O Biotechnology And New Drug Development

The tools of biotechnology are also being brought to bear in the search for new biological targets for presently available drugs as well as for the discovery of new biological molecules with therapeutic utility. Molecular cloning of novel receptors can provide access to tremendous tools for the testing of drugs (e.g., the adrenergic receptors), whereas cloning of a novel growth factor might potentially provide a new therapeutic agent. Biotechnology is also being used to screen compounds for biological activity. By using cloned and

Fever Basal Metabolic Rate
Figure 4.1 • Yearly growth of GenBank in base pairs.
Figure 4.2 • Yearly growth of GenBank in terms of gene sequences.

Figure 4.3 • Yearly approvals of biotechnology-derived drugs and vaccines.

Figure 4.3 • Yearly approvals of biotechnology-derived drugs and vaccines.

Yearly Development Biotechnology

expressed genes, it is possible to generate receptor proteins to facilitate high-throughput screening of drugs in vitro or in cell culture systems rather than in animals or tissues. Biotechnology is being investigated in completely novel approaches to the battle against human disease, including the use of antisense oligonucleotides and gene replacement therapies for the treatment of diseases such as CF and the use of monoclonal antibodies (MAbs) for the treatment of cancer.

Biotechnology encompasses many subdisciplines, including genomics, proteomics, gene therapy, made-to-order molecules, computer-assisted drug design, and pharmacoge-nomics. A goal of biotechnology in the early 21st century is to eliminate the "one-drug-fits-all" paradigm for pharmaceutical care.58

The drugs that are elaborated by biotechnological methods are proteins and, hence, require special handling. There are some basic requirements of pharmaceutical care for the pharmacist working with biotechnologically derived products41:

• An understanding of how the handling and stability of bio-pharmaceuticals differs from other drugs that pharmacists dispense

• Knowledge of preparation of the product for patient use, including reconstitution or compounding if required

• Patient education on the disease, benefits of the prescribed biopharmaceutical, potential side effects or drug interactions to be aware of, and the techniques of self-administration

• Patient counseling on reimbursement issues involving an expensive product

• Monitoring of the patient for compliance

The pharmacist must maintain an adequate knowledge of agents produced through the methods of biotechnology and remain "in the loop" for new developments. The language of biotechnology encompasses organic chemistry, biochemistry, physiology, pharmacology, medicinal chemistry, immunology, molecular biology, and microbiology. A pharmacist has studied in all of these areas and is uniquely poised to use these skills to provide pharmaceutical care with biotechnological agents when needed.

The key techniques that unlocked the door to the biotechnology arena are those of rDNA, also known as genetic engineering. rDNA techniques allow scientists to manipulate genetic programming, create new genomes, and extract genetic material (genes) from one organism and insert it into another to produce proteins.

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