Biotechnology products recombinant

Product Biologicals Biopharmacenticals Biotechnology products Recombinant DNA products API Bnlk Drng snbstance Protein... 

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... 

A small number of biotechnology products are classified as medical devices and, hence, are regulated by the Center for Devices and Radiological Health (CDRH). The first approved biotech product to come under the auspices of the CDRH was OP-1 implant. Marketed by Stryker Biotech, OP-1 implant is a sterile powder composed of recombinant human oestrogenic protein-1 (OP-1) along with bovine collagen. It is used to treat fractured bones that fail to heal. The product is mixed with sterile saline immediately before application, and entails surgical insertion of the paste into the fracture. 

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]. 

BOX 2.1. FDA PLANS TO SHIFT REVIEW AND APPROVAL OF WELL-CHARACTERIZED AND RECOMBINANT BIOTECHNOLOGY PRODUCTS FROM ITS BIOLOGICS DIVISION TO ITS DRUG DIVISION... 

All pharmaceuticals marketed in the United States, including biotechnology products, must be proven safe and effective for their intended use. The FDA requires that all recombinant proteins and other biotechnology products be produced by a manufacturer holding a certified Biologic License Establishment (BLE). The pharmaceutical company is required to collect safety and efficacy data, first in animal studies and subsequently in clinical trials. This information is submitted in a new drug... 

Adams, D. B. Cobon, G. (1984). Basis for the development of vaccines for control of diseases produced by metazoan parasites. In Biotechnology and recombinant DNA technology in animal production industries, ed. J. C. Nugent M. O Connor, pp. 67-74. Reviews in Rural Science, no. 6. CSIRO Division of Animal Health Armidale, New South Wales. 

Dempster AM. Pharmacological testing of recombinant human erythropoietin implications for other biotechnology products. Drug Dev Res 1995 35 173-8. 

Recombinant DNA methodology has come of age. It has spawned a growing industry that seeks to commercialize products derived from this technology. Most notable among these biotechnology products are those for human therapeutic use, and of these there are two categories proteins and nucleic acids. The research, development, and commercialization of therapeutic proteins derived from biotechnology is far more advanced than that of nucleic... 

Biotechnology using recombinant DNA has affected farm productivity in some areas and may become more significant over time. A full discussion of this interesting subject is beyond the present scope of this chapter, but mention of some aspects may be appropriate. 

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