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

    • THE COVEXIN 10 STORY WHAT’S SO SPECIAL ABOUT COVEXIN 10?
    • 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
    • Aluminium Adjuvants
      • Point of Zero Charge
      • Aluminium Hydroxide 9.5 – 12.1
      • Aluminium Phosphate 4.6 – 4.7
    • How Does PZC Affect an Aluminum Adjuvant PZC pH +
    • 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 + +
    • 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 + + +
    • 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 + + +
    • 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+
    • 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.
    • WHAT’S SO SPECIAL ABOUT COVEXIN 10
      • Adjuvant
      • Higher potency than competitors, even our own.
    • CLOSTRIDIAL VACCINE POTENCY Time Potency 3 yrs 6 mos Required potency
    • CLOSTRIDIAL VACCINE POTENCY
    • CLOSTRIDIAL VACCINE POTENCY Time Potency 3 yrs 6 mos Required potency
    • CLOSTRIDIAL VACCINE POTENCY Time Potency 3 yrs 6 mos New Potency Level
    • 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
    • HOW DOES THIS HELP?
    • EU MARKET COMPARISON TRIALS
      • Are our vaccines really that good?
      • Trials planned for 2005 in Spain
    • HOW THE TNT TEST WORKS Serum + Serum Toxin (10 Units) = All toxin neutralized ≥ 10 Antitoxin Units Mouse dead ≤ 10 Antitoxin Units
    • How Do We Stack Up Against the Leading Competitor?
    • How Do We Stack Up Against the Leading Competitor?
    • How Do We Stack Up Against the Leading Competitor?
    • How Do We Stack Up Against the Leading Competitor?
    • How Do We Stack Up Against the Leading Competitor?
    • WHAT’S SO SPECIAL ABOUT COVEXIN 10?
      • Manufactured in NZ using NZ ingredients
    • WHAT’S SO SPECIAL ABOUT COVEXIN 10?
      • Manufactured in NZ using NZ ingredients
    • WHAT’S SO SPECIAL ABOUT COVEXIN 10?
      • Manufactured in NZ using NZ ingredients
      • Media Production Plant on site
    • WHAT’S SO SPECIAL ABOUT COVEXIN 10?
      • Manufactured in NZ using NZ ingredients
      • Media Production Plant on site
      • Continuous flow “Flash” steriliser
    • 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
    • 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
    • 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
    • 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
    • WHAT’S SO SPECIAL ABOUT COVEXIN 10?
      • Ultrafiltration/Diafiltration process
    • WHAT’S SO SPECIAL ABOUT COVEXIN 10?
      • Ultrafiltration/Diafiltration process
      • 6000L blending vessels
    • 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