Mammalian biologics manufacturing

Single use cGMP manufacturing for clinical and commercial supply

Polpharma Biologics provides flexible development and manufacturing solutions to fuel today’s biopharma 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 and production of mammalian biologics. Through working on our own pipeline, we have gained invaluable expertise, insights and experience.

Polpharma Biologics is led by a team with 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.

Manufacturing capacity

Our mammalian manufacturing capacity is available across two of our cGMP facilities in Europe. Both facilities use the latest 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 clients with smaller capacity needs. This means we can support the increasing demand for early stage clinical trial material and orphan drugs 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. Our mammalian capacity includes:

  • 1 x 50 L SUB
  • 1 x 250 L SUB
  • 2 x 1,000 L 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 including:

  • 3 x 500 L SUB
  • 4 x 2,000 L SUB
  • Expansion available to 30,000 L
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Drug product and fill finish

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

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Working with our 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 projects we have performed process development for. Either way we understand that we are delivering material for pre-clinical and clinical trials and we always endeavor to get your product to patients.

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Let’s collaborate and create quality biologics together.

Get in touch for more information.