Sandoz: Provider of Customized Solutions in Biotech Manufacturing August 2014

Sandoz is one of the leading specialists in biotech development and manufacturing. Comprehensive know-how is based on more than two decades in microbial and mammalian cell culture production at commercial scale. Today 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 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 its 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 complements 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 can 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.

Johannes Reiter is head of Biotech Cooperations, Biochemiestrasse 10, A 6250 Kundl, Austria; 43-5338-200-2609; [email protected]; www.sandoz.com.