Privigen® Production Capacity Will Soon Double at CSL Behring’s Manufacturing Plant in Bern
Repurposed from CSL Behring’s employee magazine Global Insight.
In March 2009, CSL Behring's state-of-the-art manufacturing plant in Bern was approved by the U.S. Food and Drug Administration (FDA) for the production of Privigen®. Once the fully operational plant is ready, CSL’s Privigen-producing capacity is expected to double to meet the increasing demand worldwide. The Bern plant is expected to be fully operational by summer of 2011.
Privigen is an intravenous immunoglobulin (IVIg) for treating patients diagnosed with primary immunodeficiency (PI). Privigen is also indicated for the treatment of chronic immune thrombocytopenic purpura (ITP) to rapidly raise platelet counts to prevent bleeding. Privigen offers healthcare professionals convenience and ease-of-use. It is the first and only proline-stabilized IVIg that is always ready for immediate use, requiring no refrigeration or reconstitution.
The Bern manufacturing facility will include two identical independent production facilities using the same clean rooms. The clean rooms are special areas where conditions such as temperature, humidity and pressure are controlled and maintained.
Equipment testing qualification activities are currently underway at the Bern site. This phase will continue until February 2010 and be followed by validation activities. These activities are scheduled for completion by the end of September 2010 along with the preparation of the qualification and validation reports. A submission to the FDA for authorization is planned for spring of 2011.
CSL Behring’s substantial investment in the Bern facility was commended by the Swiss government. As the recipient of a
Tell Award, CSL Behring was recognized for making Switzerland’s most significant innovative technology investment in 2008.