Commercial Plant in Uppsala
Fresenius Kabi Uppsala is one of the most modern facilities in the world for the fill & finish of sterile products and specialized in manufacturing and processing emulsions. Starting off in a truly state-of-the-art formulation department that can accommodate small to very large batch sizes, the various ingredients undergo a sequence of process steps that will eventually turn into a stable emulsion filled in ampoules, vials or bags and ready to be transported to any location in the world.
The plant is certified under the ISO 9001:2008 standard and has been inspected by various medical authorities including the Swedish Medical Products Agency and US FDA. The plant passed its first US FDA inspection in 2001, and since then it has been supplying pharmaceutical products to worldwide markets such as Europe and RoW, US, Canada, China, Australia and Japan.
Pilot Plant in Uppsala
The Pilot Plant of Fresenius Kabi Sweden in Uppsala offers expertise in manufacturing clinical batches of sterile pharmaceuticals. Due to the regulatory approval by major authorities (FDA & EMEA), the Pilot Plant Uppsala has become an important manufacturing site for global clinical studies. The flexible setup of the compounding and filling line allows manufacturing of various sterile pharmaceuticals in a range of container closure systems meeting the demands during the clinical trial phases II/III. The Pilot Plant in Uppsala, Sweden and its affiliated analytical laboratory are co-located with the commercial plant in Uppsala. While using synergies with the commercial plant, such as common supply for hot purified water and nitrogen, the Pilot Plant Uppsala offers a higher degree of flexibility for manufacturing GMP batches due to a more manual setup than our highly automated commercial plants. This flexibility enables us to fill multiple container closure systems from a single bulk solution for testing multiple containers during the clinical phase, while saving costs and time for the clinical study. Besides manufacturing complex aqueous solutions, the Pilot Plant is also equipped with various homogenizers for manufacturing emulsions up to 2000 L. A team of highly trained engineers and scientists offers their services to implement your product in the Pilot Plant and also supports with the scale-up starting with a lab-scale batch up to 2000L. Sophisticated developmental assays help us to optimize process parameters to guarantee a smooth scale-up and consistent product quality following the Quality by Design (QbD) guideline. Once the product successfully passed the clinical study, a dedicated project team will coordinate the transfer of the product to one of our commercial plants, taking advantage of the experience and knowledge of the manufacturing process gained during the clinical phase.
- Batch sizes up to 2000L
- Compounding of complex aqueous solutions and fat emulsions
- Infusion solutions
- Parenteral nutrition products