There are a number of differences in regulatory requirements for production facilities for antibiotics and recombinant proteins (Bader, 1992). In both cases, the products must be licensed by the FDA before they can be marketed.
The recombinant protein is produced by a precisely specified process using high quality substrates and processed and purified in an aseptic pharmaceutical facility that has been inspected and licensed by the CBER (Center of Biological Evaluation and Research) of the FDA. Steps must also be taken to ensure that there is no cross contamination if more than one product is produced in the same facility. Any changes in a process or facilities must be approved by the CBER before implementation. It may take 7 years to obtain approval by the CBER for a production plant. In contrast, the requirements for an antibiotic production plant are less stringent and it may be operational in 4 years. The delay in start up to produce the recombinant protein will result in much higher costs.
It is important to remember that the detailed clinical evaluation of a microbial compound as a drug, plus FDA approval, may take 8-10 years from initial discovery and cost up to $150 X 106.
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