Pharmaceutical biotechnology
Traditional biotechnology
Modem biotechnology
-secondary metabolites
-recombinant proteins
-antibiotics
-monoclonal antibodies
-steroids
-gene therapy
-vitamins, etc
-transgenic organisms
What is a modern
pharmaceutical biotechnology?
keyword: “PHARMACEUTICAL BIOTECHNOLOGY”
GOOGLE 1996: app. 35.000 hits
GOOGLE 2006: app: 3.220.000 hits !
Pharmaceutical biotechnology:
the use of living things or parts in
order to c reate or modify drugs
Modern pharmaceutical biotechnology:
the use of living things or parts by means
of recombinant DNA technology in
order to create or modify drugs and
physiological targets
From the starting point of protein
pharmaceuticals....
100 Years ago
Senun Therapy 1893
Emil von Behring
immunizing a
“serum-horse”
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Medicine Iflfl 1
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modern biotech
BIOTECH BEACH
Transferí of
new genes
into animal
organisms
Anti-cancer
dnigs
Culture of
Plants froin
Single cells
Diagnostics
7Z
Moiioclonal
A-utibodies
Cell cultiire
Molecular
Blology
Crime solving
1
DNA technology
Genetic
Engineering
I
Banks of
DNA, RNA
and proteins
1
Synthesis
of new
proteins
I
Complete map
of the liuinan
genome
T rac ers
New types of
plants and
animais
I
New types
of food
N ew
antibiotics
Cloning-----------Mass
Production
of human
proteins
Resource bank
far rara humaii
chemicals
Gene therapy
Synthesis of
speclfic DNA
probes
Trends and perspectives
1st generation of biopharmaceuticals
2nd generation of biopharmaceuticals
Introduction of biosimilars
Novel technologies for R&D and advanced
drug delivery
• Gene therapy and tissue engineering
• Personalised drug therapy
•
•
•
•
Biopharmaceuticals or protein drugs have proven
to be safe and effective therapies in many disease
indications
r------------------------------------------------------------------------------------------------------------------------------------------------
The 1st generation biopharmaceuticals
Replacement therapies
----------------------------------------------------------
(mimic the normal function of a
V__________ protein)__________ )
Many successful products:
Erythropoietin, insulin, human
growth hormon (HGH),
interferons (IFNs), granulocyte
colony-stimulating factor (GCSF), etc.
“Antagonist” therapies
(in which protein function is
< inhibited - usually antibodies) )
1 st generation of biopharmaceuicals
Cytokines
and antagonists
Interferon alfacon-1
Interferon alfa-2a
Interferon alpha-2b
Interferon beta-1a
Interferon beta-1b
Interferon gamma-1b
Aldesleukin (IL-2)
Filgrastim (G-CSF)
Lenograstim (G-CSF)
Molgramostim (GM-CSF)
Sargramostim (GM-CSF)
Tasonermin (TNF-a)
Becaplermin (PDGF-BB)
Oprevelkin (IL-11)
Anakinra (IL-1-RA)
Hormones
and peptides
Insulin
Coagulation factors/ Antibodies
Inhibitors
Abciximab
Eptacog alfa
Adalimumab
Alemtuzumab
Antihemophilic
Factor (3)
Arcitumomab
Moroctocog alfa
Basiliximab
(FVIII mutein)
Bevacizumab
Epoetin alfa
Nonacog alpha
Gemtuzumab
Epoetin beta
Desirudin
Ibritumomab
Lepirudin
Infliximab
Drotrecogin-alfa
Palivizumab
Follitropin alfa
(Protein C act.)
Rituximab
Follitropin beta
a1-Proteinase
Trastuzumab
Somatropin
inhibitor
Omalizumab
Glucagon
Efalizumab
Teriparatide (PTH 1-34)
Catuximab
Salmon Calcitonin
Daclizumab
Thyrotropin-alfa
Panitumumab
Choriogondotropin A2
Ranibizumab
Osteogenic Protein-1
Dibotermin alpha (BMP-2)
Pegvisomant (hGH antagonist)
Nesiritide (natriuretic peptide)
Lutropin-alfa
Vaccines
Hepatitis Vaccine
LymeDiseaseVaccine
Diphtheria/T etanus/
Pertussis Vaccine
Rotavirus Vaccine
Enzymes
Alteplase (t-PA)
Reteplase
Tenecteplase (TNK-t-P)
Monteplase
Dornase-alfa (RNase)
Imiglucerase
Agalsidase alfa and beta
Laronidase
Rasburicase
Fusion Proteins
Denileukin diftitox
Etanercept
Alefacept
Limitations of the 1st generation
biopharmaceuticals:
• Marketed drugs are differently produced nature
proteins, with unoptimized physico-chemical
properties. Native proteins have not evolved to be
human drugs, but to serve a specific function in the
body. As such they are often deficient in important
drug qualities such as solubility, stability, half-life,
potency, recombinant expression yields, reduced
immunogenicity.
• Drug activity is largely restricted to nature’s existing
fepertoire of biological activities. Agonists are not—
easily transformed into antagonists.