Fire Awards: Finalist - Biotech/Health care
Maryland Heights-based Sentio BioSciences developed a new drug, Zycosan, that in December received approval from the U.S. Food and Drug Administration. Zycosan is designed to control clinical signs associated with osteoarthritis in horses. It is the second drug developed by Sentio, which has 38 employees. Co-owner and Vice President of Quality Flavia D’Souza answered questions about the company’s past year.
What was your company’s biggest achievement in the past year? Sentio’s biggest achievement last year was the approval of Zycosan in December 2022. Zycosan is the first drug product in the U.S. market for the control of clinical signs associated with ostheoarthritis in horses. Our submission was very thorough and was approved with one cycle of review by the U.S. Food and Drug Administration. The drug product was launched in May this year.
What is your company’s top goal for the next year? We are working on registering a generic human drug product by December 2023. It is classified by the FDA as a complex molecule. We are also working with the University of Missouri–St. Louis on a raw material development that was in shortage, to mitigate supply chain shortage issues. Our goals for next year are the following:
- To expand our facilities and manufacturing operations for the active pharmaceutical ingredient (API) for the new generic product being submitted to the FDA for approval.
- Complete preclinical studies in collaboration with Washington University for a new human drug product and get National Science Foundation grants and investment for next stages in product development, clinical trials and manufacturing.
- Collaborate with the API Innovation Center to fulfill our joint goal of bringing API manufacturing back to the U.S. and St. Louis.
- Get external financial and business investments to expand Sentio's growth exponentially. This can include acquisition of other companies or products to expand our product portfolio.
Are you currently hiring? If so, for what roles? Sentio is currently hiring manufacturing technicians, process engineers for first and second shift. In the past three months we have hired seven personnel in our manufacturing, quality assurance and quality control teams, including 2 summer interns on special projects.
Next year we expect to increase our manufacturing team significantly to support our new products and additional Quality Assurance and Quality Control personnel. We will look at opportunities for apprentice programs with various St. Louis educational institutions. The pharmaceutical current good manufacturing practice (cGMP) environment involves providing significant training to both new and experienced personnel. An apprentice program will be a win-win program for the individual (to up-skill) and the company.
For links to profiles of winners and finalists in the 2023 Fire Awards and Startup Exit Awards, go here:
