Use for biotechnological production

The Centralized Procedure must be used for biotechnology products and can be used for so-called high technology products as well as for new active pharmaceutical ingredients (i.e., products that have never before been approved for marketing). The Centralized Procedure is laid down in Council Regulation (EEC) N° 2309/93[ l and Directive 93/41/EEC.t ... 

For synthetic drug substances, purification is most often accomplished through crystallization. Preparative chromatography is currently more widely used for biotechnology-derived products than for synthetic drug substances... 

As described in Section 4.2, traditional biotech processes—namely, biocatalysis and microbial fermentation—are used for the production of small molecules, whereas the modern cell culture methodology allows the production of HMW biopharmaceuticals. A growth rate of 10-15% per annum is expected for the biotechnological contribution, while the average increase of the pharmaceutical market remains below 10%. In terms of technologies, the demanding mammalian cell cultures are expected to grow fastest, followed by microbial fermentation. 

In 1996, about 10 years after the introduction of the first recombinant DNA product for human use, the FDA modified and streamlined the approval process for biotechnology products considered to be well characterized. These modifications, in essence, established the direction of how biologic macromolecules are researched and developed today in biotechnology-based and traditional pharmaceutical companies [2]. Well-characterized biotechnology products include (1) synthetic peptides consisting of fewer than 20 amino acids, (2) monoclonal antibodies and derivatives, and (3) recombinant DNA-derived products. Anticipating future developments, the FDA is also prepared to consider DNA plasmid products as well-characterized when the first medicinal in this class is submitted for approval. CBER now approves well-characterized biopharmaceuticals under the BLA process [3]. 

Commonly Used Analytical Techniques for Biotechnology Products... 

Because animals do not synthesize either the aromatic or branched-chain amino acids, these materials can be applied to kill unwanted vegetation without causing harm to domestic animals or humans. Certain derivatives can often be selectively applied to combat noxious plants without appreciable harm to crops. More promising, however, is the prospect of using biotechnology to incorporate genes for enzymes specifically resistant to one of the herbicides into seeds used for crop production. 

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