Section XII Vaccines: Making difference on reduction ...metrologia.org.br/eventos/pan2018_palestras/SECTION...Instituto Butantan | 17 Bothrops jararaca sera potency by ToBI test -

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Section XII ndash Vaccines Making difference on reduction

Chair Patriacutecia dos Santos Carneiro

(Instituto Butantan SP)

Patriacutecia dos Santos Carneiro PhD

Manager of Quality Control and

Analytical Development

Aug 24 2018

Alternative methods insertion

into the QC lab routine status

and challenges

Instituto Butantan | 2

Butantan Institute 116 years old of history

wwwbutantangovbr

bull Since 1901

bull Responsible for the majority of sera and vaccines used

in Brazil

All Butantan Institute production is sent to PNI ndash Ministry of

Health in order to comply with national demand


- The National Immunization Program (PNI) in Brazil is

an international reference for public health policy

- It was created in 1973 and the program seeks social

inclusion

- All Brazilians have free access to all vaccines

recommended by the World Health Organization (WHO)

Brazilian Immunization Programe (PNI )


- ANVISA (National Health Surveillance Agency) - NRA

- Butantan has GMP certifications for API (active pharmaceutical input)

for vaccines and sera lines

- Butantan has GMP certifications for two pharmaceutical forms

solutions and suspensions of sterile small volume parenteral

solutions

- Waiting for WHO inspection ndash PQ Influenza Seasonal Vaccine

GMP Certifications ndash ANVISAWHO


Butantan Institute hyperimmune sera portfolio

13 immunoglobulins

400000 vialsyear


Butantan Institute vaccines portfolio

Ongoing

Dengue

Pandemic Influenza

Quadrivalent

Influenza rBCG

DTPHB HPV DTPa

HepA mAbs

6 vaccines of the national calendar

150 million dosesyear

Instituto Butantan |

Human resources team training (multidisciplinary training including

management and innovation) dedicated group to AM and talent setting

(attractive remuneration)

Infrastructure academia-industry interaction (transfer and commercialization

of technologies import process) technological support structures (reference

centers) and technological services (conformity assessment)

Investments financing (irregularity discontinuity) and investment in RampDampI

(tax exemption and import)

Source Agecircncia Brasileira de Desenvolvimento Industrial 2012

Alternative methods - challenges


Regulatory approval

Alternative methods


Alternative methods ndash Regulatory proposal

Associated

Labs -

RENAMA

BRACVAM CONCEAANVISA and Br Ph

propose submit recommends

approves recognizesdevelopment

validation


3Rs iniciatives in Butantan Institute

Alternative methods can be defined as any method that can be used to

replace reduce or refine the use of animal in biomedical research

testing or teaching


J Virol Methods 2008 Dec154(1-2)7-13 doi 101016jjviromet200809010 Epub 2008 Oct 30

Validation of a virus neutralization potency test in BHK-21 cells for rabies

immunoglobulins in a two-center study

de Moura WC1 Gallina NM Fuches RM Romijn PC Leite JP

In vitro test (RFFIT) in rabies serum - Replacement

Save 600 mice per batch


Tetanus antitoxin potency by ToBI test - Replacement

Po

ten

cy

(UI

mL

)

Samples

-- In vivo--In vitro

Correl = 094

0

500

1000

1500

2000

2500

3000

1 2 3 4 5 6 7 8 9 10 11 12

Tetanus Antitoxin



Single bleeding for both fractions - ReduceRefinement

Animal reduction proposal bleeding at 6 weeks for both D and T fractions

D for dT

D for DTP

T for dT and DTP

Change Control CMCB-0012418 approved in 07 may 18

Save 6 guinea-pig per batch


0

2

4

6

8

10

12

1 2 3 4 5 6 7 8 9 10 11

In vivo In vitro

14

dT DT DTP and DTPHB vaccines Diphtheria fraction potency analysis in vitro and in vivo - Replacement

-- In vivo -- In vitro

R=098P

ote

nc

y(U

Im

L)

Correl = 098



dT DT DTP and DTPHB vaccines Tetanus fraction potency analysis in vitro and in vivo - Replacement

0

2

4

6

8

10

12

14

16

0 1 2 3 4 5 6


Po

ten

cy

(UI

mL

)

Correl = 099



LAL method for endotoxin quantification in hyperimmune sera -

Replacement

0 1 2 3 4 5 6 7 800

05

10

15

LPS standard [UEmL]

Tem

pera

ture

[C

els

ius d

eg

ree]

110

120

-100

-50

00

100

200

300

+ 10UEmL

+ 1UEml

+ 01UEml

+ 001UEml

LP

S r

eco

very

[

]

LPS standard curveIn

viv

oIn

vit

ro -

LA

L

Save 6-16 rabbits per batch


Bothrops jararaca sera potency by ToBI test - Replacement

Correl = 093



Other 3Rs iniciatives in Butantan InstituteReplacement

On going in developmentinternal validation phase

MAT ndash Monocyte Activation Test (consortium by RENAMA)

Diphteria sera potency by ToBI test

Rabies potency test by ELISA (glycoproteinanti-glycoprotein)

Abnormal toxicity test banishment (already done for Influenza vaccine ndash 70 millions doses per year) on going for other

vaccines already registered (DTP DT dT HepB)


Other 3Rs iniciatives in Butantan Institute Refinement

Previous anesthesia to intracerebral challenge for

rabies and pertussis vaccines testsChange Control CMCB-0013418 approved in 14 ago 18 and

just implemented

End point to tetanus rabies and pertussis tests

Change Control CMCB-0011618 approved in 23 march 18 and

just implemented



Pool for pyrogen and potency tests in antitoxins bulk

ready-to-fillChange Control CMCB-0013118 approved in 29 june 18 and

just implemented

Previous anesthesia to bleeding guinea-pigs

immunized for dT DT and DTP vaccines

Euthanasia by isofluorane in mice


Av Vital Brasil 1500 ndash Butantatilde - Satildeo Paulo ndash SP - Brazil

Zip code - 05503-900

(+ 55 11) 26279453

wwwbutantangovbr


Diphtheria and Tetanus combined vaccine potency

by ToBI

Alternative methods recommended by Eur Ph and WHO ndash determination of Ab titration (potency)

- T fraction ELISA andor ToBI test

- D fraction ELISA andor Vero cell tests

Our propose

- Both fractions titration by ToBI test


In vitro potency test of vaccines dT DT DTP and DTPHB

+ diphtheria and tetanus toxoid

bull ToBI test (Toxin Binding Inhibition Test)

Hendriksen et al J Biol Stand 1988 The toxin binding inhibition test as areliable in vitro alternative to the toxin neutralization test in mice for theestimation of tetanus antitoxin in human sera

Similar principle of the in vivo potency test

Decrease of 200 mice per batch of each vaccine and 400 mice per batch

of anti-tetanus serum


dT DT DTP and DTPHB vaccines selectivity

Sample + toxoidSample + both (tetanus and

diphteria) toxoid

DTPHB313 UImL 318 UImL

100 1016

DTP497 UImL 514 UImL

100 1034

Tetanus Toxoid801 UImL 724 UImL

100 904

dT1001 UImL 101 UImL

100 1001

DT1381 UImL 1448 UImL

100 1048

Tetanus antitoxin NIBSC1038 UImL 1058 UImL

100 102

All results between 80-120


dT DT DTP and DTPHB vaccines linearity Diphtheria fraction

Parameter SpecificationExperimental

Results

Correlation

coefficient (r)ge 0950 09979

Y-intercept --------- 00816

slope --------- 09753

Coefficient of

determination (r2)ge 0950 09958

Relative Standard

Deviation (RSD)le 20 1 to 6


dT DT DTP and DTPHB vaccines linearity Tetanus fraction


Results

Correlation


Y-intercept --------- - 03059

slope --------- 1059

Coefficient of


Relative Standard



dT DT DTP and DTPHB vaccines repeatability Diphtheria fraction

dT(n=7)

DT(n=7)

DTPHB(n=9)

Diphtheria Toxoid(n=8)

DTP(n=7)

Mean (UImL) 338 467 657 668 1038

Standard Deviation 043 071 062 085 107

Relative Standard Deviation

(le20)13 15 9 13 10

An

aly

st

I

dT(n=3)

DT(n=3)

DTPHB(n=3)


DTP(n=3)

Mean (UImL) 276 399 609 582 927



(le20)8 4 4 6 7

An

aly

st

II


dT DT DTP and DTPHB vaccines repeatability Tetanus fraction

DTPHB(n=3)

DTP(n=3)

Tetanus Toxoid(n=3)

dT(n=3)

DT(n=3)

Mean (UImL) 313 497 801 1001 1381



(le20)9 14 8 1 2

An

aly

st

I

DTPHB(n=3)

DTP(n=3)

Tetanus Toxoid(n=3)

dT(n=3)

DT(n=3)

Mean (UImL) 321 53 874 1031 1391



(le20)4 6 11 10 2

An

aly

st

II


dT DT DTP and DTPHB vaccines intermediate precision Diphtheria fraction

SAMPLES

ANALYSTS I + II | X(An II) ndash X(An I) | x 100

X(An I)

(le20)

Mean(UImL)

SDRSD(le20)

dT 319 047 15 18

DT 446 067 15 15

DTPHB 645 058 9 7

Diphtheria Toxoid 645 084 13 13

DTP 1005 107 11 11

RE 8992003 (ANVISA) RSD le 5)


dT DT DTP and DTPHB vaccines intermediate precision Tetanus fraction

SAMPLES


X(An I)

(le20)

Mean(UImL)

SDRSD(le20)

DTPHB 317 019 6 3

DTP 513 051 10 7

Tetanus Toxoid 837 085 10 9

dT 1016 065 6 3

DT 1386 023 2 1



dT DT DTP and DTPHB vaccines accuracy Diphtheria fraction

SAMPLESX (ToBI)(UImL)

n = 7

Official ResultIn vivo

(UImL)

n = 1

X (ToBI) x 100

Official Result(80 to 120)

dT 338 30 113

DT 467 49 95

DTPHB 657 60 110

Diphtheria

Toxoid668 66 101

DTP 1038 114 91


dT DT DTP and DTPHB vaccines accuracy Tetanus fraction


n = 3


(UImL)

n = 1

X (ToBI) x 100


DTPHB 313 28 112

DTP 497 46 108

Tetanus Toxoid 801 89 90

dT 1001 123 81

DT 1381 152 91


in vivo e in vitro correlation

dT DT DTP and DTPHB vaccines Diphtheria fraction potency analysis



dT DT DTP and DTPHB vaccines Tetanus fraction potency analysis


Internal validated ToBI tests presented suitable to estimate the potency not only to

tetanus fraction but ALSO to diphtheria fraction in combined vaccines

Our data met all acceptance validation criteria as specificityselectivity linearity

precision (repeatability and intermediate precision) accuracy and in vitro and in vivo

concordance showed strong correlation (R=096) for both D and T components

The high relevance of these data for replacement of animal testing strongly impacts

the routine of Quality Control turning the analyses faster accurate and cheaper and

more importantly saving the lives of hundred of animals per year

Diphtheria and Tetanus combined vaccine potency by ToBI

Conclusion after internal validation


Av Vital Brasil 1500 ndash Butantatilde - Satildeo Paulo ndash SP -

Brazil

Zip code - 05503-900

(+ 55 11) 26279453

Thank you

patriciacarneirobutantangovbr

Biotech QC team

Patriacutecia dos Santos Carneiro PhD

Manager of Quality Control and

Analytical Development

Aug 24 2018

Alternative methods insertion

into the QC lab routine status

and challenges



wwwbutantangovbr

bull Since 1901


in Brazil







inclusion










solutions





13 immunoglobulins

400000 vialsyear



Ongoing

Dengue

Pandemic Influenza

Quadrivalent

Influenza rBCG

DTPHB HPV DTPa

HepA mAbs















Regulatory approval

Alternative methods



Associated

Labs -

RENAMA




validation





testing or teaching










Po

ten

cy

(UI

mL

)

Samples


Correl = 094

0

500

1000

1500

2000

2500

3000

1 2 3 4 5 6 7 8 9 10 11 12

Tetanus Antitoxin





D for dT

D for DTP

T for dT and DTP




0

2

4

6

8

10

12

1 2 3 4 5 6 7 8 9 10 11

In vivo In vitro

14



R=098P

ote

nc

y(U

Im

L)

Correl = 098




0

2

4

6

8

10

12

14

16

0 1 2 3 4 5 6


Po

ten

cy

(UI

mL

)

Correl = 099




Replacement

0 1 2 3 4 5 6 7 800

05

10

15

LPS standard [UEmL]

Tem

pera

ture

[C

els

ius d

eg

ree]

110

120

-100

-50

00

100

200

300

+ 10UEmL

+ 1UEml

+ 01UEml

+ 001UEml

LP

S r

eco

very

[

]


viv

oIn

vit

ro -

LA

L




Correl = 093














just implemented



just implemented





just implemented






Zip code - 05503-900

(+ 55 11) 26279453

wwwbutantangovbr



by ToBI




Our propose













diphteria) toxoid


100 1016


100 1034


100 904


100 1001


100 1048


100 102





Results

Correlation


Y-intercept --------- 00816

slope --------- 09753

Coefficient of


Relative Standard





Results

Correlation


Y-intercept --------- - 03059

slope --------- 1059

Coefficient of


Relative Standard




dT(n=7)

DT(n=7)

DTPHB(n=9)


DTP(n=7)

Mean (UImL) 338 467 657 668 1038



(le20)13 15 9 13 10

An

aly

st

I

dT(n=3)

DT(n=3)

DTPHB(n=3)


DTP(n=3)

Mean (UImL) 276 399 609 582 927



(le20)8 4 4 6 7

An

aly

st

II



DTPHB(n=3)

DTP(n=3)

Tetanus Toxoid(n=3)

dT(n=3)

DT(n=3)

Mean (UImL) 313 497 801 1001 1381



(le20)9 14 8 1 2

An

aly

st

I

DTPHB(n=3)

DTP(n=3)

Tetanus Toxoid(n=3)

dT(n=3)

DT(n=3)

Mean (UImL) 321 53 874 1031 1391



(le20)4 6 11 10 2

An

aly

st

II



SAMPLES


X(An I)

(le20)

Mean(UImL)

SDRSD(le20)

dT 319 047 15 18

DT 446 067 15 15

DTPHB 645 058 9 7


DTP 1005 107 11 11




SAMPLES


X(An I)

(le20)

Mean(UImL)

SDRSD(le20)

DTPHB 317 019 6 3

DTP 513 051 10 7


dT 1016 065 6 3

DT 1386 023 2 1





n = 7


(UImL)

n = 1

X (ToBI) x 100


dT 338 30 113

DT 467 49 95

DTPHB 657 60 110

Diphtheria

Toxoid668 66 101

DTP 1038 114 91




n = 3


(UImL)

n = 1

X (ToBI) x 100


DTPHB 313 28 112

DTP 497 46 108


dT 1001 123 81

DT 1381 152 91




















Brazil

Zip code - 05503-900

(+ 55 11) 26279453

Thank you


Biotech QC team



wwwbutantangovbr

bull Since 1901


in Brazil







inclusion










solutions





13 immunoglobulins

400000 vialsyear



Ongoing

Dengue

Pandemic Influenza

Quadrivalent

Influenza rBCG

DTPHB HPV DTPa

HepA mAbs















Regulatory approval

Alternative methods



Associated

Labs -

RENAMA




validation





testing or teaching










Po

ten

cy

(UI

mL

)

Samples


Correl = 094

0

500

1000

1500

2000

2500

3000

1 2 3 4 5 6 7 8 9 10 11 12

Tetanus Antitoxin





D for dT

D for DTP

T for dT and DTP




0

2

4

6

8

10

12

1 2 3 4 5 6 7 8 9 10 11

In vivo In vitro

14



R=098P

ote

nc

y(U

Im

L)

Correl = 098




0

2

4

6

8

10

12

14

16

0 1 2 3 4 5 6


Po

ten

cy

(UI

mL

)

Correl = 099




Replacement

0 1 2 3 4 5 6 7 800

05

10

15

LPS standard [UEmL]

Tem

pera

ture

[C

els

ius d

eg

ree]

110

120

-100

-50

00

100

200

300

+ 10UEmL

+ 1UEml

+ 01UEml

+ 001UEml

LP

S r

eco

very

[

]


viv

oIn

vit

ro -

LA

L




Correl = 093














just implemented



just implemented





just implemented






Zip code - 05503-900

(+ 55 11) 26279453

wwwbutantangovbr



by ToBI




Our propose













diphteria) toxoid


100 1016


100 1034


100 904


100 1001


100 1048


100 102





Results

Correlation


Y-intercept --------- 00816

slope --------- 09753

Coefficient of


Relative Standard





Results

Correlation


Y-intercept --------- - 03059

slope --------- 1059

Coefficient of


Relative Standard




dT(n=7)

DT(n=7)

DTPHB(n=9)


DTP(n=7)

Mean (UImL) 338 467 657 668 1038



(le20)13 15 9 13 10

An

aly

st

I

dT(n=3)

DT(n=3)

DTPHB(n=3)


DTP(n=3)

Mean (UImL) 276 399 609 582 927



(le20)8 4 4 6 7

An

aly

st

II



DTPHB(n=3)

DTP(n=3)

Tetanus Toxoid(n=3)

dT(n=3)

DT(n=3)

Mean (UImL) 313 497 801 1001 1381



(le20)9 14 8 1 2

An

aly

st

I

DTPHB(n=3)

DTP(n=3)

Tetanus Toxoid(n=3)

dT(n=3)

DT(n=3)

Mean (UImL) 321 53 874 1031 1391



(le20)4 6 11 10 2

An

aly

st

II



SAMPLES


X(An I)

(le20)

Mean(UImL)

SDRSD(le20)

dT 319 047 15 18

DT 446 067 15 15

DTPHB 645 058 9 7


DTP 1005 107 11 11




SAMPLES


X(An I)

(le20)

Mean(UImL)

SDRSD(le20)

DTPHB 317 019 6 3

DTP 513 051 10 7


dT 1016 065 6 3

DT 1386 023 2 1





n = 7


(UImL)

n = 1

X (ToBI) x 100


dT 338 30 113

DT 467 49 95

DTPHB 657 60 110

Diphtheria

Toxoid668 66 101

DTP 1038 114 91




n = 3


(UImL)

n = 1

X (ToBI) x 100


DTPHB 313 28 112

DTP 497 46 108


dT 1001 123 81

DT 1381 152 91




















Brazil

Zip code - 05503-900

(+ 55 11) 26279453

Thank you


Biotech QC team





inclusion










solutions





13 immunoglobulins

400000 vialsyear



Ongoing

Dengue

Pandemic Influenza

Quadrivalent

Influenza rBCG

DTPHB HPV DTPa

HepA mAbs















Regulatory approval

Alternative methods



Associated

Labs -

RENAMA




validation





testing or teaching










Po

ten

cy

(UI

mL

)

Samples


Correl = 094

0

500

1000

1500

2000

2500

3000

1 2 3 4 5 6 7 8 9 10 11 12

Tetanus Antitoxin





D for dT

D for DTP

T for dT and DTP




0

2

4

6

8

10

12

1 2 3 4 5 6 7 8 9 10 11

In vivo In vitro

14



R=098P

ote

nc

y(U

Im

L)

Correl = 098




0

2

4

6

8

10

12

14

16

0 1 2 3 4 5 6


Po

ten

cy

(UI

mL

)

Correl = 099




Replacement

0 1 2 3 4 5 6 7 800

05

10

15

LPS standard [UEmL]

Tem

pera

ture

[C

els

ius d

eg

ree]

110

120

-100

-50

00

100

200

300

+ 10UEmL

+ 1UEml

+ 01UEml

+ 001UEml

LP

S r

eco

very

[

]


viv

oIn

vit

ro -

LA

L




Correl = 093














just implemented



just implemented





just implemented






Zip code - 05503-900

(+ 55 11) 26279453

wwwbutantangovbr



by ToBI




Our propose













diphteria) toxoid


100 1016


100 1034


100 904


100 1001


100 1048


100 102





Results

Correlation


Y-intercept --------- 00816

slope --------- 09753

Coefficient of


Relative Standard





Results

Correlation


Y-intercept --------- - 03059

slope --------- 1059

Coefficient of


Relative Standard




dT(n=7)

DT(n=7)

DTPHB(n=9)


DTP(n=7)

Mean (UImL) 338 467 657 668 1038



(le20)13 15 9 13 10

An

aly

st

I

dT(n=3)

DT(n=3)

DTPHB(n=3)


DTP(n=3)

Mean (UImL) 276 399 609 582 927



(le20)8 4 4 6 7

An

aly

st

II



DTPHB(n=3)

DTP(n=3)

Tetanus Toxoid(n=3)

dT(n=3)

DT(n=3)

Mean (UImL) 313 497 801 1001 1381



(le20)9 14 8 1 2

An

aly

st

I

DTPHB(n=3)

DTP(n=3)

Tetanus Toxoid(n=3)

dT(n=3)

DT(n=3)

Mean (UImL) 321 53 874 1031 1391



(le20)4 6 11 10 2

An

aly

st

II



SAMPLES


X(An I)

(le20)

Mean(UImL)

SDRSD(le20)

dT 319 047 15 18

DT 446 067 15 15

DTPHB 645 058 9 7


DTP 1005 107 11 11




SAMPLES


X(An I)

(le20)

Mean(UImL)

SDRSD(le20)

DTPHB 317 019 6 3

DTP 513 051 10 7


dT 1016 065 6 3

DT 1386 023 2 1





n = 7


(UImL)

n = 1

X (ToBI) x 100


dT 338 30 113

DT 467 49 95

DTPHB 657 60 110

Diphtheria

Toxoid668 66 101

DTP 1038 114 91




n = 3


(UImL)

n = 1

X (ToBI) x 100


DTPHB 313 28 112

DTP 497 46 108


dT 1001 123 81

DT 1381 152 91




















Brazil

Zip code - 05503-900

(+ 55 11) 26279453

Thank you


Biotech QC team







solutions





13 immunoglobulins

400000 vialsyear



Ongoing

Dengue

Pandemic Influenza

Quadrivalent

Influenza rBCG

DTPHB HPV DTPa

HepA mAbs















Regulatory approval

Alternative methods



Associated

Labs -

RENAMA




validation





testing or teaching










Po

ten

cy

(UI

mL

)

Samples


Correl = 094

0

500

1000

1500

2000

2500

3000

1 2 3 4 5 6 7 8 9 10 11 12

Tetanus Antitoxin





D for dT

D for DTP

T for dT and DTP




0

2

4

6

8

10

12

1 2 3 4 5 6 7 8 9 10 11

In vivo In vitro

14



R=098P

ote

nc

y(U

Im

L)

Correl = 098




0

2

4

6

8

10

12

14

16

0 1 2 3 4 5 6


Po

ten

cy

(UI

mL

)

Correl = 099




Replacement

0 1 2 3 4 5 6 7 800

05

10

15

LPS standard [UEmL]

Tem

pera

ture

[C

els

ius d

eg

ree]

110

120

-100

-50

00

100

200

300

+ 10UEmL

+ 1UEml

+ 01UEml

+ 001UEml

LP

S r

eco

very

[

]


viv

oIn

vit

ro -

LA

L




Correl = 093














just implemented



just implemented





just implemented






Zip code - 05503-900

(+ 55 11) 26279453

wwwbutantangovbr



by ToBI




Our propose













diphteria) toxoid


100 1016


100 1034


100 904


100 1001


100 1048


100 102





Results

Correlation


Y-intercept --------- 00816

slope --------- 09753

Coefficient of


Relative Standard





Results

Correlation


Y-intercept --------- - 03059

slope --------- 1059

Coefficient of


Relative Standard




dT(n=7)

DT(n=7)

DTPHB(n=9)


DTP(n=7)

Mean (UImL) 338 467 657 668 1038



(le20)13 15 9 13 10

An

aly

st

I

dT(n=3)

DT(n=3)

DTPHB(n=3)


DTP(n=3)

Mean (UImL) 276 399 609 582 927



(le20)8 4 4 6 7

An

aly

st

II



DTPHB(n=3)

DTP(n=3)

Tetanus Toxoid(n=3)

dT(n=3)

DT(n=3)

Mean (UImL) 313 497 801 1001 1381



(le20)9 14 8 1 2

An

aly

st

I

DTPHB(n=3)

DTP(n=3)

Tetanus Toxoid(n=3)

dT(n=3)

DT(n=3)

Mean (UImL) 321 53 874 1031 1391



(le20)4 6 11 10 2

An

aly

st

II



SAMPLES


X(An I)

(le20)

Mean(UImL)

SDRSD(le20)

dT 319 047 15 18

DT 446 067 15 15

DTPHB 645 058 9 7


DTP 1005 107 11 11




SAMPLES


X(An I)

(le20)

Mean(UImL)

SDRSD(le20)

DTPHB 317 019 6 3

DTP 513 051 10 7


dT 1016 065 6 3

DT 1386 023 2 1





n = 7


(UImL)

n = 1

X (ToBI) x 100


dT 338 30 113

DT 467 49 95

DTPHB 657 60 110

Diphtheria

Toxoid668 66 101

DTP 1038 114 91




n = 3


(UImL)

n = 1

X (ToBI) x 100


DTPHB 313 28 112

DTP 497 46 108


dT 1001 123 81

DT 1381 152 91




















Brazil

Zip code - 05503-900

(+ 55 11) 26279453

Thank you


Biotech QC team



13 immunoglobulins

400000 vialsyear



Ongoing

Dengue

Pandemic Influenza

Quadrivalent

Influenza rBCG

DTPHB HPV DTPa

HepA mAbs















Regulatory approval

Alternative methods



Associated

Labs -

RENAMA




validation





testing or teaching










Po

ten

cy

(UI

mL

)

Samples


Correl = 094

0

500

1000

1500

2000

2500

3000

1 2 3 4 5 6 7 8 9 10 11 12

Tetanus Antitoxin





D for dT

D for DTP

T for dT and DTP




0

2

4

6

8

10

12

1 2 3 4 5 6 7 8 9 10 11

In vivo In vitro

14



R=098P

ote

nc

y(U

Im

L)

Correl = 098




0

2

4

6

8

10

12

14

16

0 1 2 3 4 5 6


Po

ten

cy

(UI

mL

)

Correl = 099




Replacement

0 1 2 3 4 5 6 7 800

05

10

15

LPS standard [UEmL]

Tem

pera

ture

[C

els

ius d

eg

ree]

110

120

-100

-50

00

100

200

300

+ 10UEmL

+ 1UEml

+ 01UEml

+ 001UEml

LP

S r

eco

very

[

]


viv

oIn

vit

ro -

LA

L




Correl = 093














just implemented



just implemented





just implemented






Zip code - 05503-900

(+ 55 11) 26279453

wwwbutantangovbr



by ToBI




Our propose













diphteria) toxoid


100 1016


100 1034


100 904


100 1001


100 1048


100 102





Results

Correlation


Y-intercept --------- 00816

slope --------- 09753

Coefficient of


Relative Standard





Results

Correlation


Y-intercept --------- - 03059

slope --------- 1059

Coefficient of


Relative Standard




dT(n=7)

DT(n=7)

DTPHB(n=9)


DTP(n=7)

Mean (UImL) 338 467 657 668 1038



(le20)13 15 9 13 10

An

aly

st

I

dT(n=3)

DT(n=3)

DTPHB(n=3)


DTP(n=3)

Mean (UImL) 276 399 609 582 927



(le20)8 4 4 6 7

An

aly

st

II



DTPHB(n=3)

DTP(n=3)

Tetanus Toxoid(n=3)

dT(n=3)

DT(n=3)

Mean (UImL) 313 497 801 1001 1381



(le20)9 14 8 1 2

An

aly

st

I

DTPHB(n=3)

DTP(n=3)

Tetanus Toxoid(n=3)

dT(n=3)

DT(n=3)

Mean (UImL) 321 53 874 1031 1391



(le20)4 6 11 10 2

An

aly

st

II



SAMPLES


X(An I)

(le20)

Mean(UImL)

SDRSD(le20)

dT 319 047 15 18

DT 446 067 15 15

DTPHB 645 058 9 7


DTP 1005 107 11 11




SAMPLES


X(An I)

(le20)

Mean(UImL)

SDRSD(le20)

DTPHB 317 019 6 3

DTP 513 051 10 7


dT 1016 065 6 3

DT 1386 023 2 1





n = 7


(UImL)

n = 1

X (ToBI) x 100


dT 338 30 113

DT 467 49 95

DTPHB 657 60 110

Diphtheria

Toxoid668 66 101

DTP 1038 114 91




n = 3


(UImL)

n = 1

X (ToBI) x 100


DTPHB 313 28 112

DTP 497 46 108


dT 1001 123 81

DT 1381 152 91




















Brazil

Zip code - 05503-900

(+ 55 11) 26279453

Thank you


Biotech QC team



Ongoing

Dengue

Pandemic Influenza

Quadrivalent

Influenza rBCG

DTPHB HPV DTPa

HepA mAbs















Regulatory approval

Alternative methods



Associated

Labs -

RENAMA




validation





testing or teaching










Po

ten

cy

(UI

mL

)

Samples


Correl = 094

0

500

1000

1500

2000

2500

3000

1 2 3 4 5 6 7 8 9 10 11 12

Tetanus Antitoxin





D for dT

D for DTP

T for dT and DTP




0

2

4

6

8

10

12

1 2 3 4 5 6 7 8 9 10 11

In vivo In vitro

14



R=098P

ote

nc

y(U

Im

L)

Correl = 098




0

2

4

6

8

10

12

14

16

0 1 2 3 4 5 6


Po

ten

cy

(UI

mL

)

Correl = 099




Replacement

0 1 2 3 4 5 6 7 800

05

10

15

LPS standard [UEmL]

Tem

pera

ture

[C

els

ius d

eg

ree]

110

120

-100

-50

00

100

200

300

+ 10UEmL

+ 1UEml

+ 01UEml

+ 001UEml

LP

S r

eco

very

[

]


viv

oIn

vit

ro -

LA

L




Correl = 093














just implemented



just implemented





just implemented






Zip code - 05503-900

(+ 55 11) 26279453

wwwbutantangovbr



by ToBI




Our propose













diphteria) toxoid


100 1016


100 1034


100 904


100 1001


100 1048


100 102





Results

Correlation


Y-intercept --------- 00816

slope --------- 09753

Coefficient of


Relative Standard





Results

Correlation


Y-intercept --------- - 03059

slope --------- 1059

Coefficient of


Relative Standard




dT(n=7)

DT(n=7)

DTPHB(n=9)


DTP(n=7)

Mean (UImL) 338 467 657 668 1038



(le20)13 15 9 13 10

An

aly

st

I

dT(n=3)

DT(n=3)

DTPHB(n=3)


DTP(n=3)

Mean (UImL) 276 399 609 582 927



(le20)8 4 4 6 7

An

aly

st

II



DTPHB(n=3)

DTP(n=3)

Tetanus Toxoid(n=3)

dT(n=3)

DT(n=3)

Mean (UImL) 313 497 801 1001 1381



(le20)9 14 8 1 2

An

aly

st

I

DTPHB(n=3)

DTP(n=3)

Tetanus Toxoid(n=3)

dT(n=3)

DT(n=3)

Mean (UImL) 321 53 874 1031 1391



(le20)4 6 11 10 2

An

aly

st

II



SAMPLES


X(An I)

(le20)

Mean(UImL)

SDRSD(le20)

dT 319 047 15 18

DT 446 067 15 15

DTPHB 645 058 9 7


DTP 1005 107 11 11




SAMPLES


X(An I)

(le20)

Mean(UImL)

SDRSD(le20)

DTPHB 317 019 6 3

DTP 513 051 10 7


dT 1016 065 6 3

DT 1386 023 2 1





n = 7


(UImL)

n = 1

X (ToBI) x 100


dT 338 30 113

DT 467 49 95

DTPHB 657 60 110

Diphtheria

Toxoid668 66 101

DTP 1038 114 91




n = 3


(UImL)

n = 1

X (ToBI) x 100


DTPHB 313 28 112

DTP 497 46 108


dT 1001 123 81

DT 1381 152 91




















Brazil

Zip code - 05503-900

(+ 55 11) 26279453

Thank you


Biotech QC team













Regulatory approval

Alternative methods



Associated

Labs -

RENAMA




validation





testing or teaching










Po

ten

cy

(UI

mL

)

Samples


Correl = 094

0

500

1000

1500

2000

2500

3000

1 2 3 4 5 6 7 8 9 10 11 12

Tetanus Antitoxin





D for dT

D for DTP

T for dT and DTP




0

2

4

6

8

10

12

1 2 3 4 5 6 7 8 9 10 11

In vivo In vitro

14



R=098P

ote

nc

y(U

Im

L)

Correl = 098




0

2

4

6

8

10

12

14

16

0 1 2 3 4 5 6


Po

ten

cy

(UI

mL

)

Correl = 099




Replacement

0 1 2 3 4 5 6 7 800

05

10

15

LPS standard [UEmL]

Tem

pera

ture

[C

els

ius d

eg

ree]

110

120

-100

-50

00

100

200

300

+ 10UEmL

+ 1UEml

+ 01UEml

+ 001UEml

LP

S r

eco

very

[

]


viv

oIn

vit

ro -

LA

L




Correl = 093














just implemented



just implemented





just implemented






Zip code - 05503-900

(+ 55 11) 26279453

wwwbutantangovbr



by ToBI




Our propose













diphteria) toxoid


100 1016


100 1034


100 904


100 1001


100 1048


100 102





Results

Correlation


Y-intercept --------- 00816

slope --------- 09753

Coefficient of


Relative Standard





Results

Correlation


Y-intercept --------- - 03059

slope --------- 1059

Coefficient of


Relative Standard




dT(n=7)

DT(n=7)

DTPHB(n=9)


DTP(n=7)

Mean (UImL) 338 467 657 668 1038



(le20)13 15 9 13 10

An

aly

st

I

dT(n=3)

DT(n=3)

DTPHB(n=3)


DTP(n=3)

Mean (UImL) 276 399 609 582 927



(le20)8 4 4 6 7

An

aly

st

II



DTPHB(n=3)

DTP(n=3)

Tetanus Toxoid(n=3)

dT(n=3)

DT(n=3)

Mean (UImL) 313 497 801 1001 1381



(le20)9 14 8 1 2

An

aly

st

I

DTPHB(n=3)

DTP(n=3)

Tetanus Toxoid(n=3)

dT(n=3)

DT(n=3)

Mean (UImL) 321 53 874 1031 1391



(le20)4 6 11 10 2

An

aly

st

II



SAMPLES


X(An I)

(le20)

Mean(UImL)

SDRSD(le20)

dT 319 047 15 18

DT 446 067 15 15

DTPHB 645 058 9 7


DTP 1005 107 11 11




SAMPLES


X(An I)

(le20)

Mean(UImL)

SDRSD(le20)

DTPHB 317 019 6 3

DTP 513 051 10 7


dT 1016 065 6 3

DT 1386 023 2 1





n = 7


(UImL)

n = 1

X (ToBI) x 100


dT 338 30 113

DT 467 49 95

DTPHB 657 60 110

Diphtheria

Toxoid668 66 101

DTP 1038 114 91




n = 3


(UImL)

n = 1

X (ToBI) x 100


DTPHB 313 28 112

DTP 497 46 108


dT 1001 123 81

DT 1381 152 91




















Brazil

Zip code - 05503-900

(+ 55 11) 26279453

Thank you


Biotech QC team


Regulatory approval

Alternative methods



Associated

Labs -

RENAMA




validation





testing or teaching










Po

ten

cy

(UI

mL

)

Samples


Correl = 094

0

500

1000

1500

2000

2500

3000

1 2 3 4 5 6 7 8 9 10 11 12

Tetanus Antitoxin





D for dT

D for DTP

T for dT and DTP




0

2

4

6

8

10

12

1 2 3 4 5 6 7 8 9 10 11

In vivo In vitro

14



R=098P

ote

nc

y(U

Im

L)

Correl = 098




0

2

4

6

8

10

12

14

16

0 1 2 3 4 5 6


Po

ten

cy

(UI

mL

)

Correl = 099




Replacement

0 1 2 3 4 5 6 7 800

05

10

15

LPS standard [UEmL]

Tem

pera

ture

[C

els

ius d

eg

ree]

110

120

-100

-50

00

100

200

300

+ 10UEmL

+ 1UEml

+ 01UEml

+ 001UEml

LP

S r

eco

very

[

]


viv

oIn

vit

ro -

LA

L




Correl = 093














just implemented



just implemented





just implemented






Zip code - 05503-900

(+ 55 11) 26279453

wwwbutantangovbr



by ToBI




Our propose













diphteria) toxoid


100 1016


100 1034


100 904


100 1001


100 1048


100 102





Results

Correlation


Y-intercept --------- 00816

slope --------- 09753

Coefficient of


Relative Standard





Results

Correlation


Y-intercept --------- - 03059

slope --------- 1059

Coefficient of


Relative Standard




dT(n=7)

DT(n=7)

DTPHB(n=9)


DTP(n=7)

Mean (UImL) 338 467 657 668 1038



(le20)13 15 9 13 10

An

aly

st

I

dT(n=3)

DT(n=3)

DTPHB(n=3)


DTP(n=3)

Mean (UImL) 276 399 609 582 927



(le20)8 4 4 6 7

An

aly

st

II



DTPHB(n=3)

DTP(n=3)

Tetanus Toxoid(n=3)

dT(n=3)

DT(n=3)

Mean (UImL) 313 497 801 1001 1381



(le20)9 14 8 1 2

An

aly

st

I

DTPHB(n=3)

DTP(n=3)

Tetanus Toxoid(n=3)

dT(n=3)

DT(n=3)

Mean (UImL) 321 53 874 1031 1391



(le20)4 6 11 10 2

An

aly

st

II



SAMPLES


X(An I)

(le20)

Mean(UImL)

SDRSD(le20)

dT 319 047 15 18

DT 446 067 15 15

DTPHB 645 058 9 7


DTP 1005 107 11 11




SAMPLES


X(An I)

(le20)

Mean(UImL)

SDRSD(le20)

DTPHB 317 019 6 3

DTP 513 051 10 7


dT 1016 065 6 3

DT 1386 023 2 1





n = 7


(UImL)

n = 1

X (ToBI) x 100


dT 338 30 113

DT 467 49 95

DTPHB 657 60 110

Diphtheria

Toxoid668 66 101

DTP 1038 114 91




n = 3


(UImL)

n = 1

X (ToBI) x 100


DTPHB 313 28 112

DTP 497 46 108


dT 1001 123 81

DT 1381 152 91




















Brazil

Zip code - 05503-900

(+ 55 11) 26279453

Thank you


Biotech QC team



Associated

Labs -

RENAMA




validation





testing or teaching










Po

ten

cy

(UI

mL

)

Samples


Correl = 094

0

500

1000

1500

2000

2500

3000

1 2 3 4 5 6 7 8 9 10 11 12

Tetanus Antitoxin





D for dT

D for DTP

T for dT and DTP




0

2

4

6

8

10

12

1 2 3 4 5 6 7 8 9 10 11

In vivo In vitro

14



R=098P

ote

nc

y(U

Im

L)

Correl = 098




0

2

4

6

8

10

12

14

16

0 1 2 3 4 5 6


Po

ten

cy

(UI

mL

)

Correl = 099




Replacement

0 1 2 3 4 5 6 7 800

05

10

15

LPS standard [UEmL]

Tem

pera

ture

[C

els

ius d

eg

ree]

110

120

-100

-50

00

100

200

300

+ 10UEmL

+ 1UEml

+ 01UEml

+ 001UEml

LP

S r

eco

very

[

]


viv

oIn

vit

ro -

LA

L




Correl = 093














just implemented



just implemented





just implemented






Zip code - 05503-900

(+ 55 11) 26279453

wwwbutantangovbr



by ToBI




Our propose













diphteria) toxoid


100 1016


100 1034


100 904


100 1001


100 1048


100 102





Results

Correlation


Y-intercept --------- 00816

slope --------- 09753

Coefficient of


Relative Standard





Results

Correlation


Y-intercept --------- - 03059

slope --------- 1059

Coefficient of


Relative Standard




dT(n=7)

DT(n=7)

DTPHB(n=9)


DTP(n=7)

Mean (UImL) 338 467 657 668 1038



(le20)13 15 9 13 10

An

aly

st

I

dT(n=3)

DT(n=3)

DTPHB(n=3)


DTP(n=3)

Mean (UImL) 276 399 609 582 927



(le20)8 4 4 6 7

An

aly

st

II



DTPHB(n=3)

DTP(n=3)

Tetanus Toxoid(n=3)

dT(n=3)

DT(n=3)

Mean (UImL) 313 497 801 1001 1381



(le20)9 14 8 1 2

An

aly

st

I

DTPHB(n=3)

DTP(n=3)

Tetanus Toxoid(n=3)

dT(n=3)

DT(n=3)

Mean (UImL) 321 53 874 1031 1391



(le20)4 6 11 10 2

An

aly

st

II



SAMPLES


X(An I)

(le20)

Mean(UImL)

SDRSD(le20)

dT 319 047 15 18

DT 446 067 15 15

DTPHB 645 058 9 7


DTP 1005 107 11 11




SAMPLES


X(An I)

(le20)

Mean(UImL)

SDRSD(le20)

DTPHB 317 019 6 3

DTP 513 051 10 7


dT 1016 065 6 3

DT 1386 023 2 1





n = 7


(UImL)

n = 1

X (ToBI) x 100


dT 338 30 113

DT 467 49 95

DTPHB 657 60 110

Diphtheria

Toxoid668 66 101

DTP 1038 114 91




n = 3


(UImL)

n = 1

X (ToBI) x 100


DTPHB 313 28 112

DTP 497 46 108


dT 1001 123 81

DT 1381 152 91




















Brazil

Zip code - 05503-900

(+ 55 11) 26279453

Thank you


Biotech QC team





testing or teaching










Po

ten

cy

(UI

mL

)

Samples


Correl = 094

0

500

1000

1500

2000

2500

3000

1 2 3 4 5 6 7 8 9 10 11 12

Tetanus Antitoxin





D for dT

D for DTP

T for dT and DTP




0

2

4

6

8

10

12

1 2 3 4 5 6 7 8 9 10 11

In vivo In vitro

14



R=098P

ote

nc

y(U

Im

L)

Correl = 098




0

2

4

6

8

10

12

14

16

0 1 2 3 4 5 6


Po

ten

cy

(UI

mL

)

Correl = 099




Replacement

0 1 2 3 4 5 6 7 800

05

10

15

LPS standard [UEmL]

Tem

pera

ture

[C

els

ius d

eg

ree]

110

120

-100

-50

00

100

200

300

+ 10UEmL

+ 1UEml

+ 01UEml

+ 001UEml

LP

S r

eco

very

[

]


viv

oIn

vit

ro -

LA

L




Correl = 093














just implemented



just implemented





just implemented






Zip code - 05503-900

(+ 55 11) 26279453

wwwbutantangovbr



by ToBI




Our propose













diphteria) toxoid


100 1016


100 1034


100 904


100 1001


100 1048


100 102





Results

Correlation


Y-intercept --------- 00816

slope --------- 09753

Coefficient of


Relative Standard





Results

Correlation


Y-intercept --------- - 03059

slope --------- 1059

Coefficient of


Relative Standard




dT(n=7)

DT(n=7)

DTPHB(n=9)


DTP(n=7)

Mean (UImL) 338 467 657 668 1038



(le20)13 15 9 13 10

An

aly

st

I

dT(n=3)

DT(n=3)

DTPHB(n=3)


DTP(n=3)

Mean (UImL) 276 399 609 582 927



(le20)8 4 4 6 7

An

aly

st

II



DTPHB(n=3)

DTP(n=3)

Tetanus Toxoid(n=3)

dT(n=3)

DT(n=3)

Mean (UImL) 313 497 801 1001 1381



(le20)9 14 8 1 2

An

aly

st

I

DTPHB(n=3)

DTP(n=3)

Tetanus Toxoid(n=3)

dT(n=3)

DT(n=3)

Mean (UImL) 321 53 874 1031 1391



(le20)4 6 11 10 2

An

aly

st

II



SAMPLES


X(An I)

(le20)

Mean(UImL)

SDRSD(le20)

dT 319 047 15 18

DT 446 067 15 15

DTPHB 645 058 9 7


DTP 1005 107 11 11




SAMPLES


X(An I)

(le20)

Mean(UImL)

SDRSD(le20)

DTPHB 317 019 6 3

DTP 513 051 10 7


dT 1016 065 6 3

DT 1386 023 2 1





n = 7


(UImL)

n = 1

X (ToBI) x 100


dT 338 30 113

DT 467 49 95

DTPHB 657 60 110

Diphtheria

Toxoid668 66 101

DTP 1038 114 91




n = 3


(UImL)

n = 1

X (ToBI) x 100


DTPHB 313 28 112

DTP 497 46 108


dT 1001 123 81

DT 1381 152 91




















Brazil

Zip code - 05503-900

(+ 55 11) 26279453

Thank you


Biotech QC team










Po

ten

cy

(UI

mL

)

Samples


Correl = 094

0

500

1000

1500

2000

2500

3000

1 2 3 4 5 6 7 8 9 10 11 12

Tetanus Antitoxin





D for dT

D for DTP

T for dT and DTP




0

2

4

6

8

10

12

1 2 3 4 5 6 7 8 9 10 11

In vivo In vitro

14



R=098P

ote

nc

y(U

Im

L)

Correl = 098




0

2

4

6

8

10

12

14

16

0 1 2 3 4 5 6


Po

ten

cy

(UI

mL

)

Correl = 099




Replacement

0 1 2 3 4 5 6 7 800

05

10

15

LPS standard [UEmL]

Tem

pera

ture

[C

els

ius d

eg

ree]

110

120

-100

-50

00

100

200

300

+ 10UEmL

+ 1UEml

+ 01UEml

+ 001UEml

LP

S r

eco

very

[

]


viv

oIn

vit

ro -

LA

L




Correl = 093














just implemented



just implemented





just implemented






Zip code - 05503-900

(+ 55 11) 26279453

wwwbutantangovbr



by ToBI




Our propose













diphteria) toxoid


100 1016


100 1034


100 904


100 1001


100 1048


100 102





Results

Correlation


Y-intercept --------- 00816

slope --------- 09753

Coefficient of


Relative Standard





Results

Correlation


Y-intercept --------- - 03059

slope --------- 1059

Coefficient of


Relative Standard




dT(n=7)

DT(n=7)

DTPHB(n=9)


DTP(n=7)

Mean (UImL) 338 467 657 668 1038



(le20)13 15 9 13 10

An

aly

st

I

dT(n=3)

DT(n=3)

DTPHB(n=3)


DTP(n=3)

Mean (UImL) 276 399 609 582 927



(le20)8 4 4 6 7

An

aly

st

II



DTPHB(n=3)

DTP(n=3)

Tetanus Toxoid(n=3)

dT(n=3)

DT(n=3)

Mean (UImL) 313 497 801 1001 1381



(le20)9 14 8 1 2

An

aly

st

I

DTPHB(n=3)

DTP(n=3)

Tetanus Toxoid(n=3)

dT(n=3)

DT(n=3)

Mean (UImL) 321 53 874 1031 1391



(le20)4 6 11 10 2

An

aly

st

II



SAMPLES


X(An I)

(le20)

Mean(UImL)

SDRSD(le20)

dT 319 047 15 18

DT 446 067 15 15

DTPHB 645 058 9 7


DTP 1005 107 11 11




SAMPLES


X(An I)

(le20)

Mean(UImL)

SDRSD(le20)

DTPHB 317 019 6 3

DTP 513 051 10 7


dT 1016 065 6 3

DT 1386 023 2 1





n = 7


(UImL)

n = 1

X (ToBI) x 100


dT 338 30 113

DT 467 49 95

DTPHB 657 60 110

Diphtheria

Toxoid668 66 101

DTP 1038 114 91




n = 3


(UImL)

n = 1

X (ToBI) x 100


DTPHB 313 28 112

DTP 497 46 108


dT 1001 123 81

DT 1381 152 91




















Brazil

Zip code - 05503-900

(+ 55 11) 26279453

Thank you


Biotech QC team



Po

ten

cy

(UI

mL

)

Samples


Correl = 094

0

500

1000

1500

2000

2500

3000

1 2 3 4 5 6 7 8 9 10 11 12

Tetanus Antitoxin





D for dT

D for DTP

T for dT and DTP




0

2

4

6

8

10

12

1 2 3 4 5 6 7 8 9 10 11

In vivo In vitro

14



R=098P

ote

nc

y(U

Im

L)

Correl = 098




0

2

4

6

8

10

12

14

16

0 1 2 3 4 5 6


Po

ten

cy

(UI

mL

)

Correl = 099




Replacement

0 1 2 3 4 5 6 7 800

05

10

15

LPS standard [UEmL]

Tem

pera

ture

[C

els

ius d

eg

ree]

110

120

-100

-50

00

100

200

300

+ 10UEmL

+ 1UEml

+ 01UEml

+ 001UEml

LP

S r

eco

very

[

]


viv

oIn

vit

ro -

LA

L




Correl = 093














just implemented



just implemented





just implemented






Zip code - 05503-900

(+ 55 11) 26279453

wwwbutantangovbr



by ToBI




Our propose













diphteria) toxoid


100 1016


100 1034


100 904


100 1001


100 1048


100 102





Results

Correlation


Y-intercept --------- 00816

slope --------- 09753

Coefficient of


Relative Standard





Results

Correlation


Y-intercept --------- - 03059

slope --------- 1059

Coefficient of


Relative Standard




dT(n=7)

DT(n=7)

DTPHB(n=9)


DTP(n=7)

Mean (UImL) 338 467 657 668 1038



(le20)13 15 9 13 10

An

aly

st

I

dT(n=3)

DT(n=3)

DTPHB(n=3)


DTP(n=3)

Mean (UImL) 276 399 609 582 927



(le20)8 4 4 6 7

An

aly

st

II



DTPHB(n=3)

DTP(n=3)

Tetanus Toxoid(n=3)

dT(n=3)

DT(n=3)

Mean (UImL) 313 497 801 1001 1381



(le20)9 14 8 1 2

An

aly

st

I

DTPHB(n=3)

DTP(n=3)

Tetanus Toxoid(n=3)

dT(n=3)

DT(n=3)

Mean (UImL) 321 53 874 1031 1391



(le20)4 6 11 10 2

An

aly

st

II



SAMPLES


X(An I)

(le20)

Mean(UImL)

SDRSD(le20)

dT 319 047 15 18

DT 446 067 15 15

DTPHB 645 058 9 7


DTP 1005 107 11 11




SAMPLES


X(An I)

(le20)

Mean(UImL)

SDRSD(le20)

DTPHB 317 019 6 3

DTP 513 051 10 7


dT 1016 065 6 3

DT 1386 023 2 1





n = 7


(UImL)

n = 1

X (ToBI) x 100


dT 338 30 113

DT 467 49 95

DTPHB 657 60 110

Diphtheria

Toxoid668 66 101

DTP 1038 114 91




n = 3


(UImL)

n = 1

X (ToBI) x 100


DTPHB 313 28 112

DTP 497 46 108


dT 1001 123 81

DT 1381 152 91




















Brazil

Zip code - 05503-900

(+ 55 11) 26279453

Thank you


Biotech QC team




D for dT

D for DTP

T for dT and DTP




0

2

4

6

8

10

12

1 2 3 4 5 6 7 8 9 10 11

In vivo In vitro

14



R=098P

ote

nc

y(U

Im

L)

Correl = 098




0

2

4

6

8

10

12

14

16

0 1 2 3 4 5 6


Po

ten

cy

(UI

mL

)

Correl = 099




Replacement

0 1 2 3 4 5 6 7 800

05

10

15

LPS standard [UEmL]

Tem

pera

ture

[C

els

ius d

eg

ree]

110

120

-100

-50

00

100

200

300

+ 10UEmL

+ 1UEml

+ 01UEml

+ 001UEml

LP

S r

eco

very

[

]


viv

oIn

vit

ro -

LA

L




Correl = 093














just implemented



just implemented





just implemented






Zip code - 05503-900

(+ 55 11) 26279453

wwwbutantangovbr



by ToBI




Our propose













diphteria) toxoid


100 1016


100 1034


100 904


100 1001


100 1048


100 102





Results

Correlation


Y-intercept --------- 00816

slope --------- 09753

Coefficient of


Relative Standard





Results

Correlation


Y-intercept --------- - 03059

slope --------- 1059

Coefficient of


Relative Standard




dT(n=7)

DT(n=7)

DTPHB(n=9)


DTP(n=7)

Mean (UImL) 338 467 657 668 1038



(le20)13 15 9 13 10

An

aly

st

I

dT(n=3)

DT(n=3)

DTPHB(n=3)


DTP(n=3)

Mean (UImL) 276 399 609 582 927



(le20)8 4 4 6 7

An

aly

st

II



DTPHB(n=3)

DTP(n=3)

Tetanus Toxoid(n=3)

dT(n=3)

DT(n=3)

Mean (UImL) 313 497 801 1001 1381



(le20)9 14 8 1 2

An

aly

st

I

DTPHB(n=3)

DTP(n=3)

Tetanus Toxoid(n=3)

dT(n=3)

DT(n=3)

Mean (UImL) 321 53 874 1031 1391



(le20)4 6 11 10 2

An

aly

st

II



SAMPLES


X(An I)

(le20)

Mean(UImL)

SDRSD(le20)

dT 319 047 15 18

DT 446 067 15 15

DTPHB 645 058 9 7


DTP 1005 107 11 11




SAMPLES


X(An I)

(le20)

Mean(UImL)

SDRSD(le20)

DTPHB 317 019 6 3

DTP 513 051 10 7


dT 1016 065 6 3

DT 1386 023 2 1





n = 7


(UImL)

n = 1

X (ToBI) x 100


dT 338 30 113

DT 467 49 95

DTPHB 657 60 110

Diphtheria

Toxoid668 66 101

DTP 1038 114 91




n = 3


(UImL)

n = 1

X (ToBI) x 100


DTPHB 313 28 112

DTP 497 46 108


dT 1001 123 81

DT 1381 152 91




















Brazil

Zip code - 05503-900

(+ 55 11) 26279453

Thank you


Biotech QC team


0

2

4

6

8

10

12

1 2 3 4 5 6 7 8 9 10 11

In vivo In vitro

14



R=098P

ote

nc

y(U

Im

L)

Correl = 098




0

2

4

6

8

10

12

14

16

0 1 2 3 4 5 6


Po

ten

cy

(UI

mL

)

Correl = 099




Replacement

0 1 2 3 4 5 6 7 800

05

10

15

LPS standard [UEmL]

Tem

pera

ture

[C

els

ius d

eg

ree]

110

120

-100

-50

00

100

200

300

+ 10UEmL

+ 1UEml

+ 01UEml

+ 001UEml

LP

S r

eco

very

[

]


viv

oIn

vit

ro -

LA

L




Correl = 093














just implemented



just implemented





just implemented






Zip code - 05503-900

(+ 55 11) 26279453

wwwbutantangovbr



by ToBI




Our propose













diphteria) toxoid


100 1016


100 1034


100 904


100 1001


100 1048


100 102





Results

Correlation


Y-intercept --------- 00816

slope --------- 09753

Coefficient of


Relative Standard





Results

Correlation


Y-intercept --------- - 03059

slope --------- 1059

Coefficient of


Relative Standard




dT(n=7)

DT(n=7)

DTPHB(n=9)


DTP(n=7)

Mean (UImL) 338 467 657 668 1038



(le20)13 15 9 13 10

An

aly

st

I

dT(n=3)

DT(n=3)

DTPHB(n=3)


DTP(n=3)

Mean (UImL) 276 399 609 582 927



(le20)8 4 4 6 7

An

aly

st

II



DTPHB(n=3)

DTP(n=3)

Tetanus Toxoid(n=3)

dT(n=3)

DT(n=3)

Mean (UImL) 313 497 801 1001 1381



(le20)9 14 8 1 2

An

aly

st

I

DTPHB(n=3)

DTP(n=3)

Tetanus Toxoid(n=3)

dT(n=3)

DT(n=3)

Mean (UImL) 321 53 874 1031 1391



(le20)4 6 11 10 2

An

aly

st

II



SAMPLES


X(An I)

(le20)

Mean(UImL)

SDRSD(le20)

dT 319 047 15 18

DT 446 067 15 15

DTPHB 645 058 9 7


DTP 1005 107 11 11




SAMPLES


X(An I)

(le20)

Mean(UImL)

SDRSD(le20)

DTPHB 317 019 6 3

DTP 513 051 10 7


dT 1016 065 6 3

DT 1386 023 2 1





n = 7


(UImL)

n = 1

X (ToBI) x 100


dT 338 30 113

DT 467 49 95

DTPHB 657 60 110

Diphtheria

Toxoid668 66 101

DTP 1038 114 91




n = 3


(UImL)

n = 1

X (ToBI) x 100


DTPHB 313 28 112

DTP 497 46 108


dT 1001 123 81

DT 1381 152 91




















Brazil

Zip code - 05503-900

(+ 55 11) 26279453

Thank you


Biotech QC team



0

2

4

6

8

10

12

14

16

0 1 2 3 4 5 6


Po

ten

cy

(UI

mL

)

Correl = 099




Replacement

0 1 2 3 4 5 6 7 800

05

10

15

LPS standard [UEmL]

Tem

pera

ture

[C

els

ius d

eg

ree]

110

120

-100

-50

00

100

200

300

+ 10UEmL

+ 1UEml

+ 01UEml

+ 001UEml

LP

S r

eco

very

[

]


viv

oIn

vit

ro -

LA

L




Correl = 093














just implemented



just implemented





just implemented






Zip code - 05503-900

(+ 55 11) 26279453

wwwbutantangovbr



by ToBI




Our propose













diphteria) toxoid


100 1016


100 1034


100 904


100 1001


100 1048


100 102





Results

Correlation


Y-intercept --------- 00816

slope --------- 09753

Coefficient of


Relative Standard





Results

Correlation


Y-intercept --------- - 03059

slope --------- 1059

Coefficient of


Relative Standard




dT(n=7)

DT(n=7)

DTPHB(n=9)


DTP(n=7)

Mean (UImL) 338 467 657 668 1038



(le20)13 15 9 13 10

An

aly

st

I

dT(n=3)

DT(n=3)

DTPHB(n=3)


DTP(n=3)

Mean (UImL) 276 399 609 582 927



(le20)8 4 4 6 7

An

aly

st

II



DTPHB(n=3)

DTP(n=3)

Tetanus Toxoid(n=3)

dT(n=3)

DT(n=3)

Mean (UImL) 313 497 801 1001 1381



(le20)9 14 8 1 2

An

aly

st

I

DTPHB(n=3)

DTP(n=3)

Tetanus Toxoid(n=3)

dT(n=3)

DT(n=3)

Mean (UImL) 321 53 874 1031 1391



(le20)4 6 11 10 2

An

aly

st

II



SAMPLES


X(An I)

(le20)

Mean(UImL)

SDRSD(le20)

dT 319 047 15 18

DT 446 067 15 15

DTPHB 645 058 9 7


DTP 1005 107 11 11




SAMPLES


X(An I)

(le20)

Mean(UImL)

SDRSD(le20)

DTPHB 317 019 6 3

DTP 513 051 10 7


dT 1016 065 6 3

DT 1386 023 2 1





n = 7


(UImL)

n = 1

X (ToBI) x 100


dT 338 30 113

DT 467 49 95

DTPHB 657 60 110

Diphtheria

Toxoid668 66 101

DTP 1038 114 91




n = 3


(UImL)

n = 1

X (ToBI) x 100


DTPHB 313 28 112

DTP 497 46 108


dT 1001 123 81

DT 1381 152 91




















Brazil

Zip code - 05503-900

(+ 55 11) 26279453

Thank you


Biotech QC team



Replacement

0 1 2 3 4 5 6 7 800

05

10

15

LPS standard [UEmL]

Tem

pera

ture

[C

els

ius d

eg

ree]

110

120

-100

-50

00

100

200

300

+ 10UEmL

+ 1UEml

+ 01UEml

+ 001UEml

LP

S r

eco

very

[

]


viv

oIn

vit

ro -

LA

L




Correl = 093














just implemented



just implemented





just implemented






Zip code - 05503-900

(+ 55 11) 26279453

wwwbutantangovbr



by ToBI




Our propose













diphteria) toxoid


100 1016


100 1034


100 904


100 1001


100 1048


100 102





Results

Correlation


Y-intercept --------- 00816

slope --------- 09753

Coefficient of


Relative Standard





Results

Correlation


Y-intercept --------- - 03059

slope --------- 1059

Coefficient of


Relative Standard




dT(n=7)

DT(n=7)

DTPHB(n=9)


DTP(n=7)

Mean (UImL) 338 467 657 668 1038



(le20)13 15 9 13 10

An

aly

st

I

dT(n=3)

DT(n=3)

DTPHB(n=3)


DTP(n=3)

Mean (UImL) 276 399 609 582 927



(le20)8 4 4 6 7

An

aly

st

II



DTPHB(n=3)

DTP(n=3)

Tetanus Toxoid(n=3)

dT(n=3)

DT(n=3)

Mean (UImL) 313 497 801 1001 1381



(le20)9 14 8 1 2

An

aly

st

I

DTPHB(n=3)

DTP(n=3)

Tetanus Toxoid(n=3)

dT(n=3)

DT(n=3)

Mean (UImL) 321 53 874 1031 1391



(le20)4 6 11 10 2

An

aly

st

II



SAMPLES


X(An I)

(le20)

Mean(UImL)

SDRSD(le20)

dT 319 047 15 18

DT 446 067 15 15

DTPHB 645 058 9 7


DTP 1005 107 11 11




SAMPLES


X(An I)

(le20)

Mean(UImL)

SDRSD(le20)

DTPHB 317 019 6 3

DTP 513 051 10 7


dT 1016 065 6 3

DT 1386 023 2 1





n = 7


(UImL)

n = 1

X (ToBI) x 100


dT 338 30 113

DT 467 49 95

DTPHB 657 60 110

Diphtheria

Toxoid668 66 101

DTP 1038 114 91




n = 3


(UImL)

n = 1

X (ToBI) x 100


DTPHB 313 28 112

DTP 497 46 108


dT 1001 123 81

DT 1381 152 91




















Brazil

Zip code - 05503-900

(+ 55 11) 26279453

Thank you


Biotech QC team



Correl = 093














just implemented



just implemented





just implemented






Zip code - 05503-900

(+ 55 11) 26279453

wwwbutantangovbr



by ToBI




Our propose













diphteria) toxoid


100 1016


100 1034


100 904


100 1001


100 1048


100 102





Results

Correlation


Y-intercept --------- 00816

slope --------- 09753

Coefficient of


Relative Standard





Results

Correlation


Y-intercept --------- - 03059

slope --------- 1059

Coefficient of


Relative Standard




dT(n=7)

DT(n=7)

DTPHB(n=9)


DTP(n=7)

Mean (UImL) 338 467 657 668 1038



(le20)13 15 9 13 10

An

aly

st

I

dT(n=3)

DT(n=3)

DTPHB(n=3)


DTP(n=3)

Mean (UImL) 276 399 609 582 927



(le20)8 4 4 6 7

An

aly

st

II



DTPHB(n=3)

DTP(n=3)

Tetanus Toxoid(n=3)

dT(n=3)

DT(n=3)

Mean (UImL) 313 497 801 1001 1381



(le20)9 14 8 1 2

An

aly

st

I

DTPHB(n=3)

DTP(n=3)

Tetanus Toxoid(n=3)

dT(n=3)

DT(n=3)

Mean (UImL) 321 53 874 1031 1391



(le20)4 6 11 10 2

An

aly

st

II



SAMPLES


X(An I)

(le20)

Mean(UImL)

SDRSD(le20)

dT 319 047 15 18

DT 446 067 15 15

DTPHB 645 058 9 7


DTP 1005 107 11 11




SAMPLES


X(An I)

(le20)

Mean(UImL)

SDRSD(le20)

DTPHB 317 019 6 3

DTP 513 051 10 7


dT 1016 065 6 3

DT 1386 023 2 1





n = 7


(UImL)

n = 1

X (ToBI) x 100


dT 338 30 113

DT 467 49 95

DTPHB 657 60 110

Diphtheria

Toxoid668 66 101

DTP 1038 114 91




n = 3


(UImL)

n = 1

X (ToBI) x 100


DTPHB 313 28 112

DTP 497 46 108


dT 1001 123 81

DT 1381 152 91




















Brazil

Zip code - 05503-900

(+ 55 11) 26279453

Thank you


Biotech QC team













just implemented



just implemented





just implemented






Zip code - 05503-900

(+ 55 11) 26279453

wwwbutantangovbr



by ToBI




Our propose













diphteria) toxoid


100 1016


100 1034


100 904


100 1001


100 1048


100 102





Results

Correlation


Y-intercept --------- 00816

slope --------- 09753

Coefficient of


Relative Standard





Results

Correlation


Y-intercept --------- - 03059

slope --------- 1059

Coefficient of


Relative Standard




dT(n=7)

DT(n=7)

DTPHB(n=9)


DTP(n=7)

Mean (UImL) 338 467 657 668 1038



(le20)13 15 9 13 10

An

aly

st

I

dT(n=3)

DT(n=3)

DTPHB(n=3)


DTP(n=3)

Mean (UImL) 276 399 609 582 927



(le20)8 4 4 6 7

An

aly

st

II



DTPHB(n=3)

DTP(n=3)

Tetanus Toxoid(n=3)

dT(n=3)

DT(n=3)

Mean (UImL) 313 497 801 1001 1381



(le20)9 14 8 1 2

An

aly

st

I

DTPHB(n=3)

DTP(n=3)

Tetanus Toxoid(n=3)

dT(n=3)

DT(n=3)

Mean (UImL) 321 53 874 1031 1391



(le20)4 6 11 10 2

An

aly

st

II



SAMPLES


X(An I)

(le20)

Mean(UImL)

SDRSD(le20)

dT 319 047 15 18

DT 446 067 15 15

DTPHB 645 058 9 7


DTP 1005 107 11 11




SAMPLES


X(An I)

(le20)

Mean(UImL)

SDRSD(le20)

DTPHB 317 019 6 3

DTP 513 051 10 7


dT 1016 065 6 3

DT 1386 023 2 1





n = 7


(UImL)

n = 1

X (ToBI) x 100


dT 338 30 113

DT 467 49 95

DTPHB 657 60 110

Diphtheria

Toxoid668 66 101

DTP 1038 114 91




n = 3


(UImL)

n = 1

X (ToBI) x 100


DTPHB 313 28 112

DTP 497 46 108


dT 1001 123 81

DT 1381 152 91




















Brazil

Zip code - 05503-900

(+ 55 11) 26279453

Thank you


Biotech QC team





just implemented



just implemented





just implemented






Zip code - 05503-900

(+ 55 11) 26279453

wwwbutantangovbr



by ToBI




Our propose













diphteria) toxoid


100 1016


100 1034


100 904


100 1001


100 1048


100 102





Results

Correlation


Y-intercept --------- 00816

slope --------- 09753

Coefficient of


Relative Standard





Results

Correlation


Y-intercept --------- - 03059

slope --------- 1059

Coefficient of


Relative Standard




dT(n=7)

DT(n=7)

DTPHB(n=9)


DTP(n=7)

Mean (UImL) 338 467 657 668 1038



(le20)13 15 9 13 10

An

aly

st

I

dT(n=3)

DT(n=3)

DTPHB(n=3)


DTP(n=3)

Mean (UImL) 276 399 609 582 927



(le20)8 4 4 6 7

An

aly

st

II



DTPHB(n=3)

DTP(n=3)

Tetanus Toxoid(n=3)

dT(n=3)

DT(n=3)

Mean (UImL) 313 497 801 1001 1381



(le20)9 14 8 1 2

An

aly

st

I

DTPHB(n=3)

DTP(n=3)

Tetanus Toxoid(n=3)

dT(n=3)

DT(n=3)

Mean (UImL) 321 53 874 1031 1391



(le20)4 6 11 10 2

An

aly

st

II



SAMPLES


X(An I)

(le20)

Mean(UImL)

SDRSD(le20)

dT 319 047 15 18

DT 446 067 15 15

DTPHB 645 058 9 7


DTP 1005 107 11 11




SAMPLES


X(An I)

(le20)

Mean(UImL)

SDRSD(le20)

DTPHB 317 019 6 3

DTP 513 051 10 7


dT 1016 065 6 3

DT 1386 023 2 1





n = 7


(UImL)

n = 1

X (ToBI) x 100


dT 338 30 113

DT 467 49 95

DTPHB 657 60 110

Diphtheria

Toxoid668 66 101

DTP 1038 114 91




n = 3


(UImL)

n = 1

X (ToBI) x 100


DTPHB 313 28 112

DTP 497 46 108


dT 1001 123 81

DT 1381 152 91




















Brazil

Zip code - 05503-900

(+ 55 11) 26279453

Thank you


Biotech QC team





just implemented






Zip code - 05503-900

(+ 55 11) 26279453

wwwbutantangovbr



by ToBI




Our propose













diphteria) toxoid


100 1016


100 1034


100 904


100 1001


100 1048


100 102





Results

Correlation


Y-intercept --------- 00816

slope --------- 09753

Coefficient of


Relative Standard





Results

Correlation


Y-intercept --------- - 03059

slope --------- 1059

Coefficient of


Relative Standard




dT(n=7)

DT(n=7)

DTPHB(n=9)


DTP(n=7)

Mean (UImL) 338 467 657 668 1038



(le20)13 15 9 13 10

An

aly

st

I

dT(n=3)

DT(n=3)

DTPHB(n=3)


DTP(n=3)

Mean (UImL) 276 399 609 582 927



(le20)8 4 4 6 7

An

aly

st

II



DTPHB(n=3)

DTP(n=3)

Tetanus Toxoid(n=3)

dT(n=3)

DT(n=3)

Mean (UImL) 313 497 801 1001 1381



(le20)9 14 8 1 2

An

aly

st

I

DTPHB(n=3)

DTP(n=3)

Tetanus Toxoid(n=3)

dT(n=3)

DT(n=3)

Mean (UImL) 321 53 874 1031 1391



(le20)4 6 11 10 2

An

aly

st

II



SAMPLES


X(An I)

(le20)

Mean(UImL)

SDRSD(le20)

dT 319 047 15 18

DT 446 067 15 15

DTPHB 645 058 9 7


DTP 1005 107 11 11




SAMPLES


X(An I)

(le20)

Mean(UImL)

SDRSD(le20)

DTPHB 317 019 6 3

DTP 513 051 10 7


dT 1016 065 6 3

DT 1386 023 2 1





n = 7


(UImL)

n = 1

X (ToBI) x 100


dT 338 30 113

DT 467 49 95

DTPHB 657 60 110

Diphtheria

Toxoid668 66 101

DTP 1038 114 91




n = 3


(UImL)

n = 1

X (ToBI) x 100


DTPHB 313 28 112

DTP 497 46 108


dT 1001 123 81

DT 1381 152 91




















Brazil

Zip code - 05503-900

(+ 55 11) 26279453

Thank you


Biotech QC team



Zip code - 05503-900

(+ 55 11) 26279453

wwwbutantangovbr



by ToBI




Our propose













diphteria) toxoid


100 1016


100 1034


100 904


100 1001


100 1048


100 102





Results

Correlation


Y-intercept --------- 00816

slope --------- 09753

Coefficient of


Relative Standard





Results

Correlation


Y-intercept --------- - 03059

slope --------- 1059

Coefficient of


Relative Standard




dT(n=7)

DT(n=7)

DTPHB(n=9)


DTP(n=7)

Mean (UImL) 338 467 657 668 1038



(le20)13 15 9 13 10

An

aly

st

I

dT(n=3)

DT(n=3)

DTPHB(n=3)


DTP(n=3)

Mean (UImL) 276 399 609 582 927



(le20)8 4 4 6 7

An

aly

st

II



DTPHB(n=3)

DTP(n=3)

Tetanus Toxoid(n=3)

dT(n=3)

DT(n=3)

Mean (UImL) 313 497 801 1001 1381



(le20)9 14 8 1 2

An

aly

st

I

DTPHB(n=3)

DTP(n=3)

Tetanus Toxoid(n=3)

dT(n=3)

DT(n=3)

Mean (UImL) 321 53 874 1031 1391



(le20)4 6 11 10 2

An

aly

st

II



SAMPLES


X(An I)

(le20)

Mean(UImL)

SDRSD(le20)

dT 319 047 15 18

DT 446 067 15 15

DTPHB 645 058 9 7


DTP 1005 107 11 11




SAMPLES


X(An I)

(le20)

Mean(UImL)

SDRSD(le20)

DTPHB 317 019 6 3

DTP 513 051 10 7


dT 1016 065 6 3

DT 1386 023 2 1





n = 7


(UImL)

n = 1

X (ToBI) x 100


dT 338 30 113

DT 467 49 95

DTPHB 657 60 110

Diphtheria

Toxoid668 66 101

DTP 1038 114 91




n = 3


(UImL)

n = 1

X (ToBI) x 100


DTPHB 313 28 112

DTP 497 46 108


dT 1001 123 81

DT 1381 152 91




















Brazil

Zip code - 05503-900

(+ 55 11) 26279453

Thank you


Biotech QC team



by ToBI




Our propose













diphteria) toxoid


100 1016


100 1034


100 904


100 1001


100 1048


100 102





Results

Correlation


Y-intercept --------- 00816

slope --------- 09753

Coefficient of


Relative Standard





Results

Correlation


Y-intercept --------- - 03059

slope --------- 1059

Coefficient of


Relative Standard




dT(n=7)

DT(n=7)

DTPHB(n=9)


DTP(n=7)

Mean (UImL) 338 467 657 668 1038



(le20)13 15 9 13 10

An

aly

st

I

dT(n=3)

DT(n=3)

DTPHB(n=3)


DTP(n=3)

Mean (UImL) 276 399 609 582 927



(le20)8 4 4 6 7

An

aly

st

II



DTPHB(n=3)

DTP(n=3)

Tetanus Toxoid(n=3)

dT(n=3)

DT(n=3)

Mean (UImL) 313 497 801 1001 1381



(le20)9 14 8 1 2

An

aly

st

I

DTPHB(n=3)

DTP(n=3)

Tetanus Toxoid(n=3)

dT(n=3)

DT(n=3)

Mean (UImL) 321 53 874 1031 1391



(le20)4 6 11 10 2

An

aly

st

II



SAMPLES


X(An I)

(le20)

Mean(UImL)

SDRSD(le20)

dT 319 047 15 18

DT 446 067 15 15

DTPHB 645 058 9 7


DTP 1005 107 11 11




SAMPLES


X(An I)

(le20)

Mean(UImL)

SDRSD(le20)

DTPHB 317 019 6 3

DTP 513 051 10 7


dT 1016 065 6 3

DT 1386 023 2 1





n = 7


(UImL)

n = 1

X (ToBI) x 100


dT 338 30 113

DT 467 49 95

DTPHB 657 60 110

Diphtheria

Toxoid668 66 101

DTP 1038 114 91




n = 3


(UImL)

n = 1

X (ToBI) x 100


DTPHB 313 28 112

DTP 497 46 108


dT 1001 123 81

DT 1381 152 91




















Brazil

Zip code - 05503-900

(+ 55 11) 26279453

Thank you


Biotech QC team












diphteria) toxoid


100 1016


100 1034


100 904


100 1001


100 1048


100 102





Results

Correlation


Y-intercept --------- 00816

slope --------- 09753

Coefficient of


Relative Standard





Results

Correlation


Y-intercept --------- - 03059

slope --------- 1059

Coefficient of


Relative Standard




dT(n=7)

DT(n=7)

DTPHB(n=9)


DTP(n=7)

Mean (UImL) 338 467 657 668 1038



(le20)13 15 9 13 10

An

aly

st

I

dT(n=3)

DT(n=3)

DTPHB(n=3)


DTP(n=3)

Mean (UImL) 276 399 609 582 927



(le20)8 4 4 6 7

An

aly

st

II



DTPHB(n=3)

DTP(n=3)

Tetanus Toxoid(n=3)

dT(n=3)

DT(n=3)

Mean (UImL) 313 497 801 1001 1381



(le20)9 14 8 1 2

An

aly

st

I

DTPHB(n=3)

DTP(n=3)

Tetanus Toxoid(n=3)

dT(n=3)

DT(n=3)

Mean (UImL) 321 53 874 1031 1391



(le20)4 6 11 10 2

An

aly

st

II



SAMPLES


X(An I)

(le20)

Mean(UImL)

SDRSD(le20)

dT 319 047 15 18

DT 446 067 15 15

DTPHB 645 058 9 7


DTP 1005 107 11 11




SAMPLES


X(An I)

(le20)

Mean(UImL)

SDRSD(le20)

DTPHB 317 019 6 3

DTP 513 051 10 7


dT 1016 065 6 3

DT 1386 023 2 1





n = 7


(UImL)

n = 1

X (ToBI) x 100


dT 338 30 113

DT 467 49 95

DTPHB 657 60 110

Diphtheria

Toxoid668 66 101

DTP 1038 114 91




n = 3


(UImL)

n = 1

X (ToBI) x 100


DTPHB 313 28 112

DTP 497 46 108


dT 1001 123 81

DT 1381 152 91




















Brazil

Zip code - 05503-900

(+ 55 11) 26279453

Thank you


Biotech QC team




diphteria) toxoid


100 1016


100 1034


100 904


100 1001


100 1048


100 102





Results

Correlation


Y-intercept --------- 00816

slope --------- 09753

Coefficient of


Relative Standard





Results

Correlation


Y-intercept --------- - 03059

slope --------- 1059

Coefficient of


Relative Standard




dT(n=7)

DT(n=7)

DTPHB(n=9)


DTP(n=7)

Mean (UImL) 338 467 657 668 1038



(le20)13 15 9 13 10

An

aly

st

I

dT(n=3)

DT(n=3)

DTPHB(n=3)


DTP(n=3)

Mean (UImL) 276 399 609 582 927



(le20)8 4 4 6 7

An

aly

st

II



DTPHB(n=3)

DTP(n=3)

Tetanus Toxoid(n=3)

dT(n=3)

DT(n=3)

Mean (UImL) 313 497 801 1001 1381



(le20)9 14 8 1 2

An

aly

st

I

DTPHB(n=3)

DTP(n=3)

Tetanus Toxoid(n=3)

dT(n=3)

DT(n=3)

Mean (UImL) 321 53 874 1031 1391



(le20)4 6 11 10 2

An

aly

st

II



SAMPLES


X(An I)

(le20)

Mean(UImL)

SDRSD(le20)

dT 319 047 15 18

DT 446 067 15 15

DTPHB 645 058 9 7


DTP 1005 107 11 11




SAMPLES


X(An I)

(le20)

Mean(UImL)

SDRSD(le20)

DTPHB 317 019 6 3

DTP 513 051 10 7


dT 1016 065 6 3

DT 1386 023 2 1





n = 7


(UImL)

n = 1

X (ToBI) x 100


dT 338 30 113

DT 467 49 95

DTPHB 657 60 110

Diphtheria

Toxoid668 66 101

DTP 1038 114 91




n = 3


(UImL)

n = 1

X (ToBI) x 100


DTPHB 313 28 112

DTP 497 46 108


dT 1001 123 81

DT 1381 152 91




















Brazil

Zip code - 05503-900

(+ 55 11) 26279453

Thank you


Biotech QC team




Results

Correlation


Y-intercept --------- 00816

slope --------- 09753

Coefficient of


Relative Standard





Results

Correlation


Y-intercept --------- - 03059

slope --------- 1059

Coefficient of


Relative Standard




dT(n=7)

DT(n=7)

DTPHB(n=9)


DTP(n=7)

Mean (UImL) 338 467 657 668 1038



(le20)13 15 9 13 10

An

aly

st

I

dT(n=3)

DT(n=3)

DTPHB(n=3)


DTP(n=3)

Mean (UImL) 276 399 609 582 927



(le20)8 4 4 6 7

An

aly

st

II



DTPHB(n=3)

DTP(n=3)

Tetanus Toxoid(n=3)

dT(n=3)

DT(n=3)

Mean (UImL) 313 497 801 1001 1381



(le20)9 14 8 1 2

An

aly

st

I

DTPHB(n=3)

DTP(n=3)

Tetanus Toxoid(n=3)

dT(n=3)

DT(n=3)

Mean (UImL) 321 53 874 1031 1391



(le20)4 6 11 10 2

An

aly

st

II



SAMPLES


X(An I)

(le20)

Mean(UImL)

SDRSD(le20)

dT 319 047 15 18

DT 446 067 15 15

DTPHB 645 058 9 7


DTP 1005 107 11 11




SAMPLES


X(An I)

(le20)

Mean(UImL)

SDRSD(le20)

DTPHB 317 019 6 3

DTP 513 051 10 7


dT 1016 065 6 3

DT 1386 023 2 1





n = 7


(UImL)

n = 1

X (ToBI) x 100


dT 338 30 113

DT 467 49 95

DTPHB 657 60 110

Diphtheria

Toxoid668 66 101

DTP 1038 114 91




n = 3


(UImL)

n = 1

X (ToBI) x 100


DTPHB 313 28 112

DTP 497 46 108


dT 1001 123 81

DT 1381 152 91




















Brazil

Zip code - 05503-900

(+ 55 11) 26279453

Thank you


Biotech QC team




Results

Correlation


Y-intercept --------- - 03059

slope --------- 1059

Coefficient of


Relative Standard




dT(n=7)

DT(n=7)

DTPHB(n=9)


DTP(n=7)

Mean (UImL) 338 467 657 668 1038



(le20)13 15 9 13 10

An

aly

st

I

dT(n=3)

DT(n=3)

DTPHB(n=3)


DTP(n=3)

Mean (UImL) 276 399 609 582 927



(le20)8 4 4 6 7

An

aly

st

II



DTPHB(n=3)

DTP(n=3)

Tetanus Toxoid(n=3)

dT(n=3)

DT(n=3)

Mean (UImL) 313 497 801 1001 1381



(le20)9 14 8 1 2

An

aly

st

I

DTPHB(n=3)

DTP(n=3)

Tetanus Toxoid(n=3)

dT(n=3)

DT(n=3)

Mean (UImL) 321 53 874 1031 1391



(le20)4 6 11 10 2

An

aly

st

II



SAMPLES


X(An I)

(le20)

Mean(UImL)

SDRSD(le20)

dT 319 047 15 18

DT 446 067 15 15

DTPHB 645 058 9 7


DTP 1005 107 11 11




SAMPLES


X(An I)

(le20)

Mean(UImL)

SDRSD(le20)

DTPHB 317 019 6 3

DTP 513 051 10 7


dT 1016 065 6 3

DT 1386 023 2 1





n = 7


(UImL)

n = 1

X (ToBI) x 100


dT 338 30 113

DT 467 49 95

DTPHB 657 60 110

Diphtheria

Toxoid668 66 101

DTP 1038 114 91




n = 3


(UImL)

n = 1

X (ToBI) x 100


DTPHB 313 28 112

DTP 497 46 108


dT 1001 123 81

DT 1381 152 91




















Brazil

Zip code - 05503-900

(+ 55 11) 26279453

Thank you


Biotech QC team



dT(n=7)

DT(n=7)

DTPHB(n=9)


DTP(n=7)

Mean (UImL) 338 467 657 668 1038



(le20)13 15 9 13 10

An

aly

st

I

dT(n=3)

DT(n=3)

DTPHB(n=3)


DTP(n=3)

Mean (UImL) 276 399 609 582 927



(le20)8 4 4 6 7

An

aly

st

II



DTPHB(n=3)

DTP(n=3)

Tetanus Toxoid(n=3)

dT(n=3)

DT(n=3)

Mean (UImL) 313 497 801 1001 1381



(le20)9 14 8 1 2

An

aly

st

I

DTPHB(n=3)

DTP(n=3)

Tetanus Toxoid(n=3)

dT(n=3)

DT(n=3)

Mean (UImL) 321 53 874 1031 1391



(le20)4 6 11 10 2

An

aly

st

II



SAMPLES


X(An I)

(le20)

Mean(UImL)

SDRSD(le20)

dT 319 047 15 18

DT 446 067 15 15

DTPHB 645 058 9 7


DTP 1005 107 11 11




SAMPLES


X(An I)

(le20)

Mean(UImL)

SDRSD(le20)

DTPHB 317 019 6 3

DTP 513 051 10 7


dT 1016 065 6 3

DT 1386 023 2 1





n = 7


(UImL)

n = 1

X (ToBI) x 100


dT 338 30 113

DT 467 49 95

DTPHB 657 60 110

Diphtheria

Toxoid668 66 101

DTP 1038 114 91




n = 3


(UImL)

n = 1

X (ToBI) x 100


DTPHB 313 28 112

DTP 497 46 108


dT 1001 123 81

DT 1381 152 91




















Brazil

Zip code - 05503-900

(+ 55 11) 26279453

Thank you


Biotech QC team



DTPHB(n=3)

DTP(n=3)

Tetanus Toxoid(n=3)

dT(n=3)

DT(n=3)

Mean (UImL) 313 497 801 1001 1381



(le20)9 14 8 1 2

An

aly

st

I

DTPHB(n=3)

DTP(n=3)

Tetanus Toxoid(n=3)

dT(n=3)

DT(n=3)

Mean (UImL) 321 53 874 1031 1391



(le20)4 6 11 10 2

An

aly

st

II



SAMPLES


X(An I)

(le20)

Mean(UImL)

SDRSD(le20)

dT 319 047 15 18

DT 446 067 15 15

DTPHB 645 058 9 7


DTP 1005 107 11 11




SAMPLES


X(An I)

(le20)

Mean(UImL)

SDRSD(le20)

DTPHB 317 019 6 3

DTP 513 051 10 7


dT 1016 065 6 3

DT 1386 023 2 1





n = 7


(UImL)

n = 1

X (ToBI) x 100


dT 338 30 113

DT 467 49 95

DTPHB 657 60 110

Diphtheria

Toxoid668 66 101

DTP 1038 114 91




n = 3


(UImL)

n = 1

X (ToBI) x 100


DTPHB 313 28 112

DTP 497 46 108


dT 1001 123 81

DT 1381 152 91




















Brazil

Zip code - 05503-900

(+ 55 11) 26279453

Thank you


Biotech QC team



SAMPLES


X(An I)

(le20)

Mean(UImL)

SDRSD(le20)

dT 319 047 15 18

DT 446 067 15 15

DTPHB 645 058 9 7


DTP 1005 107 11 11




SAMPLES


X(An I)

(le20)

Mean(UImL)

SDRSD(le20)

DTPHB 317 019 6 3

DTP 513 051 10 7


dT 1016 065 6 3

DT 1386 023 2 1





n = 7


(UImL)

n = 1

X (ToBI) x 100


dT 338 30 113

DT 467 49 95

DTPHB 657 60 110

Diphtheria

Toxoid668 66 101

DTP 1038 114 91




n = 3


(UImL)

n = 1

X (ToBI) x 100


DTPHB 313 28 112

DTP 497 46 108


dT 1001 123 81

DT 1381 152 91




















Brazil

Zip code - 05503-900

(+ 55 11) 26279453

Thank you


Biotech QC team



SAMPLES


X(An I)

(le20)

Mean(UImL)

SDRSD(le20)

DTPHB 317 019 6 3

DTP 513 051 10 7


dT 1016 065 6 3

DT 1386 023 2 1





n = 7


(UImL)

n = 1

X (ToBI) x 100


dT 338 30 113

DT 467 49 95

DTPHB 657 60 110

Diphtheria

Toxoid668 66 101

DTP 1038 114 91




n = 3


(UImL)

n = 1

X (ToBI) x 100


DTPHB 313 28 112

DTP 497 46 108


dT 1001 123 81

DT 1381 152 91




















Brazil

Zip code - 05503-900

(+ 55 11) 26279453

Thank you


Biotech QC team




n = 7


(UImL)

n = 1

X (ToBI) x 100


dT 338 30 113

DT 467 49 95

DTPHB 657 60 110

Diphtheria

Toxoid668 66 101

DTP 1038 114 91




n = 3


(UImL)

n = 1

X (ToBI) x 100


DTPHB 313 28 112

DTP 497 46 108


dT 1001 123 81

DT 1381 152 91




















Brazil

Zip code - 05503-900

(+ 55 11) 26279453

Thank you


Biotech QC team




n = 3


(UImL)

n = 1

X (ToBI) x 100


DTPHB 313 28 112

DTP 497 46 108


dT 1001 123 81

DT 1381 152 91




















Brazil

Zip code - 05503-900

(+ 55 11) 26279453

Thank you


Biotech QC team




















Brazil

Zip code - 05503-900

(+ 55 11) 26279453

Thank you


Biotech QC team

















Brazil

Zip code - 05503-900

(+ 55 11) 26279453

Thank you


Biotech QC team














Brazil

Zip code - 05503-900

(+ 55 11) 26279453

Thank you


Biotech QC team



Brazil

Zip code - 05503-900

(+ 55 11) 26279453

Thank you


Biotech QC team

Documents

Section XII Vaccines: Making difference on reduction ...metrologia.org.br/eventos/pan2018_palestras/SECTION...Instituto Butantan | 17 Bothrops jararaca sera potency by ToBI test -