Download Amgen Manufacturing

F a c t
Amgen Manufacturing
Amgen is a global leader in biotechnology manufacturing, producing more
than a third of the world’s output of non-vaccine and non-insulin protein
therapeutics. Amgen has developed state-of-the-art biologics
manufacturing and process development capabilities that grant the
company competitive advantages. These strengths attract partners and
fulfill the potential of the company’s promising pipeline to help meet the
needs of patients worldwide.
Global, scalable, flexible, and committed to safety and reliability, our
capabilities in process development, manufacturing, quality and supply
chain management are continually growing. The company is making
significant investments over the next several years to increase cell culture,
purification and fill/finish capacity at its plants in Puerto Rico, Rhode
Island and Colorado.
Amgen’s manufacturing capabilities are further broadened by strategic
relationships with a range of contract manufacturers in the United States,
Europe, Canada and Japan.
Leadership in Biotechnology Manufacturing
Manufacturing therapies based on proteins or peptides found in the human
body is a complex process. In the biotechnology industry, therapeutics are
manufactured using living
organisms that contain the
genetic code for the specific
molecule. Precisely controlling
the manufacturing process and
environment is necessary to
obtain consistent results.
As an industry leader, Amgen
has extensive knowledge and
first-hand expertise in clinical
and commercial manufacturing
of biologic-based medicines.
We have an outstanding track record of regulatory compliance, thanks to
stringent controls and a superior quality system.
S h e e t
Quick Facts
Locations
Thousand Oaks, California
Longmont and Boulder, Colorado
Juncos, Puerto Rico
West Greenwich, Rhode Island
Bothell, Washington
Staff
Approximately 5,800
Key Functions
– Process Development
– Manufacturing (clinical, bulk, fill
and finish; contract manufacturing)
– Quality and Regulatory Compliance
– Supply Chain Management
– Environmental Health and Safety
– Operations Planning
– Corporate Engineering and Capital
Projects
Principal Products Manufactured
– Aranesp® (darbepoetin alfa)
– Enbrel® (etanercept)
– EPOGEN® (Epoetin alfa)
– Kepivance™ (palifermin)
– Kineret® (anakinra)
– Neulasta® (pegfilgrastim)
– NEUPOGEN® (Filgrastim)
Contact
Media: (805) 447-4587
Investors: (805) 447-1060
Last Updated January 27, 2005 | Page 1
Expertise in Process Development
After a molecule has advanced to clinical trials, a process is developed for
producing it for use in that setting and later refined as needed for commercial
production. Much of what Amgen does in process development requires
breaking new ground. The company recruits chemists, biologists and
engineers from the world’s leading institutions to contribute to its process
development efforts. Amgen’s strengths in this area are difficult to match;
arguably only one or two companies are in the same league.
Investing in Future Growth
Amgen has announced plans to invest billions of dollars in capital projects to
expand its capabilities at several major locations.
Colorado
Amgen has two manufacturing facilities near Boulder: Longmont and
LakeCentre. Longmont is responsible for bulk manufacture of EPOGEN®
(Epoetin alfa) and Aranesp® (darbepoetin alfa). LakeCentre manufactures
Kineret® (anakinra), Kepivance™ (palifermin), and pipeline product
candidates in late-stage clinical development. Amgen is investing millions of
dollars to increase the capacity of its LakeCentre facility. In addition, the
company has received approvals from city planners for future growth at its
Longmont facility.
About Amgen
Amgen (Nasdaq: AMGN), the world’s
largest biotechnology company, discovers,
develops, manufactures and markets
human therapeutics for serious illness.
For 25 years, the company has tapped
the power of scientific discovery and
innovation to dramatically improve
people’s lives.
Amgen pioneered the development of
novel and innovative products based
on advances in recombinant DNA and
molecular biology. More than a decade
ago, Amgen introduced two of the first
biologically derived human therapeutics,
EPOGEN® (Epoetin alfa) and
NEUPOGEN® (Filgrastim), and they
became the biotechnology industry’s first
blockbuster medicines.
Today, Amgen is a Fortune 500 company
with more than 14,000 staff members
worldwide. We continue to be an
entrepreneurial, science-driven
organization dedicated to our mission
of serving patients.
Puerto Rico
Amgen expects to invest approximately $1.2 billion to create a state-of-the-art
biotechnology campus for bulk manufacturing in Juncos, Puerto Rico.
Amgen’s facility, currently devoted to fill and finish, will add another 500,000
square feet and will increase the number of staff to approximately 1,200. The
new site is slated to include manufacturing plants for key biologics, expanded
full-testing quality and analytical labs, additional syringe fill and lyophilization
(freeze-drying) capability, warehouses, process development facilities,
administrative and training buildings, a cafeteria and a child care center. The
company plans to begin bulk manufacture of NEUPOGEN® (Filgrastim) and
Neulasta® (pegfilgrastim) in Puerto Rico and to move production of Aranesp®
and EPOGEN® there.
Rhode Island
Amgen’s facility in West Greenwich, Rhode Island is dedicated to the
manufacture of ENBREL® (etanercept) bulk drug substance. The plant
received U.S. Food and Drug Administration (FDA) approval in December
2002. The approval process took four months—one of the fastest approvals
for a biotech plant in the history of the field. The plant currently operates
24/7 to meet demand for ENBREL.
Amgen is investing more than $1.1 billion to increase the Rhode Island
facility’s capacity. The planned expansion will add more than 500,000 square
feet of manufacturing, utility, administrative and laboratory space to the
campus. When the new plant is completed, the 75-acre campus should house
the world’s largest mammalian protein manufacturing facility, as well as the
administrative, utilities and quality and analytical laboratory buildings needed
to support manufacturing there.
Last Updated January 27, 2005 | Page 2