Sandoz: A Provider of Customized Solutions in Biotech Manufacturing July 2009

Sandoz is one of the leading specialists in microbial fermentation of classic and recombinant microorganisms. The company’s comprehensive know-how is based on more than six decades of experience in the field of classical microbial products and more than two decades in recombinant microbial production at commercial scale. Building on this know-how, Sandoz offers 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 performed in collaboration with our customers. Currently, Sandoz is manufacturing more than 25 different recombinant products for well-known pharmaceutical and biotechnology companies located in the United States, Europe, and Japan. Our FDA-approved facilities fulfill worldwide quality requirements.

Services Offered

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 operates a cell culture plant with 3,000-L and 13,000-L fermentation/purification lines in Schaftenau, Austria. This plant was extended in 2008 with a further fully integrated 2 × 13,000-L fermentation line including a corresponding downstream unit.

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.

Fill/Finish: Sandoz operates two liquid filling lines (vials, cartridges for pens) in Schaftenau, Austria.

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 resulting in 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 the manufacture of 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 of producing quantities of your microbial- or cell-culture–derived recombinant product to feed all stages of clinical development and to supply the market with your product.