The impact of genetic engineering on vaccine technology

The advent of recombinant DNA technology has rendered possible the large-scale production of polypeptides normally present on the surface of virtually any pathogen. These polypeptides, when purified from the producer organism (e.g. E. coli, Saccharomyces cerevisiae) can then be used as 'subunit' vaccines. This method of vaccine production exhibits several advantages over conventional vaccine production methodologies. These include Production of a clinically safe product the pathogen-derived...

Formulation of insulin products

Intermediate Acting Insulin Peak

Insulin, whatever its source, may be formulated in a number of ways, generally in order to alter its pharmacokinetic profile. Fast (short)-acting insulins are those preparations that yield an elevated blood insulin concentration relatively quickly after their administration (which is usually by s.c. or, less commonly, by i.m. injection). Slow-acting insulins, on the other hand, enter the circulation Table 11.3 Native and engineered human insulin preparations that have gained approval for...

Production of human insulin by recombinant DNA technology

Human insulin produced by recombinant DNA technology was first approved for general medical use in 1982, initially in the USA, West Germany, the UK and The Netherlands. As such, it was the first product of recombinant DNA technology to be approved for therapeutic use in humans. From the 1990s on, several engineered insulin products (discussed later) also gained approval (Table 11.3). The initial approach to recombinant insulin production taken entailed inserting the nucleotide sequence coding...