Moregate/New Born Calf Serum - Sterile Filtered (NBSF)/null/NBSF,Moregate,,Moregate,moregatebiotech,Moregate BioTech,+,,Array.Array.Array蚂蚁淘厂家直采.

产品名称：Moregate/New Born Calf Serum - Sterile Filtered (NBSF)/null/NBSF

产品编号：NBSF

市场价：¥20.00

场地：美国(厂家直采)

产品分类：细胞相关>细胞培养>血清>

联系QQ：1570468124

电话号码：4000-520-616

邮箱： info@ebiomall.com

美元价：$1.00

品牌： Moregate

公司：Moregate

公司分类：

商品介绍

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 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

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