNA and gene therapies.

The newly approved 900 m² GMP suite is equipped with cutting-edge technologies, including Knauer’s Impingement Jets Mixing and Cytiva’s NxGen™ microfluidic systems, enabling scalable nanoparticle formulation and assembly. It also features state-of-the-art purification tools such as ultrafiltration and diafiltration through Tangential Flow Filtration (TFF) technology, ensuring high product quality and consistency from clinical to commercial scales.

Importantly, the facility offers integrated fill and finish services, including lyophilization (freeze-drying) capabilities and secondary packaging services, providing customers with a complete end-to-end manufacturing solution for a broad range of LNP-based drug delivery systems, including early to late-stage Advanced Therapy Medicinal Products (ATMPs). This unique offering significantly streamlines the development and production process, reduces timelines, and ensures seamless project transfer from formulation through to final drug product.

CordenPharma’s strategic investment into non-viral vector technologies reflects the growing demand for next-generation drug delivery systems and our commitment to delivering innovation and manufacturing excellence in the field of advanced pharmaceuticals.

Dr. Matthieu Giraud, Sr Director, Global Head of LNPs & Nanomedicines comments: “This AIFA approval represents an important milestone in our strategic journey to become a market leader in the development and commercial supply of Lipid NanoParticles (LNPs) and polymeric nanoparticles. It reflects our drive to be on the forefront of innovative technologies supporting game-changing LNP-based delivery systems such as early to late-stage ATMPs, seamlessly integrated with our expanded fill & finish services.”