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Business Case Ardena

Ardena is a global contract development and manufacturing organization (CDMO) that provides comprehensive services for drug development. When the previous location no longer meets current needs, the company faces a major challenge in constructing a completely new facility. For example, during the planning of the building (including cleanrooms, laboratories, and a warehouse), it becomes clear that support is needed. With the changing Annex 1 guidelines and increasing customer demand for larger volumes, now is the time to scale up.

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Kees-Jan, Director of Facilities & Material Logistics at Ardena, has led the project from the start. He is responsible for facilities, maintenance, and repairs of equipment, as well as logistics and materials management. In his role, he also coordinates the validation engineers and has played a key role in the new building. Kees-Jan works closely with Yxion; together, they tackle complex challenges and ensure the successful completion of the project.

 

Support at every step 
 

“From writing URSs (User Requirement Specifications) to overseeing the cleanroom and other GMP-compliant facilities, Yxion has supported us every step of the way. Frank Martens is closely involved in project management related to Commissioning & Qualification during the initial phase, helping us draft key documents and manage potential obstacles.”

“His experience, complemented by a broad network of expertise, is indispensable. For the cleanroom, we work closely with Esther Meerkerk, who is involved virtually full-time and offers practical solutions for monitoring programs, cleaning regimens, and clothing requirements. This is crucial for compliance with Annex 1 guidelines. Mindy van Druten focuses on quality control and protocol approval; she monitors the processes with meticulous attention to detail and ensures compliance with the highest quality standards, which is essential for the implementation of any facility. Eric Frings works on various projects, including the qualification of new systems, and demonstrates an impressive ability to adapt quickly to provide the necessary support, even for the very latest systems.”

 

Reliable and Valuable

“The collaboration helped bring the new building to fruition and taught us valuable lessons about project management and working with consultants. Yxion has proven to be a flexible and reliable partner. They respond quickly when needed and always provide the right expertise at the right time.”

“In short, thanks to their professional guidance and specialized knowledge, we were able to successfully complete this extensive and complex expansion. Their contribution helped us stay within the set timelines and budgets, and they also ensured a high level of quality that meets all current guidelines and standards. We look forward to future collaborations and can wholeheartedly recommend Yxion to other organizations facing similar challenges.”

Working Together Toward Tangible Results

Innovating Together

We help clients innovate by proposing new ideas and improving processes, equipment, environments, and services. Our consultants possess a wealth of knowledge. Together, we have the right answer to every question, no matter how complex.

Sharing knowledge

At the Yxion Academy and in our professional groups, colleagues come together to exchange knowledge and experiences and discuss current developments. They work together to address client questions and identify training programs that align with both their own needs and those of their clients. In short: to learn from and with one another.

Part of a close-knit team

In addition to working hard, we also have fun, of course. We love organizing outings for the entire organization. Activities include: cycling tours, a trip to Winter Efteling, European Championship pool tournaments, dinners, and barbecues. These are moments to relax and catch up with colleagues!

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Medical Team Performing Surgical Operation in Bright Modern Operating Room

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Program and Project Management

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Cleanroom Validation

Cleanroom commissioning and maintenance

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Project and programme management

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Programme and project management

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