Mesenchymal Stem Cell (MSC) qualified FBS- COA |
CERTIFICATE OF ANALYSIS |
 |
| Product: |
Certified Foetal Bovine Serum (FBS) Qualified
for Mesenchymal Cells |
Origin |
MEXICO |
| Catalog no: |
o: 04-400-1 |
Origin |
2551815248233K5167593 |
| Lot number: |
51525 |
Dated |
JUNE 10, 2010 |
| Expiry date: |
JUNE 30, 201 |
Storage temperature: |
-20° |
|
 |
Triple 0.1 micron filtered
For In Vitro Diagnostic use (not for human or animal therapeutic use)
We certify that all lots of Biological Industries’ Foetal Bovine Serum are produced from raw materials originating in countries completely free of both BSE and FMD diseases. Therefore, they are certified for use by the European Directorate for the Quality of Medicines (EDQM).
Note: Since our sera are not pre-aged before filtration, turbidity or flocculent debris may develop upon thawing or storage of the serum. This condition does not adversely affect performance characteristics of the serum. |
| Reference |
Test |
Specification |
Result |
Units |
|
| 1 |
Alanine Transaminase (ALT) |
Check & Record |
8 |
u/L |
| 2 |
Albumin |
1.8 – 3.0 |
2.65 |
g/dL |
| 3 |
Alkaline Phosphatase |
Check & Record |
279 |
u/L |
| 4 |
Aspartate Aminotransferase (AST) |
Check & Record |
45 |
u/L |
| 5 |
Bilirubin- total |
Check & Record |
0.19 |
mg/dL |
| 6 |
Bilirubin- direct |
Check & Record |
0.1 |
mg/dL |
| 7 |
Blood Urea Nitrogen (BUN) |
Check & Record |
15 |
mg/dL |
| 8 |
Calcium |
Check & Record |
13.5 |
mg/dL |
| 9 |
Chloride |
Check & Record |
101.8 |
MMol/L |
| 10 |
Cholesterol |
Check & Record |
35 |
mg/dL |
| 11 |
Creatinine |
Check & Record |
3.14 |
mg/dL |
| 12 |
Creatinine Kinase (CK) |
Check & Record |
213 |
u/L |
| 13 |
Electrophoretic Pattern |
Normal |
Normal |
|
| 14 |
Endotoxin testing |
Check & Record |
<0.5 |
EU/mL |
| 15 |
Gamma-Glutamyl Transferase (GGT) |
Check & Record |
7 |
u/L |
| 16 |
Glucose |
Check & Record |
100.5 |
mg/dL |
| 17 |
Hemoglobin |
0-25 |
3.0 |
mg/dL |
| 18 |
High Density Lipoproteins (HDL) |
Check & Record |
9.1 |
mg/dL |
| 19 |
IgG |
Not more than 500 |
227 |
mg/dL |
| 20 |
Lactate Dehydrogenase |
Check & Record |
1219 |
u/L |
| 21 |
Low Density Lipoproteins (LDL) |
Check & Record |
13.5 |
mg/dL |
| 22 |
Mycoplasma testing |
Negative |
Negative |
|
| 23 |
Osmolality |
270-345 |
303 |
mOsm/kg |
| 24 |
Performance testing: Growth assay |
>80% |
Pass |
|
| 25 |
Performance testing: Hybridoma growth |
>80% |
Pass |
|
| 26 |
Performance testing: Plating assay |
>80% |
Pass |
|
| 27 |
pH |
7.0-8.0 |
7.39 |
|
| 28 |
Phosphorous (inorganic) |
Check & Record |
10.5 |
mg/dL |
| 29 |
Potassium |
Check & Record |
>10 |
MMOL/L |
| 30 |
Sodium |
Check & Record |
38 |
MMOL/L |
| 31 |
Sterility testing |
Negative |
Negative |
|
| 32 |
Total protein |
3.0-5.0 |
3.7 |
g/dL |
| 33 |
Triglycerides (TG) |
Check & Record |
62 |
mg/dL |
| 34 |
Uric acid |
Check & Record |
3.0 |
mg/dL |
| 35 |
VT-Bluetongue Virus (BTV) |
Negative |
Tested |
|
| 36 |
VT- Bovine Viral Diarrhea (BVD) |
Negative |
Tested |
|
| 37 |
VT- Parainfluenza Type 3 (PI-3) |
Negative |
Tested |
|
| 38 |
VT- Bovine Rhinotracheitis (IBR) |
Negative |
Tested |
|
| 39 |
Human Messenchymal Stem Cells expansion test |
Pass |
Pass |
|
|
| |
Quality Control Tests: - Certified FBS |
- Alanine Transaminase (ALT) Lactate dehydrogenase/NADH, colorimetric determination at 340nm.
- Albumin Bromcresol Green (BCG). Gustafsson JEC. Improved specificity of serum albumin determination and estimation of "acute phase reactants" by use of the bromcresol green reaction, Clin Chem 1977: 22, 616
- Alkaline Phosphatase Para-nitrophenyl phosphate. Bowers GN, McComb RB. A continuous spectrophotometric method for measuring the activity of serum alkaline phosphatase, Clin Chem 1966:12 (2): 70-89 Tietz NW, Burtis CA, Duncan P, et al ; A reference method for measurement of alkaline phosphatase activity in human serum, Clin Chem 1983: 29 (5): 751-756
- Aspartate aminotransferase (AST) Malate dehydrogenase/NADH, colorimetric determination at 340nm.
- Bilirubin- total Sodium nitrite/ biliverdin. Colorimetric determination.
- Bilirubin- direct Diazo reaction based on the reaction of bilirubin with a diazotized sulfanilic acid, Burtis CA, Ashwood ER, editors. Tietz Textbook of Clinical Chemistry, 3rd ed. Philadelphia, PA: WB Saunders: 1999: 1136.
- Blood urea nitrogen (BUN) Urease hydrolysis to ammonia and carbon dioxide. Colorimetric determination. Talke H, Schubert GE. Klinische Wochenschrift 1965: 43: 174
- Calcium Arsenazo III dye. Tietz NW, editor. Fundamentals of clinical chemistry, Philadelphia PA: WB Saunders: 1970: 638
- Chloride Ion selective electrode.
- Cholesterol Enzymatic (cholesterol esterase/oxidase/peroxidase). Allain CC, Poon LS, Chan CS, et al, Enzymatic determination of total serum cholesterol, Clin Chem 1974: 20 (4): 470-475. Roeschlau P, Bernt E, Gruber WA. Enzymatic determination of total cholesterol in serum, Z Klin Chem Klin Biochem 1974: 12: 226
- Creatinine Alkaline Picrate. Reflectance spectrophotometry at 500nm. Fabiny DL, Ertingshausen G, Automated reaction-rate method for determination of serum creatinine with the centrifichem, Clin Chem 1971: 17: 696-700; Soldin S, Henderson L, Hill G, The effect of bilirubin and ketones on reaction rate methods for the measurement of creatinine, Clin Biochem 1978: 82-6
- Creatinine kinase (CK) Enzymatic reaction: N-acetyl-L-cysteine as an enzyme reactivator. The rate of formation of NADPH IS measured by reflectance spectrophotometry at 340nm and is proportional to the activity of CK in the sample.
- Electrophoretic Pattern Cellulose Acetate
- Endotoxin testing Guideline on Validation of the Limulus Amebocyte Lysate test as an End Product Endotoxin Test for Human and Animal Parenterals Drugs, Biological Products and Medical Devices- U.S. Department of Health and Human Services, FDA, December 1987
- Gamma-Glutamyl Transferase (GGT) L-Gamma-glutamyl-3-carboxy-4-nitroanilide substrate/glycylglycine Theodorsen L, Stromme JH, Gamma-Glutamyl- 3-carboxy-14-nitroanilide: the substrate of choice for routine determinations of GGT activity in serum, Clin Chem Acta 1976: 72: 205
- Glucose Hexokinase/Glucose-6-phosphate dehydrogenase. Colorimetric determination.
- Hemoglobin Average absorbance value. Fleming AF, Woolf AJ. Clin Chem 1965: 12: 67
- High Density Lipoproteins (HDL) Enzymatic reaction: Cholesterol esterase-cholesterol oxidase-peroxidase-chromogen. Warnick GR, Nauck M, Rifai N, Evaluation of methods for measurement of HDL-Cholesterol: from ultracentrifugation to homogeneous assays, Clin Chem 2001, 47 (9): 1579-1596
- IgG Radial Immunodiffusion method, Mancini et al, Immunochemistry, vol 2, Page 255-262, 1965
- Lactate dehydrogenase Pyruvate to lactate, NADH oxidation measured by reflectance spectrophotometry at 340nm. Recommendation of the German Society for Clinical Chemistry, Z. Klin Chem Klin Biochem 1970: 8: 658, 1972:10: 182
- Low Density Lipoproteins (LDL) LDL= Cholesterol - HDL – Triglycerides/5
- Mycoplasma testing Detection of mycoplasma contamination of bovine serum by the large volume method, ASTM: E 1536-00
- Osmolality Freeze-point depression assay.
- Performance testing: Growth assay Biological Industries specifications. Cell line used: human diploid lung fibroblast cells (MRC-5), ATCC CCL-171. Biological Industries growth promotion assay measures the ability of each FBS lot to support proliferation of fastidious human diploid fibroblasts through multiple subcultures.
- Performance testing: Hybridoma growth Biological Industries specifications. Cell line used: Sp2/0-Ag14 myeloma-derived hybridoma. Hybridoma growth test analyzes the ability of each FBS lot to support growth of hybridoma cells.
- Performance testing: Plating assay Biological Industries specifications. Cell line used: African green monkey kidney cells (Vero), ATCC CRL-81. Analysis of cellular attachment and proliferation of Vero cells.
- pH Potentiometric determination.
- Phosphorous (inorganic) Phosphomolybdate: Inorganic phosphate reacts with ammonium molybdate to form a heteropolyacid complex.
- Potassium Ion selective electrode.
- Sodium Ion selective electrode.
- Sterility testing Current edition of USP.
- Total protein Biuret method. Biuret method for the determination of total protein in serum and exudates, Fundamentals of Clinical Chemistry 1976: 302- 304
- Triglycerides Enzymatic assay (Glycerol Phosphate Oxidase). Fossati P, Prencipe L, Serum triglycerides determined colorimetrically with an enzyme that produces hydrogen peroxide, Clin Chem 1982: 28: 2077-2080; McGowan MW, Artiss JD, Strandbergh DR, et al, A peroxidase-coupled method for the colorimetric determination of serum triglycerides, Clin Chem 1983: 29: 538-542
- Uric acid Uricase/Allantoin. Trivedi R, Berta E, Rebar L, Enzymatic uric acid determination at 500nm by Trinder method, Clin Chem 1976: 22: 1223; Kabasakalian P, Kalliney S, Wescott A, Determination of uric acid in serum, with use of uricase and tribromophenol-aminoantipyrine chromogen, Clin Chem 1973: 19: 522.
- VT-Bluetongue Virus (BTV) Virus testing is performed according to the Code of Federal Regulations (CFR), Title 9, Part 113.53 (c) [113.46, 113.47].
- VT- Bovine Viral Diarrhea (BVD) Virus testing is performed according to the Code of Federal Regulations (CFR), Title 9, Part 113.53 (c) [ 113.46, 113.47].
- VT- Parainfluenza Type 3 (PI-3) Virus testing is performed according to the Code of Federal Regulations (CFR), Title 9, Part 113.53 (c) [ 113.46, 113.47].
- VT- Bovine Rhinotracheitis (IBR) Virus testing is performed according to the Code of Federal Regulations (CFR), Title 9, Part 113.53 (c) [ 113.46, 113.47].
- Performance testing: Human mesenchymal stem cells 3-passage growth test for FBS.
|
| |
| |
|
| |
|
