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) | |||||||||||||
| ||||||||||||||
| Antibodies | ||||||||||||||
| ||||||||||||||
| 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 | ||||||||||||
| ||||||||||||||
| 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 | ||||||||||||||
| ||||||||||||||
| 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 | |
EP/USP
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.
EMEA/CPMP/CVMP
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.
USDA 9CFR Part 113.53c
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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谁的答案详细、真实分就给谁...(勿灌水，否则必究之)
想做临床的血标本的一些代谢组学研究，不知道应该用血浆还是血清，大家的说法好像也不太一致，请大神指导啊，最好有些参考文献，谢谢！
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产品特点：低lgG，低内毒素，促细胞生长优良
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血浆是由抗凝的血液中分离出来的液体,其中含有纤维蛋白原,若向血浆中加入Ca2+,血浆会发生再凝固,因此血浆中不含游离的Ca2+.血清是由凝固的血中分离出来的液体,其中已无纤维蛋白原,但含有游离的Ca2+,若向其中再加入Ca2+,血清也不会再凝固.此外,血浆与血清的另一个区别是：血清中少了很多的凝血因子,以及多了很多的凝血产物.
各位大神，本人实验室小白一枚，现在要保存乙肝病人的血清，以后用来做实验感染细胞。为了最大限度保持病毒的感染活力，应该怎么保存呢？直接-80度冷冻可以吗？需要加甘油吗？
血清的基本成分是水，水中溶有蛋白质、脂肪、糖、无机盐、维生素等营养成分，也溶有人体代谢产物。血清中有抗体，这是被称作免疫球蛋白的蛋白质。
你说的应该称抗毒血清。
因制作时是将蛇毒、病原菌产的毒等小量多次地注射到免子、马血管内，每日慢慢加大注射量，一定时间后，因该动物体内产生抗体，经检测，达到一定效价后，就可以抽血。血液分离血清后再经提纯，就成了抗毒血清。
如蛇、白喉、破伤风、狂犬病抗毒血清等都是如此制备，用来治疗相应毒素反应。
该生物制剂是异种血清，对人会有过敏反应，注射前均要做皮试。阴性可注射，阳性必需作脱敏疗法才行。
1)提供基本营养物质：氨基酸、维生素、无机物、脂类物质、核酸衍生物等，是细胞生长必须的物质。
2)提供结合蛋白：结合蛋白作用是携带重要地低分子量物质，如白蛋白携带维生素、脂肪、以及激素等，转铁蛋白携带铁。结合蛋白在细胞代谢过程中起重要作用。
3)提供激素和各种生长因子：胰岛素、肾上腺皮质激素(氢化可的松、地塞米松)、类固醇激素(雌二醇、睾酮、孕酮)等。生长因子如成纤维细胞生长因子、表皮生长因子、血小板生长因子等。
4)对培养中的细胞起到某些保护作用：有一些细胞，如内皮细胞、骨髓样细胞可以释放蛋白酶，血清中含有抗蛋白酶成分，起到中和作用。这种作用是偶然发现的，现在则有目的的使用血清来终止胰蛋白酶的消化作用。因为胰蛋白酶已经被广泛用于贴壁细胞的消化传代。血清蛋白形成了血清的粘度，可以保护细胞免受机械损伤，特别是在悬浮培养搅拌时，粘度起到重要作用。血清还含有一些微量元素和离子，他们在代谢解毒中起重要作用，如SeO3,硒等
5)提供促接触和伸展因子使细胞贴壁免受机械损伤。
6)血清中有抗体，这是被称作免疫球蛋白的蛋白质，血清可以抗病毒,增强抵抗力血清属于生物制剂。
