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HyClone Laboratories, Inc. was founded nearly 30 years ago by a virologist, Dr. Rex Spendlove, because he was not satisfied with the quality of commercially available animal sera for his virology work. Since that time HyClone has worked to improve serum quality through collection, processing, and filtration innovation. For example, serum endotoxin and hemoglobin are indicators of the care exercised during blood collection and processing. Through the use of a patented, disposable, closed-system cardiac puncture collection system and rapid processing, HyClone reduced serum hemoglobin and endotoxin levels significantly. HyClone was the first to use serial 100nm pore-size filters and later serial 40nm pore-size filters.

HyClone believes there is virus present in all commercial-size batches of animal sera1 and that safe use is based on informed consumers managing the reduction of viral load. Therefore, this article addresses serum treatments designed to reduce adventitious agents yet preserve growth promoting characteristics, while also being commercially feasible and reliable. A method to assess risk is also discussed.

 
Introduction
Risk Assessment
     Figure 1.  Preliminary Raw Materials Risk Assessment Worksheet
     Figure 2.  Recipient Preliminary Risk Assessment
Regulatory Control
Gamma Irradiation - Serum
     Table 1.  Gamma Irradiation - Virus Recovery Matrix
     Table 2.  Irradiated FBS Analysis
Heat Treatment
     Table 3.  Heat Treatment Chart
Acid Treatment
     Table 4.  Acid Treatment Chart
     Table 5.  Acid Treatment - Equine Serum Chart
Total Sterility Assurance
Article References

 

Keys to Our Success Section Navigation
  Processes
  Heat Inactivation - Are You Wasting Your Time?
> Viral Safety in Serum for Cell Culture Use
 
   Introduction
Assessment of Risk for use of Animal–Derived Material
   Figure 1. Preliminary Raw Materials Risk Assessment Worksheet
   Figure 2. Recipient Preliminary Risk Assessment
Regulatory Control
Gamma Irradiation - Serum
   Table 1. Gamma Irradiation - Virus Recovery Matrix
Table 2. Irradiated FBS Analysis
Heat Treatment
   Table 3. Heat Treatment Chart
Acid Treatment
   Table 4. Acid Treatment Chart
Table 5. Acid Treatment - Equine Serum Chart
Total Sterility Assurance
Article References

 

 

 

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