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news.Bayer HealthCare has announced that the European Medicines Agency has granted license approval to the company for its new sterile filling facility on its Berkeley, California campus. The approval closely follows authorization already given by the FDA in August 2008, said Bayer.
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Together, these licenses from the regulatory bodies ensure this facility is ready to support the supply of Bayer’s Kogenate FS/ Kogenate Bayer (antihemophilic factor [recombinant]) line of products in its largest markets, the US and EU, said Bayer.
The forward-looking technology and design of the new sterile filling facility (SFF) represent a key investment by the company in further strengthening its bio-manufacturing operations on the west coast of the US, added Bayer. The facility will be utilized in the late-stage production processes of filling and lyophilization for Bayer’s Kogenate FS/ Kogenate Bayer line of products, a treatment for hemophilia A.
The 44,000sqft SFF significantly increases the product output, or capacity, and supports larger lot sizes, according to Bayer. It also features a new automated loading and unloading system. The high level of automation within the facility further minimizes the risk of external contamination and provides even greater assurance of product quality, as it requires fewer personnel to operate, said Bayer. This capacity increase, product reproducibility and reliability will reportedly support the Kogenate product line’s significant growth in several emerging markets.
Joerg Heidrich, senior vice president of Bayer HealthCare, said: “These regulatory approvals for the Berkeley SFF represent a significant milestone for us and come at an opportune time given the continued expansion of the Kogenate product line in existing and new markets around the world.”