Collection And Processing Of Serum

Blood is generally collected from two sources: animals slaughtered for food consumption or from donor herds maintained on controlled farms designed primarily to supply material to the pharmaceutical and biotechnology industries. A schematic overview of the collection and manufacturing steps is provided in Figure 4.1. For FBS, at the time of collection the adult animal is humanely killed, hung on an elevated rail and the gravid uterus is removed to a separate processing area. The

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Figure 4.1 Schemetic of the collection and manufacturing steps in the production of animal sera.

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Figure 4.1 Schemetic of the collection and manufacturing steps in the production of animal sera.

foetus can then be separated from the uterus and blood collected aseptically via cardiac puncture or, less frequently, by umbilical cord collection. For newborn (NB), calf (CS) or adult bovine serum (ABS; 12-60 months old) and other adult sera such as porcine serum (PS), the animal is humanely killed and hung. A trocar or canula is then inserted into the heart or jugular vein and the blood collected by gravity into collection devices. These types of sera can normally be traced back to the collection point and date of collection.

Donor animals are those maintained on controlled farms whereby the health and husbandry of individual animals is known. Donor sera can thus be traced back to the specific animal and date of collection. During the collection process, animals are safely restrained, the site of collection is swabbed and a sterile needle inserted into the jugular to collect material. The amount of material collected is controlled to maintain the health and well being of the herd and, ultimately, the quality of the final product.

Once collected, the blood is allowed to clot under controlled conditions and centrifuged. The serum is then pooled into small sub-lots and frozen. The time and temperature for clotting are determined by the typical clotting tendencies for each serum type. Haemoglobin levels in sera are considered a marker for how well serum has been handled and transported. High haemoglobin content (resulting from haemolysis) may indicate that the serum was allowed to sit for extended periods and/or at too high a temperature prior to processing. High endotoxin levels indicate contamination that may be due to poor collection and blood processing techniques.

When enough sub-lots of serum to prepare a single large-volume lot of material are available, most reputable vendors will test samples of the unfiltered sub-lots against set quality specifications. These tests may include endotoxin, mycoplasma, viral screening and bioburden levels. A typical manufacturing scheme is then to thaw the bulk material and filter sterilize it through a series of filters of descending porosity under cleanroom conditions. Typically, the smallest filter is 0.1 |im for FBS. Serum from older animals is significantly higher in protein and lipid content and is most often 0.2 |im filtered, but this can vary from supplier to supplier. The filtered material is collected into a single, sterile, large volume vessel which may exceed 2000 l, depending on the serum supplier. After mixing to homogeneity, the sera can then be dispensed into sterile containers. Once filtration and filling is complete, the packaged material is frozen for long-term storage until final testing is completed.

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