Recombinant drugs

Evidently, resolution of the three-dimensional structures of proteins will aid in the design of rational approaches for constructing drug conjugates, as demonstrated by the above-mentioned examples. Evaluation of molecular structure at this level may prove to be one of the more successful approaches used in the design of recombinant drug conjugates. 

Several recombinant drugs treat inherited conditions by replacing missing or malfunctioning proteins. Several of these are enzymes, proteins that drive biochemical reactions. The body has many different enzyme proteins, each of which performs a specific job in the construction or breakdown of chemicals. Some inherited conditions are caused by a destructive buildup of substances, a buildup that occurs because of an error in the gene for a particular enzyme that breaks down that chemical. 

Hepatitis - piSINFECTANTS AND ANTISEPTICS] (Vol 8) -treatment using recombinant drugs [GENETIC ENGINEERING - PROCEDURES] (Vol 12)... 

Standard calibrators were prepared by spiking the recombinant drug to standard zero from the kit they were run against the kit standards and found to be comparable. To prepare VS/QCs, PTH was screened in plasma samples from 32... 

Protein impurities are either process- or product-related impurities. Process-related impurities include proteins added to the culture medium, proteins used during purification, such as nucleases and chromatography ligands, and proteins from the host organism. Product-related impurities include degra-dates, aggregates, and conformational isomers of the recombinant drug product. 

A simple example of mapping is shown in Figure 4A for a performance qualification run for a recombinant drug product filled and released by mass. Each vial contains only a few micrograms of active protein, and therefore it is... 

W. Jelkmann, The enigma of the metabolic fate of circulating erythropoietin (EPO) in view of the pharmacokinetics of the recombinant drugs rhEPO and NESP. Eur J Haematol 69 265-274 (2002). 

Insulin was the first recombinant drug, approved in 1982. There are now about 150 biopharmaceuticals approved for treatment of a variety of disorders. The value is US 30 billion (<7% of total drug market) and currently about 500 biopharmaceuticals are undergoing clinical trials. 

Due to the strict requirements concerning the purity of recombinant drug substances, guidelines and regulations can only be a certain help in how to approach a problem and give an idea about limits. However, the requirements always need to be evaluated on a case-by-case basis and... 

Recombinant drugs, e.g., human insulin, plasminogen activator (tPA), interferons, interleukins, growth factors and others, constitute a steadily growing subset of drugs in the mar-... 

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