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.

About the Author

Author Details
Friedrich Nachtmann is at Sandoz GmbH, Biochemiestrasse 10, A 6250 Kundl, Austria; +43-5338-200-680; friedrich.nachtmann@sandoz; www.sandoz.com.