Patient safety is a primary concern when developing drugs. For biopharmaceuticals, one of the approaches to safeguard patient safety is to monitor and control critical quality attributes (CQAs) for a process. Two types of CQAs are host cell and process-related impurities. Host cell impurities (e.g. HCP, DNA) are automatically classified as critical quality attributes (CQAs) and levels are monitored. Process-related impurities are introduced by the upstream and downstream processes (e.g. cell culture medium, purification systems and buffer components). A streamlined risk-based approach has been designed to identify which process-related impurities are CQAs, based on potential impact on patient safety and assessment of the necessity to demonstrate clearance or control through the manufacturing process to levels below a determined Permitted Daily Exposure (PDE). These impurities are categorized as CQAs. It is recommended that this assessment be initially performed during early phases of clinical studies and updated at each clinical phase or whenever a change is made to the process. Information from these ongoing assessments supports regulatory submissions for clinical trials and the marketing application. In this presentation, a streamlined process for assessment will be discussed, with specific examples.

Process-related impurity assessments in downstream development: A streamlined life-cycle approach

2019 Spring National Meeting

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