Biotechnological production

Vital Safety Evaluation of Biotechnology Products Derived from CeU Liaes of Human or Animal Origin," ICH Harmonized Tripartite Guideline,... 

Biotechnology. Particular attention must be paid to the detection of DNA in all finished biotechnology products because of the possibiUty that such DNA could be incorporated into the human genome and thus become a potential oncogene. The absence of DNA at the picogram-per-dose level should be demonstrated in order to assure the safety of biotechnology products (157). 

Kharazipour, A., Hiitterman, A., Biotechnological production of wood composites. In Bruce, A. and Palfreyman, J.W. (Eds.), Forest Products Biotechnology, Ch. 9. Taylor and Francis, London, 1998, pp. 141-150. 

Category production range single plant examples of biotechnology products... 

S5(R2) Detection of Toxicity to Reproduction for Medicinal Products Toxicity to Male Fertility Biotechnological Products... 

Q4B Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria (RAAPAC) Quality of Biotechnological Products... 

Quality of Biotechnological Products Analysis of the Expression Construct in Cells Used for Production of r-DNA-Derived Protein Products... 

Quality of Biotechnological Products Stability Testing of Biotechnological/Biological Products... 

Steinbuchel, A. and Lutke-Eversloh, T. 2003. Metabolic engineering and pathway construction for biotechnological production of relevant polyhydroxyalkanoates in microorganisms. Biochemical Engineering Journal 16 81-96. 

Lee, P. and Schmidt-Dannert, C., Metabolic engineering towards biotechnological production of carotenoids in microorganisms, Appl. Microbiol. Biotechnol. V60, 1, 2002. 

In this chapter, the discussion will be limited to medicinal products, meant for humans, that contain chemically synthesized active ingredients. Different or additional requirements might apply in the case of radiopharmaceuticals, blood products, biological products, biotechnology products, herbal products, and homoeopathic products. For these more specialized topics, the contents of this chapter may provide some relevant information, but interested readers should seek additional information from the relevant guidelines. 

In this table, it can be recognized that there are problems inherent in these types of formulations from both the patient s and the manufacturer s point of view. This is why most pharmaceutical companies make attempts to avoid these types of dosage forms, if at all possible. However, with the advent of biotechnological products, which often do not lend them, selves to conventional dosage formulations, parenteral and invasive measures may be the only answer. 

Marasco, E. and C. Schmidt-Dannert (2003). Towards the biotechnological production of aroma and flavor compounds in engineered microorganisms. Appl. Biotechnol. Food Sci. Pol. 1(3) 145-157. 

Nevertheless, there are several hurdles to overcome. Biotransformation has to compete with a chemical production process. The production of bio-based bulk chemicals and intermediates from white biotechnology must be economically viabile [67]. This means that the biotechnological product must be cheaper to produce or of higher quality than products based on classical chemical routes. And, incidentally, switching to a novel process takes time and money. Therefore, process solutions are required which are adapted to the special needs of biocatalyzed reactions. Within this chapter, several specific tasks have been addressed, illustrating universal possibilities to overcome the limitations found in bioprocesses. 

Frense, D. (2007) Taxanes perspectives for biotechnological production. Applied Microbiology and Biotechnology, 73, 1233-1240. 

Fluorescent pseudomonads are capable of synthesizing poly(3HAMCL)s from a large number of substrates. Work on the biotechnological production of poly(3HAMCL) has focused mainly on two model systems - Pseudomonas oleo-vorans and P. putida. P. oleovorans is able to use alkanes and alkenes as substrate due to the presence of the OCT-plasmid while P. putida, which does not have this plasmid, cannot. In contrast to P. oleovorans, however, P. putida can use carbohydrates such as glucose and fructose for the production of poly(3HAMCL). 

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