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Test Facility Animal Capacity
| Non-human Primate Facility: |
179 rooms |
| Dog Facility: |
33 rooms |
| Rabbit and Guinea Pig Facility: |
10 rooms |
| Rodent Facility: |
53 rooms |
Study Animals
Cynomolgus monkey, Rhesus monkey, Common marmoset, Beagle dog, Rabbit,
Rat, Mouse
SNBL offers juvenile studies in cynomolgus and rhesus monkeys (minimum
age at first administration, 8 to 12 months), beagles (3 weeks), and rats
(5 days). SNBL also offers studies in mature and aged primates and beagles.
Study Types
In addition to general single and repeated dose toxicity studies and pharmacokinetics
(PK) studies, SNBL provides dedicated pharmacokinetic sampling of blood
and urine (samples consigned to the Sponsor) and offers hemolysis tests
in human (vitro) samples. Hormonal effects of test compounds can be detected in cynomolgus
monkeys by synchronizing administration with the menstrual cycle. Dogs
and non-human primates can be repeatedly screened through long-term maintenance
agreements (separate study contracts).
Study Timelines
A draft report can be submitted 1 to 1.5 months after gross pathology.
If histopathological examinations are required, the draft report is submitted
2 to 2.5 months after gross pathology. The final report follows one month
later.
Test Article
GLP studies:
- Test article characterization
- Test article stability
- Stability and homogeneity of combined test article and vehicle
Analysis method validation tests (non-GLP) are also available.
Administration Routes
In addition to general oral, subcutaneous, intra-peritoneal and intravenous
administration, SNBL offers other dosing methods such as oral capsule administration
to non-human primates. Atomized powder can be nebulized directly onto the
nasal mucosa of non-human primates by a specialized administration device.
Intranasal, intratracheal, intraarterial (coronal/femoral), intraportal,
intravaginal suppository, endorectal suppository, articular cavity, intraosseous
implantation, subcutaneous implantation, intramuscular implantation, epidural
(other routes upon request)
Intravenous infusion to conscious animals
Restraint apparatus enables intravenous administration to non-human primates,
beagles, rabbits, and rats. Repeat 2-hour continuous intravenous administration is performed in non-human primates, beagles, and rats.
Continuous intravenous administration via indwelling catheter
A tether, swivel, and jacket enable continuous intravenous administration
to conscious animals. SNBL has experience of administration to rats (20+ studies), beagles (20+), and non-human primates (40+) for up
to 26 weeks.
Examinations during administration to beagles and non-human primates include
electrocardiography (ECG), body temperature measurement, and blood sampling
for pharmacokinetics.
Blood Sampling
In addition to venous blood sampling, SNBL offers arterial sampling from
beagles and non-human primates.
For TK, blood can be drawn from non-human primates every few minutes from
immediately after administration. Blood can be also drawn from the portal
veins of beagles and non-human primates with an indwelling catheter.
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Body Temperature, Blood Pressure, and Electrocardiogram (ECG) Examination
| Body temperature is measured rectally. Blood pressure is measured in the
forelimb in non-human primates and dogs, and in the tail in rats via a
cuff. ECG is recorded without anesthesia for non-human primates and dogs.
A new ECG system (JET-3ETA) has been introduced (transmitter: JET-3ETA,
receiver: Bluetooth, analysis software: PONEMAH Physiology Platform Plus). |
JET System (for ECG) |
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Sperm Morphology
A new system, HTM-IVOS, for sperm morphology has been introduced.
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Ocular Examination
HTM-IVOS |
In addition to gross, macroscopic and ocular fundus examinations using
an indirect ophthalmoscope or a slit lamp, and fundoscopy, the following
examinations are performed:
- Pupillary response (mydriatic and miotic effects are examined) to several
drugs
- Light reflex examination (papillary response to direct 300W illumination
and in a darkened room)
- Corneal examination using fluorescein
- Fluorescent fundus examination
- Measurement of lacrimation
- Electroretinogram examination (non-human primate, beagle, rat, and mouse)
- Intra-ocular pressure examination
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Urinalysis and Blood Tests
In addition to standard parameters, the following can also be evaluated:
Urinalysis:
Osmotic pressure, creatinine, creatinine clearance, Ca, NAG activity, Mg,
inorganic phosphorus, 17-OHCS, ß2-microglobulin, γ-GTP, protein, glucose, myoglobin, albumin, etc
(parameters vary according to species) |
Automatic analyzer (JCA-BM8)
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Hematology:
Fibrinogen, fibrin degradation products, plasma plasminogen, α2-plasmin inhibitor, erythrocyte morphology, whole blood methemoglobin,
whole blood calcium ions, hemoglobin A1c, antithrombin III, blood gas, platelet aggregation, bleeding time, erythrocyte
sedimentation rate, etc
(parameters vary according to species) |
Hematology system (ADVIA120) |
Blood chemistry:
LAP, γ-GTP, direct bilirubin, indirect bilirubin, phospholipids,
free fatty acids, uric acid, HDL-cholesterol, free-cholesterol, C-reactive
protein, LDH isozyme, ALP isozyme, CPK isozyme, cholinesterase, lactic
acid, ß2-microglobulin, Mg, Fe, UIBC, bile acid, amylase, ketone bodies, troponin
T and I, etc
(parameters vary according to species)
Hormones and other parameters:
FSH, TSH, LH, GH, prolactin, ACTH, total T4, free T4, total T3, free T3,
testosterone, progesterone, estradiol, aldosterone, cortisol, histamine,
insulin, ferritin, osteocalcin, intact PTH, etc
(parameters vary according to species)
Liver and renal function tests, and circulating blood volume measurement
are also offered. |
Pathology
Testicular differential diagnosis
Fixation by systemic perfusion
Determined with a flow rate variation roller pump
Fifteen slice brain slide preparation
Specific regions can be consolidated on one slide using Brain MatrixR
Immunohistochemical stain
Enzymatic and fluorescent antibody methods
Preparation of non-decalcified sections of hard tissue
MMA, Rigolac, technovit resin embedding, thin sectioning, ground sectioning,
frozen non-decalcified sectioning
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Preparation of specimens for medical equipment (materials and apparatus)
Implant, stent, and GDC coil
Morphometry
Quantitative analysis of HE-stained, and specially or immunohistochemically
stained sections
Special staining
Azan stain, periodic acid Schiff (PAS) stain, Kluver-Barrera's (KB) stain,
PAM stain, silver impregnation, calcium stain, phosphotungstic acid hematoxylin
(PTAH) stain, Grimelius stain, Fontana-Masson stain, Congo red stain, Sudan
black B stain, Sudan III stain, oil red O stain, Elastica Van Gieson stain,
Masson-Trichrome stain, May-Grunwald Giemsa stain, Toluidine blue stain,
etc.
Electron microscopy
Transmission and scanning electron microscopy
Medical electron microscopy is also available
 
M Cell (Peyer's patch), Transcytosis of poliovirus
The Journal of Immunology 2009,182 (10) : 6061-70 |
SNBL also offers separate sample preparation and pathological examination.
1 month from receipt of samples to results. |
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NHP Intestinal villous M Cell
(Peyer's patch)
BBRC (Biochemical Biophysical Research Communications)
368 (2008) 501-507 |
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