Strategies for successful manufacturing of highly potent oral solids

September 26, 2025

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The article discusses essential strategies for manufacturing highly potent oral solids (HPAPIs) and offers guidance for sponsors evaluating Contract Development and Manufacturing Organizations (CDMOs). It emphasizes stringent containment and safety protocols, noting that both occupational exposure limits (OELs) and meticulous regulatory alignment are fundamental for safe HPAPI handling. Key manufacturing recommendations include use of roller compaction (dry granulation) to improve powder flow, minimize airborne contamination, and support scalable production via geometrically scalable equipment trains. The importance of cross-functional collaboration—spanning formulation, analytical, manufacturing, and quality assurance teams—is underscored to ensure consistent execution and control through scale-up phases. Finally, choosing CDMOs with both scalable facilities and proven capability in HPAPI manufacturing helps sponsors meet regulatory requirements and maintain product integrity across clinical and commercial supply chains