STI’s R&D staff are highly experienced in formulation and analytical development with a combined 50+ years of experience. Our R&D staff have expertise in developing complex products in various dosage forms ranging from complex oral solids, inhalation products and injectables, including lyophilization cycle development.
STI has designed, built and equipped its own product development lab. Design of the lab allows for maximal flexibility and efficiency by having the various unit operations compartmentalized into suites. Multiple different projects can be run at the same time as the various stages are in dedicated suites, (i.e. tablet compression in one suite and lyophilization in another, capsule filling in another Suite). A dedicated HVAC unit is utilized for the laboratory area that is kept seperate from the general office space.
Dosage forms ranging from solid orals to injectables and lyophilized products have been developed internally including modified release, controlled release and complex products in various dosage forms. The Product Development Laboratory equipment includes: • Pilot Lyophilizer • tablet press • high shear granulator • capsule filling and in-process testing equipment • fluid bed processor • tablet coater
Along with the Product Development lab STI has its own supporting analytical laboratory. Our analytical aboratory consists of two labs, a Wet Lab – pH, Water Determination, Dissolution baths, LOD, MilliQ Water system and an HPLC/Instrument Lab (Waters HPLC running Empower 3). Analytical Method Development is performed internally. Both the Formulation and Analytical teams have experience and success in troubleshooting product/analytical issues to assist our CMOs. R&D staff are cross trained and experienced to review and draft corresponding CMC sections of a dossier. R&D staff also have experience with API manufacturing and development and review DMFs for compliance as well as product assessments. Our R&D staff are highly trained experts that routinely interface with our CMOs, Regulatory staff and form the backbone of our company.