1 / 22

October 2013

October 2013. OUTLINE. Introduction about the Instituto Butantan Infrastructure at Instituto Butantan Translational medicine at Instituto Butantan. ABOUT US. The Instituto Butantan is a biomedical research and biological product manufacturing center founded in 1901.

yin
Télécharger la présentation

October 2013

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. October 2013

  2. OUTLINE • Introduction about the Instituto Butantan • Infrastructure at Instituto Butantan • Translational medicine at 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”

  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

  5. OUR PRODUCTS – Sera and immunoglobulins 400.000 vials per year

  6. OUR PRODUCTS – vaccines 150 millions of doses per year

  7. PIPELINE PRODUCTS In partnership with other manufacturers and institutions > 50 PATENTS

  8. OUTLINE • Introduction about the Instituto Butantan • Infrastructure at Instituto Butantan • Translational medicine at Instituto Butantan

  9. 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) 8

  10. 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

  11. 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 10

  12. Diffusion and Culture • 4 Museums • 300.000 visitors per yeas • Didactic materials • Courses and trainings 11

  13. OUTLINE • Introduction about the Instituto Butantan • Infrastructure at Instituto Butantan • Translational medicine at Instituto Butantan

  14. R&D of new products • Demand pull Product life cycle Technology Transformation Idea Tech. R&D Candidate Product R&D Product • Supply push

  15. R&D infrastructure at InstitutoButantan • Partners Technology Transformation Product life cycle GMP industrial plants Pre-clinical GLP labs Pilot plants (cGMP) Pharmacovigilance Basic research labs Academic interface Clinical trial sponsor Clinical trial sponsor • Partners

  16. Sanofi-Pasteur/Butantan influenza vaccine tech transfer • Demand pull • MoH • Sanofi-Pasteur Technology Transformation Product life cycle GMP industrial plants Pilot plants (cGMP) Pharmacovigilance Clinical trial sponsor

  17. NIH/Butantan Dengue vaccine R&D process • Demand pull • MoH/DVI Technology Transformation Product life cycle GMP industrial plants Pilot plants (cGMP) Pharmacovigilance Clinical trial sponsor Clinical trial sponsor • NIH/NIAID

  18. Butantan pulmonary sufactant R&D process • Demand pull • MoH Technology Transformation Product life cycle GMP industrial plants Pre-clinical GLP labs Pilot plants (cGMP) Pharmacovigilance Basic research labs Academic interface Clinical trial sponsor Clinical trial sponsor

  19. Butantan/Cristália Silica adjuvant R&D process Technology Transformation Product life cycle GMP industrial plants Pre-clinical GLP labs Pilot plants (cGMP) Pharmacovigilance Basic research labs Academic interface Clinical trial sponsor Clinical trial sponsor • Supply push • Cristália

  20. Butantan MPLA adjuvant R&D process Technology Transformation Product life cycle GMP industrial plants Pre-clinical GLP labs Pilot plants (cGMP) Pharmacovigilance Basic research labs Academic interface Clinical trial sponsor Clinical trial sponsor • Supply push

  21. 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

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

More Related