| QUALITY TESTING
Tests are performed according to the guidelines listed in The Code
of Federal Regulations (CFR) issued by the Food and Drug Administration
(FDA) Title 21 and the United States Department of Agriculture (USDA)
Title 9.
| An
overview of the tests routinely performed are |
| Endotoxin |
Level
of Endotoxin is determined by using the Limulus Amebocyte Lysate
(LAL) gel clot method. |
pH
|
Measurement
using standard methods for determining hydrogen ion concentration. |
Osmolality
|
Measured by
freezing point depression. |
| Hemoglobin |
Determined by
colorimetric assay. |
| Mycoplasma |
All sera are
tested for the absence of mycoplasma by the indirect fluorescent
DNA Bisbenzimide staining technique for cell cultures. |
| Virus
Testing |
All batches
of serum are carefully tested for virus contamination in accordance
with modified CFR Title 9 Part 113.53. Virus testing is species
specific. Serum of bovine origin is tested for the presence
of Bovine Viral Diarrhea virus (BVD), Infectious Bovine Rhinotracheitis
virus (IBR) and Parainfluenza virus Type 3 (PI-3). |
Protein
Electrophoresis
Identity Profile |
This test is
quantified for albumin and globulin fractions as percentages
of total protein. |
| Total
protein |
Determined spectrophotometrically
at 540 nm by the Biuret colorimetric assays. |
| Sterility |
No contamination
detected when inoculated into Fluid Thioglycollate, and Trypticase
Soy Broth (soy-bean casein) and incubated at 30°-35°C
and 20°-25°C respectively for 14 days, according to
the US Pharmacopeia <71>, CFR Title 9 Part 113.26 and
CFR Title 21 Part 610.12. |
| Chemistries |
Characteristic
profile of all serum batches are obtained by SMAC analysis or
equivalent. |
ADDITIONAL TESTING
Each batch of Fetal Bovine Serum is tested for performance by directly
measuring its effectiveness in cell culture systems.
GROWTH PROMOTION BY HARVEST TO PLANT RATIO
Cell lines used:
Human lung, MRC-5 (fibroblast, adherent)
Hamster, golden Syrian, kidney, BHK-21 (fibroblast, adherent)
Mouse SP2/0 Ag-14 (lymphoblast, suspension)
Medium used is Eagle’s Minimal Essential Medium with Non-Essential
Amino Acids and phenol red, without L-glutamine. L-glutamine is
added at the same time as the serum preparatory to the growth assay.
The procedure uses 5% and 10% supplemental Fetal Bovine Serum.
Procedure: The medium is inoculated with the appropriate cell line
to give a final concentration of 1.0 x 105
viable cells/mL and incubated at 32-37° C with an atmosphere
containing 5% CO2. At about 90% confluency
the cells are counted and reinoculated into fresh medium at the
same concentration. This is continued until the fourth passage and
the cell counts from these data are compared with a proven acceptable
control lot of Fetal Bovine Serum.
ADVENTITIOUS VIRUSES
All Bovine sera are tested for the presence of Bovine Viral Diarrhea
virus (BVD), Infectious Rhinotracheitis virus (IBR) and Parainfluenza
virus Type 3 (PI-3) in accordance with the Code of Federal Regulations
Title 9 part 113.53.
Horse serum is tested for the presence of Equine Infectious Anemia
virus (EIA)
Porcine serum is tested for Porcine Parvovirus (PPV)
ANTIBODY SERUM NEUTRALIZATION
Fetal Bovine Serum is tested for the presence of antibodies to BVD,
IBR and PI-3
PROTEIN ELECTROPHORETIC PROFILE
Quantifies albumin, alpha, beta and gamma globulins in g/dL and
as percentage of the total protein.
CUSTOMIZED TEST PANELS AVAILABLE ON REQUEST
|
