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Alvotech prepares for commercial biosimilar production in new facility with single-use bioreactors in Reykjavik, Iceland.
Alvotech opened a new biologics manufacturing plant dedicated to the development and manufacturing of biosimilar monoclonal antibodies (mAbs), the company announced on June 8, 2016. The facility opening marks a significant milestone for Alvotech, an independent sister company of the global pharmaceuticals company Alvogen.
Alvotech worked with the US FDA and the European Medicine Agency to design and build the 13,000-m2 facility, which is located in the science park of the University of Iceland in Reykjavik. The manufacturing process is based on 1000-L and 2000-L single-use bioreactor fermentation design and has a total capacity of 16,000 L laid out in two independent up- and downstream areas. The facility also houses fully automated vial and syringe filling capabilities and quality control laboratories.
“We have 8000 L in place (four, 1000-L and two, 2000-L tanks) and are ramping up in the near future to keep up with demand,” says Eef Schimmelpennink, CEO of Alovtech. “Manufacturing for development and tech transfer has started, and commercial production will be in line with demand driven by loss of exclusivity of products in our portfolio.” Alvotech’s initial pipeline comprises six biosimilar mAbs which will be brought to market after patents expire.
The facility uses the SmartFactory platform from Finesse, a California-based manufacturer of measurement and control solutions for life-sciences process applications. The process control, batch automation, and data management platform features an open architecture with universal controllers. Process flow can be designed in a modular and scalable manner while maintaining quality and regulatory compliance in electronic batch records. The flexibility of the SmartFactory lets a user select the level of automation required for each unit operation. Users can also focus simultaneously on the compatibility of single-use materials between upstream and downstream for global process yield optimization, according to a Finesse press release.