Biosimilars manufacturing facility
Leading biopharmaceutical company Alvotech officially opened its new biosimilar facility in Iceland on 8 June 2016. The facility will be dedicated to the production of biosimilars of monoclonal antibodies (mAbs).
Alvotech broke ground on the industry-leading biologics manufacturing plant in November 2013, marking a significant milestone for the company.
The new manufacturing facility is located in the science park of the University of Iceland in Reykjavik. The location provides a favourable environment with strong regulatory system, low operating costs, and a skilled talent pool and high-quality standards for the operation.
The project has generated approximately 200 new jobs during construction and operation.
The state-of-the-art facility is spread over an area of 13,000m² (139,930ft²) for the development and manufacturing of biosimilar monoclonal antibodies, as well as 2,500m² (26,909ft²) of office space.
The vertically integrated biologics manufacturing plant includes fully automated vial and syringe filling capabilities and quality control labs.
The facility will employ the manufacturing process based on 1,000l and 2,000l single-use bioreactor fermentation design with a total capacity of 16,000l spread out in two independent upstream and downstream areas.
The manufacturing laboratories are built using world-class, scalable and cost-efficient manufacturing technologies through the Finesse turnkey SmartFactory GMP manufacturing platform suite, which includes automation platform and best of breed bio-manufacturing equipment from upstream through downstream.
The facility employs SmartFactory single-use CGMP manufacturing technology, which eliminates the risk of cross contamination in fermentation and ensures production of high-quality products.
The facility also includes high-yield fermentation and downstream process, aseptic filling and finishing lines for vials and prefilled syringes, cGMP manufacturing capacity for clinical and commercial-scale manufacturing with high-throughput research and development (R&D) capabilities.
The key feature of the facility is that it operates on clean renewable energy. The entire energy supply for the facility is derived from domestically produced geothermal and hydroelectric power.
Alvotech is a biopharmaceutical company involved in the development and manufacturing of biosimilars for the global markets. The company’s product portfolio includes molecules for treating conditions in the areas of oncology, respiratory, cardiology and gastroenterology.
Alvotech currently has six biosimilar monoclonal antibodies in its pipeline, which are being developed mainly to treat cancer, autoimmune disease, inflammatory diseases and other diseases. These products will be developed in its five R&D centres located in Germany, Switzerland and Malta, and manufactured at its headquarters in Iceland.
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