Pleasure to meet you

The two of us - fresh PhDs in biotechnology, Ghent University - started off with the plan to help people with intestinal inflammation by administering live, food-derived bacteria that were engineered to produce a natural anti-inflammatory.

Two groundbreaking publications - one on concept, the second on strain architecture - paved the way for the world’s first-ever intervention study using a GMO Live Biotherapeutic Product. Several of our gradually refined GMO LBPs were evaluated in clinical trials according to ICH guidelines, across Europe and North America, with the most recent being a successful Phase 2a study in type 1 diabetes.

With a background that spans both national and international contexts across academic and corporate environments - including our role as spin-off co-founders - we have shaped a transformative journey of over more than two decades. We look back on a lifetime of experiences—rich with inspiration, global exposure, challenges, eureka moments, and victories. Through innovation, strategic insight, and unwavering dedication, we have driven the creation of a product platform that uniquely meets the rigorous standards of the pharmaceutical industry.

Along the way, through scientific innovation, problem-solving, and strategic planning, we learned how to design and develop GMO LBPs. Scientific questionnaires, due diligence, and gap analyses have been instrumental in shaping our understanding. We established GMP manufacturing processes for both LBP drug substance (DS) and drug product (DP), developed and validated analytical methods for QC release and stability testing, and documented everything in the CMC sections for our IND and IMPD submissions.

Looking forward to be of your assistance,
Sabine Neirynck and Lothar Steidler