• South American Defined Fetal Bovine Serum

South American Defined Fetal Bovine Serum

Product Description

I. Fetal Bovine Serum (FBS) is a complex mixture of plasma fibrin that removes fibrin. FBS contains the least amount of antibodies and complement and other harmful components to the cells because FBS should be taken from fetal bovines under caesarean section that have not been exposed to the external environment. Therefore, FBS has the highest quality.

Product Characteristics

Uruguayan blood source

Low endotoxin level

No mycoplasma and no virus

Multi-stage Filtering System

100% Performance Inspection

Frozen Storage

USDA/EU Pharmacopoeia Standards met

Product Features

FBS Collection

·Animal donor, original country and traceability of FBS from all available countries such as USA, Uruguay, New Zealand and China meet the requirements of the USDA.

·All the virus screenings of animal donors according to the USDA standards show negative results. Blood from donors is collected into a closed sterile system using cardiac and venipuncture methods under conditions of qualified hygiene standards.

·FBS with low levels of endotoxin and hemoglobin is isolated from blood via secondary centrifugation at low temperature.

FBS Processing

·Collected FBS is filtered through a series of medical-grade 100 to 30 nm filter membranes according to the cGMP standards.

·Filtered FBS is packed and canned into gamma-irradiated PETG plastic flasks on a hundred-grade clean bench and stored at -20°C environment. Sampling inspection of each batch of FBS is carried out as required.

Microbiological Tests

·All batches of FBS are identified by bacteria and fungi tests as required by US Pharmacopoeia XXIII and Article IX of Federal CFR.

·All batches of FBS are monitored for mycoplasma contamination according to the large batch method of Barile and Kern as well as the PCR method.

Viral Monitoring

·FBS is monitored in accordance with US federal requirements for animal-derived products, including hand-foot-mouth virus (HFMDV), bovine spongiform encephalopathy virus (BSEV), bovine viral diarrhea virus (BVDV), infectious bovine rhinotracheitis virus (IBRV) and parainfluenza 3 virus (PI3V). 

Although all monitoring methods are sensitive, it is well known that this does not guarantee the absence of any virus.

Endotoxin Monitoring

·All batches of FBS are monitored by tachypleus amebocyte lysate (TAL).

Biochemical Analysis

·All FBS products are tested for osmotic pressure and pH and for hemoglobin level using spectrophotometer. The biochemical indexes of FBS products are tested by sampling. Various testing and analysis instruments are calibrated by the standards of the National Technical Committee for Standardization.

Heat Inactivation

·FBS is inactivated by heat at 56°C for 30 minutes and then cooled down to room temperature. Heat inactivation can cause a small amount of precipitation in FBS after freezing and thawing, which is a normal condition.

Performance Tests

·Each batch of FBS products are tested by various representative cell line culture tests, such as clone, adherent, proliferation and other performance tests.

FBS Storage and Disposal

·Duoning FBS is packed in sterile PETG plastic flasks and stored at -20°C environment.

·In order to ensure high product performance, the repeated freezing and thawing process should be avoided as far as possible. If the whole flask of thawed FBS cannot be used completely within 4 weeks, it is recommended to store it after aseptic subpackaging.

FBS Storage and Contamination

FBS for long-term storage must be kept in cryogenic refrigerator at -20°C to -70°C and the storage period in refrigerator at 4°C should be no more than 1 month.

FBS is filtered by 0.22μm or 0.1μm filter for degerming..

FBS can be placed at 37°C overnight to check the availability of microbial contamination without filtering. FBS will be turbid if there is microbial contamination, while FBS will still be clear if there is no microbial contamination. As it is difficult to filter FBS directly in the laboratory, FBS is usually added to the medium for filtering. The filter membrane can be used to filter the medium prepared in the laboratory.

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