Business Case for the Smart BioMaterials Consortium (SBMC)

From Lab to GMP Production

Jan Rietsema, CEO of SBMC, knows what he wants: to build a production facility for the future of regenerative medicine—with cleanrooms where biomaterials are developed to help the body heal itself.

His team operates in accordance with ISO 13485 and provides services on a fee-for-service basis. But when it comes to GMP production, they’ve found that this requires a different kind of expertise.

Where ISO leaves room for interpretation and focuses on the system level, GMP is black and white. It requires forward thinking for every installation, every material used, and every action you take.

“Building cleanrooms is one thing. But delivering a suitable facility that customers can actually use? That’s something else entirely.”

Not just hands, but brains

Jan brings in Marco Dekkers for project management. Stephan Tijssen and Olaf Rubingh handle the GMP guidelines. And it all starts with a GAP assessment. What’s already up to standard? What needs to change? What needs to be done right now?

“I appreciate their flexibility. If a contractor says on Friday, ‘Testing on Monday,’ then Stephan or Olaf are simply there.” You have someone looking over your shoulder who’s done this hundreds of times before. They adjust the design where necessary. They oversee communication between contractors. And they ensure that knowledge sticks.

“You can build the most beautiful facility… But if your team or client can’t work with it, it’s of little use,” Jan emphasizes.

From the cleanroom

We’re speaking with Jan from the new facilities: “Not long ago, this existed only on paper. Everything you see here has been worked out in detail—within the schedule and budget I had in mind. This is an investment in the future—not just in infrastructure or knowledge, but for the thousands of medical devices that will come out of this cleanroom.”

“We’re not your average customer. And we had little GMP experience. Thanks to the dedication of Marco, Stephan, and Olaf, we now have four fully-fledged cleanrooms here.”

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 a suitable answer for every question, no matter how complex.

Sharing Knowledge

During the Yxion Academy and 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 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!