제품상세

<Collected from the source>

When searchers choose their serum an important factor that should be taken into consideration is the source, which also emphasises the traceability of the serum.

Our system of vertical integration allows us to be certain of the origins and traceability of our FBS.

Each manufactured batch is rigorously controlled, from the collection of serum and throughout all stages of its treatment and production through to final packaging on our premises.

BioWest Fetal Bovine Serum is derived from clotted whole blood aseptically collected from fetus via cardiac puncture.

The serum is collected or imported and treated in agreement with the European regulations.

<Filtration>

Final Filter Size: 0.1µm x 3

<Sterility>

All sera are tested for the absence of aerobic and anaerobic bacteria, fungi, yeast and Mycoplasma.

The sterility test is based on the European Pharmacopoeia requirements. The sera are tested for the absence of Mycoplasma by culture.

<Virus Tested>

All of our sera are tested for:

- Bovine Viral Diarrhoea (BVD)

- Cytopathogenic agents e.g. Infectious Bovine Rhinotracheitis (IBR) / BHV-1

- Hemadsorbing agents e.g. Parainfluenza Type 3 (Pl3)

Sera are tested by inoculation to permissive cells. The revelation is made by immunofluorescence for pestiviruses. Cytopathogenic agents and hemadsorbing agents are detected by microscopicobservations.

<Endotoxin>

All sera are tested to determine the levels of endotoxins. BioWest carries out a chromokinetic quantitative test, according to the method D of the European Pharmacopoeia.

The endotoxin reagent is standardized against the US reference endotoxin.

Endotoxin specification: < 30 EU/ml.

<Haemoglobin>

The haemoglobin level is measured by spectrophotometer.

Haemoglobin specification: < 30 mg/100ml.

<pH>

pH specification: 6,8 to 8,0.

<Osmolality>

Determined by a lowered freezing temperature. The osmometer is calibrated against standard solutions.

<Cell Culture>

Biological performance is assessed using cell culture medium supplemented with the serum being tested.

During the test period, cultures are examined microscopically for any morphological abnormalities that may indicate toxic components in the serum.

-Cell Culture Tests: Cell Growth, Plating Efficiency, Cloning Efficiency.

-Cell Lines Tested: The following cell lines are tested with the serum:

HELA -Cancer Cell/Human.

L929 -Fibroblast-Mouse/ As Macrophage

SP2/0-AG14 -Mouse/Lymphoma

MRC- 5 -Human/Lung.

<Total Protein>

Determined by Biuret Colorimetry.

<Storage conditions>

- 18°C to - 40°C, protected from light.

Bottles can be stored between -40°C and -80°C for a short period (few days).

Shelf life: 5 years

Recommended use: - Respect storage conditions of the serum

- Do not use the serum after its expiry date

- Store serum in an area protected from light

- Manipulate serum in aseptic conditions (e.g.: under laminar air flow)

- Wear clothes adapted to the manipulation of serum to avoid contamination (e.g.: gloves, mask, hygiene cap, overall…)

- In order to preserve all serum qualities, it is recommended to thaw out the flask, to aliquote, then to re-freeze the produced flasks rather than to thaw out and re-freeze the flask at each use.

- It is recommended to use the serum immediately after its thaw out. However, if it is not useful, it is possible to store thaw out serum, at +2°C / +8°C, until 26 weeks without significant decrease of its performances in cell culture.

The product is intended to be used in vitro, in laboratory only. Do not use it in therapy, human or veterinary applications.

<Note>

The raw serum may be treated (Heat Inactivated, Gamma Irradiated, pH modified) before filtration for different reasons:

- Importation regulation

- Exportation necessity

- Technical or quality aspects

To be informed if your batch is concerned by treatment before filtration, please contact Biowest.

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