Amgen 2012 Annual Report Download - page 28

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Commercial Bulk Manufacturing
We operate commercial bulk manufacturing facilities in Puerto Rico and in several locations throughout the United States
for most of our products. (See Item 2. Properties.) We have the option to supplement commercial bulk manufacturing for ENBREL,
Prolia®, XGEVA® and Vectibix® with a third-party contract manufacturer.
Commercial Formulation, Fill and Finish Manufacturing
We perform most of our commercial protein formulation, fill and finish manufacturing in our Puerto Rico facility.
Formulation, fill and finish manufacturing for Nplate® and Vectibix® is performed by third-party contract manufacturers. 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 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. We also utilize third-party contract manufacturers for certain 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, California and the Netherlands 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.
Other
In addition to the manufacturing and distribution activities noted above, our operations in the United States, Puerto Rico and
the Netherlands perform key manufacturing support functions, including quality control, process development, procurement,
distribution and production scheduling. Certain of those manufacturing and distribution activities are highly regulated by the FDA
as well as other international regulatory agencies. See Government Regulation — FDA Regulation of Manufacturing Standards.
Manufacturing Initiatives
We have multiple ongoing initiatives that are designed to optimize our manufacturing network and/or mitigate risks while
continuing to ensure adequate supply of our commercial products. The facilities impacted by each of these initiatives will require
qualification and licensure by various regulatory authorities. These initiatives include the construction of a formulation and fill
facility at our Puerto Rico site; and as part of a risk mitigation strategy, we plan modification and expansion of our recently acquired
formulation, fill and finish site in Ireland to manufacture our products.
In addition to these initiatives, we have projects designed to operate our facilities at appropriate production capacity over
the next few years, further optimize manufacturing asset utilization, continue our use of third-party contract manufacturers and
maintain a state of regulatory compliance. See Item 1A. Risk Factors — Manufacturing difficulties, disruptions or delays could
limit supply of our products and limit our product sales.
Raw Materials and Medical Devices
Certain raw materials necessary for the commercial and clinical bulk manufacturing of our products are provided by
unaffiliated third-party suppliers, certain of which may be our only sources for such materials. Also, certain medical devices and
components necessary for the formulation, fill and finish of our products are provided by unaffiliated third-party suppliers, certain
of which may be the sole sources. Certain of the raw materials, medical devices and components are the proprietary products of
those unaffiliated third-party suppliers and are specifically cited in our drug application with regulatory agencies so that they must
be obtained from the specific sole source or sources and could not be obtained from another supplier unless and until the regulatory
agency approved such supplier. We currently attempt to manage the risk associated with such suppliers by inventory management,
relationship management and evaluation of alternative sources when feasible. We also monitor the financial condition of certain
suppliers and their ability to supply our needs.
Certain of the raw materials required in the commercial and clinical manufacturing of our products are sourced from other
countries and/or derived from biological sources, including mammalian tissues. In addition, one of our marketed products also
uses bovine serum and human serum albumin. Some countries in which we market our products may restrict the use of certain