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Role of lab.animal in Quality Control of biological products.

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Presentation on theme: "Role of lab.animal in Quality Control of biological products."— Presentation transcript:

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2 Role of lab.animal in Quality Control of biological products

3 The quality control testing of vaccines : 1. in -process control 2. final bulk testing

4 Order : Rodentia Family : Muridae Genus : Mus

5 In the 18 th and 19 th centuries ↓ Used occasionally by early investigators In the early 1900s ↓ Gained general acceptance as a lab-animal

6 Small body size Ease of handling Low cost of maintenance

7 Genetic Embryology Nutrition Infectious disease Toxicity test Basic research Vaccine development

8 Adult weight (g) Male 20-40 Female 18-40 Diploid number of chromosomes 40 Food intake 15-100 gr bw/day Water intake 15-100 ml bw/day Urine production 1-1.5 ml/ day Lifespan (years) 1.5-2 Rectal temperature ( ºc) 37-38 Blood volume (ml/100 gr) 5.8-7.0 (5-6% of body weight)

9 RBC (×10 6 /mm 3 ) 8.7-10.5 Haemotacrit (Vol.%) 40-50 WBC(×10 3 /mm 3 ) 5-11 Neutrophils(%) 10-40 Lymphocytes(%) 55-75 EosinoPhils(5) 0-4 Monocytes(%) 0.1-3.5 Basophils(%) 0-1.0 Serum protein (g/100ml) 4-6 Globulin(g/100 ml) 0.6

10 Temperature ( ºC) 20-24 Relative humidity (%) 50-70 Ventilation(chenges/hour) 10-15 Light / dark hours 14/10or12/12

11 One individually housed adult (cm 2 ) 180 Breeding animal with pups(cm 2 ) 200 Group, per adult (cm 2 ) 80 Minimum cage heigh (cm) 12

12 Intravenous (I.V.) 0.2 ml Intra-muscular (I.M.) 0.05 ml/site Intra-peritoneal (I.P.) 2-3 ml Sub-coetaneous (S.C.) 0.5 ml/site* Oral 20 ml/kg Intra-dermal (I.D.) 100 μl/site

13 Order : Rodentia Family : Muridae Genus : Rattus

14 Background The first repots ↓ From Germany around 1880

15 Application Behavioral Nutrition Oncology Parasitological Immunogenetics

16 Adult weight (g) Male 450-520 Female 250-300 Diploid number of chromosomes 42 Food intake 10-100 gr bw/day Water intake 10-100 ml bw/day Urine production 10-15 ml/ day Lifespan (years) 2-3 Rectal temperature ( ºc) 36-40 Blood volume (ml/kg) 54-70

17 RBC (×10 6 /mm 3 ) …………………………………………. 7-10 WBC(×10 3 /mm 3 ) 6-17 Neutrophils(%) …………………………………………….9-34 Lymphocytes(%) 65-85 EosinoPhils(5)……………………………………………….0-6 Monocytes(%) 0-5 Basophils(%) …………………………………………………0-1.5 Serum protein (g/100ml) 5.6-7.6 Globulin(g/100 ml) …………………………………………1.8-3

18 Temperature ( ºC) 20-24 Relative humidity (%) 60 Ventilation(chenges/hour) 10-15 Light / dark hours 12/14or12/10

19 One individually housed adult (cm 2 ) 350 Breeding animal with pups(cm 2 ) 800 Group, per adult (cm 2 ) 250 Minimum cage heigh (cm) 15

20 Intra-venous (I.V.) 1 ml Intra-muscular(I.M.) 0.1 ml/site Intra-peritoneal(I.P.) 5-10 ml Sub-coetaneous(S.C.) 1-2 ml/site* Oral 10 ml/kg ml/kg Intra-dermal(I.D.) 100 μl/site

21 Order : Rodentia Sub-order : hystricomorpha Family : Caviidae Genus : Cavia

22 Background Use of lab-animal ↓ 19 th century

23 Hair types Peruvian Abyssinian English

24 Advantage One of the least aggressive Convenient size Immunological response resembles that of man

25 Application Immunological Physiological Pharmacological Very susceptible to a number of infectious diseases (tuberculosis) (diphtheria) (leptospirosis)

26 Adult weight (g) Male 850-1200 Female 700-900 Diploid number of chromosomes 64 Food intake 6-100 gr bw/day Water intake 10-100 ml bw/day Urine production 2.5-100 ml/100 gr bw/ day Lifespan (years) 4-8 Rectal temperature ( ºc) 38.5-40 Blood volume (ml/kg) 69-75

27 RBC (×10 6 /mm 3 ) 4.5-7 WBC(×10 3 /mm 3 ) 7-18 Neutrophils(%) 28-44 Lymphocytes(%) 39-72 EosinoPhils(5) 1-5 Monocytes(%) 3-12 Basophils(%) 0-3 Serum protein (g/100ml) 4.6-6.2 Globulin(g/100 ml) 1.7-2.6

28 Temperature ( ºC) 20-24 Relative humidity (%) 50 Ventilation(chenges/hour) 10-15 Light / dark hours 14/10

29 One individually housed adult (cm 2 ) 600 Breeding animal with pups(cm 2 ) 1200 Group, per adult (cm 2 ) 1000 Minimum cage heigh (cm) 18

30 Intra-venous (I.V.) 0.5 ml Intra-muscular(I.M.) 0.3 ml/site Intra-peritoneal(I.P.) 10-15 ml Sub-coetaneous(S.C.) 0.5 ml/site* Oral 5 ml/kg Intra-dermal(I.D.) 100 μl/site

31 Order : Lagomorpha Family : Leporida

32 The most widely used breed for laboratory use Dutch breed (less than 2 kg) New Zealand (2-5 kg) Flemish Giant (more than 5 kg)

33 Background First experiments ↓ Between the 6 th & 10 th centuries

34 Advantage Non-spontaneous ovulation No seasonal anoestrous Gestation is short Easy to collect semen

35 Application Studies on reproduction Pyrogenicity testing Serology Production of antiserum Cardiac surgery Orthopedics Hypertension Vaccine QC (clostridium)

36 Adult weight (g) 900-6000 Diploid number of chromosomes 44 Food intake 4 gr bw/day Water intake 10 ml bw/100 gr bw /day Urine production 50-75 ml/100 gr bw/ day Lifespan (years) 6-12 Rectal temperature ( ºc) 38.5-40 Blood volume (ml/kg) 57-65

37 RBC (×10 6 /mm 3 ) 4-7 WBC(×10 3 /mm 3 ) 9-11 Neutrophils(%) 20-75 Lymphocytes(%) 30-85 EosinoPhils(5) 0-4 Monocytes(%) 1-3 Basophils(%) 2-7 Serum protein (g/100ml) 5.4-7.5 Globulin(g/100 ml) 1.5-2.8

38 Temperature ( ºC) 15-21 Relative humidity (%) 50-60 Ventilation(chenges/hour) 5-15 Light / dark hours 12/12

39 One individually housed adult (cm 2 ) 1 kg : 1400 3 kg : 2500 5 kg : 3000 Breeding animal with pups(cm 2 ) 1 kg :3000 5 kg : 5000 Minimum cage heigh (cm) 1-2 kg 30 3 kg : 35 4-5 kg : 40

40 Intra-venous (I.V.) 1-10 ml Intra-muscular(I.M.) 0.5 ml/site Intra-peritoneal(I.P.) 50-100 ml Sub-coetaneous(S.C.) 1-5 ml/site* Oral 5 ml/kg Intra-dermal(I.D.) 100 μl/site

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