Biotechnology definition

The above definition of classical biotechnological processes can easily be adapted to the concept of molecular farming. With plant cell fermentation the analogy is ob-... 

Unfortunately, even the planning of green biotechnology has now evolved into a wicked problem with complex structures and no obvious causal chains. This applies also to the PA. These problems cannot be determined completely in a quantitative and scientific manner, and there are no existing solutions in the sense of definitive and objective answers alone. Wicked problems have been addressed mainly through formalized (linear) methods that are suitable only for the solution of tame problems. 

Summing up, a robust and easy to handle SMB-design uses 4 zones, a recycling pump fixed in respect to the columns and two pumps for the control of the outlet flow rates. Extremely high precision of all technical components of the SMB is needed. All pumps and valves have to be exactly synchronized. The flow rates should not vary by more thanl % from the preset value. All connections between the different parts of the system must be carefully optimized in order to minimize the dead volume. All columns should be stable and nearly identical in performance. If the SMB-technology is to be used in Biotechnology, GMP issues (cleaning, process and software validation) also have to be considered. In addition and as with any continuous process in that particular area, the definition of a batch could be a problem. 

One of the most actively investigated aspects of the biohydrolysis of carboxylic acid esters is enantioselectivity (for a definition of the various stereochemical terms used here, see [7], particularly its Sect. 1.5) for two reasons, one practical (preparation of pure enantiomers for various applications) and one fundamental (investigations on the structure and function of hydrolases). The synthetic and preparative aspects of enantioselective biocatalysis by hydrolases have been extensively investigated for biotechnology applications but are of only secondary interest in our context (e.g., [16-18], see Sect. 7.3.5). In contrast, the fundamental aspects of enantioselectivity in particular and of structure-metabolism relationships in general are central to our approach and are illustrated here with a number of selected examples. 

As a result of the pharmacopoeial harmonization process, general chapter 2.2.47. of the Ph.Eur. and general chapter 8 of the JP (Capillary Electrophoresis) and general chapter < 1047) of the USP (Biotechnology-Derived Articles — Tests, Capillary Electrophoresis ) have been harmonized to a major extent. At present some minor differences exist between the text and a few equations in the pharmacopoeia. In these chapters, the following definition of CE is given ... 

While it might be assumed that biologic refers to any pharmaceutical product produced by biotechnological endeavour, its definition is more limited. In pharmaceutical circles, biologic ... 

As used herein, biotechnology medicines or products of pharmaceutical biotechnology are afforded a much broader definition. Unlike the term biopharmaceutical , the term... 

Table 1.3. A summary of the definition of the terms biologic , biopharmaceuticaf and biotechnology medicine as used throughout this book. Reprinted from European Journal of Pharmaceutical Sciences, vol 15, Walsh, Biopharmaceuticals and Biotechnology, p 135-138, 2002, with permission from Elsevier Science...

In 1992 Mel Klegerman and I edited a text book called Pharmaceutical Biotechnology Fundamentals and Essentials (Interpharm Press, Buffalo Grove, IL). We intended this book to encapsulate as much as possible the area identified as pharmaceutical biotechnology and in the introductory chapter, we tried to provide a suitable definition of the term at that time. 

The current methods available for testing food derived from modern biotechnology, e. g. for the content of genetically modified food, provide results in internal, not easily convertible units. This makes compliance with legal limits, which are usually given as mass fractions, difficult or even impossible. In order to improve this unsatisfactory situation, a definition of the measurands and standardization of all details of the evaluation procedure is proposed. Such measures... 

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