Adult Bovine Serum – Raw (ABSR), is obtained from blood taken from cattle 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 collected in lined sanitary buckets and allowed to clot naturally without the addition of any clotting factors. The blood is then transferred to a temperature controlled clean environment where the liquid component of the blood is drained and separated using a continuous flow separator before being dispensed into 5L Bottles and immediately frozen.
| SPECIFICATION - Adult Bovine Serum - RAW (ABSR) | |
| Product | Adult Bovine Serum - Raw |
| Catalogue No. | ABSR |
| Certificate of Suitability | New Zealand R1-CEP2001-093 |
| Source | Bovine blood from healthy animals which have been inspected ante and post mortem by Australian or New Zealand Government veterinarians and passed as fit for human consumption. |
| Collection Method | Blood is collected into sanitary containers. Serum is produced in temperature controlled conditions.The blood is drained and separated using a continuous flow separator. It is then immediately frozen. |
| Irradiation | Irradiation can be performed on request |
| Pack Size | 5 Litre container or to Customer Specifications |
| Storage | -20 degrees Centigrade |
| Expiry Date | Six years from the date of manufacture |
| Test | Method | Specification |
| Aerobic Microbial Count | CFU/ml | < 1000 CFU/mL |
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
EDQM
The European Directorate for the Quality of Medicines (EDQM) has originated from the European Pharmacopoeia Secretariat which, with the addition of new responsibilities changed its name to the European Department for the Quality of Medicines (EDQM). The EDQM sits alongside the European Medicines Agency (EMEA).
Amongst other activities, the EDQM is responsible for the European Pharmacopeia and the issuing of Certificates of Suitability (CEP).
Certificates of Suitability (CEP) are recognised by all signatory states of the European Pharmacopoeia Convention and by the European Union. Other countries have also chosen to recognise them. In the case of Fetal Bovine Serum and other Bovine Serum a CEP can be used by the manufacturers of Fetal Bovine Serum and other Bovine Serum which is intended for use in the manufacture of pharmaceutical products to demonstrate compliance with the Bovine Serum monographs of the European Pharmacopoeia and the EDQM requirements for substances concerned by TSE risk.
The discovery of Bovine Spongiform Encephalopathy (BSE), which is one of a group of similar infections now referred to as Transmissible Spongiform Encephalopathies (TSEs), and it’s spread over many countries of the European Union as well as its discovery in Canada, the USA and Japan is well known. The European events provided the impetus for the Council of Europe Public Health Committee (CEPHC) to pass Resolution AP-CSP (99) 5 addressing the TSE concerns and creating a Certificate of Suitability (COS) pursuant to Directive 75/318/EEC.
The granting of a CoS to a manufacturer, for a particular product, certifies that the product in question has been assessed for the level of risk of transmission of TSEs, and that the risk level is considered low enough that the product is certified as suitable for use in the manufacture of medicinal products in the European Union.
The process of approval requires the manufacturer to submit a dossier that covers all relevant aspects of the collection of raw material and further processing that is performed to reach the product that is offered to end users. This dossier is detailed and covers the specific material that is collected, the collection method, process validation, testing, traceability, quality systems and an expert review.
Only after this dossier has been examined and approved by two rapporteurs and, if necessary, by a panel of experts appointed by the European Directorate for the Quality of Medicines (EDQM) is the manufacturer granted a COS.
Moregate Biotech has been granted a COS for:
- Fetal Bovine Serum – Australian Origin – CEP2000-187
- Fetal Bovine Serum – New Zealand Origin – CEP2000-188
- Adult Bovine Serum - New Zealand Origin – CEP2001-093
- Adult Bovine Serum (Defibrinated) - New Zealand Origin – CEP2000-174
- Bovine Plasma – New Zealand Origin – CEP2003-199
- Bovine Serum Albumin – manufactured in Australia from New Zealand origin Bovine Plasma – CEP2003-205
- Bovine Plasma – Australian Origin - CEP 2005-192
- Bovine Serum Albumin – manufactured in Australia from Australian origin Bovine Plasma - CEP 2005-191
Copies of the Certificates of Suitability are available upon request
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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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。
谁的答案详细、真实分就给谁...(勿灌水，否则必究之)
Nutrients.2017May10;9(5).
ClinicalSignificanceandPrognosticEffectofSerum25-hydroxyvitaminDConcentrationsinCriticalandSevereHand,FootandMouthDisease.
手足口病危重儿血清25-羟维生素D浓度的临床意义与预后影响
作者党红星，刘成军，李静，程时骄，许峰
摘要
Abstract
目的：探讨血清25羟维生素D[25（OH)D]浓度与手足口病危重症的关系及评估手足口病危重儿血清25-羟维生素D浓度的临床意义与预后影响。
OBJECTIVE:
Toexaminetheassociationofserum25-hydroxyvitaminD[25(OH)D]concentrationswithcriticalandseverehand,footandmouthdisease(HFMD)andassesstheclinicalsignificanceandprognosticeffectof25(OH)DconcentrationsinchildrenwithHFMD.
方法：本研究为前瞻性观察研究。
METHODS:
ThisisaProspectiveobservationalstudy.
将138例手足口病患儿分为普通组（49例）、重症组（52例）和危重组（37例）。另选取同期门诊体检的59例健康儿童作为对照组。
The138childrenwithHFMDweredividedintocommon(49cases),severe(52cases),andcritical(37cases)HFMDgroups.Another59healthychildrenundergoingoutpatientmedicalexaminationsduringthesameperiodwerechosenasthecontrolgroup.
测定所有对象的血清25（OH）D浓度，每组再分为血清25（OH）D正常组（≥30ng/mL）；不足组（20-29.9ng/mL）；缺乏组（低于20ng/mL）。
Serum25(OH)Dconcentrationsweremeasuredinallthesubjects,andeachgroupwassuBDividedbyserum25(OH)Dconcentrationinto25(OH)Dnormal(≥30ng/mL);insufficiency(20-29.9ng/mL),anddeficiency(<20ng/mL)groups.
手足口病危急重症组在入住儿科ICU（PICU）时记录小儿危重病例评分（PCIS）。
Thepediatriccriticalillnessscore(PCIS)wasrecordedforthecriticalandsevereHFMDgroupuponadmissiontothepediatricintensivecareunit(PICU).
监测小儿危重手足口病患者血乳酸（LAC）、血清钙离子（Ca2+）、D-二聚体（DD）、乳酸脱氢酶（LDH）、肌酸激酶同工酶（CK-MB）水平；脑干脑炎、神经源性肺水肿、循环衰竭的发生情况；14天病死率。
ChildrenwithcriticalandsevereHFMDwerealsomonitoredforbloodlactate(LAC),serumcalciumions(Ca++),D-dimer(DD),lactatedehydrogenase(LDH),andcreatinekinase-MB(CK-MB)levels;theincidencesofbrainstemencephalitis,neurogenicpulmonaryedema,andcirculatoryfailure;andthe14-daymortalityrate.
结果：
RESULTS：
各组血清25（OH）D浓度普遍较低。
Serum25(OH)Dconcentrationsweregenerallylowinallgroups.
与对照组（28.1±6.6ng/mL,8%）、普通组（29.5±8.1ng/mL,10%）和重症组（31.9±9.7ng/mL,8%）相比，危重组患者血清25（OH）D平均浓度（20.0±8.4ng/mL）明显较低，血清25（OH）D缺乏比例（18％）明显较高(P＜0.05）。
ThecriticalHFMDgroupshowedasignificantlylowerserum25(OH)Dmeanconcentration(20.0±8.4ng/mL)andahigherproportionofdeficiency(18%)comparedwiththecontrolgroup(28.1±6.6ng/mL,8%),common(29.5±8.1ng/mL,10%)andsevere(31.9±9.7ng/mL,8%)HFMDgroups(p<0.05).
在危重组中，25（OH）D缺乏组比25（OH）D正常组及不足组具有更低的PCIS值（P＜0.05）；而比后两组具有更高LAC、LDH、CK-MB和DD；具有（更高的）脑干脑炎、神经源性肺水肿、循环衰竭发生率及病死率（P＜0.05）。
InthecriticalandsevereHFMDgroups,the25(OH)DdeficiencygrouphadlowerPCISsthanthe25(OH)Dnormalandinsufficiencygroups(p<0.05);andhadhighervaluesthanthelattertwogroupsforLAC,LDH,CK-MBandDD;andtheincidencesofbrainstemencephalitis,neurogenicpulmonaryedema,circulatoryfailure,andmortality(p<0.05).
死亡组较存活组具有显著降低的血清25（OH）D浓度和PCIS（P＜0.05），具有较高的LAC、LDH、CK-MB和DD水平；较高的脑干脑炎、神经源性肺水肿、循环衰竭发病率（P＜0.05）。
Thedeathgroupshowedsignificantlylowerserum25(OH)DconcentrationsandPCISsthanthesurvivalgroup(p<0.05)andhadhigherLAC,LDH,CK-MBandDDlevelsandhigherincidencesofbrainstemencephalitis,neurogenicpulmonaryedema,andcirculatoryfailure(p<0.05).
Logistic回归分析显示，血清25（OH）D浓度是影响重症手足口病患儿病死率的独立因素。
Logisticregressionanalysisrevealedthattheserum25(OH)DconcentrationwasanindependentfactorthatinfluencedmortalityinchildrenwithcriticalandsevereHFMD.
CONCLUSIONS:
结论：
在这项研究中，我们发现，血清25（OH）D浓度在手足口病危重患儿中大幅降低，并与手足口病的严重程度相关。
Inthisstudy,wefindtheserum25(OH)DconcentrationsaresubstantiallyreducedinchildrenwithcriticalandsevereHFMDandareassociatedwiththeseverityofHFMD.
血清25（OH）D浓度对判断重症手足口病进展和预测死亡风险具有临床价值。
Theserum25(OH)DconcentrationsmayhaveclinicalvaluefordeterminingtheprogressionofcriticalHFMDandpredictingtheriskofdeath.
在确定25（OH）D浓度在手足口病诊断的临床价值之前，仍需进一步的证据。
Furtherevidenceisneededbeforeitcanbestatedthat25(OH)DconcentrationshaveclinicalvalueinHMFDdiagnosis.
关键词：
KEYWORDS:
25-hydroxyvitaminD;criticalillness;footandmouthdisease;hand
25羟维生素D；危重病；手足口病
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.
