Biotechnology…A Promise Come True
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Biotechnology…A Promise Come True. Max Saráchaga Medical Director Amgen. Treating Disease. Treating People,. 2. People are part of an astonishing variety of life. Protein. We ’ re all made of the same material. Typical Cell. Sugar. Fat.

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Biotechnology…A Promise Come True

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Biotechnology a promise come true

Biotechnology…A Promise Come True

Max Saráchaga

Medical Director

Amgen


Biotechnology a promise come true

Treating Disease

Treating People,

2


Biotechnology a promise come true

People are part of an astonishing variety of life.


Biotechnology a promise come true

Protein

We’re all made of the same material.

Typical Cell

Sugar

Fat


Biotechnology a promise come true

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.


Biotechnology a promise come true

Different Treatments

______ ________

____________ ________

Different Causes of Disease,

Biotech Medicines:

Live,

Large

& Complex


Biologics differ from traditional drugs in both complexity and sensitivity

Biologics Differ From Traditional Drugs in Both Complexity and Sensitivity

Biologics(Protein-based medicines)

Pharmaceuticals

(Chemically-based drugs)

Small

Large

Simple

Complex

Stable

Complex Degradation

Size

Single defined structure

Heterogeneous ‘product’

Structure

Stability

Unique bank of living cells;

Unlikely to achieve identical copy

Predictable chemical & reagent reaction;

Identical copy can be made

Properties

Variability

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


Biotechnology a promise come true

Validation testing may be defined as “the act of proving that any procedure, process, equipment, material, activity or system leads to the expected results.”

We must validate that downstream processing continues to remove viruses, DNA and toxins from the protein product stream.

Biotech Medicine: The final protein must have precisely the right amino acid sequence, folded into precisely the right three-dimensional shape.

Downstream

Extraction/

Purification/

Dilution

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/Selection

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 won’t 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.


Biocomparables similar not identical to original products

Biocomparables are similar...

....but not identical

Impact of small differences in either biological or manufacturing process could lead to different clinical efficacy and safety for patients

Biocomparables:Similar, not Identical to Original Products

Different cell lines

Different manufacturing processes

No therapeutic substitution

Immunogenicity differences


Biotechnology a promise come true

We must always keep patients in mind.

10


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, we’re 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

Amgen: A Biotechnology Pioneer


Our worldwide presence and a leader in biotechnology manufacturing

Our Worldwide Presence and a Leader In Biotechnology Manufacturing

  • 54 Countries by 2011

  • 75 Countries by 2015

Cambridge, MA

Norway

Denmark

Woburn, MA

Luxembourg

Finland

Toronto, ON

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

Japan

Hungary

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


Our products oncology nephrology bone metabolism inflammation

Our ProductsOncology, Nephrology, Bone, Metabolism, Inflammation…

For additional information about Amgen products, including important safety information, please visit www.amgen.com


Research and development at amgen

Guiding Principles

Focus on serious illness

Be modality independent

Assess efficacy in patients

Seamless integration from research through commercialization

Research and Development at Amgen


Pioneering science delivers vital medicines

Pioneering ScienceDelivers Vital Medicines

Our Mission : To serve Patients

For more information, visit www.amgen.com


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