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Domestic and international bovine serum products and regulations

1. The source of bovine serum


Bovine serum is derived from the blood of domestic cattle and is the supernatant component of whole blood centrifuged for coagulation or fibrinogen removal. Bovine serum is a byproduct of the meat industry. During slaughter, blood can be collected from adult cows, calves, very young calves, or from fetal cows when pregnancy is discovered after slaughter, or from "donor cows".


The classification of bovine serum is usually defined by the age of the cow at the time of blood collection. The age of the blood supply cattle can affect the characteristics of bovine serum, for example, the IgG (Immunoglobulin G) content of bovine serum varies greatly among different ages of cattle.


2. Regulations related to bovine serum


Due to the importance of bovine serum in the production of biopharmaceuticals such as human and veterinary vaccines, many countries have included it in their pharmacopoeias. The definition and quality standards of bovine serum are specified in the Pharmacopoeia of the People's Republic of China and the Veterinary Pharmacopoeia of the People's Republic of China, as well as in the United States Pharmacopeia USP and the European Pharmacopoeia EP.


(1) Classification of bovine serum in the United States Pharmacopeia


According to the United States Pharmacopeia, bovine serum products from different age sources are classified as follows. All bovine serum is collected in slaughterhouses that have been inspected and registered by the government.


Fetal bovine serum (FBS), also known as fetal bovine serum, is obtained from the fetuses of healthy prenatal cows that have been examined by licensed veterinarians before and after slaughter and deemed suitable for human consumption.


Newborn calf serum: Newborn calf serum, abbreviated as NBCS (Newborn Calf Serum), also known as Newborn Bovine Serum, is obtained from cows under 20 days old.


Calf Serum: Calf Serum is obtained from cows aged 20 days to 12 months.


Adult Bovine Serum (ABS), also known as Adult Bovine Serum, is obtained from cows over 12 months old and has been declared suitable for human consumption.


Donor bovine serum: Donor bovine serum, also known as donor Calv serum, is obtained by repeatedly drawing blood from controlled, government inspected, and registered donor cattle. These cows are aged between 12 and 36 months.




(2) European Pharmacopoeia Classification of Bovine Serum


The European Pharmacopoeia emphasizes that bovine serum can only be sourced from countries with no or controllable risk of mad cow disease (BSE).


Fetal bovine serum: taken from unborn cows.


Donor calf serum: taken from donor cows less than 1 year old.


Donor bovine serum: taken from donor cattle less than 3 years old.


Cow serum: taken from cows less than 1 year old.


Ø Adult bovine serum: For countries without the risk of mad cow disease, there is no age limit for blood collection from cows; For countries with controllable mad cow disease, blood samples should be taken from cattle less than 21 months old.


(3) Regulations on bovine serum in the Chinese Pharmacopoeia


The 2020 edition of the Pharmacopoeia of the People's Republic of China defines newborn bovine serum as: serum collected from newborn cows that have not eaten within 14 hours of birth, separated, sterilized, and filtered before production.


The definition of bovine serum in the 2020 edition of the Pharmacopoeia of the People's Republic of China is:


Newborn calf serum: Blood samples are collected from newborn calves who have not consumed colostrum within 14 hours of birth, and the serum is separated and filtered out to produce bacteria.


Fetal bovine serum: Whole blood of fetal cattle aged 230-240 days is collected from the heart, separated from the serum, and filtered out for bacterial production. Mainly used for cell culture.


Due to the natural nature of bovine serum, raw materials are crucial for the quality of bovine serum products. The International Serum Industry Association (ISIA) has been developing a traceability certification program since 2009, which plays an important role in ensuring the quality, safety, and repeatability of each batch of bovine serum.


Classification and sources of bovine serum


Table 3: Sources of bovine serum (domestic and foreign)


The classification of serum in China is mainly based on the age of the fetal cattle at the time of serum extraction, while in foreign countries it is classified based on the place of origin, with Australian fetal cattle serum being the best.


name

Month age

remarks

Fetal bovine serum (special grade)

March

The grading ratio is determined by the age of the donor, and there are also classifications based on the effectiveness of serum culture

Fetal bovine serum (premium grade)

April to May

Fetal bovine serum (standard)

From June to August

Fetal bovine serum

Healthy newborn cows that have not been breastfed within 2 hours of birth

Most domestic manufacturers label this serum as fetal bovine serum or classify it as special grade newborn bovine serum

Newborn bovine serum

Healthy newborn cows that have not been breastfed within 14 hours of birth

The 2020 edition of the pharmacopoeia has clear product quality control standards.

Calf serum

Healthy live cattle born in October

/

Adult bovine serum

Healthy live adult cattle

It is generally not used for cell culture, mainly due to high serum protein content.

 

name

Month age

remarks

Fetal bovine serum (North America)

August

Market price North America>Australia>South America

Fetal bovine serum (South America)

Fetal bovine serum (Australia)

Newborn bovine serum

Newly born cows within 14-20 days of birth

/

Calf serum

Healthy live cattle within 10 months of birth

/

Adult bovine serum

Healthy live adult cattle aged 12-24 months

/


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