The factors can be grouped into the following:
1. Inexistence of BSE prion and pathogenic viruses in the origin.
2. Production performed in an aseptic way, so that the endotoxin content is minimum.
3. A production with the utmost diligence, in order to avoid protein denaturation.
4. The maximum amount of serum resulting from early age foetuses, which are richer in “true” fetal or embryonic nutrients. Trinity Tek highlights this fourth point.
Not exactly. To ensure the good quality of a serum it is necessary that its origin is free of the BSE causing prions, FMD, Bluetongue and Akabane – causing viruses among others, but also the serum should have been properly produced from the beginning, and not only in the final processing site with or without ISO’s certifications.
No, in Australia and New Zealand there are veterinary controls and campaigns against Akabane, in USA against Bluetongue, in South America against FMD and in EU against BSE.
Beside the Certificate of Analysis the essential one is the Approval of the plant given by the D.G. SANCO, because it means that the country of origin is free of BSE, FMD, Bluetongue and Akabane, and the FBS have been produced under a HACCP System in compliance of the Regulation (EU) 142/2011.
It is a necessary requirement but not enough, because endotoxin only measures the amount of serum contaminants, not the value and effectiveness of its proteins. There may be a serum with low endotoxin or produced without contamination, but not produced with the precise speed to ensure the preservation and effectiveness of its proteins.
Hemoglobin is not a toxic substance then it is contained within red blood cells for cellular oxygenation. Nevertheless, when its presence is high, it has the undesirable effect of dyeing the serum of red, and avoids a clear observation of cell growth under a microscope.
The fewer the times the serum is submitted to thawing/freezing, the better its quality. Ideally, the serum should be thawed from the beginning, and, in case of need, subdivided. The thaw should always be practiced by immersion in slightly warm water to the normal mammal temperature (for security to no more than 35°C), followed by a light mix without shaking it.
As long as your product has not been thawed for a long period of time, there should not be any problem.
There is no difference. It is the same serum.