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
HOW CAN WE HELP?

Whether you are looking to advance a biosimilar program, work on innovative molecules or learn more about our capabilities, we look forward to hearing from you.

CMO

Formulation Development

Whilst applying a broad array of high-throughput technologies, we provide rapid formulation development accompanied by simultaneous real-time and accelerated stability testing according to ICH standards.

CMO

Drug Product Manufacturing

We provide a full range of contract biomanufacturing services for mammalian and microbial biosimilar and innovative molecules.

CMO

Fill & Finish

We operate a state-of-the-art biopharmaceutical cGMP fill & finish plant in Europe. The facility is equipped with disposable liquid filling technologies and lyophilization capabilities.