Impacto Biotech Farmacia

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BIOTECHNOLOGY

The application of science and technology to living organisms,

as well as parts, products and models thereof, to alter living or

non-living materials for the production of knowledge, goods and

services.

(OECD Biotechnology Statistics. Paris, 2006)

BIOLOGIA

Agriculural producs

Stem cells

Cloning

Knock-out animals

BIOQUMICA

Biopharmaceuticals

Green chemistry

Bioremediation

Biofuels

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Biotechnology applications

• Medicine and health care

 –  Biopharmaceuticals (recombinant insulin or monoclonal antibodies) (9%

turnover of pharmaceutical co. in EU) –  Recombinant vaccines (17% turnover vaccines in EU)

 –  In vitro diagnostics, mainly immunoassays and nucleic-acid tests (30%turnover in EU)

• Primary production and agro-food

 –  Breeding and propagation of crops, livestock and fish

 –  Feed additive production

 –  Veterenary and food diagnostics

 –  Veterinaty vaccines

 –  Enzymes for food production

• Industrial production processes, energy and the environment

 –  Textile finishing

 –  Pulp and paper manufacturing

 –  Detergents

 –  Certain chemical products

 –  Bioethanol production –  bioremediation

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MODERN BIOTECHNOLOGIES IN HEALTHCARE (1)

Nucleic-Acid

related

technologies

High-throughput sequencing of

genome, gene, DNA

DNA synthesis and amplificationGenetic engineering

Anti-sense technology

siRNA technology

Analysis and

modification of genetic

material

Protein related

technologies

High throughput protein/peptide

identification, quantification and sequencing

Analysis and

modification ofproteins

Metabolite-related

technologies

High-throughput metabolite

identification and quantification

Metabolic pathway engineering

Analysis of metabolites

(small molecules)

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MODERN BIOTECHNOLOGIES IN HEALTH CARE(2)

Cellular /sub-

cellular related

technologies

Cell hybridizacion/fusion

Tissue engineering

Embryo technology

Stem-cell-related technologies

Gene delivery

Fermentation and downstream

processing

Cell manipulation for

various applications

Supporting tools Bioinformatics

Application of

computational tools

and storage biological

data

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MEDICAL AND PHARMACEUTICAL

BIOTECHNOLOGY 

Imp act of biotechnolog y  

PREVENTION 

DIAGNOSIS 

THERAPEUTICS 

MEDICINE

PHARMACY

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MEDICAL AND PHARMACEUTICAL

BIOTECHNOLOGY 

Imp act of biotechnolog y  MEDICINE

PHARMACY

RECOMB INANT VACCINES 

DIAGNOSIS 

BIOPHARCAEUTICALS 

ORGANIC INTERMEDIATE PRODUCTION 

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VACCINES

Process of viral infection

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The immune response

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The adpative immune system

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FIRST GENERATION VACCINES

A traditional vaccine consists of live attenuated bacteria or viruses, of dead or inactivated bacteria of of specific surface

proteins of pathogens, e.g. harvested from the plasma of infected

patients.

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RECOMBINANT VACCINES

Proteins or naked DNA

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HER-2/NEU Protein as Target

Growingcancer 

cells

Breast cancer patient

Her-2/neu gene

Growth factor HER-2/NEU receptor 

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An Antibody Called Herceptin 

Growthslows

Breast cancer patient

Growth factor Herceptin blocks receptor 

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Old Way

PathologyPatient’s

tissue sample

Molecular diagnostics

Genetics

Immunochamical

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DIAGNOSTICS

• Genetic testing

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Molecular Diagnostics

Microarray image

Old Way

Proteins

DNA

New Way

Patient’s tissue sample

or blood sample

Genomics

Proteomics

PathologyPatient’s

tissue sample

Mass spectrometry Proteomic image

Gene chip

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Monoclonal antibodies

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DIAGNOSTICS

Infectious disease testing

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DIAGNOSTICS

• Protein based

 –  Detection of a protein by a specific antobody

• Tests that are used to identify changes in the levels of proteins

during disease• Identify foreign proteins during an infection

• DNA-based

 –  Identify alterations in the DNA sequence correlating with

disease or a heightened risk of developing the disease

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DIAGNOSTICS

• Infectious disease testing –  Viral (HIV, hepatitis, EBV, RSV, herpes and CMV)

 –  Bacterial (TB, lyme, H. Pyroli, salmonella and sexual transmitteddiseases)

• Cancer –  Genes and viruses associated with specific cancers

 –  Flourescence in situ hybridization (FISH) permits to see taggedsequences in cells

 –  Serum screening: p.e. PSA (prostate specific antigen)

• Genetic testing

 –  FISH is applied for genetic screening for chromosomeabnormalities

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DIAGNOSTICS

• Sensitivity down to a single molecule

• Results are obtained faster 

• The amplification technique this will dominate the market

EU 2004

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BIOPHARMACEUTICALS

• Peptides and proteins produced in large scale

produced through recombinat DNA technologies

using microorgnanisms or cell curtures as “cell

factories” 

• 1982 Recombinant human insulin

• 15% turnover out of all pharmacuticals

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BIOPHARMACEUTICALS

• Hormones: insulin, growth hormone

• Thrombolytic agents

• Blood factors: factor VIII, factor IX

• Haematopietic growth factors

• Interferons

• Interleukin based products

• Monoclonal antibodies•  Antisense therapy

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ORGANIC INTERMEDIATE PRODUCTS

• Enzyme and/or microorganisms production

 –  Antibiotics

 –  Vitamins

 –  amino acids

 –  Biotechnology based polymers

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EMERGING BIOTECHNOLOGY

APPLICATIONS• Cell-based therapies

 –  Tissue engineering, aimed at regernetaring diseased tissuesand organs through the use of cells and the aid of supportingstructures and/or biomolecules.

•  Autologous skin replacements, cartilage and bonde products

• Stem cells

 Application in clinic: bone marrow transplantation froleukemia patients

 –  Embryonic stem cells, capable of differenciate in any of the200 cell types.

 –  Adult stem cells, capable of mature only in that type of tissue

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EMERGING BIOTECHNOLOGY

APPLICATIONS

• Gene Therapy

 –  Introduction of a gene into a cell, resulting in a product which

achieves a specific therapeutic goal.

 –  This has been applied for the treatment of one type of 

severe combined immunodeficiency.•  Antisense and RNA interference (RNA-based

therapies)

The goal is the selective inhibition of gene expression and thus

protein production.

 –  Antisense technology uses synthesized short, single

stranded sequences of nucleic acids

 –  RNA interference goal is to silence gene expression by

enzymatic cleavage.

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EMERGING BIOTECHNOLOGY

APPLICATIONS

• Therapuetic vaccines

Not used in a prophylactic sense, but for the treatment of 

varioues diseses, including infectious diseses.

This vaccines use disease specific proteins as antigens to boostor induce a specific response in the patient with the aim of 

treating an already existing condition.

• Pharmacogenetics –  The study of the influence of genetic variation on inter-

individual differences in drug response with the aim of 

tailoring therapy to individual genetic make-up