Amgen 2010 Annual Report Download - page 41

dispenses the formulated bulk protein into vials or syringes. Finally, in the finish process, our products are packaged
for distribution.
We operate commercial and/or clinical manufacturing facilities in the United States, Puerto Rico and the
Netherlands. (See Item 2. Properties.) Manufacturing of Sensipar»/Mimpara», our small molecule product, is
currently performed by third-party contract manufacturers, although we are in the process of transferring certain
finishing aspects to our facility in Puerto Rico. 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, Nplate», Prolia»and XGEVA
TM
as well as a number of our clinical product candidates. In addition to
producing our own commercial quantities of Epoetin alfa, we also supply Epoetin alfa in the United States to J&J
under a supply agreement. (See Business Relationships — Johnson & Johnson.)
The global supply of our principal products depends on actively managing the inventory produced at our
facilities and by third-party contract manufacturers and the uninterrupted and efficient operation of our facilities
and those of our third-party contract manufacturers. During the manufacturing scale-up process, and even after
achieving sustainable commercial manufacturing, we may encounter difficulties or disruptions due to defects in raw
materials or equipment, contamination or other factors that could impact product availability. (See Item 1A. Risk
Factors — Manufacturing difficulties, disruptions or delays could limit supply of our products and limit our product
sales and — We rely on third-party suppliers for certain of our raw materials, medical devices and components.)
We have obtained from various parties certain licenses we deem necessary or desirable for the manufacture of
our products. The 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.) We perform all of the commercial bulk manufacturing of all of our proteins
except ENBREL, Prolia»and XGEVA
TM
, which we supplement with a third-party contract manufacturer.
Commercial Formulation, Fill and Finish Manufacturing
Our primary commercial formulation, fill and finish manufacturing facility is located in Puerto Rico. We
perform the commercial formulation, fill and finish manufacturing for our proteins at that facility, except for
Vectibix»and Nplate». We operate a commercial formulation, fill and finish manufacturing facility in the
United States for Vectibix»and 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. We also conduct
certain finish activities in the Netherlands. (See Item 2. Properties.)
Clinical Manufacturing
Clinical bulk, formulation, fill and finish manufacturing facilities are operated primarily in our Thousand
Oaks, California location. (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 certain of our
clinical products.
See Item 1A. Risk Factors — We perform a substantial amount of our commercial manufacturing activities at
our Puerto Rico manufacturing facility and a substantial amount of our clinical manufacturing activities at our
Thousand Oaks, California manufacturing facility; if significant natural disasters or production failures occur at the
Puerto Rico facility, we may not be able to supply these products or, at the Thousand Oaks facility, we may not be
able to continue our clinical trials.
Distribution
We operate distribution centers in the United States, principally in Kentucky and California, and in the
Netherlands for worldwide distribution of the majority of our commercial and clinical products. In addition, we also
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