Looking for space?
Login
Search
Close this search box.

Ardena's Nanomedicine Facility secures full GMP approval for manufacturing


Oss, The Netherlands — Ardena has announced a significant milestone with its state-of-the-art nanomedicine facility at Pivot Park receiving full Good Manufacturing Practice (GMP) approval from the Dutch Healthcare Authority. This approval underscores Ardena’s commitment to advancing the development and manufacturing of complex nanomedicine formulations, catering to a growing demand for innovative therapeutic solutions.

The approval follows a €20 million investment in a state-of-the-art 45,000 sqft facility offering GMP-compliant Grade C and Grade D cleanrooms designed specifically for nanomedicine manufacturing. The fit-for-purpose cleanrooms, alongside additional GMP production spaces, dedicated laboratories for process development and analytical capabilities, and advanced warehouse facilities, reflect Ardena’s commitment to meeting stringent regulatory standards, including the latest updates to Annex 1 for the manufacture of sterile products.

Jeremie Trochu, CEO of Ardena, highlighted the significance of this development: “Achieving full GMP approval for our manufacturing operations is a significant step forward for Ardena. This accomplishment underscores our commitment to equipping clients with world-class capabilities for the development and manufacturing of complex nanomedicine formulations. We are proud of our team’s dedication to maintaining the highest regulatory and quality standards.”

The expanded capabilities include manufacturing and GMP release of nanomedicines. These products include advanced nanoparticulate drug delivery systems, as well as imaging agents and tissue engineering products. The facility is equipped to handle a wide range of nanomedicines, including lipid-based nanoparticles, polymeric nanoparticles and metal/metal oxide nanoparticles. The facility also includes purpose-built automated manufacturing flows, and fully integrated analytical capabilities for characterizing complex nanomedicine formulations. 

“Our nanomedicine facility is one of the very few CDMO sites worldwide dedicated exclusively to nanomedicine development and manufacturing,” Trochu added. “We are uniquely positioned to meet the evolving needs of this fast-growing sector. This achievement exemplifies Ardena’s ability to deliver cutting-edge solutions and support our clients in bringing life-changing therapies to patients.”

Read the full press release here.

Find more news here.

Search

Recent Posts

Looking for
space to grow?

More information
Join us at Pivot Park

Learn about
our companies?

Send us a message
Contact us at Pivot Park

or call

+31 (0)412 84 60 10

Linkedin-in Youtube
Address

Pivot Park – Building RK
Kloosterstraat 9
5349 AB Oss
The Netherlands
+31 (0)412 – 84 60 10
info@pivotpark.com

Post address

Pivot Park  Exploitatie B.V. 
Building OP
Kloosterstraat 9
5349 AB Oss
The Netherlands

Disclaimer  |  Privacy Statement  |  Cookie Statement  |  Purchase conditions

Pivot Park Captains' Dinner

10 years ago, Pivot Park opened its doors to the world. Thanks to your commitment, support and confidence, we have been able to grow it into the successful and innovative biopharmaceutical campus it is today.

Now it’s time to celebrate!

We are therefore delighted to invite you – along with all your fellow CEOs at Pivot Park – to a special night out featuring inspiring art, a wonderful dinner and lots of opportunities to network and exchange ideas.

Erwin Wurm | Am I a House?

For the first time, the artist shows a cross-section of his work, from Narrow Furniture to One Minute Sculptures, within the walls of a historic building. Villa Constance, a former home that today houses Museum Jan Cunen, is not only a location but also part of the conversation. Because what exactly is a house?
Read more (NL)

#100YEARSPHARMAFUTURE

The development of medicines in Oss began one hundred years ago. It was then that the foundations were laid for what would become a flourishing pharmaceutical sector in the Netherlands, leading to groundbreaking discoveries such as insulin and the anti-conception pill.

Today, the entire chain is still represented in Oss, from early-stage research to the commercial scale production of medicines. Working in Oss, we focus on the health of people all over the world. Employees at dozens of companies large and small put their heart and soul into new medicines, products and services that will improve lives worldwide. Together, our strength lies in our combination of broad knowledge about the development of medicines and a thorough understanding of the requirements of high-quality production.

This shared past and common values stimulate strong bonds among everyone who works in pharmaceuticals in Oss. We build on qualities, expertise and networks that go back decades. And with a wide variety of pharmaceutical companies, suppliers and scientific institutions all located nearby, we offer an attractive business climate and an excellent basis for international collaboration.

We are proud to work together to create a better and healthier future for all, a collaboration that in turn fuels growing employment: today, most pharmaceutical jobs in the Netherlands are in Oss. Here we connect talent and companies and stimulate entrepreneurship, while our expert employees are our most important asset. Their drive ensures that Oss has an influence on health all over the world.

Pharma in Oss offers endless opportunities to startups and talent in a city and region that is a joy to live and work in. We are committed to collaboration and sustainable and successful entrepreneurship. Oss’s pharmaceutical companies are intrinsically competitive while also being committed to quality and safety. This, plus their focus on new health solutions and contemporary technology, makes us a leader in our pursuit of a better life for people worldwide.