Contract Development & Manufacturing

OVERVIEW

Polpharma Biologics is a fully integrated biopharmaceutical CDMO – offering the complete spectrum of services from cell line generation to drug substance and drug product development and manufacturing.

 

Continued Investment

By continuously investing in state-of-the-art infrastructure and personnel, we achieve and maintain the highest level of quality while securing competitive prices for our customers.

Our offerings are tailor-made for companies around the world seeking to develop either innovative biologics or biosimilars.

Flexibility and speed are integral components of our modular one-stop-shop. We provide our clients with what they need, when they need it.


State-of-the-Art Facilities

  1. Utrecht, Netherlands
    Cell Line Development
    Center of excellence for the development of mammalian cell lines for monoclonal antibodies (MAbs) and other therapeutic proteins with a strong focus on CQA modulation and titer optimization.
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  2. Gdańsk, Poland
    Development & GMP Manufacturing
    Our integrated biopharmaceutical development and GMP drug substance manufacturing facility in Gdańsk is one of the most modern in Europe, employing both microbial and mammalian systems, as well as aseptic fill & finish of final drug product. We use high-throughput process development technologies and modular, single-use cGMP manufacturing.
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  3. Duchnice, Poland (Polpharma Biologics’ CMO partner)
    Large scale facility for drug substance manufacturing and sterile fill & finish
    To serve the growing global demand for biopharmaceuticals, we have included into our network the new Polpharma’s commercial-scale GMP production facility for drug substance manufacturing and aseptic fill & finish.
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At Polpharma Biologics, we are eager to support your next biopharmaceutical project with our integrated development and large-scale production capabilities.

HOW CAN WE HELP?

Whether you are looking to advance a biosimilar program, work on innovative molecules or learn more about our capabilities, we look forward to hearing from you.

CDMO

Drug Substance

Our drug substance process development and manufacturing services are fully integrated across our site network for seamless process transfer, scale-up and end-to-end supply chain efficiency.

CDMO

Drug Product

We provide comprehensive drug product support, from formulation and filling process development to lab- and commercial-scale production. We offer sterile fill & finish of vials, pre-filled syringes and cartridges as well as lyophilization.

CDMO

Quality

Quality, safety and efficacy are adamant fundamentals of our business. Discover how we work towards the highest quality aspirations and review our manufacturing certificates and inspection history.

CDMO

Regulatory

We provide regulatory CMC support to our global customers.

INTEGRATED CAPABILITIES

In addition to the CDMO services we offer customers, we have our own proprietary pipeline of biosimilars, and we are leveraging this experience to develop innovative NBEs.

Biosimilars

Leveraging our expertise in mammalian cell culture and microbial production, Polpharma Biologics develops biosimilars, with a pipeline of six products. We welcome inquiries around partnering and co-development.

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Novel Biologics 2

As part of our commitment to improving human lives by providing high-quality biologics, we develop next-generation biotherapeutics, including novel antibodies. Starting at discovery, we advance these therapies into clinical studies and look to engage collaborative partners for their full clinical development.

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