HyClone* Fetal Bovine Serum, EMEA Conforming (U.S.), Defined

The European Agency for the Evaluation of Medicinal Products (EMEA) has issued two directives that apply to the use of bovine serum in the production of medicinal products.

• EMEA/CVMP/743/00-FINAL from the Committee for Veterinary Medicinal Products (CVMP) Guideline on Requirements and Controls Applied to Bovine Serum Used in the Production of Immunological Veterinary Medicinal Products
• EMEA/CPMP/BWP/1793/02 from the Committee for Proprietary Medicinal Products (CPMP) Note for Guidance on the Use of Bovine Serum in the Manufacture of Human Biological Medicinal Products

To support medicinal manufacturers who utilize bovine serum in their processes, a line of EMEA conforming products that meet the scope of both directives has been created.

We recognize the need for high quality, traceable bovine serum, which is tested (and inactivated as required) to meet both directives.Where applicable, our EMEA Conforming products are tested per European Pharmacopoeia protocols and irradiated at the required minimum dose. These EMEA Conforming products provide medicinal manufacturers with the assurance of receiving high quality, consistent product that conforms to the requirements. Complete versions of both

directives can be found atwww.emea.eu.int.

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 (0.04µm) 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.

Hemoglobin (spectrophotometric): ≤10mg/dl

Sterility Testing(Current USP and EP Ph.Eur. 2.6.1) Bacteria & Fungi: No Growth

Fluorescent Antibody

Bluetongue: Not Detected

Bovine Adenovirus: Not Detected

Bovine Parvovirus: Not Detected

Bovine Respiratory Syncytial Virus: Not Detected

Bovine Viral Diarrhea Virus: Not Detected

Bovine Leukemia Virus: Not Detected

Rabies: Not Detected

Reovirus: Not Detected

Cytopathogenic Agents, e.g. IBR: Not Detected

Hemadsorbing Agents, e.g. PI3: Not Detected

(Points to Consider and EP Ph. Eur. 2.6.7)

Large Volume, Direct Culture: Not Detected

Hoechst DNA Stain: Not Detected

Ouchterlony/Double Immunodiffusion: Satisfactory

Antibodies: Pass

Interference/Comparative Titration: No Interference

Quantitation: Tested

Gamma Irradiation >30kGy (>30Mrad)

Bovine Viral Diarrhea Virus: Not Detected

Antibodies: Pass

Interference/Comparative Titration: No Interference

Quantitation: Not Detected

Certificate of Suitability: Included