Process Effects on Drug Product Quality in Pharmaceutical Manufacturing:A Validated Measurement Process

摘要

Pharmaceutical manufacturing is an industry laden with many challenges and risks because of the life-changing nature of its products — drugs that can affect millions of human lives. Manufacturers perform immensely complex research and testing daily while facing economic challenges and regulatory requirements. This article covers the benefits of surface plasmon resonance (SPR) in the drug development pipeline and describes a recent validation guide specifically for the implementation of SPR technology in regulated workflows.