Contract Pharma speaks with Dr. Asma Patel, VP of Global and Scientific Consulting - Drug Product, about the best practices for solving complex formulation challenges.
As drug candidates become increasingly complex, formulation teams face growing challenges related to solubility, bioavailability, manufacturability, and scale-up. In a recent discussion with Contract Pharma, Dr. Asma Patel, Vice President, Global Commercial and Scientific Consulting, Drug Product at Quotient Sciences, highlights the importance of integrating formulation development, manufacturing, and clinical evaluation to reduce development risk.
According to Dr. Patel, successful formulation strategies are guided by early clinical insight rather than relying solely on laboratory-based predictions. "Addressing solubility and bioavailability challenges is most effective when formulation design is tightly coupled to in vivo performance," she explains. This approach enables sponsors to evaluate multiple formulation options, identify the most promising path forward, and build confidence in scale-up and commercialization plans.
How clinically-informed formulation development reduces risk
Dr. Patel also emphasized the value of combining clinically informed development with flexible manufacturing and emerging AI-enabled technologies. By generating data earlier and linking formulation decisions to clinical outcomes, developers can reduce uncertainty, minimize downstream rework, and create formulations that are scientifically robust, scalable, and commercially viable.
Complex small molecule formulations offer the potential for more targeted drug delivery, but challenges around solubility, bioavailability, scale-up, and manufacturability can slow development.