Fill & Finish

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

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

Filling area:

  • Inside filling machine class A in open active RABS with surrounding class B
  • OPTIMA Multi-Use L line.
  • SU Technology designed to mimize 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

  • Fully-automatic loading/unloading system
  • 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 2 Inspection Booths

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.

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

Analytical Development & QC Services

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