Instituto Butantan | 0 October 2013. Instituto Butantan | 1 Introduction about the Instituto...

Instituto Butantan | 1

October 2013


• Introduction about the Instituto Butantan

• Infrastructure at Instituto Butantan

• Translational medicine at Instituto Butantan

OUTLINE


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”


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


OUR PRODUCTS – Sera and immunoglobulins400.000 vials per year


OUR PRODUCTS – vaccines 150 millions of doses per year


PIPELINE PRODUCTS In partnership with other manufacturers and institutions

> 50 PATENTS





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)


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


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


DIFFUSION AND CULTURE

12

4 Museums

300.000 visitors per yeas

Didactic materials

Courses and trainings





OUTLINE


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



Academic interface

Pilot plants (cGMP)

Clinical trial sponsor

R&D infrastructure at Instituto Butantan


Pharmacovigilance Basic research labs

Pre-clinical GLP labs GMP industrial plants

Partners

Partners



Pilot plants (cGMP)


Sanofi-Pasteur/Butantan influenza vaccine tech transfer

Pharmacovigilance

GMP industrial plants

Sanofi-Pasteur

Demand pullMoH



Pilot plants (cGMP)


NIH/Butantan Dengue vaccine R&D process


Pharmacovigilance

GMP industrial plants

NIH/NIAID

Demand pullMoH/DVI



Academic interface

Pilot plants (cGMP)


Butantan pulmonary sufactant R&D process




Demand pullMoH



Academic interface

Pilot plants (cGMP)


Butantan/Cristália Silica adjuvant R&D process




Cristália

Supply push



Academic interface

Pilot plants (cGMP)


Butantan MPLA adjuvant R&D process




Supply push


• 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


Av. Vital Brasil, 1500 - ButantãSão Paulo – SPZip Code - 05503-900(+ 55 11) 2627-9300www.butantan.gov.br

Instituto Butantan | 0 October 2013. Instituto Butantan | 1 Introduction about the Instituto...

Documents

Transcript of Instituto Butantan | 0 October 2013. Instituto Butantan | 1 Introduction about the Instituto...