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Instituto Butantan | 1
October 2013
Instituto Butantan | 2
• Introduction about the Instituto Butantan
• Infrastructure at Instituto Butantan
• Translational medicine at Instituto Butantan
OUTLINE
Instituto Butantan | 3
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”
Instituto Butantan | 4
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
Instituto Butantan | 5
OUR PRODUCTS – Sera and immunoglobulins400.000 vials per year
Instituto Butantan | 6
OUR PRODUCTS – vaccines 150 millions of doses per year
Instituto Butantan | 7
PIPELINE PRODUCTS In partnership with other manufacturers and institutions
> 50 PATENTS
Instituto Butantan | 8
• Introduction about the Instituto Butantan
• Infrastructure at Instituto Butantan
• Translational medicine at Instituto Butantan
OUTLINE
Instituto Butantan |
21 research laboratories
1 Biotechnology center
1 Hospital specialized in Envenomation treatment
1 Housing and care facility for research animals
SCIENTIFIC RESEARCH AND DEVELOPMENT
9
+150 Researchers (PhD level)
500 Postgraduate students
2 Postgraduate MSc/PhD programs (Toxinology and Biotechnology)
Instituto Butantan |
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
10
Instituto Butantan |
CLINICAL TRIALS AND PHARMACOVIGILANCE
11
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
Instituto Butantan |
DIFFUSION AND CULTURE
12
4 Museums
300.000 visitors per yeas
Didactic materials
Courses and trainings
Instituto Butantan | 13
• Introduction about the Instituto Butantan
• Infrastructure at Instituto Butantan
• Translational medicine at Instituto Butantan
OUTLINE
Instituto Butantan |
TechnologyTechnologyTechnologyTechnology TransformationTransformationTransformationTransformation Product life cycleProduct life cycleProduct life cycleProduct life cycle
Demand pull
Idea Candidate Product
Supply push
Tech. R&DTech. R&D Product R&DProduct R&D
R&D of new products
Instituto Butantan |
TechnologyTechnologyTechnologyTechnology TransformationTransformationTransformationTransformation Product life cycleProduct life cycleProduct life cycleProduct life cycle
Academic interface
Pilot plants (cGMP)
Clinical trial sponsor
R&D infrastructure at Instituto Butantan
Clinical trial sponsor
Pharmacovigilance Basic research labs
Pre-clinical GLP labs GMP industrial plants
Partners
Partners
Instituto Butantan |
TechnologyTechnologyTechnologyTechnology TransformationTransformationTransformationTransformation Product life cycleProduct life cycleProduct life cycleProduct life cycle
Pilot plants (cGMP)
Clinical trial sponsor
Sanofi-Pasteur/Butantan influenza vaccine tech transfer
Pharmacovigilance
GMP industrial plants
Sanofi-Pasteur
Demand pullMoH
Instituto Butantan |
TechnologyTechnologyTechnologyTechnology TransformationTransformationTransformationTransformation Product life cycleProduct life cycleProduct life cycleProduct life cycle
Pilot plants (cGMP)
Clinical trial sponsor
NIH/Butantan Dengue vaccine R&D process
Clinical trial sponsor
Pharmacovigilance
GMP industrial plants
NIH/NIAID
Demand pullMoH/DVI
Instituto Butantan |
TechnologyTechnologyTechnologyTechnology TransformationTransformationTransformationTransformation Product life cycleProduct life cycleProduct life cycleProduct life cycle
Academic interface
Pilot plants (cGMP)
Clinical trial sponsor
Butantan pulmonary sufactant R&D process
Clinical trial sponsor
Pharmacovigilance Basic research labs
Pre-clinical GLP labs GMP industrial plants
Demand pullMoH
Instituto Butantan |
TechnologyTechnologyTechnologyTechnology TransformationTransformationTransformationTransformation Product life cycleProduct life cycleProduct life cycleProduct life cycle
Academic interface
Pilot plants (cGMP)
Clinical trial sponsor
Butantan/Cristália Silica adjuvant R&D process
Clinical trial sponsor
Pharmacovigilance Basic research labs
Pre-clinical GLP labs GMP industrial plants
Cristália
Supply push
Instituto Butantan |
TechnologyTechnologyTechnologyTechnology TransformationTransformationTransformationTransformation Product life cycleProduct life cycleProduct life cycleProduct life cycle
Academic interface
Pilot plants (cGMP)
Clinical trial sponsor
Butantan MPLA adjuvant R&D process
Clinical trial sponsor
Pharmacovigilance Basic research labs
Pre-clinical GLP labs GMP industrial plants
Supply push
Instituto Butantan | 21
• 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
SUMMARY
Instituto Butantan | 22
Av. Vital Brasil, 1500 - ButantãSão Paulo – SPZip Code - 05503-900(+ 55 11) 2627-9300www.butantan.gov.br