We specialize in early-phase drug product formulation development. Our philosophy is to develop “fit-for-purpose” formulations in early phases to minimize complexity and accelerate timelines.
J-STAR’s Drug Product R&D has developed formulation technologies to optimize API properties, such as in situ salt formation, localized pH adjustment, co-solvents, cyclodextrin complexation, particle size reduction, amorphous solid dispersions, hot-melt extrusion, DS-DP coprocessing, co-precipitation, lipid-based formulation and nanosuspension. We excel in solving challenging problems in early phase drug product development and extend these capabilities into our GMP manufacturing for preclinical, Phase I and II clinical batches, providing a rapid transition from development to manufacturing. We also apply a Quality by Design (QbD) approach to improve late phase and commercial processes. With a commitment to responsive customer service, J-STAR is your reliable partner for your drug product development needs. Experience the difference with J-STAR as your trusted “one-stop shop” for drug development success.
We can simultaneously develop both drug substance and drug product within the same J-STAR team. This integrated approach enables robust drug products by combining our expertise in drug substance crystal screening and form control with enabling technologies for drug product or intermediate. This synergistic development effort provides desired quality attributes, such as improved powder flowability, optimized particle shape and size, increased bulk density, enhanced solubility, and improved stability. Our exceptional ability to bridge the gap between drug substance and drug product offers significant value to our customers. By minimizing unexpected issues arising from drug substance–drug product mismatches, we deliver cost and time savings and improve the likelihood of success in early-phase development.
