Biotechnologically produced drugs

Claude JR. Difficulties in conceiving and applying guidelines for the safety evaluation of biotechnologically-produced drugs Some examples. Toxicol Letts 1992 64/65 349-55. 

Delivery of large-molecular-weight, biotechnology-produced drugs info the body is difficult because of the poor absorption of these compounds, the acid lability of peptide bonds, and the rapid enzymatic degradation of these drugs in the body. In addition, protein pharmaceuticals are susceptible to physical instability, complex feedback control mechanisms, and peculiar dose-response relationships. 

Louie S, Rho J. Pharmacotherapeutics of biotechnology-produced drugs. In Zifo SW, ed. Pharmaceutical Biotechnology A Programmed Text. 

A major advance in simplifying quality control of biotechnologically produced drugs has been the development of electrospray mass spectrometry, which can measure exactly the molecular weight of a particular protein and also detect and characterise small amounts of contaminating proteins. Figure 27.8 shows the electrospray mass spectmm of human insulin. 

It may be necessary to exclude certain undesirable contaminants from starting materials, such as pseudomonads from bulk aluminium hydroxide gel, or to include some form of pre-treatment to reduce their bioburdens by irradiation, such as for ispaghula husk and spices. For biotechnology-derived drugs produced in human or animal tissue culture, considerable efforts are made to exclude cell lines contaminated with latent host viruses. Official guidelines to limit the risk of prion contamination in medicines require bovine-derived ingredients to be obtained from sources where bovine spongiform encephalopathy (BSE) is not endemic. 

Type of drug. This category considers whether the drug is a biotechnology-derived and produced drug or a conventional pharmaceutical synthesized in a laboratory. 

Biotechnologically Produced Proteins and Peptides as Approved Drugs... 

Most of the controlled-rclease delivery systems available in the market for systemic delivery of drugs utilize oral, parenteral, and transdermal route for their administration. Advances in biotechnology produced many gene, peptide, and protein drugs with specific demands on route of delivery. Thus, other routes such as buccal, nasal, ocular, pulmonary, rectal, and vaginal are gaining more attention. 

Various drugs have been immobilized in radiation polymerized HEMA in order to produce drug delivery devices, such as ergota-mine,[ll3] salicylic acid,[114,115] and hormones.[116] The ability of diffusing numerous drugs into polymers may be used in different types of biotechnologies such as membrane separation and drug... 

Low reactant/product quantity The pharmaceutical and biotechnology industries produce drugs, enzymes, and biomaterials in small quantities. The production of... 

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