Classification and production technique of newborn calf serum

Abstract

The invention discloses a classification and production technique for new-born calf serum. Albumen, hemoglobin and bacterial endotoxin quantitative determination, microbiology determination and antibody determination are carried out on the new-born calf serum; then new-born calf serums with identical backgrounds are classified and amalgamated; cell proliferation spectral test and basic quality control are carried out on the classified and amalgamated new-born calf serums; the cell proliferation spectral test consists of continous cell culture proliferation test and primary cell culture test; Finally, according to cell proliferation and antibody background, the usages of the serums are classified. The calf serums produced by the technique of the invention has clear classification and exclusive usages, thus meeting the requirement that the production of different vaccines of biomedicine needs different serums, improving the quality of the vaccines and reducing the production cost.

Description

Technical field [0001] The invention relates to a classified production process for newborn calf serum. Background technique [0002] At present, the bovine serum in the domestic market is produced in accordance with the requirements of the national standard. [0003] The national standard stipulates that newborn calf serum products meet the following requirements: 1: Newborn calf serum is divided into top, super, special, and super according to the time after birth (within 0.5 hours, within 2 hours of birth, within 4 hours of birth, and within 14 hours of birth). Normal level 4; 2: The total protein content is 3.5-5.0 (W / V,), hemoglobin content ≤0.035 (W / V), endotoxin content ≤10EU / ml, sterility test negative, mycoplasma negative and coliphage negative ; 3: Bovine diarrhea virus antibody and foot-and-mouth disease antibody are negative; 4: The serum promotes the growth of BHK cells and SP2 / 0 cells (see Table 12 for details). [0004] The inventor of the present application disco...

AI Technical Summary

Problems solved by technology

Although there are available data on using A549 cells as the attachment efficiency and SP2 / 0 cells as the cloning efficiency to measure the quality of serum, no one uses different cell lineages for cell proliferation tests or attachment tests for different production purposes, nor See information and products on Serum Antibody Detection and Classification of Newborn Cattle Serum for Production Purposes

This forces vaccine manufacturers to run a serum screening program first before producing vaccines, resulting in increased costs and waste

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