How to judge the quality of Fetal Bovine Serum through COA

01
Fetal Bovine Serum

Fetal bovine serum is a serum obtained from bovine embryos and is commonly used to prepare animal cell culture media. Fetal bovine serum contains various growth factors and has low levels of antibodies.
Fetal bovine serum is an important tool in cell culture, how to determine its quality? Today, we are trying to help you determine the quality of fetal bovine serum on hand from the perspective of COA.
After reading this article, you can master the following skills:
 
√ Understand what COA is and what its purpose is;
Understand the key indicators in COA and understand their significance;
Quickly determine the quality of the batch of fetal bovine serum from a COA;
Can answer some common questions about the use of serum.

02
What is COA
What is the purpose of it

COA, abbreviated as Certificate of Analysis, is a document that confirms the quality of a product. Its main function is to provide detailed specifications and test results of the product. Speaking of people, it is a quality inspection report.
COA is a key criterion for evaluating the suitability and safety of products when purchasing and using certain chemical, biological, or other technological materials.
 
For biological products such as fetal bovine serum, COA will demonstrate key quality indicators such as sterility, virus detection, and protein content, which are crucial for the reliability of the experiment.

03
Key indicators

The key indicators of COA (Certificate of Analysis) are detailed descriptions of product quality, which are crucial for ensuring that products meet specific standards. The following are some common key indicators and their meanings:

• Harmful microorganisms

Bovine serum products should be filtered and sterilized before production, and should not contain bovine diarrhea virus, bacteriophages, mycoplasma, or fungal contamination.
——The 2020 edition of the Chinese Pharmacopoeia (Veterinary) for newborn bovine serum standards.

Bacteria, fungi, and mycoplasma all tested negative; The results for bovine diarrhea virus, type III parainfluenza virus, and bovine infectious rhinotracheitis virus were all negative.

All batches of COA showed negative results for all six indicators mentioned above.

• Endotoxin

Bacterial endotoxin content in serum ≤ 10 EU/ML
——The 2020 edition of the Chinese Pharmacopoeia (Veterinary) for newborn bovine serum standards
  
Endotoxins originate from the cell wall components of Gram negative bacteria, which can easily stimulate the production of immune responses in cells and have certain toxic effects. In serum and other products, the level of endotoxins should be as low as possible to avoid adverse effects on sensitive applications such as cell culture.
  
The 2000 version of the domestic quality control standards for biological products clearly guides the maximum limit of serum endotoxin content to 10EU/ml, and the global standard for Kangtai bovine serum is endotoxin content ≤ 5EU/ml.

• Total protein content

The protein content in serum should be between 35-50g/l
——The 2020 edition of the Chinese Pharmacopoeia (Veterinary) for newborn bovine serum standards
  
The significance of this indicator is to determine the age of the batch of fetal bovine serum and evaluate the impact of serum on cell culture.
  
Determine the age of fetal bovine serum: Fetal bovine serum is collected from fetal cows aged 6-8 months. As the fetus develops, the protein content in the serum will gradually increase. If the protein content is too high, it may indicate that the collection time of fetal bovine serum is too late, and it may even be collected after the calf is born.
  
Evaluate the effect of serum on cell culture: Various components in fetal bovine serum, including proteins, are usually beneficial to cells, but excessive addition may lead to excessive concentration and damage to cells. Therefore, understanding the total protein content helps determine the appropriate serum concentration, which is usually recommended between 10% -20%, depending on cell type and culture conditions.

• Hemoglobin content 

 
Hemoglobin content in serum ≤ 200mg/l
——The 2020 edition of the Chinese Pharmacopoeia (Veterinary) for newborn bovine serum standards
  
The domestic quality control standards describe and define bovine serum as a light yellow, clear, slightly viscous liquid that is free from hemolysis and foreign substances.
  
In the production process of fetal bovine serum, improper handling may lead to the release of hemoglobin from red blood cells and its dissolution in the serum. This not only changes the color of the serum, usually making it appear red or pink, but may also have an impact on the quality and application of the serum.
  
The factors that determine the color of serum are hemoglobin and bilirubin, with the former showing a reddish color when the content is high, and the latter showing a golden yellow color when the content is high. We cannot simply judge its quality based on the depth of color.
 
It should be noted whether the hemoglobin content in COA is within the standard range. A high hemoglobin content may indicate the presence of hemolysis in the serum, indicating a serious hemolysis phenomenon during the serum collection process. To some extent, it reflects the non-standard and imprecise collection process.

In summary, the key indicators in the COA report provide a comprehensive analysis of product quality, ensuring the quality and safety of the product.

These indicators are not only important quality control tools for manufacturers and suppliers, but also provide users with necessary information to make informed decisions.