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Biotechnology…A Promise Come True

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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  1. Biotechnology…A 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 We’re 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, Large & Complex

  7. 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

  8. 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.

  9. 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

  10. We must always keep patients in mind. 10

  11. 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

  12. 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

  13. Our ProductsOncology, Nephrology, Bone, Metabolism, Inflammation… For additional information about Amgen products, including important safety information, please visit www.amgen.com

  14. Guiding Principles Focus on serious illness Be modality independent Assess efficacy in patients Seamless integration from research through commercialization Research and Development at Amgen

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

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