GMP Manufacturing

Polpharma Biologics manufactures biosimilar medicines for the rapidly growing EU, US and international markets. Over the last several years, we have expanded our capacity to include two cGMP facilities in Central Europe, each housing state-of-the-art equipment, leading-edge technology and highly-skilled personnel to ensure excellence across every aspect of our operations.

 

Leading the Way in Biosimilars

By recognizing the growing need for biopharmaceutical manufacturers with the comprehensive capabilities to bring these critical therapies to market and investing in the infrastructure to do so, Polpharma Biologics is at the forefront of the biosimilars movement. We look forward to continuing on our path as a market leader in the development of biopharmaceuticals to meet the growing global demand for biosimilars.


From Lab to Market

Polpharma Biologics is one of the only one-stop-shop biopharmaceutical manufacturers with the capacity to conduct large-scale production of biosimilars. All of our development and manufacturing activities are done in-house, which greatly reduces risk and increases efficiency. Technology is transferred seamlessly from process development to clinical manufacture using the same or comparable equipment, and we have the flexibility to make quick, contextual decisions that best support a viable commercial strategy. Following approval, we look to engage highly capable commercialization partners to help market the product.

Polpharma Biologics is one of the only one-stop-shop biopharmaceutical manufacturers with the capacity to conduct large-scale production of biosimilars.


Key Capabilities

  • End-to-end expertise, from clinical trial material to large volume commercial API manufacturing
  • Two state-of-the-art facilities in Gdańsk and Duchnice, Poland (Duchnice operational 2021, our CMO partner)
  • Modular, single-use technology for faster time to market and reduced capital spend
  • Flexible aseptic fill-finish of final drug product into vials, syringes and cartridges
  • Integrated primary and secondary packaging
SEE OUR FACILITIES

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