Amgen 2009 Annual Report Download - page 34

We operate commercial and clinical manufacturing facilities in several locations throughout the United
States, Puerto Rico and the Netherlands (see “Item 2. Properties”). Manufacturing of Sensipar®, our small mole-
cule product, is performed entirely by third-party contract manufacturers. We also use and expect to continue to
use third-party contract manufacturers to produce or assist in the production of certain of our large molecule
marketed products, including ENBREL and Nplate®, and a number of our clinical product candidates, including
denosumab.
The global supply of our principal products is dependent on actively managing the inventory produced at
our facilities and by third-party contract manufacturers and the uninterrupted and efficient operation of our
manufacturing facilities. During the manufacturing scale-up process, and even after achieving sustainable com-
mercial manufacturing, we may encounter difficulties or disruptions due to defects in raw materials or
equipment, contamination or other factors which may impact product availability. (See “Item 1A. Risk Factors —
Manufacturing difficulties, disruptions or delays could limit supply of our products and limit our product sales.”)
We have obtained from various parties licenses that we deem to be necessary or desirable for the manu-
facture of our products. These licenses generally require us to pay royalties to the licensors based on product
sales.
Commercial Bulk Manufacturing
We operate commercial bulk manufacturing facilities in Puerto Rico and in several locations throughout the
United States (see “Item 2. Properties”). Other than for ENBREL, we perform all of the commercial bulk manu-
facturing for our proteins. We supplement our own bulk manufacturing of ENBREL with a third-party contract
manufacturer.
In addition to producing our own commercial quantities of bulk Epoetin alfa, we also supply bulk Epoetin
alfa in the United States to J&J under a supply agreement (see “Business Relationships — Johnson & Johnson”).
Commercial Formulation, Fill and Finish Manufacturing
Our primary commercial formulation, fill and finish manufacturing facility is located in Puerto Rico. In addi-
tion, we operate a commercial formulation, fill and finish manufacturing facility in California for Vectibix®and
conduct certain finish activities in the Netherlands (see “Item 2. Properties”). Other than for Nplate®, we perform
substantially all of our commercial formulation, fill and finish activities for our proteins in Puerto Rico. The
formulation, fill and finish for Nplate®is performed by a third-party contract manufacturer. In addition to the
formulation, fill and finish of ENBREL performed by us in Puerto Rico, fill and finish of a certain portion of
ENBREL is also performed by third-party contract manufacturers (see “Item 1A. Risk Factors — We manu-
facture and formulate, fill and finish substantially all our products at our Puerto Rico manufacturing facility; if
significant natural disasters or production failures occur at this facility, we may not be able to supply these
products”).
Clinical Manufacturing
Clinical bulk, formulation, fill and finish manufacturing facilities are operated in several locations through-
out the United States and in Puerto Rico (see “Item 2. Properties”). Certain finishing activities for our clinical
products are performed in the Netherlands. In addition, we also utilize third-party contract manufacturers for cer-
tain of our clinical products.
Distribution
We operate distribution centers in the United States, principally in Kentucky and California, and the Nether-
lands for worldwide distribution of the majority of our commercial and clinical products. In addition, we also use
third-party distributors to supplement distribution of our commercial and clinical products in certain areas of the
world.
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