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Introducing Your Trusted CDMO Partner

Mastering Large Molecule Fill Finish

We guide a worldwide portfolio of customers through the formulation and analytical development, manufacturing, sterile fill-finish, packaging and labeling of injectable drug products to GMP standards.

Accelerate your injectable drug development with Ardena's expertise and cutting-edge aseptic facility.

Our Aseptic Services

Sterile Fill & Finish Services
  • Sterile drug products – aseptically prepared
  • Liquid formulations in vials
  • Wide range of molecules:
    - Small molecules (including peptides)
    - Nanomedicines
    - Biotechnology products (e.g. recombinant proteins, monoclonal antibodies)
  • Small to medium scale batch sizes
  • Clinical trial material (IMP)
Aseptic Production Area
  • 300m² production area designed in accordance with EU GMP Annex 1
  • Cleanroom area (Grade C) with a separate weighing room, compounding room and 2 filling rooms
  • Visual inspection room
  • Secondary packaging and labeling room
  • Material and drug product staging area
  • State-of-the-art environmental control and monitoring (EMS)
Closed Isolator Filling Rooms
  • Physical barrier between drug product and environment
  • Integrated EMS
  • Automated VHP decontamination cycle
  • Power supply backup (UPS and EPS)

Our New Aseptic Plant

Infosheet

Our Fill & Finish Services

Our expert team members share deep, scientific understanding and insights into injectable drug development and manufacturing.

Why Ardena?

Always agile, we reliably guide you and your molecule through the challenging terrain of innovative drug development with deep scientific expertise.

Integrated service

By seamlessly integrating our services on one multidisciplinary platform, we're able to better mitigate development risks, ensure a smooth project execution, and ultimately reduce time-to-clinic.

Agile operations

Especially in the early phase of development, the study design is subject to constant change. Therefore, we are always agile, ready to change course as the drug development program does. 

Dossier centric approach

In drug development, compliance with regulation is critical. When designing experiments and products, we consider regulatory requirements from the outset, developing product and dossier in parallel, side by side.

Phase-appropriate development

Each phase of drug development is critical and requires specific expertise. We know "what" and "when" is needed at each phase. Depending on the development phase, we apply appropriate quality standards.

Contact us

Get in touch to see how we can craft your path to the clinic with dedicated capabilities and unique expertise.

Your molecule, your journey, our mission.

Ardena.com

info@ardena.com

Ghent, Belgium

© Ardena Holding NV.

Speak To Our Experts

Head of Sales PHARM Division

Hi there, I'd love to schedule a meeting with you to understand your project and answer any of your questions. Just complete the form and we'll be in touch. 


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Our Infosheet

Explore our range of molecules:

  • Small molecules (including peptides)
  • Nanomedicines
  • Biotechnology products
  • (e.g. recombinant proteins, monoclonal antibodies)
  • Small to medium scale batch sizes
  • Clinical trial material (IMP)
Please fill all the required fields!
Please accept terms and conditions to proceed

Welcome to Ardena

We'd love to hear about your project, so we can get you in touch with the best expert from our team!

Project Overview*
Your Name*
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