Why more pharma companies outsource intermediate manufacturing is no longer just a cost question. Based on real project experience, this article explains how outsourcing intermediates helps drug developers improve speed, manage impurity risk, and maintain regulatory control while focusing on core innovation.

This article shares practical, field-based experience on designing robust analytical methods for complex intermediates, focusing on impurity identification, method robustness, and regulatory expectations.

The Rise of High-Potency Intermediates highlights a fundamental shift in pharmaceutical manufacturing, where potency-related risks emerge early at the intermediate stage. As oncology and targeted therapies expand, manufacturers must integrate exposure control, impurity strategy, and scalable process design to ensure compliance, safety, and long-term supply reliability.