New Born Bovine Calf Serum (NBSF) is obtained from blood taken from calves aged less than 20 days, deemed fit for human consumption following ante and post mortem veterinary inspection.? The blood is collected in slaughter-houses supervised by government veterinarians.?
The blood is allowed to clot naturally or manually defibrinated 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 New Born Bovine Serum, is thawed, pooled and filtered through a series of sterile membranes down to 0.2 microns before being finally packaged, usually in 500ml or 1L bottles. No further processing, additions or deletions are performed.
| Specification - New Born Calf Serum - Sterile Filtered (NBSF) |
| Product | New Born Calf Serum - Sterile Filtered |
| Catalogue No. | NBSF |
| Source | Bovine blood from healthy calves aged less than 20 days old 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 into aseptic containers, defibrinated and centrifuged under temperature controlled conditions. Serum is subsequently passed through a series of filters terminating with 0.2 micron pharmaceutical grade filters. Product is dispensed in ISO 14644 Class 5 Laminar Flow Workstation via a closed system. It is then immediately frozen. |
| Description | A clear orange viscous liquid with a characteristic odour. |
| Pack Size | 500ml & 1000ml sterile PET & PETG "Nalgene" bottles |
| Storage | -20 degrees Centigrade |
| Expiry Date | Six years from the date of manufacture |
| Test | Method | Specification |
| Visual Examination | Visual | Satisfactory |
| Specificity | Species I.D. | Bovine |
| Sterility | Millipore Steritest Broth Culture 14 Day Incubation | Sterile |
| Mycoplasma | Broth Culture 35 Day Incubation | Not detected |
| Viruses | Modified 9CFR (113-53c) | |
| Bovine Viral Diarrhea Virus (BVDV) | Fluorescent antibody | Not Detected | | Infectious Bovine Rhinotracheitis | Cytopathic agents | Not Detected |
|
| Antibodies | | |
| Para Influenza 3 (PI3) | Elisa | Not Detected | | BVD | VNT | As reported | | IBR | VNT | As reported | | PI3 | Elisa | As reported |
|
| pH | pH Meter | 6.9 - 7.9 |
| Osmolality: | Osmometer | 240 - 340 mOsmol/kg |
| Total Protein | Beckman Coulter Synchron Clinical Systems | 50 - 80 mg/ml |
| Albumin | Electrophoresis | As Reported mg/ml |
| Total Globulins | Electrophoresis | As Reported mg/ml |
| Alpha 1 | Electrophoresis | As reported % | | Alpha 2 | Electrophoresis | As reported % | | Gamma | Electrophoresis | As reported % |
|
| Electrophoresis pattern | Agarose Gel Plate | Typical |
| Haemoglobin | UV/VIS Spectrophotometer | ≤ 0.25 mg/ml |
| Endotoxin | Kinetic - Turbidimetric | ≤ 30 IU/ml |
| FUNCTIONALITY TEST |
| Cell Line Used | | |
| MDBK: | Cell Culture | ≥ 80% of FCS Control | | Hybridoma: | Cell Culture | ≥ 80% of FCS Control | | MRC-5: | Cell Culture | ≥ 80% of FCS Control | | Vero: | Cell Culture | ≥ 80% 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 |
| Calcium (Alb Corr.) | | As Reported mmol/l |
| Phosphate | | 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 | | As Reported mmol/l |
| Triglyceride | | As Reported mmol/l |
The European Pharmacopeia consists of a number of general and specific monographs covering various classes of products.
The monographs set out requirements to be met and followed for all products in the class.
Recently the EP has introduced a Monograph for Bovine Serum – Monograph No 04/2006:2262 to be found in E.P. 5.4
This monograph provides a definition of Bovine Serum and sets out details of production, and requirements for viral inactivation parameters, quality control testing, storage conditions and labelling.
Moregate Bovine Serum products meet these requirements and Certificates of Analysis are modeled on the QC test requirements.
?
The United States Pharmacopeia-National Formulary (USP-NF) contains standards for medicines, dosage forms, drug substances, excipients, medical devices, and dietary supplements.
Within the Pharmacopeia are Monographs and general chapters.
The monographs consist of information such as the ingredient name, definition, packaging and labelling requirements, storage and a specification.
The specifications list tests to be performed along with the procedure to be followed and the acceptable limit.
The European Medicines Agency (EMEA) is a decentralised body of the European Union with headquarters in London. It sits alongside the European Directorate for the Quality of Medicines (EDQM).
The main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use.
The EMEA publishes guidelines on quality, safety and efficacy testing requirements.
These guidelines are prepared by committees, and those guidelines which relate to the use of Bovine Serum, including Fetal Bovine Serum, in the manufacture of medicines include:
CPMP: Committee for Proprietary Medicinal Products
Note for Guidance on the Use of Bovine Serum in the Manufacture of Human Biological Medicinal Products
Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Human and Veterinary Medicinal Products. (Also adopted by the CVMP)
CVMP: Committee for Veterinary Medicinal Products
Requirements and Controls applied to Bovine Serum used in the production of Immunological Veterinary Medicinal products.
These Guidelines include requirements for Virus Testing of Fetal Bovine Serum and other Bovine Serum. Further reference to these requirements can be found in “Virus Testing”.?
All Moregate Biotech Fetal Bovine Serum and other Bovine Serum meet the requirements of the Guidelines in relation to Fetal Bovine Serum and Bovine Serum.
Ingredients of animal origin used in the United States of America, in the manufacture of veterinary and human biologics are required to be in compliance with the Code of Federal Regulations, Title 9 – Animals and Animal Products, Chapter 1 - Animal and Plant Health Inspection Service, Department of Agriculture Part 113-53c, commonly referred to as 9CFR Part 113-53c.
This legislation sets out the requirements for detection of extraneous viruses, detailing the methods to be used and the list of viruses that shall be tested for. ?
Over time 9CFR Part 113-53c became the accepted standard for the testing of animal sera, particularly Fetal Bovine Serum for adventitious viral agents.
Bovine Respiratory Syncytical Virus, Bovine Viral Diarrhea Virus, Bovine Parvovirus, Bluetongue Virus, Bovine Adenovirus, Rabies Virus and Reovirus are tested for by fluorescent antibody
Infections Bovine Rhinotracheitis tested for by Cytopathic Agents.
Infectious Influenza 3 tested for by Haemadsorbing Agents
Hazards Identification
- Not hazardous
- Get Medical attention immediately.
First Aid Measures
Get Medical attention immediately.
Ingestion
If swallowed, give several glasses of water to drink to dilute.
Skin Contact
Wash skin with soap and copious amounts of water.
Eye Contact
Flush with water for at least 15 minutes, lifting upper and lower eyelids occasionally.
Accidental Release
Procedures for Personal Precaution
Exercise appropriate precautions to minimize direct contact with skin or eyes.
Methods for Cleaning Up
Mop up
Ventilate area and wash spill site after material pickup is complete
Handling and Storage
Handling
Normal measures for preventive fire protection
Storage
Keep tightly closed under correct storage conditions
Exposure Controls / Personal Protection
- Wash thoroughly after handling
- Protective gloves
Disposal Considerations
Contact a licensed professional waste disposal service to dispose of this material.
Transport Information
- Non-hazardous for road transport
- Non-hazardous for sea transport
- Non-hazardous for air transport
Note: The above information is believed to be correct, but shall be used as a guide only.
Disclaimer: For pharmaceutical use only.
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