Challenges in qualification & management of raw materials in advanced therapy medicinal products

Abstract

Raw materials play a vitally important role in the manufacturing of advanced therapy medicinal products. The ability of raw materials to directly impact the safety, purity and efficacy of the final product has led to the requirement that advanced therapy medicinal product manufacturers control the quality of raw materials in their manufacturing processes. However, some challenges exist in the raw material qualification process specific to the management of biological-derived materials, raw material grades and labels, qualifying suppliers and establishing robust supply chains. Therefore, a risk-based strategy is commonly employed to address these challenges in the management of raw materials for advanced therapymedicinal products.