Biosimilar clinical and commercial manufacturing

Polpharma Biologics provides flexible development and manufacturing solutions to provide material for your biosimilar clinical trials and commercial supply. The way we have designed our facilities provides maximum flexibility, scalability and efficiency.

Biosimilar mammalian manufacturing capabilities

Our biosimilar mammalian manufacturing is available across our two cGMP manufacturing facilities in Europe. Both facilities use the latest single use 50 – 2000 L scale bioreactors.

Our significant biosimilar drug substance manufacturing capacity is available for preclinical, clinical and commercial supply and also includes a range of smaller single use bioreactors from 50-500 L aimed at supporting clients with smaller capacity needs. This means we can support the increasing demand for early stage biosimilar clinical trial material at optimal costs.

Capacities

Small to mid-scale
- Multiple rocker bioreactors
- Multiple 50 L SUBs
- 1 x 250 L SUB
- 3 x 500 L SUBs
Large scale manufacturing
- 2 x 1000 L SUBs
- 4 x 2000 L SUBs
Expansion available to 30,000 L

Biosimilar microbial manufacturing capabilities

Our biosimilar microbial facilities are physically separated and operated by dedicated staff with fed batch fermentation available up to 500 L/batch (nominal volume) for preclinical, clinical and commercial supply. The upstream process includes primary recovery in stainless steel technology and the downstream process is done in single-use technology for fast changeover and zero cross-contamination risk.

Capacities

1 x 50 L Stainless Steel
1 x 500 L Stainless Steel

Biosimilar drug product manufacturing and fill finish

We also provide integrated drug product development, manufacturing and fill finish of sterile biologics in liquid and lyophilized forms for biosimilars at lab and large-scale. Find out more about our full range of drug product solutions.

Working with our biosimilar manufacturing group

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

Our extensive capacity means we can transfer in external processes or continue with integrated biosimilar projects. We understand that we are delivering material for pre-clinical, clinical trials and for patients in urgent need of treatment, we always endeavor to get your biosimilar to where it needs to be.