Sentio BioSciences LLC
Sentio BioSciences LLC is a US-based specialty pharmaceutical company dedicated to transforming complex ideas into commercial human and animal therapeutic treatments. With over 15 years of proven experience in product development, regulatory approval, and commercialization of small molecules, Sentio offers cGMP manufacturing and CDMO services for essential and complex medicines. The company is committed to strengthening the US pharmaceutical supply chain, workforce development, and innovation through licensing and collaborations. Sentio's mission emphasizes high-quality products, compliance, safety, and continuous improvement, supported by a diverse and performance-driven team.
Industries
Nr. of Employees
small (1-50)
Sentio BioSciences LLC
218 A Millwell Dr, Maryland Heights, MO 63043, United States
Products
Pentosan polysulfate sodium
Active pharmaceutical ingredient and drug product developed and commercialized for equine osteoarthritis; listed as advanced through clinical phases to commercial availability.
SENT008 (pipeline code)
Development-stage product code listed for osteoarthritis (preclinical stage indicated).
SENT012 (pipeline code)
Development-stage product code listed for osteoarthritis (preclinical stage indicated).
Melarsomine dihydrochloride
Product code listed for parasitic indication with product development through commercial status indicated.
SENT005 (pipeline code)
Generic essential medicine development code listed under urology with regulatory batches indicated.
Pentosan polysulfate sodium
Active pharmaceutical ingredient and drug product developed and commercialized for equine osteoarthritis; listed as advanced through clinical phases to commercial availability.
SENT008 (pipeline code)
Development-stage product code listed for osteoarthritis (preclinical stage indicated).
SENT012 (pipeline code)
Development-stage product code listed for osteoarthritis (preclinical stage indicated).
Melarsomine dihydrochloride
Product code listed for parasitic indication with product development through commercial status indicated.
SENT005 (pipeline code)
Generic essential medicine development code listed under urology with regulatory batches indicated.
Services
Development and cGMP manufacturing services including route scouting, process design, DOE, technology transfer, clinical and commercial batches, packaging, labeling and serialization.
Compendia and non-compendia method development, method validation, routine release testing, stability testing, structural characterization and outsourcing coordination for specialized analyses.
Preparation and support for DMF, IND/ANDA/NADA/ANADA submissions, CMC packages, ongoing regulatory filings, adverse event reporting and FDA audit support.
Formulation development for parenteral, capsule, tablet and emulsion dosage forms including related stability and container–closure integrity testing.
API and drug-product stability testing across long-term, intermediate and accelerated conditions, forced-degradation and stress studies, freeze–thaw and extractables/leachables assessments.
Subcontracting services for toxicology studies and clinical trial manufacturing/supply support.
Development and cGMP manufacturing services including route scouting, process design, DOE, technology transfer, clinical and commercial batches, packaging, labeling and serialization.
Compendia and non-compendia method development, method validation, routine release testing, stability testing, structural characterization and outsourcing coordination for specialized analyses.
Preparation and support for DMF, IND/ANDA/NADA/ANADA submissions, CMC packages, ongoing regulatory filings, adverse event reporting and FDA audit support.
Formulation development for parenteral, capsule, tablet and emulsion dosage forms including related stability and container–closure integrity testing.
API and drug-product stability testing across long-term, intermediate and accelerated conditions, forced-degradation and stress studies, freeze–thaw and extractables/leachables assessments.
Subcontracting services for toxicology studies and clinical trial manufacturing/supply support.
Expertise Areas
- Contract development and manufacturing (CDMO) for small molecules
- Process development and scale-up (batch, flow and continuous)
- High-potency and controlled-substance handling
- Analytical method development and validation
Key Technologies
- Flow chemistry and continuous manufacturing
- Batch chemical synthesis (high-temp/high-pressure reactors)
- HPLC (UV and RI detectors)
- LC‑MS and GC (outsourced/integrated workflows)