Bayer’s SFF gains EMEA approval

By Nick Taylor

- Last updated on GMT

Related tags: Food and drug administration, Bayer

Bayer HealthCare’s new sterile filling facility (SFF) has been granted license approval by the European Medicines Agency (EMEA).

The facility in Berkley, California has been built to meet the demand in Europe and the US for Kogenate (antihemophilic Factor [Recombinant]), Bayer’s treatment for haemophilia.

Covering 44,000 sq ft the facility increases Bayer’s production capacity, supports larger lot sizes and incorporates increased levels of automation.

Johannes Schweppenhaeuser, Director, Final Product Manufacturing, Bayer HealthCare Pharmaceuticals, said: “This facility is truly state-of-the-art and represents the latest, most reliable freeze-drying technology available, launching us ahead of other SFF facilities on the US West Coast​.

The high level of automation, in conjunction with Bayer’s rigorous process standards, results not only in higher output, but most importantly, further risk reduction​.”

A feature of the facility is the new automated loading and unloading system (ALUS), which Bayer claims reduces the risk of external contamination and provides assurance of product quality.

The plant was approved by the US Food and Drug Administration (FDA) in August, with authorisation from other countries including Canada said to be in the final stages.

Until these approvals are gained Kogenate products will continue to be manufactured at Bayer’s existing facility in Berkeley.

Expansion of haemophilia portfolio

Bayer is intending on expanding its haemophilia portfolio and currently has several products in its pipeline for treatment of the disease.

A formulation of Kogenate with liposomes is currently in Phase II, which only needs to be administered once a week. Bayer claims this is the only long-acting recombinant Factor VIII product in late-stage clinical trials.

Further down the pipeline Bayer is preparing Phase I clinical trials for its recombinant Factor VIIa, which is intended for use in the treatment of patients who develop inhibitors to FVIII and FIX.

Related topics: Ingredients

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