[excerpt] The number of therapeutic proteins is increasing rapidly. Advanced cell-based manufacturing technologies help when it comes to producing recombinant proteins.
Protein-based therapeutics is the newest class of chemical compounds being developed by the drug industry, and it is estimated that about 900 to 1,200 clinical candidate proteins and/or peptides are currently being investigated. In addition, 140 therapeutic proteins have been approved and 500 are in clinical trials, and it is expected that at least 50 biotherapeutics will come on to the market over the next few years.
Many of these biotherapeutics are produced using technologically advanced cell biosystems. These include microbial and mammalian systems, as well as transgenic plants and animals. These cell-based protein manufacturing technologies offer certain advantages, but they present a number of challenges as well. The use of microbes for human applications is decades old, but the advent of genetic engineering provided the means to produce recombinant proteins in bacteria and yeast, making them productive bioreactors.
The biopharma operations of Cambrex Corp., East Rutherford, N.J., offers process expertise that includes microbial and yeast cell culture. "The use of microbial cells for protein production is a well-established technology. Some advantages of using microbial cells are: they can be easily scaled up, cost of production is low, yield is high, and they are ideal for the production of low complexity proteins," says Peter Van Hoorn, PhD, the company's executive vice president.
Escherichia coli (bacterial) and Saccharomyces cerevisiae (yeast) make up about 40% of the therapeutic protein production market. "We typically use E. coli, S. cerevesiae, and P. pastoris for production of our proteins," says Van Hoorn. "Each of these systems is amenable to production of different types of proteins." For example, insulin, growth hormones, and growth factors can be easily produced in E. coli.
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