Excipients animal derived

In the last 10 years, there has been great concern regarding the use of animal-derived excipients in pharmaceutical formulations. There is a possibility of contamination of an excipient by either an undetected virus [e.g., hepatitis C, human immunodeficiency virus (HIV)] or prion that may cause transmissible... 

Currently, there are some concerns regarding Transmissible Spongiform Encephalopathies (TSE) via animal-derived excipients such as gelatin. TSEs are caused by prions that are extremely resistant to heat and normal sterilization processes. TSEs have a very long incubation time with no cure and include diseases such as the following ... 

Cholesterol is generally regarded as an essentially nontoxic and nonirritant material at the levels employed as an excipient. It has, however, exhibited experimental teratogenic and reproductive effects, and mutation data have been reported. Cholesterol is often derived from animal sources and this must be done in accordance with the regulations for human consumption. The risk of bovine spongiform encephalopathy (BSE) contamination has caused some concern over the use of animal-derived cholesterol in pharmaceutical products. However, synthetic methods of cholesterol manufacture have been developed. ... 

In an attempt to follow these recommendations and to increase product safety, a new rFVlll product was developed by the introduction of modifications to the fermentation, the purification process and the drug product formulation. These eliminated the requirements for human- and animal-derived raw materials and excipients at all stages of the production process. In order to distinguish between dif-... 

Excipients of human or animal origin should be identified. The genus, species, country of origin, source (e.g., pancreas), and manufacturer or supplier should be clearly indicated. Furthermore, for excipients derived from ruminant materials, the application should state whether the materials are from bovine spongiform encephalopathy countries as defined by the U.S. Department of Agriculture (9 CFR 94.11). 

For the purposes of this guidance, natural product refers to materials (e.g., drug substance, excipients) that are derived from plants, animals, or microorganisms. The specific recommendations for natural products are not applicable to inorganic compounds (e.g., salts, minerals). 

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