About Quality Control
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Biowest Quality Certification
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 test procedure is based on either European or US Pharmacopoeia, 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.
Biowest sera are all tested for the absence of aerobic and anaerobic bacteria, fungi, and yeast.
Each final product batch of sera are tested for Mycoplasma.
The sera are tested for the absence of Mycoplasma using a cell culture assay in Axcell Biotechnologies media by culture method. Our test is accurate within the limits of the detection method used.
Depending on the species of the serum, each batch of serum is tested for adventitious viruses using cell culture techniques.
Sera are tested for the absence of the indicated viruses by inoculation with GBK cells. The detection of virus is made by indirect immunofluorescence. Antibody Testing : the presence of specific antibodies is detected utilizing an ELISA Assay. For exemple, the serum from equidae is tested for the presence of Equine Infectious Anemia antibodies.
All Biowest pH meters are calibrated daily with standard solutions.
All Biowest pH meters are calibrated daily with standard solutions.
All Biowest pH meters are calibrated daily with standard solutions.
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 threeimportant 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 | CancerHuman |
| L929 | Fibroblast, Macrophage | Mouse |
| SP2/0-AG14 | Lymphoma | Mouse |
| MRC-5 | Lung | Human |
Bovine Spongiform Encephalopathy (BSE) is tested for bovine derived material. According to the European Regulation EC n° 999/2001, animals are tested for BSE before the corresponding blood is allowed to be processed. The EU is a pioneer in BSE testing and individual identification of animals through ear tagging. This ensures the best possible traceability and the lowest BSE risk. Consequently the EU origin is the first choice of researchers in Japan and other selective markets.
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. https://www.woah.org/en/what-we-do/standards/codes-and-manuals/terrestrial-code-online-access/?id=169&L=1&htmfile=chapitre_bse.htm
All Biowest products have labels indicating suitable storage conditions, batch number, and the expiry date.
Biowest guarantees optimal serum performance when the product is 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.
These products are intended for research applications or further manufacturing only. .
It is the end user’s responsibility to qualify these products for their specific application.
These products are not for use in therapy, human or veterinary applications nor as an Active Pharmaceutical Ingredient or for food or animal feed.
Their safety and efficiency have not been established for diagnostic or other clinical uses.