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Moregate/New Born Calf Serum - Sterile Filtered (NBSF)/null/NBSF
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产品说明
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)ProductNew Born Calf Serum - Sterile FilteredCatalogue No.NBSFSourceBovine 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 MethodBlood 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.DescriptionA clear orange viscous liquid with a characteristic odour.Pack Size500ml & 1000ml sterile PET & PETG "Nalgene" bottlesStorage-20 degrees CentigradeExpiry DateSix years from the date of manufactureTestMethodSpecificationVisual ExaminationVisualSatisfactorySpecificitySpecies I.D.BovineSterilityMillipore Steritest Broth Culture 14 Day IncubationSterileMycoplasmaBroth Culture 35 Day IncubationNot detectedVirusesModified 9CFR (113-53c)Bovine Viral Diarrhea Virus (BVDV)Fluorescent antibodyNot DetectedInfectious Bovine RhinotracheitisCytopathic agentsNot DetectedAntibodiesPara Influenza 3 (PI3)ElisaNot DetectedBVDVNTAs reportedIBRVNTAs reportedPI3ElisaAs reportedpHpH Meter6.9 - 7.9Osmolality:Osmometer240 - 340 mOsmol/kgTotal ProteinBeckman Coulter Synchron Clinical Systems50 - 80 mg/mlAlbuminElectrophoresisAs Reported mg/mlTotal GlobulinsElectrophoresisAs Reported mg/mlAlpha 1ElectrophoresisAs reported %Alpha 2ElectrophoresisAs reported %GammaElectrophoresisAs reported %Electrophoresis patternAgarose Gel PlateTypicalHaemoglobinUV/VIS Spectrophotometer≤ 0.25 mg/mlEndotoxinKinetic - Turbidimetric≤ 30 IU/mlFUNCTIONALITY TESTCell Line UsedMDBK:Cell Culture≥ 80% of FCS ControlHybridoma:Cell Culture≥ 80% of FCS ControlMRC-5:Cell Culture≥ 80% of FCS ControlVero:Cell Culture≥ 80% of FCS ControlBIOCHEMICAL PROFILE - Beckman DXC 800 AnalyserSodiumAs Reported mmol/lPotassiumAs Reported mmol/lChlorideAs Reported mmol/lBicarbonateAs Reported mmol/lAnion GapAs Reported mmol/lGlucoseAs Reported mmol/lUreaAs Reported mmol/lCreatinineAs Reported µmol/lUrea/CreatinineAs Reported (ratio)UrateAs Reported mmol/lBilirubin totalAs Reported µmol/lCalciumAs Reported mmol/lCalcium (Alb Corr.)As Reported mmol/lPhosphateAs Reported mmol/lAlkaline PhosphataseAs reported U/lGamma Glutamyl TransferaseAs reported U/lAlanine Transaminase (Glutamic Pyruvic Transaminase)As reported U/lAspartate Transaminase (Glutamic Oxaloacetic Transaminase)As reported U/lLactate DehydrogenaseAs reported U/lCholesterolAs Reported mmol/lTriglycerideAs Reported mmol/lEP/USPThe 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. 5.4This 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/CVMPThe 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 ProductsNote for Guidance on the Use of Bovine Serum in the Manufacture of Human Biological Medicinal ProductsNote 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 ProductsRequirements 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 113.53cIngredients 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 antibodyInfections Bovine Rhinotracheitis tested for by Cytopathic Agents.Infectious Influenza 3 tested for by Haemadsorbing AgentsHazards IdentificationNot hazardousGet Medical attention immediately.First Aid MeasuresGet Medical attention immediately.IngestionIf swallowed, give several glasses of water to drink to dilute.Skin ContactWash skin with soap and copious amounts of water.Eye ContactFlush with water for at least 15 minutes, lifting upper and lower eyelids occasionally.Accidental ReleaseProcedures for Personal PrecautionExercise appropriate precautions to minimize direct contact with skin or eyes.Methods for Cleaning UpMop upVentilate area and wash spill site after material pickup is completeHandling and StorageHandlingNormal measures for preventive fire protectionStorageKeep tightly closed under correct storage conditionsExposure Controls / Personal ProtectionWash thoroughly after handlingProtective glovesDisposal ConsiderationsContact a licensed professional waste disposal service to dispose of this material.Transport InformationNon-hazardous for road transportNon-hazardous for sea transportNon-hazardous for air transportNote: The above information is believed to be correct, but shall be used as a guide only.Disclaimer: For pharmaceutical use only.

Moregate Biotech 公司在澳大利亚的布里斯班和新西兰的汉密尔顿都建有符合GMP条件的生产设施,产品的原材料分别取自澳大利亚和新西兰。自公司成立以来,已经为各大国际制药企业和众多研究机构提供产品、原料和服务,在世界各地范围内,Moregate都赢得了良好产品声誉和客户满意度。

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