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Traceable to the source

When scientists select their sera, the geographical source and the products traceability are of paramount importance.

Our Fetal Bovine Serum is extracted from clotted whole blood collected aseptically from the fetus via cardiac puncture.
Biowest rigorously controls each manufactured batch:

  • From the serum collection,
  • During its treatment and production,
  • To the final packaging on our premises.

Biowest analyses, classifies, and tests its products before shipment to customers worldwide.
Our Quality System can trace raw materials back to the original supplier and slaughterhouses where they were collected.
Biowest's system of vertical integration provides origin certification and full sera traceability.

 
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FBS Sources Worldwide

Biowest supplies a wide range of sera origins including sources from South America as well as from the European Union (EU) and from sources approved by United States Department of Agriculture (USDA).

The choice of FBS origin is determined by customer needs, import requirements and worldwide supply.
Professionals will find Biowest to be the ideal partner for meeting their requirements, such as choosing the origin of serum which provides optimal performance and results.
FBS is considered to be an animal by-product which is not intended for human consumption.
Biological safety is controlled by EU rules on animal by-products:

 

Filtration and Packaging

Raw pooled Fetal Bovine Serum is filtered by three series of 0.1 micron sterilizing filters.
The sterile serum is true-pooled to ensure homogeneity.
Biowest products are packaged via an aseptic filling process.

We ensure that the industrial sterility standards at a level of 10-4 are met at every step of manufacturing.
Our products demonstrate a bacterial and fungal contamination level of less than 1 of 10,000 units throughout fabrication.
The highest level of sterility assurance (≥10-6) cannot be achieved without terminal sterilization.
The filtration and dispensing are performed under positive pressure in HEPA-filtered environmentally controlled rooms.
Final Filter Size: Triple  0.1 micron
Each Batch is delivered with a Certificate of Analysis – see page Quality Control on FBS.

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Quality Control on FBS

Biowest Fetal Bovine Serum specific formulations are determined and selected in relation to optimal growth of specific cell lines. There are thousands of different cell lines.

Two batches of FBS cannot be identical, a batch of FBS which works well for one cell line may not work well for another cell line.
Each Batch is delivered with a Certificate of Analysis.

 

The sterility testing procedure is based on either European, or US Pharmacopeaia - depending on the location of the final filtration.
To achieve the highest Sterility Assurance Level, a representative number of samples from each production batch is selected for sterility testing before distribution.
Biosera sera are all tested for the absence of aerobic and anaerobic bacteria, fungi, and yeast.
All the sera and each final product batch are tested for Mycoplasma.
The sera are tested by means of a cell culture assay in Axcell Biotechnologies media using a culture method. Our test is accurate within limits of method detection.

All of our serum 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 for the absence of the indicated viruses by inoculation to permissive cells.
The revelation is made by immunofluorescence for pestiviruses.
Cytopathogenic agents and hemadsorbing agents are detected by microscopic observations.
The antibodies are tested by an Elisa method.

All Biowest pH meters are calibrated daily with standard solutions.

Osmolality is determined by a lowered freezing temperature, following European Pharmacopeia EU Ph. 2.2.35.
The osmometer is calibrated using traceable standards.

All Biowest sera are tested to determine and quantify endotoxin levels employing a chromokinetic - quantitative test - method D of the European Pharmacopoeia EU Ph. 2.6.14.

The residual haemoglobin concentration in each batch is determined by a quantitative and colorimetric assay to verify that the proper collection and processing procedures have been followed.

 
Protein detection Methodology
Protein Biuret Colorimetry
Albumin Immunoturbidimetry
Globulin Immunoturbidimetry

 

Test Method
ALAT (SGPT) UV Kinetic at 37°C
Alkaline Phosphatase Colorimetric Kinetic at 37°C
ASAT (SGOT) UV Kinetic at 37°C
Bilirubin DPD / Cafeine Colorimetry
Calcium Arsénazo Colorimetry
Gamma GT Colorimetric Kinetic at 37°C
Cholesterol Cholesterase Trinder Colorimetry
Creatinine Colorimetric Kinetic (Jaffé)
Chloride Indirect Potentiometry
Glucose Hexokinase UV
Iron TPTZ Colorimetry
Lactate Dehydrogenase (LDH) UV Kinetic at 37°C
Phosphorus Phosphomolybdate Colorimetry
Potassium Indirect Potentiometry
Sodium Indirect Potentiometry
Tryglicerides Glycerokinase Trinder Colorimetry
Urea Urease UV
Uric Acid Uricase Trinder Colorimetry

Each batch of serum is tested for IgG using an ELISA method.

Each batch of serum is manufactured for maximum in vitro growth support of particular cell lines.
As well as conforming to our strict Quality Control specifications, each batch of sera fulfils two important performance criteria:

  • Growth Promotion
  • Plating Efficiency
  • Cloning Efficiency

The biological performance is assessed using cell culture medium supplemented with a final concentration of 10% serum. During the test period, cultures are examined under microscope for morphological abnormalities that could indicate toxic components in the serum.    
The following cell lines are used to measure growth potential and functionality:

Cell Line Type Species
HELA Cancer Human
L929 Fibroblast, Macrophage Mouse
SP2/0-AG14 Lymphoma Mouse
MRC-5 Lung Human

The European Union is a pioneer in BSE testing and all cattle are tested for BSE in accordance to the EU Regulation EC n° 999/2001, before the blood is allowed to be processed.
Biowest collects individual animal identification and ear tag information, ensuring the best possible traceability.
Japan and other select markets make the EU sera origin their first choice.

Test Method
Prionics Western Blot
Bio-Rad ELISA

Note: Even though the World Animal Health Organization (OIE) confirms that blood and blood products like FBS do not pose a risk for the transmission of BSE, some countries still have BSE requirements for FBS - see OIE Terrestrial Code 11.4 - BSE.

 

All Biowest products are labelled indicating suitable storage conditions, batch number, and the expiry date.
Biowest guarantees optimal serum performance when properly stored:

  • Animal sera and plasma require storage at -20°C.
  • Respect the expiry date.
  • The shelf life for animal serum is 60 months, and for animal plasma is 48 months.
 
 

Intended Use

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These products are intended for research applications.

It is the end user's responsibility to qualify these products for their specific application.
These products are not for diagnostic use.
Their safety and efficiency have not been established for diagnostic or other clinical uses.