Drug product
manufacturing

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.