Sandoz is one of the leading specialists in biotech development and manufacturing. Comprehensive know-how is based on more than wo decades in microbial and mammalian cell culture production at commercial scale. Today Sandoz offer a broad variety of integrated services including innovative expression systems, process development, scale-up, and production of recombinant products derived from microbial systems and mammalian cell culture in state-of-the-art facilities.
Our expertise is based on numerous projects successfully erformed in collaboration with our customers. Currently, Sandoz is manufacturing more than 25 different recombinant products for well-known pharmaceutical and biotechnology companies located in USA, Europe, and Japan. our FDA approved facilities fulfill worldwide quality requirements. Services Offfered
Production of Recombinant Peptides and Proteins: 150-L, 1,300-L, 3,000-L, 13,000- L, and 40,000-L fermentors are available in our facility in Kundl, austria. each fermentation unit is fully equipped with a separate downstream line including all state-of-the-art isolation, recovery and purification techniques. Since 2004, Sandoz has operated a mammalian cell culture plant with 3,000-L and 13,000-L fermentation/purification lines in Schaftenau, Austria. That plant was extended in 2008 with a further fully integrated 2 × 13,000-L fermentation line.
Development and Scale-Up: In addition to the large-scale production capabilities, Sandoz offers aligned pilot plant facilities operated by a customer-oriented team with extensive know-how in technology transfer, development, and scale-up of processes for recombinant proteins.
Innovative Expression Technology: With the proprietary NaFt system (Npro autoprotease Fusion technology) Sandoz developed a tool for improved expression and isolation of fusion proteins. this system leads to controllable, quantitative, and autoproteolytic cleavage for an authentic N-terminus. this effective and high-yielding expression technology is a complement to our production technology and offers a highly cost-competitive option for manufacturing peptides and proteins.
Integrated Services: All phases of process development and commercial-scale manufacturing are supported by a competent analytical department, regulatory specialists, and independent quality assurance.
Manufacturing for Clinical Trials and Commercial Supply: Sandoz is capable to produce quantities of your microbial or cell-culture derived recombinant product to feed all stages of clinical development and supply the market with your product.
Friedrich Nachtmann is at Sandoz GmbH, Biochemiestrasse 10, A 6250 Kundl, Austria; +43-5338-200-680; friedrich.nachtmann@sandoz; www.sandoz.com.