Drug product animal-derived materials

The FDA has issued a guidance suggesting that animal-derived materials such as egg yolk lecithin, and egg phospholipid) used in drug products, originating from Belgium, France, and the Netherlands between January and June 1999 should be investigated for the presence of dioxin and polychlorinated biphenyls. The contamination in the animal-derived product was probably due to contaminated animal feed. 

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). 

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-... 

All materials used in the manufacture of drug products and product contact processing materials have to be assessed for the risk of contamination with transmissible spongiform encephalopathy (TSE). Materials of the highest risk are those potentially derived from animal origin and include amino acids, some enzymes and charcoal supports for catalysts. 

Exhibit 1.5 provides a brief explanation of patents. Patents are the pillars that support the drug industry. In contrast, traditional medicines, which are mainly derived from natural products of plant or animal origins, are not patentable. This is because traditional medicines consist of a multitude of compounds and it is difficult to establish patent claims based on varying quantities of materials. 

Although all the main classes of steroids have now been attained by total synthesis, most drugs are in fact, as noted above, prepared by partial synthesis from natural products that contain the steroid nucleus. The bulk of the world s supply of steroid starting material is derived by differing chemical routes from only two species of plants the Mexican yam, a species of Dioscorea, and the humble soybean. The advantage of using plants rather than valuable domestic animals as raw material is fairly obvious. 

Petroleum is a thick, viscous hquid mixture of literally thousands of compounds, most of them hydrocarbons, formed from the decomposition of marine plants and animals. Petroleum and petroleum-derived products fuel automobiles, aircraft, and trains. They provide most of the greases and lubricants required for the machinery of our highly industrialized society. Furthermore, petroleum, along with natural gas, provides close to 90% of the organic raw materials used in the synthesis and manufacture of synthetic fibers, plastics, detergents, drugs, dyes, and a multitude of other products. 

---