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111 Years Producing Immunobiologicals: New Challenges Jorge Kalil Instituto Butantan

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111 Years Producing Immunobiologicals: New Challenges Jorge Kalil Instituto Butantan Engineering Conferences International ECI Digital Archives Vaccine Technology IV Proceedings Spring 5-21-2012 111 years producing immunobiologicals: New challenges Jorge Kalil Instituto Butantan Follow this and additional works at: http://dc.engconfintl.org/vaccine_iv Part of the Biomedical Engineering and Bioengineering Commons Recommended Citation Jorge Kalil, "111 years producing immunobiologicals: New challenges" in "Vaccine Technology IV", B. Buckland, University College London, UK; J. Aunins, Janis Biologics, LLC; P. Alves , ITQB/IBET; K. Jansen, Wyeth Vaccine Research Eds, ECI Symposium Series, (2013). http://dc.engconfintl.org/vaccine_iv/6 This Conference Proceeding is brought to you for free and open access by the Proceedings at ECI Digital Archives. It has been accepted for inclusion in Vaccine Technology IV by an authorized administrator of ECI Digital Archives. For more information, please contact [email protected]. THE EFFORTS OF A PUBLIC INSTITUTE TO DEVELOP NEW VACCINES PROF . J ORGE KALIL PORTUGAL , 2012 AAGENDA OVERVIEW OF IMMUNIZATION PROGRAM IN BRAZIL AND INSTITUTO BUTANTAN BUTANTAN DEVELOPMENTS Instituto Butantan | 1 AAGENDA OVERVIEW OF IMMUNIZATION PROGRAM IN BRAZIL AND INSTITUTO BUTANTAN BUTANTAN DEVELOPMENTS Instituto Butantan | 2 THE IMPACTS OF VACCINATION IN BRAZIL Children vaccination coverage by type of vaccination Vaccination coverage in Brazil % (2000 to 2010) 120 110 100 Over 70 million 90 children successfully vaccinated in two 80 decades Implementation of the MMR vaccine and DTP + Hib vaccine 70 (tetravalent) in 100% municipalities 60 50 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 BCG MMR Hepatitis B Oral Polio Tetravalent (DTP+Hib) Rotavirus Instituto Butantan | 3 THE IMPACTS OF VACCINATION IN BRAZIL Number of cases for tetanus – accidental and neonatal Number of cases – Accidental and neonatal Tetanus Accidental Neonatal (1990 – 2010) (1983 – 2010) Cases Cases 1,800 0.500 800 1,600 700 1,400 0.400 Elimination 600 Plan 1,200 0.300 500 Strengthening 1,000 actions in areas 400 800 of potential risk 0.200 Emergency Plan for 300 600 high-risk counties 200 400 0.100 200 100 0 0.000 0 90 91 92 93 94 95 96 97 98 99 00 01 02 03 04 05 06 07 08 09 10 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 00 01 02 03 04 05 06 07 08 09 10 Number of accidental tetanus per year Number of neonatal tetanus per year Incidence per 100K inhabitants Source: Sinan/SVS/MS, data in 25/08/11Ministry of Health, Brazil , 2010. Instituto Butantan | 4 THE IMPACTS OF VACCINATION IN BRAZIL The number of severe cases and deaths due to influenza A H1N1 has been falling since March 2010 Number of severe cases and deaths due to influenza A H1N1 Brazil (2010) 80 79 12 70 65 65 10 59 Vaccination 60 campaign 8 50 47 47 42 43 40 6 34 Deaths Deaths Severe Cases Cases Severe Severe 30 27 4 21 19 20 19 20 15 17 17 17 13 10 10 10 11 10 2 10 8 1 1 0 0 0 Weeks * * epidemiological week of onset of symptoms Severe hospitalized cases of pandemic influenza (H1N1) Deaths from pandemic influenza (H1N1) Source: Sinan/SVS, Ministry of Health, Brazil , 2010. Instituto Butantan | 5 BRAZIL HAS BECOME AN INTERNATIONAL REFERENCE IN IMMUNIZATION Strategy Brazil decided in the mid 80's to become self-sufficient in vaccines and immunization programs Decision This was a State decision rather than a government decision Why Too important to depend on availability and pricing Instituto Butantan | 6 NATIONAL IMMUNIZATION PROGRAM (PNI) IN BRAZIL PNI – Founded in 1973 PNI – General Information of Brazil (2011) Smallpox Eradication Poliomyelitis 194 MM inhabitants Measles (autocne transmission) 43 types of immunobiological 26 Vaccines 13 sera from animal Neonatal tetanus 4 sera from human Under Accidental tetanus Control 77% produced in Brazil Tuberculosis Diphtheria ~ 300 MM doses of vaccines per year Pertussis 30 K vaccination rooms Hepatite B Influenza Expansion of national self-sufficiency Pneumococcus Source: SVS/Ministry of Health, National Immunizatation Program, Brazil, 2011. Instituto Butantan | 7 WHAT DO WE ARE ? BUTANTAN – A P UBLIC INSTITUTION OF THE STATE GOVERNMENT OF SÃO PAULO In 1901 Butantan was established to produce serum against the bubonic plague Vital Brazil, the first director, investigated antivenoms against snake bites Currently, Butantan is the main public producer of vaccines, antivenoms, antitoxins in Latin America Fully dedicated to develop scientific research and production of immunobiological products for public health Instituto Butantan | 8 RESEARCH & DEVELOPMENT LABORATORIES ~21 scientific labs ~180 Researchers 85% are PhD 1 Biotechnology Center Multiple laboratories 1 Hospital (10 hospital beds) 1 Central Animal Facility Training programs (PAP) Graduate studies in Toxicology Masters and PhDs Instituto Butantan | 9 SCREENING OF BIOACTIVE COMPOUNDS OF ANIMAL VENOMS Pharmacological Activities ANALGESIC ANTIINFLAMATORY ANTI -MICROBIOLOGICAL ANTI-COAGULANT ANTI-TUMORAL NERVOUS SYSTEM ACTION ANTI-VENOMS REACTIVITY ANTI-HYPERTENSION Venom Composition by Transcriptomics and Proteomics Instituto Butantan | Plasma fractioning by chromatography Plasma fractioning by chromatography Instituto Butantan | INDUSTRIAL COMPLEX 7 Main Industrial Plants (Buildings) Anaerobic vaccines ( tetanus and botulinic ) and Anatoxin Purification Biological control Aerobic Vaccine (Diphtheria and Pertussis ) Hepatitis Influenza Rabies Blood Products (under construction) Control, Serums, Formulation and Filling 6 Pilot Plants Dengue / Rotavírus (Under Construction) Recombinant (BCG) Monoclonal Antibodies Influenza Blood Products Instituto Butantan | 12 WHAT DO WE DO ? NATIONAL SUPPLIERS OF VACCINES FOR THE MINISTRY OF HEALTH ‘Market Share’ per Suppliers (1) Products (Vaccines) (2010) FUNED 3% FAP 4% DTP DT dT Butantan Biomanguinhos 51% 42% Rabies Hepatitis B Note: Part of Butantan’s production was sent to other Influenza Institutes, such as Biomanguinhos. Not computed in the (Flu) analysis 1Source: Ministry of Health, 2010 Instituto Butantan | 13 WHAT DO WE DO ? NATIONAL SUPPLIERS OF ANTIVENOMS AND ANTITOXINS FOR THE MINISTRY OF HEALTH ‘Market Share’ per Suppliers (1) Products (Sera) (2010) Snakes AV IVB 25% Butantan Scorpion AV Spider AV Caterpillar AV 56% FUNED 19% Tetanus AT Diphitheria AT AntiRabies Note: Part of Butantan’s production was sent to other Institutes, such as FUNED and CPPI. Not computed in the analysis Botulism AB & E 1Source: Ministry of Health, 2010 Instituto Butantan | 14 VACCINES WITH EXTERNAL COOPERATION Cooperation Projects NIH-PATH Rotavirus (pentavalent) NIH-DVI Dengue (tetravalent) Sabin Vaccine Institute - George Washington University Necator - Schistosoma Children’s Hospital Harvard - PATH Pneumococcus (cellular) Infectious Diseases Research Institute Visceral Leishmaniosis (for dogs) Ludwig Institute for Cancer Research Adjuvant for ovarian cancer BR Foods Lung Surfactant Recombinant OncoBCG for bladder Universidade de São Paulo – Medical School cancer Institut Pasteur – Paris / Novartis - Siena / Recombinant BCG-Pertussis Albert Einstein College of Medicine Instituto Butantan | 15 AAGENDA OVERVIEW OF IMMUNIZATION PROGRAM IN BRAZIL AND INSTITUTO BUTANTAN BUTANTAN DEVELOPMENTS Instituto Butantan | 16 WHAT DO WE WANT TO DO ? Presentation and discussion of vaccines projects Area Vaccines Projects 1 Vaccines - Research and Pertussis low improvemen t Adjuvant Bp MPLA Recombinant onco BCG Silica nanostructure mesoporous – vaccine antigens encapsulated Vaccines - Collaborative Rotavirus (pentavalent) development Dengue (tetravalent) Streptococcus pneumoniae (cellular - SPWCV) BCG-Pertussis Vaccines – Basics R&D Leptospira Techtransfer Several vaccines under negociation 1 Not exhaustive Instituto Butantan | 17 Pertussis low vaccine Product - Pertussis low vaccine Butantan – Composition Challenges: – B.pertussis whole cell with lower content of – Scale-up LPS Production Technology Objectives: – Organic extraction of the cells to reduce LPS – To make available an alternative vaccine for content immunization of children, adolescent, pregnant women and adults ~ 70% reduction of LPS – “in line ” process without additional costs Phase of Development – Pre-clinical studies performed in Butantan and in the Netherlands Institute Vaccine (NIV) – Phase I (2012) – Brazil Instituto Butantan | 18 Pertussis low vaccine - technical and scientific aspects New developments in Pertussis Vaccines with Appropriate technologies ® = Patents Whole Cell Pertussis Vaccine Whole Cell Pertussis ~ 70% reduction of LPS Less reactogenic Low LPS content Low cost B. pertussis WCP WCP ® fermentation low Tangential Organic filtration extraction Instituto Butantan | Adjuvant – Monophosphoryl lipid A ( Bp MPLA) Product - Monophosphoryl lipid A ( Bp MPLA) Butantan – Composition Challenges: – Bp MPLA derived from LPS of B.pertussis – Scale-up Production Technology Objectives: – Purification of B.pertussis followed by LPS – To optimize immunolgical response of pre- hydrolises exisiting and new vaccines Phase of Development – To increase production capacity – Scale-up Bp MPLA – Clinical trial Pandemic H1N1 + BpMPLA – Pre-clinical Human rabies – Animal Study Dog Leishimania – In development Hepatites B + BpMPLA Seazonal Influenza + BpMPLA Instituto Butantan | 20 Recombinant BCG-Pertussis Neonate vaccine / Onco BCG for Bladder cancer Product - Recombinant BCG – Pertussis Butantan – Composition Challenges: – Recombinant BCG strain expressing the S1 – To produce the vaccine by fermentation
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