A REVIEW ON THE APPLICATION OF QUALITY BY DESIGN IN THE FORMULATION AND MANUFACTURING OF ANTI-CANCER PHARMACEUTICALS

Abstract

The formulation and manufacturing of anti-cancer pharmaceuticals present unique scientific and regulatory challenges due to the complex nature of oncology therapies, their narrow therapeutic indices, and the critical need for product consistency and safety. QbD (Quality by Design) offers a robust, systemic, and risk-based framework that integrates product and process understanding from early development to commercial production. The paper begins by outlining the fundamental elements of QbD, including the establishment of a Quality Target Product Profile (QTPP), identification of critical quality attributes (CQA’s), Critical Material Attributes (CMAs), and Critical Process Parameters (CPPs), as well as the implementation of Design of Experiments (DoE), risk assessment tools and control strategies.

Case studies from recent literature highlight the successful implementation of QbD tools in liposomal doxorubicin, paclitaxel nanoparticles. This review reinforces the role of QbD as a transformative paradigm in oncology drug development, offering a robust platform for improving product efficacy, safety, manufacturing efficiency, and regulatory flexibility.