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Latest Strategies For Ensuring Robust QC Processes During Manufacturing And Scaling

26 Jun 2025
CMC & Process Development
  • Aligning analytical workflows with FDA/EMA requirements, ensuring robust impurity profiling, and validating methods for large-scale manufacturing

  • Leveraging HRMS, HPLC, and automation to enhance detection of impurities, degradation products, and truncated sequences

  • Establishing consistent, reproducible QC processes across internal teams and CDMOs to ensure compliance and scalability

Industry Expert
Phillip Ross, Senior Director, Analytical Development, Quality Control, CMC - Wave Life Sciences