Ostia Sciences Inc. and EXPERT’Biome™ CDMO by Lallemand are proud to announce a significant research and development milestone. Together, they have successfully produced a new oral care probiotic through Contract Development and Manufacturing Organization, adhering to the highest industry standards, to launch clinical trials.
Ostia Sciences is set to commence clinical trials for oral health applications, advancing the development of its groundbreaking Streptococcus salivarius (SALI-10) probiotic strain. Pre-clinical findings indicate that this strain produces a bacteriocin, named Salivaricin 10, the world’s first phosphorylated lantibiotic, which will be tested in clinical trials to evaluate its ability to maintain a healthy oral microbiome, in addition to other beneficial effects such as supporting a healthy immune response.
Dr. Abdelahhad Barbour, CEO of Ostia Sciences, elaborates: “After securing full intellectual property (IP) rights, we are ready to advance our research and support the development of our SALI-10 probiotic, targeting oral and respiratory health.”
Ostia Sciences partnered with EXPERT’Biome™ CDMO by Lallemand for comprehensive project development support. This collaboration included lab-scale production to identify the optimal bioprocess for balancing yield and viability and scaling up to 150L to validate process scalability and robustness. These developments have been efficiently produced at industrial scale in Lallemand’s French GMP pharma plant. Formulation trials were also conducted to develop lozenges and determine the appropriate overage based on stability data.
Laurie Rey, Head of EXPERT’Biome™ CDMO by Lallemand, explains: “Leveraging our lab and plant capacity, along with our experienced team, we supported Ostia Sciences from end-to-end in developing their next-generation probiotics. We chose to formulate lozenges, a dosage form particularly suited for slow dissolution in the mouth, which is the site of action for SALI-10.”
Dr. Barbour adds: “EXPERT’Biome™’s regulatory support team assisted in submitting our application to the National Regulatory Authority. It was reassuring to rely on experts with the necessary knowledge to navigate regulatory waters.”
The clinical trials will be starting soon, with preliminary results expected by the end of the year. Ostia Sciences aims to commercialize its probiotic solution by the beginning of 2026.
