Biosimilars
Biosimilars are biotechnologically produced drugs that are highly similar to already approved biological reference products. They exhibit no clinically significant differences in efficacy, safety, or quality but undergo their own approval process, which requires extensive comparative studies.
Since biological medicines are derived from living cells, biosimilars are more complex than conventional generics of chemically synthesized substances. Their development and production demand state-of-the-art biotechnological methods and strict regulatory controls.
Biosimilars contribute to a more cost-effective healthcare system by offering an equivalent therapeutic alternative once the patent of the original product expires. They are primarily used in the treatment of chronic diseases such as cancer, autoimmune disorders, and diabetes.
These drugs often have special requirements in terms of product preparation, filling and processing, as well as storage and transport conditions, as they are more sensitive than chemical drugs .
Our systems offer the highest level of In-Process-Controls (IPC) for precisely this purpose, in order to protect the drugs during production and minimise product loss in the various process phases.
Only state-of-the-art, Annex 1-compliant machines and systems from renowned manufacturers such as SKAN, Groninger, Martin Christ, Fedegari and Koerber Pharma are installed.
With the Robocell filling system from Groninger and SKAN, we can fill batch sizes of up to 100 liters. We offer maximum flexibility in processing ready-to-use syringes up to 10 ml, vials up to 50 ml, and cartridges up to 3 ml in glass or polymer, while ensuring minimal product losses with 100 % check weight control.
With the Groninger Flexfill filling system, we can fill batch sizes of up to 600 liters. We offer maximum flexibility in processing ready-to-use syringes up to 50 ml, vials up to 100 ml, and cartridges up to 3 ml in glass or polymer. This line is equipped with peristalitc and rotary piston pumps and various gassing and vacuum options.
