Latest Strategies For Ensuring Robust QC Processes During Manufacturing And Scaling
26 Jun 2025
CMC & Process Development
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Aligning analytical workflows with FDA/EMA requirements, ensuring robust impurity profiling, and validating methods for large-scale manufacturing
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Leveraging HRMS, HPLC, and automation to enhance detection of impurities, degradation products, and truncated sequences
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Establishing consistent, reproducible QC processes across internal teams and CDMOs to ensure compliance and scalability