Biosimilar manufacturing

Extensive manufacturing facilities for clinical and commercial supply of microbial and mammalian biosimilars

Our manufacturing capabilities cross two sites and fuel our biosimilar pipeline. We provide maximum flexibility, scalability and efficiency to produce drug substance and drug product for pre-clinical, clinical and commercial supply.

Manufacturing capabilities

We have built a modern and fully integrated environment for the development, production and fill-finish of both mammalian and microbial biosimilars.

Our manufacturing team has decades of international experience and a proven track record in biologics development, clinical and commercial production, registration and commercialization. All our activities are supported by our Quality Control and Quality Assurance department.

Mammalian manufacturing capacity

Our mammalian manufacturing capacity is across two of our cGMP facilities in Europe. Both facilities use single use 50 – 2000 L scale bioreactors. Our significant drug substance manufacturing capacity is available for preclinical, clinical and commercial supply.

This includes a range of smaller single use bioreactors from 50-500 L aimed at supporting smaller capacity needs. This means we can support smaller clinical trial material at optimal costs.

Gdańsk

Our Gdansk site includes mammalian and microbial R&D and manufacturing facilities for mid-scale production including drug product and fill finish.

2 x 50 L SUB
1 x 250 L SUB
2 x 1000L SUB

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Warsaw

Our Warsaw site is one of the largest biologics manufacturing sites in Europe, with capabilities for preclinical, clinical and commercial supply to EU and US standards.

2 x 50 L SUB
4 x 500 L SUB
4 x 2000 L SUB

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Microbial manufacturing facilities

We have built a modern and fully integrated environment for the development and production of biosimilars medicines using microbial expression systems. Our microbial facilities are based at out Gdansk site and include:

Physically separate microbial production suite operated by dedicated staff
cGMP fermentation scale of 500 L/batch (nominal volume) for clinical and commercial supply
Upstream process including primary recovery in stainless steel technology
Downstream process in single-use technology for fast changeover and zero cross-contamination risk

Drug product and fill finish capabilities:

For our biosimilars we also complete drug product development and cGMP manufacturing of sterile biologicals in liquid and lyophilized forms at lab and large-scale. Our fill finish facility supports vials, cartridges and syringes up to 60 pieces a minute.

We have rapid and highly automated formulation development
Drug product pooling with a range of volume from 4 L up to 200 L with local LAF
Mixers and jacket cooling available for 50 L up to 200 L batches
Filling area for syringes, vials and cartridges upto 60pcs/min
Freeze drying with a 6.77m2 usable area upto 28,400 vials a batch

Press Releases published: 21.02.2024

Polpharma Biologics’ investigational biosimilar shows PK/PD comparability to inflammato...

Polpharma Biologics, an international biotech company dedicated to the development and manufacturing of biosimilars,...

Articles published: 25.08.2023

Polpharma Biologics announces FDA approval of Tyruko® - first and only approved biosimi...

Polpharma Biologics, an international biotech company dedicated to the development and manufacture of biosimilars, an...

Press Releases published: 24.07.2023

Polpharma Biologics announces first-of-a-kind multiple sclerosis biosimilar natalizumab...

Polpharma Biologics today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Me...

Press Releases published: 29.08.2022

European Commission approves FYB201/Ranivisio^®1 (Ranivisio - Ranibizumab), a...

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Press Releases published: 25.07.2022

Polpharma Biologics announces FDA file acceptance for review of natalizumab, first pro...

Polpharma Biologics announced today that the U.S. Food and Drug Administration (FDA) has accepted the first-ever Biol...

Press Releases published: 14.07.2022

Polpharma Biologics announces EMA acceptance of Marketing Authorization Application for...

European Medicines Agency (EMA) has accepted the first-ever Marketing Authorization Application (MAA) for biosimilar...

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Let’s collaborate and deliver quality biosimilars together.

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