October 2013
Instituto Butantan
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OUTLINE
• Introduction about the Instituto Butantan
• Infrastructure at Instituto Butantan
• Translational medicine at Instituto Butantan
Instituto Butantan
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ABOUT US
The Instituto Butantan is a biomedical research and biological
product manufacturing center founded in 1901.
Mission: “To develop research and products that contribute
with health access, and to share knowledge with the society”
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IMMUNOBIOLOGICAL PROGRAM OF BRASIL
• Self-sufficiency as a public policy in Brazil since 1984
• It is incumbent upon the Unified Health System (… ) to participate in
the production of drugs, equipment, immunobiological products, blood
products and other inputs. (Federal Constitution of Brazil, Art.200)
• National Immunization Program is the major customer of products from
public manufacturers licensed by the national regulatory agency (ANVISA)
Public manufacturers
• Sera and immunoglobulins
• Vaccines
• Blood derivatives (projected)
• Biological drugs (ongoing)
• Synthetic drugs
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OUR PRODUCTS – Sera and immunoglobulins
400.000 vials per year
Anti-Bothrops (pentavalent) serum
Anti-Bothrops (pentavalent) / Anti-Lachesis serum
Anti-Bothrops (pentavalent) / Anti-Crotalus serum
Anti-Crotalus serum
Anti-Micrurus serum
Anti-Tityus serum
Diphtheria
antitoxin
Tetanus antitoxin
Anti-Loxosceles/ Anti-Phoneutria /Anti-Tityus serum
Botuline (A&AE)
antitoxin
Anti-Lonomia serum
Anti-Rabies serum
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OUR PRODUCTS – vaccines
150 millions of doses per year
Diphtheria-TetanusPertussis (whole cell)
Diphtheria –Tetanus
(DT/Td)
Rabies
Hepatitis B
Influenza
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PIPELINE PRODUCTS
In partnership with other manufacturers and institutions
Rotavirus
(pentavalent)
vaccine – NIH-PATH
Dengue
(tetravalent)
vaccine – NIH
DPT(low)/HBV/HiB
– Biomanguinhos
Blood derivatives -
Silica (adjuvant) –
Hemobrás
Cristália
Pneumococcus
vacc.– Children’s
Leishmaniasis
vaccine – Infectious
Pulmonary
surfactant –
Diseases Research
BR Foods
BCG-Pertussis
recombinant –
Inst. Pasteur/Novartis/ A.
Einstein Coll. of Med.
MPLA adjuvant
OncoBCG
recombinant –
Universidade de São Paulo
Haemophilus
influenzae B vacc.
Hospital Harvard-PATH
NecatorSchistosoma vacc.–
Sabin Vacc.Inst./ GWU
HPV vaccine –
Merck Sharp & Dome
Hep A vaccines –
Merck Sharp & Dome
> 50 PATENTS
Instituto Butantan
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OUTLINE
• Introduction about the Instituto Butantan
• Infrastructure at Instituto Butantan
• Translational medicine at Instituto Butantan
Instituto Butantan
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SCIENTIFIC RESEARCH AND DEVELOPMENT
 21 research laboratories
 1 Biotechnology center
 1 Hospital specialized in
Envenomation treatment
 1 Housing and care facility for
research animals
+150 Researchers (PhD level)
500 Postgraduate students
2 Postgraduate MSc/PhD programs (Toxinology and Biotechnology)
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MANUFACTURING
7 Main manufacturing plants
 Serum. Quality control . Formulation , filling and packaging.
 Anaerobic vaccines and anatoxin purification (tetanus and botulism)
 Aerobic vaccines (diphtheria and pertussis)
 Hepatitis B
 Influenza
 Rabies
 Blood derivatives (in process)
6 Pilot plants
1 Farm with 600 equines + 2 third part farms
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CLINICAL TRIALS AND PHARMACOVIGILANCE
Clinical trials
 Design and analysis of clinical studies
 Electronic Data Capture (21CFR11) & Risk-based monitoring system
 Partnership with University Hospitals research centers
Pharmacovigilance
 Collaboration with the National Immunization Program
 Safety Data Exchange Agreements with partner manufacturers.
SAC – Consumer Service
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DIFFUSION AND CULTURE
 4 Museums
 300.000 visitors per yeas
 Didactic materials
 Courses and trainings
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OUTLINE
• Introduction about the Instituto Butantan
• Infrastructure at Instituto Butantan
• Translational medicine at Instituto Butantan
Instituto Butantan
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R&D of new products
Demand pull
Idea
Tech. R&D
Technology
Candidate
Product R&D
Transformation
Product
Product life cycle
Supply push
Instituto Butantan
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R&D infrastructure at Instituto Butantan
Partners
Basic research labs
Academic interface
Technology
Pre-clinical GLP labs
Pilot plants (cGMP)
Clinical trial sponsor
GMP industrial plants
Pharmacovigilance
Clinical trial sponsor
Transformation
Product life cycle
Partners
Instituto Butantan
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Sanofi-Pasteur/Butantan influenza vaccine tech transfer
Demand pull
MoH
Sanofi-Pasteur
Technology
Pilot plants (cGMP)
GMP industrial plants
Pharmacovigilance
Clinical trial sponsor
Transformation
Product life cycle
Instituto Butantan
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NIH/Butantan Dengue vaccine R&D process
Demand pull
MoH/DVI
Technology
Pilot plants (cGMP)
Clinical trial sponsor
GMP industrial plants
Pharmacovigilance
Clinical trial sponsor
Transformation
Product life cycle
NIH/NIAID
Instituto Butantan
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Butantan pulmonary sufactant R&D process
Demand pull
MoH
Basic research labs
Academic interface
Technology
Pre-clinical GLP labs
Pilot plants (cGMP)
Clinical trial sponsor
GMP industrial plants
Pharmacovigilance
Clinical trial sponsor
Transformation
Product life cycle
Instituto Butantan
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Butantan/Cristália Silica adjuvant R&D process
Basic research labs
Academic interface
Technology
Pre-clinical GLP labs
Pilot plants (cGMP)
Clinical trial sponsor
GMP industrial plants
Pharmacovigilance
Clinical trial sponsor
Transformation
Product life cycle
Supply push
Cristália
Instituto Butantan
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Butantan MPLA adjuvant R&D process
Basic research labs
Academic interface
Technology
Pre-clinical GLP labs
Pilot plants (cGMP)
Clinical trial sponsor
GMP industrial plants
Pharmacovigilance
Clinical trial sponsor
Transformation
Product life cycle
Supply push
Instituto Butantan
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SUMMARY
• The Unified Health System of Brazil is creating a vertical integration aiming
self-sufficiency in vaccines and immunobiologicals
• Public manufacturers, such as Butantan, have infrastructure to develop and
partner from tech transfer to technological/product R&D
• Capacity is not restricted to supply but also pointed toward development of
new products for the Unified Health System
Instituto Butantan
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Av. Vital Brasil, 1500 - Butantã
São Paulo – SP
Zip Code - 05503-900
(+ 55 11) 2627-9300
www.butantan.gov.br
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