2005 4-k o'connell whats special about c10 MSD Finca Productiva Salud Del Hato

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MSD Finca Productiva Salud Del Hato

MSD Finca Productiva Salud Del Hato

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  • 1. THE COVEXIN 10 STORY WHAT’S SO SPECIAL ABOUT COVEXIN 10?
  • 2. WHAT’S SO SPECIAL ABOUT COVEXIN 10
    • Adjuvant
      • 2 weeks of age
      • 3 months of age
      • 6 months of age
      • Sheep or cattle
      • 1 or 2 ml dose
      • Proven passive transfer
      • Proven to overcome maternal interference
      • Proven 1 year DOI
      • Single 1 or 2 ml dose for annual boost
      • 10 Clostridials per single dose
  • 3. Aluminium Adjuvants
    • Point of Zero Charge
    • Aluminium Hydroxide 9.5 – 12.1
    • Aluminium Phosphate 4.6 – 4.7
  • 4. How Does PZC Affect an Aluminum Adjuvant PZC pH +
  • 5. How Does PZC Affect an Adjuvant pH 7.2 pH AlOOH PZC 9.5+ Alum PZC 4.5+ Point at Which Typical Vaccines are Blended + +
  • 6. How Does PZC Affect an Adjuvant pH 7.2 pH AlOOH PZC 9.5+ Alum PZC 4.5+ Point at Which Typical Vaccines are Blended Protein of Interest PZC 5.5 0 + + +
  • 7. How Does PZC Affect an Adjuvant pH 7.2 pH AlOOH PZC 9.5+ Alum PZC 4.5+ Point at Which Typical Vaccines are Blended Protein of Interest PZC 7.8 + + +
  • 8. Aluminum Hydroxide Clostridial Toxoids Clostridial Toxoids Alum Blending Blending Al 3+ Al 3+ Al 3+ Al 3+ Al 3+ Al 3+ Al 3+ Al 3+ Al 3+ Al 3+
  • 9. Alum vs. Aluminum Hydroxide
    • Alum in Covexin 10
      • Very efficient process
      • Precipitated in presence of toxoids so more antigen can be associated (trapped) in the gel
      • Not as affected by charge interference as proteins are trapped, not bound solely by charge
      • Better stability of proteins
      • Positively charged toxoids can still be trapped in the matrix and associated with the adjuvant
      • Can be autoclaved or filter sterilized on-site prior to blending with no effect on the adjuvant properties.
      • Extremely higher potency
      • Blending involves a large drop in pH which can be denaturing to the proteins, this has pros and cons.
    • Aluminum Hydroxide
      • Passive process – Relies on interaction between charge groups.
      • Like charges repel each other. Limited amount of binding to adjuvant due to charge interference
      • A lot of toxoids in clostridial vaccines will not be bound to the adjuvant because of steric hindrance
      • Requires that all antigens be negatively charged to stick to the adjuvant. Toxoids having a net positive charge will be repelled.
      • Preformed prior to blending and must be re-sterilized by heat. This process alters the adjuvant properties and is not consistent from batch to batch.
      • Blending can be done without a change in pH, but more optimal binding can occur with a drop in pH during blending, depending upon the pI of proteins of importance.
  • 10. WHAT’S SO SPECIAL ABOUT COVEXIN 10
    • Adjuvant
    • Higher potency than competitors, even our own.
  • 11. CLOSTRIDIAL VACCINE POTENCY Time Potency 3 yrs 6 mos Required potency
  • 12. CLOSTRIDIAL VACCINE POTENCY
  • 13. CLOSTRIDIAL VACCINE POTENCY Time Potency 3 yrs 6 mos Required potency
  • 14. CLOSTRIDIAL VACCINE POTENCY Time Potency 3 yrs 6 mos New Potency Level
  • 15. RESULTING RELEASE LEVELS ≥ 2.5 U/ml ≥ 4.6 U/ml C. septicum ≥ 1.0 U/ml ≥ 6.6 U/ml C. sordelli ≥ 2.5 U/ml ≥ 4.9 U/ml C. tetani ≥ 3.5 U/ml ≥ 6.0 U/ml C. novyi B ≥ 10.0 U/ml ≥ 11.7 U/ml C. haemolyticum Ph Eur pass Ph Eur pass C. chauvoei ≥ 5.0 IU/ml ≥ 5.3 IU/ml C. perfringens D ≥ 10.0 IU/ml ≥ 18.2 IU/ml C. perfringens B & C ≥ 0.5 U/ml ≥ 0.5 U/ml C. perfringens A Potency: EU Pharm Release Specification Covexin 10 Release specification Component
  • 16. HOW DOES THIS HELP?
  • 17. EU MARKET COMPARISON TRIALS
    • Are our vaccines really that good?
    • Trials planned for 2005 in Spain
  • 18. HOW THE TNT TEST WORKS Serum + Serum Toxin (10 Units) = All toxin neutralized ≥ 10 Antitoxin Units Mouse dead ≤ 10 Antitoxin Units
  • 19. How Do We Stack Up Against the Leading Competitor?
  • 20. How Do We Stack Up Against the Leading Competitor?
  • 21. How Do We Stack Up Against the Leading Competitor?
  • 22. How Do We Stack Up Against the Leading Competitor?
  • 23. How Do We Stack Up Against the Leading Competitor?
  • 24. WHAT’S SO SPECIAL ABOUT COVEXIN 10?
    • Manufactured in NZ using NZ ingredients
  • 25. WHAT’S SO SPECIAL ABOUT COVEXIN 10?
    • Manufactured in NZ using NZ ingredients
  • 26. WHAT’S SO SPECIAL ABOUT COVEXIN 10?
    • Manufactured in NZ using NZ ingredients
    • Media Production Plant on site
  • 27. WHAT’S SO SPECIAL ABOUT COVEXIN 10?
    • Manufactured in NZ using NZ ingredients
    • Media Production Plant on site
    • Continuous flow “Flash” steriliser
  • 28. WHAT’S SO SPECIAL ABOUT COVEXIN 10?
    • Manufactured in NZ using NZ ingredients
    • Media Production Plant on site
    • Continuous flow “Flash” steriliser
    • 4000L scale fermenters
  • 29. WHAT’S SO SPECIAL ABOUT COVEXIN 10?
    • Manufactured in NZ using NZ ingredients
    • Media Production Plant on site
    • Continuous flow “Flash” steriliser
    • 4000L scale fermenters
    • Computer controlled fermentations
  • 30. WHAT’S SO SPECIAL ABOUT COVEXIN 10?
    • Manufactured in NZ using NZ ingredients
    • Media Production Plant on site
    • Continuous flow “Flash” steriliser
    • 4000L scale fermenters
    • Computer controlled fermentations
    • Toxin production monitored though a unique liquid chromatography process
  • 31. WHAT’S SO SPECIAL ABOUT COVEXIN 10?
    • Manufactured in NZ using NZ ingredients
    • Media Production Plant on site
    • Continuous flow “Flash” steriliser
    • 4000L scale fermenters
    • Computer controlled fermentations
    • Toxin production monitored though a unique liquid chromatography process
    • Continuous feed centrifugation
  • 32. WHAT’S SO SPECIAL ABOUT COVEXIN 10?
    • Ultrafiltration/Diafiltration process
  • 33. WHAT’S SO SPECIAL ABOUT COVEXIN 10?
    • Ultrafiltration/Diafiltration process
    • 6000L blending vessels
  • 34. WHY IS COVEXIN 10 BETTER THAN ULTRAVAC, ETC
    • New technology
    • 2 week age claim
    • Neonatal coverage
    • Proven to work in the face of maternal interference
    • NZ ingredients/manufacturing
    • Low dose/less crap in the vaccine
    • Cell free (except for C. chauvoei)
    • Complete Coverage for all possible clostridia
    • Meets modern regulatory requirements