2005 4-k o'connell whats special about c10 MSD Finca Productiva Salud Del Hato
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Transcript of 2005 4-k o'connell whats special about c10 MSD Finca Productiva Salud Del Hato
THE COVEXIN 10 STORYTHE COVEXIN 10 STORY
WHAT’S SO SPECIAL WHAT’S SO SPECIAL ABOUT COVEXIN 10?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
AlOOHPZC 9.5+
+
AlumPZC 4.5+
+
Point at Which TypicalVaccines are Blended
How Does PZC Affect an Adjuvant
pH 7.2
pH
AlOOHPZC 9.5+
+
AlumPZC 4.5+
+
Point at Which TypicalVaccines are Blended
Protein of Interest
+ PZC 5.5
0
How Does PZC Affect an Adjuvant
pH 7.2
pH
AlOOHPZC 9.5+
AlumPZC 4.5+
Point at Which TypicalVaccines are Blended
Protein of Interest+ PZC 7.8
+
+
Al3+
Al3+
Al3+
Al3+
Aluminum Hydroxide
Al3+
Clostridial Toxoids
Al3+
Al3+
Al3+
Al3+
Al3+
Clostridial ToxoidsAlum
Blending Blending
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
Pot
ency
3 yrs6 mosRequiredpotency
CLOSTRIDIAL VACCINE CLOSTRIDIAL VACCINE POTENCYPOTENCY
C. sordellii
0.0
5.0
10.0
15.0
0 10 20 30
Months
An
tib
od
y
resp
on
se (
U/m
L)
363028 1 st te st
363028 2nd te st
C. sordellii
0.0
5.0
10.0
15.0
0 10 20 30Months
An
tib
od
y
resp
on
se (
U/m
L)
363027 1 st te st
363027 2nd te st
CLOSTRIDIAL VACCINE POTENCY
Time
Pot
ency
3 yrs6 mosRequiredpotency
CLOSTRIDIAL VACCINE POTENCY
Time
Pot
ency
3 yrs6 mos
New PotencyLevel
RESULTING RELEASE LEVELSRESULTING RELEASE LEVELS
≥ 2.5 U/ml≥ 4.6 U/mlC. septicum
≥ 1.0 U/ml≥ 6.6 U/mlC. sordelli
≥ 2.5 U/ml≥ 4.9 U/mlC. tetani
≥ 3.5 U/ml≥ 6.0 U/mlC. novyi B
≥ 10.0 U/ml≥ 11.7 U/mlC. haemolyticum
Ph Eur passPh Eur passC. chauvoei
≥ 5.0 IU/ml≥ 5.3 IU/mlC. perfringens D
≥ 10.0 IU/ml≥18.2 IU/mlC. perfringens B & C
≥ 0.5 U/ml≥ 0.5 U/mlC. perfringens A
Potency:
EU Pharm Release Specification
Covexin 10 Release specification
Component
HOW DOES THIS HELP?Immune Response in Cattle to C. perfringens D antigen in different formulations
Day0 V1+Day28 V2+14 V2+14+1m V2+14+2m
Days
Uni
ts/m
L
SecondVaccination
MinimumPotency Level
FirstVaccination
EU MARKET COMPARISON EU MARKET COMPARISON TRIALSTRIALS
• Are our vaccines really that good?• Trials planned for 2005 in Spain
HOW THE TNT TEST WORKSHOW 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 How Do We Stack Up Against the Leading Competitor?Leading Competitor?
Level of Protection For C. perf type C After Vaccination
0
2
4
6
8
10
Covexin 8 Vision 8
Nu
mb
er o
f C
alve
s O
ffer
ing
P
rote
ctio
n A
fter
Ch
alle
ng
e
10 IU ToxinChallenge
How Do We Stack Up Against the How Do We Stack Up Against the Leading Competitor?Leading Competitor?
Level of Protection For C. perf type C After Vaccination
0
2
4
6
8
10
Covexin 8 Vision 8
Nu
mb
er o
f C
alve
s O
ffer
ing
P
rote
ctio
n F
rom
Ch
alle
ng
e
5 IU ToxinChallenge
How Do We Stack Up Against the How Do We Stack Up Against the Leading Competitor?Leading Competitor?
Level of Protection For C. perf type D After Vaccination
0
2
4
6
8
10
Covexin 8 Vision 8
Nu
mb
er o
f C
alve
s O
ffer
ing
P
rote
ctio
n F
rom
Ch
alle
ng
e
2 IU ToxinChallenge
How Do We Stack Up Against the How Do We Stack Up Against the Leading Competitor?Leading Competitor?
Level of Protection for C. perf type D After Vaccination
0
2
4
6
8
10
Covexin 8 Vision 8
Nu
mb
er o
f C
alve
s O
ffer
ing
P
rote
ctio
n F
rom
Ch
alle
ng
e
1 IU ToxinChallenge
How Do We Stack Up Against the How Do We Stack Up Against the Leading Competitor?Leading Competitor?
Level of Protection For C. novyi After Vaccination
0123456789
10
Covexin 8 Vision 8
Nu
mb
er o
f C
alve
s O
ffer
ing
P
rote
ctio
n F
rom
Ch
alle
ng
e
0.5 U/mL ToxinChallenge
WHAT’S SO SPECIAL ABOUT WHAT’S SO SPECIAL ABOUT COVEXIN 10?COVEXIN 10?
• Manufactured in NZ using NZ Manufactured in NZ using NZ ingredientsingredients
WHAT’S SO SPECIAL ABOUT WHAT’S SO SPECIAL ABOUT COVEXIN 10?COVEXIN 10?
• Manufactured in NZ using NZ Manufactured in NZ using NZ ingredientsingredients
WHAT’S SO SPECIAL ABOUT WHAT’S SO SPECIAL ABOUT COVEXIN 10?COVEXIN 10?
• Manufactured in NZ using NZ Manufactured in NZ using NZ ingredientsingredients
• Media Production Plant on siteMedia Production Plant on site
WHAT’S SO SPECIAL ABOUT WHAT’S SO SPECIAL ABOUT COVEXIN 10?COVEXIN 10?
• Manufactured in NZ using NZ Manufactured in NZ using NZ ingredientsingredients
• Media Production Plant on siteMedia Production Plant on site• Continuous flow “Flash” steriliserContinuous flow “Flash” steriliser
WHAT’S SO SPECIAL ABOUT WHAT’S SO SPECIAL ABOUT COVEXIN 10?COVEXIN 10?
• Manufactured in NZ using NZ Manufactured in NZ using NZ ingredientsingredients
• Media Production Plant on siteMedia Production Plant on site• Continuous flow “Flash” steriliserContinuous flow “Flash” steriliser• 4000L scale fermenters4000L scale fermenters
WHAT’S SO SPECIAL ABOUT WHAT’S SO SPECIAL ABOUT COVEXIN 10?COVEXIN 10?
• Manufactured in NZ using NZ Manufactured in NZ using NZ ingredientsingredients
• Media Production Plant on siteMedia Production Plant on site• Continuous flow “Flash” steriliserContinuous flow “Flash” steriliser• 4000L scale fermenters4000L scale fermenters• Computer controlled fermentationsComputer controlled fermentations
WHAT’S SO SPECIAL ABOUT WHAT’S SO SPECIAL ABOUT COVEXIN 10?COVEXIN 10?
• Manufactured in NZ using NZ Manufactured in NZ using NZ ingredientsingredients
• Media Production Plant on siteMedia Production Plant on site• Continuous flow “Flash” steriliserContinuous flow “Flash” steriliser• 4000L scale fermenters4000L scale fermenters• Computer controlled fermentationsComputer controlled fermentations• Toxin production monitored though a Toxin production monitored though a
unique liquid chromatography processunique liquid chromatography process
WHAT’S SO SPECIAL ABOUT WHAT’S SO SPECIAL ABOUT COVEXIN 10?COVEXIN 10?
• Manufactured in NZ using NZ ingredientsManufactured in NZ using NZ ingredients• Media Production Plant on siteMedia Production Plant on site• Continuous flow “Flash” steriliserContinuous flow “Flash” steriliser• 4000L scale fermenters4000L scale fermenters• Computer controlled fermentationsComputer controlled fermentations• Toxin production monitored though a unique Toxin production monitored though a unique
liquid chromatography processliquid chromatography process• Continuous feed centrifugationContinuous feed centrifugation
WHAT’S SO SPECIAL ABOUT WHAT’S SO SPECIAL ABOUT COVEXIN 10?COVEXIN 10?
• Ultrafiltration/Diafiltration processUltrafiltration/Diafiltration process
WHAT’S SO SPECIAL ABOUT WHAT’S SO SPECIAL ABOUT COVEXIN 10?COVEXIN 10?
• Ultrafiltration/Diafiltration processUltrafiltration/Diafiltration process• 6000L blending vessels6000L blending vessels
WHY IS COVEXIN 10 BETTER WHY IS COVEXIN 10 BETTER THAN ULTRAVAC, ETCTHAN ULTRAVAC, ETC
• New technologyNew technology• 2 week age claim2 week age claim• Neonatal coverageNeonatal coverage• Proven to work in the face of maternal Proven to work in the face of maternal
interferenceinterference• NZ ingredients/manufacturingNZ ingredients/manufacturing• Low dose/less crap in the vaccineLow dose/less crap in the vaccine• Cell free (except for C. chauvoei)Cell free (except for C. chauvoei)• Complete Coverage for all possible clostridiaComplete Coverage for all possible clostridia• Meets modern regulatory requirementsMeets modern regulatory requirements