QC, QA & CMC

QC, QA & CMC

  • Developing and validating robust methods for product characterization, batch release, and stability studies
  • Real-time batch release tools for small batch sizes of therapeutic vaccines
  • Applying quality by design and statistical tools to expedite batch release
  • Implementing the appropriate process analytical technology and real-time monitoring to optimize process workflows while remaining cost effective
  • Multiplex assays for QA/QC of complex/combination vaccines
  • Will cell-based potency assays be replaced with newer technologies e.g., HPLC, LCMS, NGS?
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