Biotechnology-derived products based

In light of recent experience with biotechnology-derived products, it is reasonable to expect that pharmacogenomics-based drugs will be expensive relative to traditional modes of treatment (Richmond et al., 1999). If the price of these innovations is viewed out of context from the consumption of other health care goods and services, the response may well be to reduce or deny access to these products. In an era of escalating health care cost, "inputs" to the production of health care, such as pharmaceuticals, physician visits, lab-... 

Biotechnology-derived products have led to renewed interest in establishing reference standards based on the same bulk of material. Thus a single formulation, assay, and reference standard may be the fact worldwide. This situation can become complex such as with insulin where both biotechnology-derived insulin and animal-source insulin are in the marketplace at the same time. 

For biotechnologically derived products the acceptable levels of foreign proteins should be based on the sensitivity/selectivity of the test method, the dose to be given to a patient, the frequency of administration of the drug, the source, and the potential immunogenicity of protein contaminants [10]. Levels of specific foreign proteins range from 4 ppm to 1000 ppm. 

In 1997 the ICHS6 guidance on preclinical safety evaluation of biotechnology-derived products [2] introduced the concept of the case-by-case approach. This means that each new test article (product) or product class must have a science-based testing program custom prepared for that product... 

In this chapter, pharmaceutical and health-care products, such as prescription drugs, generic drugs, OTC products, animal health products, dietary supplements (vitamins and herbal drugs), and biotechnology-derived products, are discussed in relationship to the format of preformulation reports. Topics of the preformulation study are discussed in detail. Models for some of the reports are provided in the hope that the pharmaceutical development team will devise an individual report format based on particular needs and resources. Analytical techniques useful for preformulation and regulatory conformity or requirements relative to product registration processes are also enumerated. 

A subtle but important benefit of biotechnology is the use of genetic probes and tests based on the polymerase chain reaction to screen for and identify pathogens in foods. The economics could result in 40 billion/year cost savings as a result of reduced illness. Clearly, these are public benefits from many of the biotechnology-derived products that are currently available and will become available in the next century. As more sophisticated products become available, the benefits should continue to increase. Biotechnology very likely offers the best answer to respond to society s demands for plentiful new food varieties. These foods must be appetizing, nutritious, safe and healthy with minimal envirotunental... 

After the approval of the first product, recombinant insulin, in 1982, progress in the development of new recombinant protein pharmaceuticals was slow ([10], Fig. 17.1). The number of biotechnology-derived drugs and vaccines approved by the US Food and Dmg Administration (FDA) has increased significantly only since 1995. More recently, sales of biologies have skyrocketed, e.g. from 900 million in 1999 to an estimated 3.5 billion in 2001 for monoclonal antibodies [11]. The annual global market for biopharmaceuticals is estimated to have increased from 12 billion US to 30 billion US in 2003 [12]. 500 candidate biopharmaceuticals are undergoing clinical evaluation and over one hundred protein-based therapeutics are in the... 

In 1996, about 10 years after the introduction of the first recombinant DNA product for human use, the FDA modified and streamlined the approval process for biotechnology products considered to be well characterized. These modifications, in essence, established the direction of how biologic macromolecules are researched and developed today in biotechnology-based and traditional pharmaceutical companies [2]. Well-characterized biotechnology products include (1) synthetic peptides consisting of fewer than 20 amino acids, (2) monoclonal antibodies and derivatives, and (3) recombinant DNA-derived products. Anticipating future developments, the FDA is also prepared to consider DNA plasmid products as well-characterized when the first medicinal in this class is submitted for approval. CBER now approves well-characterized biopharmaceuticals under the BLA process [3]. 

Commercial feasibility can now only be measured by the considerable interests and investments that agriculturally-based firms are making in biotechnology, since very few biotechnology-derived agricultural products have been marketed. 

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