Analytical development & QC services

Fill & finish of vials, pre-filled syringes and cartridges deploying single-use technology

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

Analytical Development & QC Services

We run multiparametric experiments in parallel using ambr® high-throughput systems to optimize media and culture conditions for scalability. Required USP process characterization is performed based on qualified scale-down models and is supported by high-throughput analytical instrumentation.

  • 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

Working with our fill finish team

“We are committed to positive outcomes and delivering projects on time to specification”

We can support any projects fill finish requirements and utilize our know-how, state-of-the-art equipment and proprietary technologies to deliver. We understand that we are delivering products for clinical and commercial supply and we always endeavor to get your product to patients, on time.

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Let’s collaborate and create quality biologics together.

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