Drug product

Clinical and commercial supply

Polpharma Biologics operates a state-of-the-art biopharmaceutical cGMP drug product manufacturing and fill finish plant. The facility is equipped with disposable liquid filling technologies and lyophilization capabilities, and is run by highly qualified and experienced personnel.

Drug product pooling area:

  • Class C room/working with a range of volume from 4 L up to 200 L with local LAF
  • Bioburden reduction filtration
  • Class A redundant sterile filtration
  • SU technology to transfer product to filling line
  • Mixers and jacket cooling available for 50 L up to 200 L batches

Filling area:

  • Inside filling machine class A in open active RABS with surrounding class B
  • OPTIMA Multi-Use L line.
  • SU technology designed to minimize dead volumes
  • Sterile redundant filtration
  • Syringes from 0.5 ml up to 10 ml
  • Vials 2R up to 30R
  • Cartridges: up to 10ml
  • Up to 60 pcs/min; 2-headed

Freeze drying area:

  • 8 shelves (920 mm x 920 mm) with a 6.77 m2 usable area
  • 2R approx. 28,400 vials / batch, 3,550 vials per shelf
  • 15R approx. 12,700 vials / batch, 1,590 vials per shelf
  • 20R approx. 8,000 vials / batch, 1,000 vials per shelf
  • Inspection area:

    • Manual inspection will be performed on all filled containers, performed in dedicated CNC class area using two inspection booths

Working with our drug product team

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

We can support a variety of drug product manufacturing requirements and utilize our know-how, state-of-the-art equipment and proprietary technologies to deliver products for clinical and commercial supply. We always endeavour to get your product to patients, on time, to the highest quality.

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Related material

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