(CordenPharma Photo) – Organic phase preparation – ATEX compounding skid.
Advanced Therapy Medicinal Products (ATMPs) are reshaping the future of modern medicine by offering novel treatment options for diseases that were previously untreatable. From gene therapies to mRNA-based treatments, ATMPs are advancing rapidly. While viral vectors initially dominated the field, the focus is increasingly shifting toward non-viral delivery systems – particularly Lipid Nanoparticles (LNPs) and polymeric nanoparticles – thanks to the scalability, safety, and regulatory advantages linked to their recent clinical success.
Despite their promise, non-viral delivery platforms come with their own set of complexities, especially when it comes to consistent and compliant manufacturing. This is where experienced, integrated partners such CordenPharma can make a real difference. Unlike traditional drugs that are chemically synthesized or biologically derived, ATMPs often rely on delivering genetic material or cells to achieve a therapeutic effect. Here, the delivery process is key, because a critical understanding of how the therapeutic cargo is transported into the body can determine the success or failure of a treatment.
Viral vectors, while effective, come with significant limitations: high production costs, complex regulatory hurdles, limited payload capacity, and safety concerns such as immunogenicity. In contrast, LNPs and polymeric nanoparticles offer a non-viral alternative that is more scalable, flexible, and often safer for repeated dosing.
In fact, (LNPs) have been successfully employed commercially for enabling the delivery of mRNA in COVID-19 vaccines (Spikevax® by Moderna and Comirnaty® by BioNTec and Pfizer) or synthetic oligos (Onpattro® by Alnylam) for the treatment of rare diseases such as transthyretin amyloidosis (ATTR). They encapsulate nucleic acids in lipid layers, helping them cross cell membranes and escape endosomes for intracellular delivery.
Polymeric nanoparticles provide even more design flexibility. Their surfaces and release profiles can be engineered for targeted delivery and extended circulation times. However, these systems are highly sensitive to formulation and processing conditions, making consistent GMP-scale production a significant technical hurdle.
The success of mRNA vaccines demonstrated the real-world viability of LNP-based therapeutics. Since then, the industry has embraced non-viral platforms for applications ranging from gene editing and oncology to rare disease treatment.
CordenPharma is uniquely positioned to support non-viral ATMP innovators with a fully integrated development and manufacturing platform from lipid supply and custom synthesis to non-viral carrier LNP-based formulation development and cGMP manufacture. We bring together deep technical knowledge, flexible GMP infrastructure, and true end-to-end supply capabilities tailored specifically for nanoparticle-based delivery systems, including injectable Fill & Finish. By combining these capabilities under one roof, we eliminate the silos that often cause delays, inconsistencies, or failed tech transfers during scale-up.
One of the biggest risks in ATMP development is the fragmentation of the supply chain. For complex products like LNPs and polymeric nanoparticles, inconsistent raw material sourcing or disconnected manufacturing stages can introduce unacceptable variability, delays or even significant disruptions from a supply chain perspective.
We address this with an integrated supply model, aligning everything from formulation development and raw material qualification to GMP manufacturing and logistics. This holistic approach minimizes risk and accelerates time to clinic and commercialization.
Additionally, innovators benefit from a customer centric culture geared towards a collaborative approach that is tailored to the unique needs of each non-viral delivery system project, helping it move quickly from concept to clinic with confidence.
On a positive note, we recently announced that our CordenPharma Caponago (IT) facility has received Good Manufacturing Practice (GMP) certification from the Italian Medicines Agency (AIFA), that operates on behalf of EMA, for the production of non-viral vectors, including lipid nanoparticles (LNPs) and polymeric nanoparticles.
This fantastic milestone, linked to the successful manufacture of a complex late-stage nanomedicine at GMP scale to be employed as a first line treatment for Oncology Gene therapy applications, enhances CordenPharma’s position as a full-service CDMO partner for ATMPs such as mRNA and gene therapies.
The newly approved 900 m² GMP suite is equipped with cutting-edge technologies including an ATEX suite capable of handling up to and beyond 500 L of compounding with solvents, Knauer’s Impingement Jets Mixing, and Cytiva’s NxGen™ microfluidic systems, enabling scalable nanoparticle formulation and assembly from early-stage clinical application to commercial. It also features state-of-the-art purification tools such as ultrafiltration and diafiltration through Tangential Flow Filtration (TFF) equipped with single use flow paths, ensuring high product quality and consistency from clinical to commercial scales.
Importantly, the facility offers outstanding formulation, process, and analytical development services integrated fill and finish, including lyophilization (freeze-drying) and secondary packaging capabilities, providing customers with a complete manufacturing solution under one roof. This end-to-end offering significantly streamlines the development and production process, reducing timelines and ensuring 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 its commitment to delivering innovation and manufacturing excellence in the field of advanced pharmaceuticals.
