As oral solid dose (OSD) products become increasingly complex, drug developers face growing challenges related to formulation, manufacturing, scale-up, and commercialization. Highly potent APIs (HPAPIs), controlled substances, poorly soluble compounds, and advanced formulation technologies require specialized expertise, manufacturing capabilities, and integrated development strategies to establish scalable processes and reduce manufacturing risk.
Manufacturing risk in complex OSD programs rarely results from a single challenge. Instead, it often emerges through the interaction of formulation complexity, process development, scale-up, technology transfer, and commercialization. As regulatory expectations increase and timelines become more demanding, drug developers must proactively address these risks to support robust, reproducible manufacturing processes throughout the product lifecycle.
This white paper examines the technical and operational considerations associated with manufacturing complex oral solid dose products. It explores challenges related to HPAPIs, controlled substances, solubility enhancement techniques, and advanced formulation technologies, while outlining the specialized capabilities that support scalable development, efficient technology transfer, and commercial manufacturing.
Readers will also learn how Bora Pharmaceuticals supports complex oral solid dose programs through integrated development and manufacturing capabilities at its Maple Grove, Minnesota facility. From advanced formulation technologies and scalable equipment platforms to HPAPI containment, controlled substance expertise, solvent handling capabilities, and cross-functional technical support, the paper highlights the capabilities Bora provides to help support complex OSD development and manufacturing.
