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:
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.
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
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.
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.