Drug Product Development

While bioactive compounds are frequently derived from natural and synthesis sources, few of these compounds become drug substances, and even fewer are developed into drug products. Among the many barriers separating Drug Substance from Drug Product, the inherent, undesirable physicochemical properties of many drug candidates rank as one of the industry’s most challenging obstacles. Successfully resolving this issue to bridge the gap between Drug Substance and Drug Product is one of J-Star Research’s specialties and greatest strengths.

With the ability to develop both Drug Substance and Drug product under the same umbrella, our team enjoys a synergism absent in most CROs. We enable the development of robust drug product processes to meet Quality Target Product Profile (QTPP) requirements by seamlessly combining expert drug substance crystal design with the rapid and simultaneous optimization of desirable drug product intermediate properties, including improved powder flowability, optimized shape and size, increased bulk density, enhanced solubility and dissolution rate, and improved bioavailability.

Normally this kind of work is conducted in the early formulation development stage, but J-Star can leverage its expertise in drug substance crystallization and modification to complete it earlier - even before preclinical study! Our ability to bridge the Drug Substance and Drug Product interface is a major competitive advantage, producing shorter development timelines and improved Drug Product ruggedness.