Biosimilars – Injectables in Vials, pre-fillable Syringes (PFS) and Cartridges
A biosimilar is a biological medicine highly similar to an already approved reference product. It contains the same active ingredient, such as a monoclonal antibody or protein, and aims to deliver the same efficacy, safety, and quality. Due to their complexity, biologics cannot be exactly copied, so biosimilars undergo extensive testing of structure, function, efficacy, safety, and immune response. They provide cost-effective alternatives to established biologics.
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.
Our biosimilar processes include:
- Storage of APIs at −80 °C
- Controlled thawing with HOF thawing units
- Single-use compounding systems up to 100 L
- Sterile filtration and use of pre-sterilized filters and tubing (PUPSIT tested)
- Compatible with PFS syringes, vials, or cartridges
- Filling in a Class A sterile cleanroom using Groninger technology with:
– Product priming at beginning of batch
– 100% check weight control with re-dosing
– Fully automated, monitored movements, no manual handling - Visual inspection and packaging
- Cold storage and GDP-compliant transport at 2–8 °C
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.
