Developments In OSD Manufacturing: What Biotechs Need To Know

The manufacturing of oral solid dosage (OSD) forms has seen a "quiet revolution," with significant advancements in processes, technologies, and strategy despite the dosage form itself remaining unchanged. These innovations are crucial for overcoming persistent challenges in drug development, such as poor solubility and the safe handling of highly potent compounds (HPAPIs).

For biotech companies, these changes offer opportunities to accelerate timelines, reduce risk, and improve patient outcomes. Key developments include advanced formulation techniques—like spray drying and nano-milling—to enhance bioavailability for complex molecules. Containment strategies have evolved to safely handle HPAPIs through enhanced isolator technology and closed transfer systems. Furthermore, facilities are becoming more flexible with modular GMP suites, and digital transformation is driving quality control through process analytical technology (PAT) and real-time data capture. Understanding these shifts and aligning with manufacturing partners who possess the requisite expertise and infrastructure is essential for successful scale-up and regulatory compliance.