Fill and Finish of Biopharmaceuticals

Boehringer Ingelheim BioXcellence™ offers its customers the entire drug product manufacturing chain comprising filling, lyophilisation, visual inspection, labeling and packaging. Within our global manufacturing network we can supply different dosage forms such as liquid or lyophilized preparations in vials and technically more complex dosage forms such as prefilled syringes and double-chamber cartridges. We have recently installed a new combined line for mono- and dual-chamber cartridges with a state-of-the-art isolator technique. Products of the different dosage forms manufactured on our modern filling lines are approved by the European EMA, the U.S. Food and Drug Administration (FDA), the Japanese Ministry of Health, Labour and Welfare (MHLW) and many other authorities.

• Five aseptic filling suites.
  
• Filling volume is flexible between 0.5 mL to 100 mL for vials, 0.5 mL to 10 mL for glass or plastic syringes, and 0.5 mL to 3 mL for single-chamber cartridges. For double chamber cartridges the volumes range from 2 x 1 mL or 2 x 1.5 mL up to a format of 2.0 x 5.3 mL.
  
• Six freeze-drier capacities are available (1 x 7 m², 3 x 22 m², 2 x 26 m²).
• Visual inspection is performed as a 100% control.
• Inspection process includes camera and manual control for vials and syringes.
• Facility concepts allow for high flexibility and a broad product spectrum.
• Special features are the electronic batch record and the barcode-controlled application of material and equipment.
• Lot sizes ranging from 3,000 – 150,000.
• Semi-automated secondary packaging.