Viral clearance studies are required for pharmaceuticals derived from human and/or animal sources such as recombinant proteins produced in eukaryotic cell lines, human blood products and vaccines, and even for some critical class III medical devices. It is mandatory to demonstrate that steps in the manufacturing process are capable of inactivating or removing potential viral contaminants. For this, a laboratory-scale (downscale) of the process step is developed and challenged with different model virus solutions. The viral concentrations are quantitatively determined in the feed material and the relevant product fraction. The ratio of both defines the reduction in virus and specifies the viral inactivation or viral removal capacity of the investigated process step…
Tag: <span>geographic origin</span>
It is a common belief that fetal bovine serum (FBS) collected from certain geographical regions, such as New Zealand, is of superior quality to material collected from South America. Whilst it is true that origin does have an impact on the price of serum, it does not affect the quality or biological performance of the product. FBS collected under similar conditions from any geographical region will demonstrate comparable ability to support cell growth. For FBS, the term “quality” is frequently confused with “health status.” It is the health status of the geographical region from which the serum is collected that will dictate its potential use, the availability of material for import, and eventually, the price. It should be noted that health status should be considered a result of more than just the geographical source of the material, but also the regulatory infrastructure and how well regulations are enforced by the countries within that region…
Since its inception in 2006, the International Serum Industry Association (ISIA) has been focused on providing a more informative characterization standard for animal sera. A fundamental aspect of this effort has been the development of a program focused on product traceability from abattoir to end-user. This goal has been achieved in part by implementing the ISIA-sponsored audit program. Serum vendors determined to be compliant with all audit requirements are awarded ISIA Traceability Certifications. In conjunction with Oritain Global Ltd, ISIA has developed and implemented a method for establishing geographical origin of serum products. The method and its capability of determining geographical origin are described in this paper…
The continued use of animal serum as an important component in biotechnology manufacturing processes has raised questions regarding both the reliability of geographic origin and possible adulteration of product. The International Serum Industry Association (ISIA) has implemented a traceability certification program designed to demonstrate traceability from slaughterhouse or abattoir to the end-user. This is based on an audit performed by an independent, approved third-party auditor according to an approved audit plan, using a detailed audit checklist. Recent advances have led to the development of a complementary testing program to determine geographic origin of material. The methodology described in this paper differentiates fetal bovine serum from newborn calf serum on the basis of biochemical composition…