Sera Processing
Using industry leading techniques, blood is aseptically collected at abattoirs, centrifuged to isolate the serum and immediately frozen for testing and further processing. The raw sera is then true pooled and is triple 0.1 micron sterile filtered with a Sterility Assurance Level (SAL) of 10-3. Every lot then must pass USP <71> and EP 2.6.1 sterility testing, growth promotion testing, as well as test negative for mycoplasma and number of industry-monitored viruses. Authenticity of the serum is verified using industry leading measurements of Gamma-Glutamyl Transferase and Corning’s high internal standard of ≤ 10 IU/L. Additional testing includes endotoxin, hemoglobin, pH, osmolality, total protein, and a biochemical profile that contains various metals, proteins, hormones and other metabolites.
EDQM Certificates of Suitability
Fetal Bovine Serum, United States Origin
This product has been granted a Certificate of Suitability, R0-CEP 2018-271, by the European Directorate for the Quality of Medicines (EDQM) certifying that the product meets the criteria described in the current version of the monograph no. 1483 of the European Pharmacopoeia “Product with risk of transmitting agent of animal spongiform encephalopathies.”
Origin Statement
Corning’s premium FBS is only collected from government approved abattoirs in the United States, Australia, and New Zealand. All fetal bovine serum is derived from fetuses collected from healthy bovine cows and heifers that have passed ante and post mortem inspection and were found free of contagious diseases.
Corning’s regular FBS is derived from government registered facilities in North, Central, and South America and outside the United States. All fetal bovine serum is derived from fetuses collected from healthy bovine cows and heifers that have passed ante and post mortem inspection and were found free of contagious diseases. The material was exported from the country of origin accompanied with a Veterinarian Health Certificate.
Treatment
Dialyzed
Gamma Irradiated
Heat Inactivated
Ultra Low IgG
None
Tetracycline Negative
Heat Inactivated and Gamma Irradiated
Charcoal Dextran Stripped
Serum Origin
United States
South American
New Zealand
Canadian
Australian
USDA Safety Tested
Size
50 mL
100 mL
500 mL
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