A apresentação está carregando. Por favor, espere

A apresentação está carregando. Por favor, espere

Experiências Nacionais e Desafios no Desenvolvimento de Novas Tecnologias Preventivas e Terapêuticas Pesquisa em Vacina Anti-HIV: Questões Éticas e Regulatórias.

Apresentações semelhantes


Apresentação em tema: "Experiências Nacionais e Desafios no Desenvolvimento de Novas Tecnologias Preventivas e Terapêuticas Pesquisa em Vacina Anti-HIV: Questões Éticas e Regulatórias."— Transcrição da apresentação:

1 Experiências Nacionais e Desafios no Desenvolvimento de Novas Tecnologias Preventivas e Terapêuticas Pesquisa em Vacina Anti-HIV: Questões Éticas e Regulatórias Celio L Silva Brasília, Outubro 2006

2 Modern vaccines Antigens Delivery systems Pre-clinical and clinical studies Profilactic or therapeutic vaccine efficacy Regulation Academy Company Scalle up Quality Control Immune potentiators or immune regulators (Adjuvants)

3 Modern vaccines Antigens Delivery systems Pre-clinical and clinical studies Profilactic or therapeutic vaccine efficacy Regulation Academy Company Scalle up Quality Control Immune potentiators or immune regulators (Adjuvants) NBR ISO IEC 17025

4 Platforms for R&D&I Infrastructure Human resources Technological capabilities Academy (REDE TB and CPT) Company (Farmacore) Regulation Technological platform for R&D&I NBR ISO IEC Institutional organization

5 Modern vaccines Antigens Delivery systems Pre-clinical and clinical studies Profilactic or therapeutic vaccine efficacy Regulation Academy Company Immune potentiators or immune regulators (Adjuvants) Scalle up Quality Control NBR ISO IEC 17025

6 Th2 Humoral I.R. Th1 Cellular I.R. Immuno modulators or imuno potentiators ADJUVANTS Heat Shock Proteins (HSPs) CpGs ODN TDM KLK Liposomes Water-in-oil emulsion NBR ISO IEC 17025

7 HSPs-Peptide complex PEPTIDE Tumoral Viral Bacterial Fúngal Protection against Cancer Infectious diseases HSP Nature Reviews Immunology 2002 NBR ISO IEC 17025

8 Viral peptides chaperoned by Heat Shock Proteins (HSPs) DNAhsp65 1.Phase I/II clinical trial of DNAhsp65 in patients coinfected with HIV/TB, especially those in advanced immunodeficiency status and non-responsive to antiretroviral regimens 2.Evaluate the ability of DCs pulsated with inactivated virus and stimulated with DNAhsp65 to enhance specific and unspecific anti-HIV immune response. Therapeutical vaccine Immunological mediators NBR ISO IEC 17025

9 Modern vaccines Antigens Pre-clinical and clinical studies Profilactic or therapeutic vaccine efficacy Regulation Academy Company Scalle up Delivery systems Immune potentiators or immune regulators (Adjuvants) Quality Control NBR ISO IEC 17025

10 Delivery systems NBR ISO IEC 17025

11 Liposomes SUV LUV MLV SUV LUV MLV SUV 25 – 100 nm 20 nm – 3  m DNA vaccine: gD-p24(Gag) DNA vaccine: p24(Gag)-hsp65 Mucosal administration NBR ISO IEC 17025

12 days 100% 75% 50% 25% DNA Protein Prime Booster Single dose vaccines using “prime – boost” concept Fast release - daysSlow release – weeks to months PRIMEBOOSTER DNAgD-p24(Gag) recombinant Protein p24 DNAgD-p24(Gag) rp24(Gag) NBR ISO IEC 17025

13 Modern vaccines Antigens Pre-clinical and clinical studies Profilactic or therapeutic vaccine efficacy Regulation Academy Company Scalle up Delivery systems Immune potentiators or immune regulators (Adjuvants) Quality Control NBR ISO IEC 17025

14 Production of pilot lots in GMP conditions Upstream Downstream NBR ISO IEC DNAhsp65 and rhsp65 produced in GMP

15 Production of Delivery Systems in GLP conditions PLGA microspheres Liposomes NBR ISO IEC 17025

16 Modern vaccines Antigens Pre-clinical and clinical studies Profilactic or therapeutic vaccine efficacy Regulation Academy Company Scalle up Delivery systems Immune potentiators or immune regulators (Adjuvants) Quality Control NBR ISO IEC 17025

17 Quality Control NBR ISO IEC 17025

18 Modern vaccines Antigens Pre-clinical and clinical studies Profilactic or therapeutic vaccine efficacy Regulation Academy Company Scalle up Delivery systems Immune potentiators or immune regulators (Adjuvants) Quality Control NBR ISO IEC 17025

19 NBR ISO IEC Guidelines for Nonclinical Safety Assessment

20 Nonclinical Toxicity Studies NBR ISO IEC 17025

21 Types of Nonclinical Toxicity Studies NBR ISO IEC 17025

22 Modern vaccines Antigens Delivery systems Pre-clinical and clinical studies Profilactic or therapeutic vaccine efficacy Regulation Academy Company Scalle up Quality Control Immune potentiators or immune regulators (Adjuvants)

23 Certification BPL NRB ISO/IEC 17025:2005 Boas Práticas de Laboratório Organização dos processos e das condições sob as quais os ensaios serão: Planejados; Executados; Monitorados; Registrados, Relatados Exigências Regulatórias Nacionais e Internacionais: ANVISA INMETRO FDA (USA) CE (EUROPA) NBR ISO IEC 17025

24 Boas Práticas de Laboratório Certificações CERTIFICAÇÕES Eficácia e Segurança Facilidades para registro de Produtos Diferencial competitivo Adequação ao mercado internacional NBR ISO IEC 17025

25 Agradecimentos


Carregar ppt "Experiências Nacionais e Desafios no Desenvolvimento de Novas Tecnologias Preventivas e Terapêuticas Pesquisa em Vacina Anti-HIV: Questões Éticas e Regulatórias."

Apresentações semelhantes


Anúncios Google