Drug Product Manufacturing

State-of-the-art biologics drug product manufacturing for clinical and commercial supply

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. A seamless transition into cGMP production is supported by close alignment and anticipation of commercial-scale requirements during both incoming process transfers and in-house scale-up.

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

Manufacturing with us

Our extensive capacity means we can transfer in external processes or work with existing partners. Either way we understand that we are delivering material for clinical and commercial trials and we always endeavor to deliver your product, on time.

SEE OUR FACILITIES

Polpharma Biologics operates three integrated facilities across Central Europe. Learn more about our specific capabilities by location.

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

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.

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.