Fetal Bovine Serum is derived from the blood of fetuses of slaughtered dams which have passed ante and post mortem veterinary inspection in government supervised slaughter-houses and are passed as fit for human consumption. The blood is obtained by cardiac puncture utilising a single-use needle, tube and bag.
The blood is allowed to clot naturally and is then centrifuged to obtain the liquid fraction of the blood which is now regarded as semi-processed serum. No other additions or deletions of material are permitted.
STERILE FILTERED: Semi-processed Raw Fetal Bovine Serum, is thawed, pooled and filtered through a series of sterile membranes down to 0.1 microns before being finally packaged, usually in 500ml or 1L bottles. No further processing, additions or deletions are performed. However, subsequent treatment, including gamma irradiation or heat inactivation, may be carried out and the bottles labelled accordingly.
| Specification - Fetal Bovine Serum - Sterile Filtered (FBSF) |
| Product | Fetal Bovine Serum - Sterile Filtered |
| Catalogue No. | FBSF |
| Certificate of Suitability | Australia: R1-CEP 2000-187-Rev 00New Zealand: R1-CEP 2000-188-Rev 00 |
| Source | Bovine blood from fetuses of healthy cows which have been inspected ante and post mortem by Australian or New Zealand Government veterinarians and passed as fit for human consumption. |
| Collection/Processing Method | Blood is collected via cardiac puncture into sterile bags. Blood is separated by cup centrifugation and double spun. Serum is subsequently passed through a series of filters terminating with triple 0.1 μm pore size filters. Product is dispensed in IS0 14644 Class 5 Laminar Flow Workstation via a closed system. It is then immediately frozen. |
| Description | A clear amber viscous liquid with a characteristic odour. |
| Pack Size | 500ml & 1000ml sterile PET & PETG square media bottles |
| Storage | -20 degrees Centigrade |
| Expiry Date | Six years from the date of manufacture |
| Test | Method | Specification |
| Visual Examination | Visual Examination | Satisfactory |
| Specificity | Species I.D. | Bovine |
| Sterility | Millipore Steritest Broth Culture 14 Day Incubation | Sterile |
| Mycoplasma | Broth Culture 35 Day Incubation | Not Detected |
| Viruses: | 9CFR (113-53c) |
|
| Bovine Respiratory Syncytial VirusFluorescent AntibodyNot DetectedBovine Viral Diarrhea VirusFluorescent AntibodyNot DetectedBovine ParvovirusFluorescent AntibodyNot DetectedBluetongue VirusFluorescent AntibodyNot DetectedBovine AdenovirusFluorescent AntibodyNot DetectedRabies VirusFluorescent AntibodyNot DetectedReovirusFluorescent AntibodyNot DetectedInfectious Bovine RhinotracheitisCytopathic AgentsNot DetectedPara Influenza 3 (PI3)Haemadsorbing AgentNot Detected |
| EMA/CHMP/BWP |
|
|
| 7.3.2Test for specified virusesNot Detected7.3.3BVDVNot Detected7.3.4Serum Neutralization AssayAs Reported |
| Antibodies: |
|
|
| BVDVNTAs ReportedIBRVNTAs ReportedPI3ElisaAs ReportedBT (Australia)ElisaAs ReportedAkabane (Australia)ElisaAs ReportedEBLElisaAs Reported |
| pH | pH Meter | 6.9 - 7.6 |
| Osmolatlity | Osmometer | 280-0365 mOsmol/kg |
| Total Protein | Beckman Coulter Synchron Clinical Systems | 30 - 45 mg/m |
| Albumin | Electrophoresis | As Reported % |
| Total Globulins: |
|
|
| AlphaElectrophoresisAs Reported %BetaElectrophoresisAs Reported %GammaElectrophoresisAs Reported % |
| IgG | ELISA | ≤ 400 mg/l |
| Electrophoresis pattern | Agarose Gel Plate | Typical |
| Haemoglobin | UV/VIS Spectrophotometer | ≤ 0.18 mg/ml |
| Endotoxin | Kinetic Turbidimetric | ≤ 5 IU/ml |
| Functionality Test |
| Cell Line Used |
|
|
| MDBK:Cell Culture≥ 85% of FCS ControlHybridoma:Cell Culture≥ 85% of FCS ControlMRC-5:Cell Culture≥ 85% of FCS ControlVero:Cell Culture≥ 85% of FCS Control |
| Biochemical Profile - Beckman DXC 800 Analyser |
| Sodium |
| As Reported mmol/l |
| Potassium |
| As Reported mmol/l |
| Chloride |
| As Reported mmol/l |
| Bicarbonate |
| As Reported mmol/l |
| Anion Gap |
| As Reported mmol/l |
| Glucose |
| As Reported mmol/l |
| Urea |
| As Reported mmol/l |
| Creatinine |
| As Reported μmol/l |
| Urea/Creatinine |
| As Reported (ratio) |
| Urate |
| As Reported mmol/l |
| Bilirubin total |
| As Reported μmol/l |
| Calcium |
| As Reported mmol/l |
| Alkaline Phosphatase |
| As Reported U/l |
| Gamma Glutamyl Transferase |
| As Reported U/l |
| Alanine Transaminase (Glutamic Pyruvic Transaminase) |
| As Reported U/l |
| Aspartate Transaminase (Glutamic Oxaloacetic Transaminase) |
| As Reported U/l |
| Lactate Dehydrogenase |
| As Reported U/l |
| Cholesterol |
| ≤ 1.2 mmol/l |
| Triglyceride |
| As Reported mmol/l |
澳大利亞 Moregate Biotech 公司是澳洲本土的一家專(zhuān)業(yè)生產(chǎn)各類(lèi)牛血清和牛血清白蛋白的生產(chǎn)企業(yè)，公司成立于1975年，至今已經(jīng)有38年歷史了。
Moregate Biotech 公司在澳大利亞的布里斯班和新西蘭的漢密爾頓都建有符合GMP條件的生產(chǎn)設(shè)施，產(chǎn)品的原材料分別取自澳大利亞和新西蘭。自公司成立以來(lái)，已經(jīng)為各大國(guó)際制藥企業(yè)和眾多研究機(jī)構(gòu)提供產(chǎn)品、原料和服務(wù)，在世界各地范圍內(nèi)，Moregate都贏得了良好產(chǎn)品聲譽(yù)和客戶(hù)滿(mǎn)意度。
Moregate的胎牛血清的原料都采自澳洲本土或者是新西蘭本土的未出生胎牛，經(jīng)過(guò)嚴(yán)格的檢驗(yàn)檢疫，合格后才能投入后續(xù)生產(chǎn)。經(jīng)過(guò)嚴(yán)格的除菌過(guò)濾后（3次0.1微米），再經(jīng)過(guò)QC檢測(cè)合格后才能投放市場(chǎng)銷(xiāo)售。因此，Moregate從原材料和品質(zhì)上都保證了胎牛血清的最佳性能。
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