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Biotechnology

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Biotechnology A Promise Come True Max Sar chaga Medical Director Amgen * At Amgen, whether it s giving back to the communities in which we live and work, or ... – PowerPoint PPT presentation

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Title: Biotechnology


1
BiotechnologyA Promise Come True
Max Saráchaga Medical Director Amgen
2
  • Treating Disease

Treating People,
2
3
People are part of an astonishing variety of life.
4
Protein
Were all made of the same material.
Typical Cell
Sugar
Fat
5
When complex processes are all working precisely,
we are healthy
But for many people, something goes wrong.
Disease is the result.
Chronic Kidney Disease
Erythropoietin (EPO) Protein
People with kidney disease do not make enough of
the EPO protein, produced by the kidneys to
stimulate production of red blood cells.
6
  • Different Treatments
  • ______ ________
  • ____________ ________

Different Causes of Disease,
Biotech Medicines
Live,
Complex
Large
7
Biologics Differ From Traditional Drugs in Both
Complexity and Sensitivity
Biologics (Protein-based medicines)
Pharmaceuticals (Chemically-based drugs)
Large
Small
Complex
Simple
Complex Degradation
Stable
Size
Heterogeneous product
Single defined structure
Structure
Stability
Unique bank of living cells Unlikely to achieve
identical copy
Predictable chemical reagent reaction Identical
copy can be made
Variability
Properties
Manufacturing
Many products well-characterized Correlation of
structure-function elusive
Easy to fully characterize
Characterization
Sensitive to storage and handling conditions
More stable
Stability
Higher potential
Lower potential
Immunogenicity
8
Identify and isolate gene that will produce a
medically useful protein
Put gene into DNA vector
Typical Protein Production Process
Typical Protein Production Process
Typical Protein Production Process
Typical Protein Production Process
Typical Protein Production Process
Transfer into Host Cell Expression Screening/Sele
ction
Fermentation is the science of growing host cells
in large quantities, so that the gene inside them
produces the protein that we want in large
quantities.
DNA vectors are used to move genes into new
organisms. They are generally plasmids (pieces of
bacterial DNA that can live and replicate outside
the chromosome).
Genes wont produce proteins outside of a living
cell, so we have to insert our gene into a living
cell (a host cell).
Fermentation units. Host cells thrive in these
vats (also called bioreactors) filled with a
life- sustaining bath of nutrients.
Chinese hamster ovary (CHO) cells were introduced
in the early 1960s as an ideal cell line for
genetic studies.
9
Biocomparables Similar, not Identical to
Original Products
Different cell lines Different manufacturing
processes
No therapeutic substitution Immunogenicity
differences
10
We must always keep patients in mind.
10
11
Amgen A Biotechnology Pioneer
  • Founded in 1980, Amgen was one of the first
    biotechnology companies to successfully discover,
    develop, and make protein-based medicines
  • Today, were leaders in the next wave of
    innovation
  • Developing therapies in multiple modalities
  • Driving cutting-edge research and development
  • Continuing to advance the science of
    biotechnological manufacturing

12
Our Worldwide Presence and a Leader In
Biotechnology Manufacturing
  • 54 Countries by 2011
  • 75 Countries by 2015

Cambridge, MA
Denmark
Norway
Woburn, MA
Luxembourg
Toronto, ON
Finland
West Greenwich, RI
Sweden
The Netherlands
Washington, DC
Belgium
Estonia
Ireland
Burnaby, BC
Latvia
Lithuania
Bothell, WA
United Kingdom
Russia
Seattle, WA
Czech Republic
Longmont, CO
France
Poland
Boulder, CO
Switzerland
Slovakia
Hungary
Japan
Turkey
India
Romania
South San Francisco, CA
United Arab Emirates
Bulgaria
Hong Kong
Greece
Slovenia
Thousand Oaks, CA
Austria
Germany
Mexico City, Mexico
Italy
Louisville, KY
Spain
Australia
Portugal
Juncos, Puerto Rico
Brazil
35 of worldwide manufacturing capacity
13
Our Products Oncology, Nephrology, Bone,
Metabolism, Inflammation
For additional information about Amgen products,
including important safety information, please
visit www.amgen.com
14
Research and Development at Amgen
  • Guiding Principles
  • Focus on serious illness
  • Be modality independent
  • Assess efficacy in patients
  • Seamless integration from research through
    commercialization

15
Pioneering Science Delivers Vital Medicines
Our Mission To serve Patients
For more information, visit www.amgen.com
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