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End-to-End Manufacturing and Supply

As the first biotechnology company to scale up protein manufacturing successfully from the small quantities used for research to the much larger quantities needed for clinical trials and marketing, Technical Operations has provided a key element to our growth.

Today, the combined organization of Genentech and Roche is a world leader in biologics manufacturing, with more FDA-approved manufacturing capacity for the production of biotech medicines than any other company.

Genentech Technical Operations takes raw materials and makes them into the final medicine that is delivered to patients. But it's responsible for so much more, managing all aspects of drug manufacturing and supply, such as quality, engineering, supply chain and manufacturing. These functions support Genentech's end-to-end process, which consists of two primary manufacturing operations:

• Drug substance production — using genetically modified cells to serve as mini-factories that can manufacture the required proteins.
• Drug product production — creating the final formulation of the medicine into a sterile liquid or powder that is placed in a vial, syringe or device and packaged for worldwide distribution.

During all phases of both processes the goal remains clear: support Genentech's business sustainability with uninterrupted supply to patients while meeting quality and compliance requirements as efficiently as possible.