CMO

Polpharma Biologics provides drug product development and cGMP manufacturing of sterile biologicals in liquid and lyophilized forms at lab and large-scale.

Our deep understanding of the nature of large molecules derived from our drug substance development activities serves as the basis for an efficient formulation and fill & finish process development. This synergistic approach enables us to provide targeted and rapid drug product development.

Drug Product and Fill Finish Capabilities:

Formulation Development
Whilst applying a broad array of high-throughput technologies, we provide rapid formulation development accompanied by simultaneous real-time and accelerated stability testing according to ICH standards.
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Drug Product Manufacturing
We operate a state-of-the-art biopharmaceutical drug product manufacturing plant in Europe. The facility works with a range of volumes from 4 L up to 200 L with local LAF
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Fill Finish
We operate a state-of-the-art biopharmaceutical cGMP fill & finish plant in Europe. The facility is equipped with disposable liquid filling technologies and lyophilization capabilities, and is run by highly qualified and experienced personnel.
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Analytical Development & QC Services
We utilize a number of advanced techniques to quickly establish processes that will yield the optimal outcome at the highest level of efficiency. We apply quality-by-design (QbD) principles to guarantee the quality, safety and efficacy of your products.
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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.

CMO Drug Product Solutions

Polpharma Biologics provides drug product development and cGMP manufacturing of sterile biologicals in liquid and lyophilized forms at lab and large-scale.