Over a decade of GMP manufacturing experience

Over a decade of GMP manufacturing experience

Benefit from our extensive experience in nanomedicine development and manufacturing, spanning diverse therapeutic areas and applications.

At Ardena, we have over a decade of experience in the development and cGMP-compliant manufacturing of nanoparticles for medical applications. Therefore, the success of the corona vaccines did not come as a surprise to us. For many years prior, we realized the potential of nanoparticle-based medicinal products. We have manufactured nanomedicines for our clients’ clinical studies with applications ranging from drug delivery to medical devices.

Our extensive nanoparticle portfolio

In recent years LNPs have understandably attracted a lot of attention, and we are very comfortable in working with such lipid-based nanoparticles. Our nanoparticle expertise goes beyond, with equal experience in the production of a wide range of other nanoparticles, such as polymer-based and metal-/metal oxide-based nanoparticles, offering properties that are highly complementary to their lipid-based equivalents.

Our cGMP capabilities: From preclinical to clinical batches

Ardena produces both preclinical and cGMP-compliant clinical batches. Our state-of-the-art facility combined with rigorous quality control measures ensures production of the highest-quality material that is fully compliant with cGMP requirements. We are particularly experienced in early clinical development of a program, bringing molecules from the lab bench to first-in-human studies. When we collaborate on a project, our experienced process development team will streamline the process, ensure its scalability and identify critical process parameters based on current practices in the industry.

Our analytical expertise

In parallel, our team of analytical experts identifies and develops analytical methods following the latest ICH guidelines, instilling confidence in regulatory authorities regarding the quality of your product. This is especially crucial for complex formulations such as nanomedicines, where comprehensive analytical characterization is essential — often in-depth analysis is required for DS and novel excipients.

Our regulatory affairs team

We specialize in navigating the intricate landscape of nanomedicine regulations and guidelines. With our experienced QA and CMC Regulatory Affairs teams in control, we have the expertise and insight to safely guide your nanomedicine through the complex regulatory pathway, ensuring its successful advancement into the clinic and beyond.

Explore our tailored nanomedicine solutions

Contact us to discuss your nanomedicine project with our experts