Pharmaceutical Outsourcing Company Focus: A Russell Publishing Publication

COMPANY DESCRIPTION

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 five 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, 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 as well as fill and finish operations.

Our expertise is based on numerous projects successfully performed in collaboration with our customers. Currently, Sandoz is manufacturing more than 15 different recombinant products for well-known pharmaceutical and biotechnology companies located in USA, Europe and Japan.

COMPANY BACKGROUND

Date Founded 1946
# of employees 23,000 (approx., worldwide)

Key Personnel

• Dr. E. Meijnders, CEO
• Dr. Ameet Mallik, Head Biopharmaceuticals
• Dr. F. Nachtmann, Head Biotech Cooperations

SERVICES & CAPABILITIES

Sandoz is a fully integrated manufacturer of biopharmaceutical products and is capable to produce quantities of your microbial or mammalian cell culture derived recombinant product to feed all stages of clinical development and to supply the market with your product. Sandoz offers PRODUCTION OF RECOMBINANT PEPTIDES AND PROTEINS in 1300L, 3000L, 13000L and 40000L microbial fermenters in the facility in Kundl, Austria. Each fermentation unit is fully equipped with a corresponding downstream line including all state-of-the-art isolation, recovery
and purification techniques.

In the field of MAMMALIAN CELL CULTURE, Sandoz offers cGMP production of glycosylated proteins and antibodies for clinical and commercial use at 3000L, 13000L and 2 x 13000L scale in facilities near Kufstein, Austria.

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 and antibodies. For earlier stage projects a small scale
production plant for the manufacture of clinical phase I to phase III material is available.

Sandoz is also in the position to offer a variety of facilities and technologies to manufacture clinical and commercial FINISHED PRODUCTS. Our facilities allow both lyophilization of active substance and liquid filling into various product formats.

All phases from process development to commercial scale manufacturing are
supported by a competent analytical team, regulatory specialists and
independent quality assurance. Our FDA approved facilities fulfill worldwide quality requirements.

The flexibility of production capabilities and fully integrated services accompanied with a highly skilled and customer-oriented team makes Sandoz an ideal partner for production cooperations.