Fetal Bovine Serum

Many years ago, commercially available fetal bovine serum was abnormally colored due to the presence of high levels of hemoglobin. In addition, endotoxin levels were unacceptable. That is when HyClone first started producing the industry's first amber-colored FBS, consistently low in hemoglobin and endotoxin.

From that beginning our pioneering efforts have resulted in unique FBS collection and filtration methods. In fact, HyClone used triple 100nm (0.1 m) filtration for years before the procedure became the standard in the industry. Today our 40nm (0.4 m) filtration procedure is state-of-the-art in commercial serum processing.

Over thirty years ago, HyClone began quantifying more than 200 serum components. Our extensive database is one of the many reasons why HyClone is known as the technical leader in the industry. Over twenty years ago, HyClone emphasized the importance of traceability and souring. We published several articles and were in contact with regulatory officials regarding this issue.

With almost four decades of FBS production experience behind us, we continue to consistently produce the highest quality FBS available for cell culture. Our experience, innovative processes, and attention to detail have resulted in many assurances of quality.

• Traceability is critical to the safe use of bovine derived materials in the manufacture of products for human and animal use. Control over collection and processing has permitted HyClone to maintain traceability.

  To collect fetal bovine blood, HyClone utilizes a closed-system cardiac puncture method and assigns each bottle a number. This bottle number provides forward traceability through processing, manufacturing, and delivery to the customer, and traceability back through the United States Department of Agriculture (USDA) and abattoir brand inspection records, to animal origin. On the majority of our products, HyClone controls collection and processing which provides customers traceability and peace of mind. All FBS collected by HyClone is sourced from regulatory agency inspected facilities (USDA, Canadian Food Inspection Agency, New Zealand and Australian Ministry of Agriculture and Forestry). Animals from which serum is derived receive ante- and post-mortem health inspection at the abattoir by veterinary inspectors and are determined to be free of infectious and contagious diseases. Each serum lot history record contains individual raw bottle numbers traceable to the abattoir's records. The actual raw serum bottle numbers in the lot history records provide the traceability requested by the FDA.

• HyClone utilizes a patented, closed-system collection method that results in serum of exceptional quality. Controlling the initial collection of fetal blood is as important to serum quality as sterile filtration and aseptic packaging. Our collection method, careful temperature control, and rapid processing in regional laboratories are keystones to our quality.
• Lot-to-lot consistency is another key to HyClone's serum excellence. Variability in FBS components is natural and is the result of a variety of factors such as age of fetus, geographical origin, etc. Our large lot sizes of 3,000 liters, coupled with true-pool processing, temper this natural serum component variability, which increases consistency.
• Low endotoxin and hemoglobin levels are excellent measures of quality as they indicate that the serum was carefully collected and processed quickly.