Defined FBS is the highest quality FBS available and is widely used by those cell culturists who have a concern for viral contaminants and require an extensive biochemical profile. Defined FBS is filtered through serial 40nm (0.04 µm) pore-size rated filters, which are the most retentive filters used in commercial FBS production. This type of filtration is a practical, cost-competitive method of viral load reduction. Data shows that 40nm filtration will remove as many as eight logs of viral challenge. This is a dramatic improvement over the current industry standard of using filters with mean pore sizes of 100nm. Studies demonstrate that this filtration regimen has no adverse effect on cell growth. Finished Defined FBS has over 50 components analyzed and the results are included on the Certificate of Analysis and the Biochemical Assay.

Assays (subject to change without notice): Progesterone, Insulin, Cholesterol, High Density Lipo-Protein Cholesterol, Low Density Lipo-Protein Cholesterol, Triglycerides, Gamma Globulin, Phospholipids, Alkaline Phosphatase, Lactate Dehydrogenase, Glutamic Pyruvic Transaminase (SGPT), Glutamic Oxaloacetic Transaminase (SGOT), Thiamine (B1), Riboflavin (B2), Pyridoxine (B6), Nicotinic Acid (Niacin), Vitamin H (Biotin), Vitamin A (Retinol), Carotene, Total Vitamin E (Tocopherol), Cyanocobalamine (B12), Pteroylglutamic Acid (Folate), Vitamin C, 1,25 Dihydroxy Vitamin D, pH, Total Protein, Albumin, Blood Urea Nitrogen, Creatinine, Total Bilirubin, Inorganic Phosphorus, Osmolality, Iron, Selenium, IgG, Sodium, Potassium, Calcium, Chloride, Magnesium, Glucose, Copper, Total Iron Binding Capacity (TIBC), and Percent Saturation.

HyClone recognizes the challenges in changing regulatory filings, so we also offer an option to those serum users who need to meet the human guideline requirements, but prefer to continue using the same products (no changes to the product part number) with the addition of three tests.

These products are ordered using the non-EMEA part numbers and are tested per the information below. Standard serum products that require EMEA/CPMP/ BWP/1793/02 conformance are provided with the standard Certificate of Analysis, in addition to an addendum, which includes the additional testing results. It is the combination of both documents that provide assurance that the product purchased is EMEA/CPMP/ BWP/1793/02 Conforming.