Sandoz Manufacturing

Sandoz Manufacturing

Sandoz: Over 35 years of biomanufacturing experience1

sandoz-biosimilars manufacture
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Sandoz biosimilars and novel biologics share identical manufacturing standards2

Sandoz biosimilars are manufactured using the same state-of-the-art biological production technologies and quality standards as novel biologics.3 Biosimilar production is carried out on a clinical and commercial scale, using both microbial and cell-culture technologies.4

  • Each part of the manufacturing process is optimized in repeating steps until it is capable of producing the same molecular structure as the originator product.5
  • This rigorous and comprehensive approach to establishing comparability results in the production of biosimilars that are highly similar in potency, safety, and purity, compared with their reference biologics.3
  • Sandoz biosimilar production takes place at clinical- and commercial-scale state-of-the-art facilities: Kundl and Schaftenau in Austria and Menges in Slovenia.4,6,7

References: 1. BioProcess International. A decade of microbial fermentation. http://www.bioprocessintl.com/upstream-processing/fermentation/a-decade-of-microbial-fermentation-331179. Published June 1, 2012. Accessed September 7, 2016. 2. Data on File. Manufacturing Manual Version 2.0. Sandoz Inc. Princeton, NJ. 3. McCamish M, Woollett G. The state of the art in the development of biosimilars. Clin Pharmacol Ther. 2012;91:405-417. 4. Data on file. S-XBP-1335749. Sandoz Inc. Princeton, NJ. 5. McCamish M, Woollett G. Worldwide experience with biosimilar development. mAbs. 2011;3(2):209-217. doi:10.4161/mabs.3.2.15005. 6. ICIS. Contract biopharm manufacturing stays robust. http://www.icis.com/resources/news/2004/01/16/549775/contract-biopharm-manufacturing-stays-robust/. Published January 16, 2004. Accessed September 7, 2016. 7. Sandoz.com. Sandoz Inaugurates BioInject – a new state-of-the-art biopharmaceutical manufacturing facility in Schaftenau, Austria. https://www.sandoz.com/news/media-releases/sandoz-inaugurates-bioinject-new-state-art-biopharmaceutical-manufacturing. Published September 17, 2015. Accessed October 10, 2016.