EMEA Conforming Serum Products

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, HyClone has created a line of EMEA Conforming products that meet the scope of both directives.

Guideline on Requirements and Controls Applied to Bovine Serum Used in the Production of Immunological Veterinary Medicinal Products
The following is an excerpt from EMEA/CVMP/743/00-FINAL, which summarizes the scope of the directive:

"Starting materials of animal origin are necessary for the production of immunological veterinary medicinal products. Attempts should be made to reduce the use of bovine serum in the production of immunological veterinary medicinal products and whenever possible, the use of non-ruminant materials is preferred.

It is, however, recognized that materials of animal origin, including bovine serum, are still essential ingredients of the cell culture media used in the production of many veterinary vaccines. Different risks are associated with the use of such starting materials. Indeed, the nature and quality of the bovine serum can profoundly influence the quality of the manufacturing process and of the finished product."

Note for Guidance on the Use of Bovine Serum in the Manufacture of Human Biological Medicinal Products
The following is an excerpt from EMEA/CPMP/BWP/1793/02, which summarizes the scope of the directive:

"This Note for Guidance outlines the general principles, which should be applied to the control of quality and safety of bovine serum used during the manufacture of human biological medicinal products including vaccines and biotech products. This includes serum used directly during production cell growth and serum used during cell growth prior to a production phase, for example in the growth of cells prior to vaccine production. Serum that is used minimally, such as in the establishment of a master cell bank, during cryopreservation or during a developmental phase, such as during transfection in the generation of genetically engineered cells, also falls within the scope of this Note for Guidance."

HyClone recognizes 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 at www.emea.eu.int.

For those customers who must meet either the veterinary or human guideline, HyClone offers the following EMEA/CVMP/743/00 & EMEA/CPMP/BWP/1793/02 Conforming products.