Industries, commercialization biopharmaceuticals

Figure 5.8 Typical industrial-scale fermentation equipment as employed in the biopharmaceutical sector (a). Control of the fermentation process is highly automated, with all fermentation parameters being adjusted by computer (b). Photographs (a) and (b) courtesy of SmithKline Beecham Biological Services, s.a., Belgium. Photograph (c) illustrates the inoculation of a laboratory-scale fermenter with recombinant microorganisms used in the production of a commercial interferon preparation. Photograph (c) courtesy of Pall Life Sciences, Dublin, Ireland...

Table 5.10 Various products (non-biopharmaceutical) of commercial significance manufactured industrially using microbial fermentation systems...

Since the commercial introduction of the P-CAC in 1999, several industrial applications have been shown to be transferable to the system. Moreover, users in the biopharmaceutical and foodstuff industry have seen their productivity increasing dramatically as a result of using the P-CAC technology. Furthermore, a P-CAC has been shown capable of continuously separating stereoisomers when using chiral stationary phases even when there is more than one chiral center in the desired molecule. Below some of the applications are described in more details. Others are proprietary and hence cannot be disclosed. 

Industries Involved in Commercialization of Biopharmaceuticals from Plants ... 

The world s population continues to grow and the average life expectancy continues to increase. Pharmaceutical and biopharmaceutical products are more in demand as the population expands, requiring novel and specialized medications to treat common and debilitating diseases. The industry is challenged to rapidly discover and commercialize products to treat existing unmet medical needs and emerging threats as viruses mutate into new diseases that threaten the stability of the world as we know it. 

The analytical capability of MS has been evolving at an astounding rate as Nobel laureates and developers push what is an inherently powerful analytical technique to even higher levels of capability. During the last decade, numerous ionization and analyzer configurations have been commercialized. Some of the most recent developments have made MS the gold standard for many pharmaceutical analyses, and has made the biopharmaceutical industry the major purchaser of mass spectrometers (Cudiamat, 2005). 

Specialized research groups. To develop a drug from conception to commercialization, the biotechnology/biopharmaceutical industry (which has been highly entrepreneurial) has reached out and established global strategic partnerships with numerous companies. 

Since the first product, the recombinant kallilcrein inhibitor ecallantide (KALBITOR , Dyax, USA), was approved by the FDA in 2009, several more followed, mainly being peptides and small proteins. Antibodies and fragments thereof are currently in clinical trials awaiting approval [154]. Several more biopharmaceutical products such as insulin, interferon-alpha 2b, and hepatitis B vaccine are on the market in India and other Asian countries [155]. Apart from biopharmaceuticals, a range of industrial enzymes, among them phytase, nitrate reductase, or lipase, are commercially available. Direct information on the production process is mostly not available, but it can be concluded from journal and patent literature that mostly the AOXl promoter is used in these cases, and other expression systems like the GAP promoter are applied as well. In total, approximately 70 products are on the market, and a list can be found at http // www.pichia.com/science-center/commercialized-products/ [156]. 

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