Kuijpers delivers complete package for Repligen’s new production facility

Repligen produces so-called OPUS® columns—chromatography columns that pharmaceutical manufacturers need to produce medicines and vaccines. Repligen’s client base includes pharmaceutical companies like Moderna, Roche, and Janssen. Until a few years ago, the Breda site was merely a warehousing and distribution location for the American manufacturer. That changed when the market expanded and the need arose for a large production site on the European continent. Since Breda had the space for such a facility, Repligen decided to build there.

Although Repligen already has an OPUS® production facility in the United States, it was impossible to replicate it in Breda. “Critical production environments here are subject to different laws, regulations, and ISO standards,” explains Patrick Leendertse, who is responsible for the Breda site. “So this project started with entirely new calculations, risk assessments, and an extensive permit process.” Repligen brought in DPS Engineering and later Kuijpers, along with cleanroom alliance PP4CE (Professional Partners for Controlled Environments). “These parties did an enormous amount of work behind the scenes to prepare the project with the right data.”

Once the preliminary design was ready, the Kuijpers project team, led by Vincent van der Molen, worked on the detailed design. The team also handled the execution. Kuijpers equipped the entire building with the installations Repligen needed to produce according to the GMP quality assurance system. This included cleanrooms with air treatment systems that meet GMP qualifications and ISO standards; the walls and ceilings of the cleanrooms were installed by Brecon, one of the other specialists within the PP4CE alliance. The installation of systems for the office areas was also part of the assignment. Vincent: “A major advantage is that, thanks to our partnership within PP4CE, we have all the expertise for a facility like this in-house—from engineering and consultancy to execution and automation.

We applied that full spectrum here. And because of our integrated approach, we didn’t lose time handing off between disciplines. Our execution team was already involved during the design phase, and our engineers were part of the implementation. That synergy brings huge benefits, especially under time pressure.” Kuijpers has also signed a maintenance contract to keep the facility in top condition for the next five years, including all process equipment.

For Patrick, Kuijpers being the main contractor was a great solution. “Breda was still a small site a few years ago,” he says. “Only twelve people worked there, and I joined as the thirteenth to oversee the construction. It was very convenient to have one party leading the project and managing everything. I discussed everything with Vincent, my single point of contact, and he coordinated his project team. That worked smoothly and pleasantly.”

That approach created clarity in a project with plenty of challenges. “A tight schedule, restrictive COVID measures, and a complete concrete floor on the ground level that had to be replaced,” Patrick lists. The latter was necessary due to regulations for ethanol disposal. “We had to implement extra measures,” says Vincent. “Think of installing double-walled drainage pipes two meters deep and burying special storage tanks on the outdoor site.” Given the time pressure, it was decided to carry out these groundworks in parallel with the technical installations.

“The steel structure for all the installations was already in place while the excavators were roaring underneath,” Patrick recalls. “It was a strong display of flexibility and creativity from Kuijpers. Even the drying time required for the new concrete floor—which meant it couldn’t be walked on for a long time—didn’t cause any delays.” After a year of construction, installation, testing, qualification, and validation, the production facility became operational in mid-2021. Today, more than fifty people work at Repligen Breda.

Patrick: “When I walk through the building with clients now, you can tell they’re impressed. And rightly so: we’ve built a fantastic production facility here with high-quality installations and top-notch finishing.” It’s a solid foundation for Repligen to work toward its ultimate goal: achieving seventy percent more production capacity and sixty percent more output per year to meet the urgent global demand for chromatography columns.