Fill & Finish of Biopharmaceuticals
At the Boehringer Ingelheim Biopharmaceutical Operations in Biberach, Germany we can supply liquid or lyophilized preparations in vials and pre-filled syringes. We provide the entire manufacturing chain like filling, lyophilisation, visual inspection, labelling and packaging.
An increasing number of products in processing
Since 1986 we have a constantly increasing number of products that are processed in our facility in Biberach. Several of the world's top twenty biopharmaceuticals have been developed and are being produced at this site.
Capabilities
- Four aseptic filling lines (FDA-approved)
- Four Freeze dryers
- Lot size 2.500 - 100.000
- Automatic and manual visual inspection
- Semi-automated packaging
- Automated top loading cartoone type Dividella
Pre-filled syringes
In a move to improve the one-stop shop service for clients, we develop liquid formulations for stable biopharmaceuticals in pre-filled syringes. Stability batches and clinical samples are manufactured in accordance with cGMP requirements on a pilot-scale syringe filler. Glass or plastic syringes are filled at production level under state-of-the-art conditions within a restricted access barrier system (RABS). The facility is approved by the U.S. Food andl Drug Administration (FDA) and the Japanese Ministry of Health, Labour and Welfare (MHLW ) and has the capacity to prepare 25 million syringes per year.
Inhalative dosage forms
With two inhalation devices, Respimat® and Handihaler®, Boehringer Ingelheim has proprietary devices for pulmonary administration of biopharmaceuticals in liquid as well as in solid preparations. The Respimat® is a highly innovative pocket-size device, which produces a standing cloud and achieves high lung depositions. The powder inhaler Handihaler®, likewise pocket-size, can deliver up to 50 mg of powder. This system is particularly suitable for high doses or active substances not sufficiently stable in solution.
