Manufacturing and expanding access to high-quality, more affordable biologics is critical to realizing Sandoz purpose to pioneer access for patients. Our expertise is grounded in more than 70 years of experience and we build on this every day by continually investing in the tools and infrastructure necessary to support quality and excellence in our biosimilar medicines.
Sandoz biosimilars and novel biologics share identical manufacturing standards.1
Sandoz biosimilars are manufactured using the same state-of-the-art biological production technologies and quality standards as novel biologics.2
Biosimilar production is carried out on a clinical and commercial scale, using both microbial and cell-culture technologies.3
Each part of the manufacturing process is optimized so that it is capable of producing the same molecular structure as the originator product.4
This rigorous and comprehensive approach establishes comparability results in the production of biosimilars that are highly similar in potency, safety and purity, compared with their reference biologics.2
Sandoz biosimilar production takes place at clinical- and commercial-scale state-of-the-art facilities: Kundl and Schaftenau in Austria and Menges in Slovenia.3,5,6
References: 1. Data on File. Manufacturing Manual version 2.0. Sandoz Inc. Princeton, NJ. 2. McCamish M, Woollett G. The state of the art in the development of biosimilars. Clin Pharmacol Ther. 2012;91:405-417. 3. Data on file. S-XBP-1335749. Sandoz Inc. Princeton, NJ. 4. McCamish M, Woollett G. Worldwide experience with biosimilar development. mAbs. 2011;3(2):209-217. doi:10.4161/mabs.3.2.15005. 5. ICIS. Contract biopharm manufacturing stays robust. http://www.icis.com/resources/news/2004/01/16/549775/contract-biopharmma.... Published January 16, 2004. Accessed October 7, 2020. 6. Sandoz. Sandoz Inaugurates BioInject – a new state-of-the-art biopharmaceutical manufacturing facility in Schaftenau, Austria. Published September 17, 2015. Accessed October 7, 2020