Analytical development & QC services

Polpharma Biologics method development, qualification and validation for late stage development define the robust control strategy required to manufacture and commercialize biologic molecules.

Aggregation and particle characterization:

  • HIAC for pharmacopoeial measurements
  • MFI for particles counting and imaging
  • Nephelometer for turbidity measurement
  • DLS and SEC-UPLC for aggregation determination
  • Other capabilities:
  • Rheometer and mVROC for rheological properties determination
  • Visual inspection station
  • Container closure integrity determination by dye ingress test
  • Stability chambers
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