Optimizing Highly Potent API Drug Development And Manufacturing

The development and manufacturing of highly potent active pharmaceutical ingredients (HPAPIs) present unique challenges that require specialized expertise, advanced containment strategies, and a deep understanding of regulatory requirements. As the pharmaceutical industry increasingly focuses on targeted therapies and low-dose formulations, companies must adopt innovative approaches to ensure safety, efficacy, and scalability.

This eBook explores key aspects of HPAPI drug development, from classification and risk assessment to containment technologies and outsourcing strategies. It highlights the latest trends in oral solid dosage (OSD) manufacturing and discusses how contract development and manufacturing organizations (CDMOs) can support successful formulation and production. Through expert insights and real-world case studies, this resource provides valuable perspectives on optimizing HPAPI workflows, ensuring compliance, and leveraging process advancements. Whether navigating early-phase development or scaling up for commercialization, this guide offers a comprehensive look at the evolving landscape of HPAPI drug manufacturing.