Biotechnological methods, evaluation

Trucksess MW and Pohland AE (2000) Methods and method evaluation for mycotoxins. Molecular Biotechnology 22 287-292. 

Another biotechnological method was evaluated for the production of sorbitol cell immobilization. The advantage of this technology is to ensure the long-term activity of... 

G.S. Sayler and G. Stacey. 1986. Methods for Evaluation of Microorganism Properties. In Biotechnology Risk Assessment (J.R. Fiksel and V.T. Covello eds.) Pergamon Press, N.Y. 

Before a biotechnology process can be validated, it is essential to evaluate the inherent risk factors associated with the product source, raw materials, and processing operations. Furthermore, the analytical methods that allow characterization and validation of the process, as well as characterization of raw materi-... 

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... 

Fenn JB, Mann M, Meng CK Electrospray ionization for mass spectrometry of large biomolecules. Science (1989) 246 64-71. Patrick JS, Lagu AL Review applications of capillary electrophoresis to the analysis of biotechnology-derived therapeutic proteins. Electrophoresis (2001) 22 4179-4196. Sowell J, Salon J, Strekowski L, et al Covalent and noncovalent labeling schemes for near-infrared dyes in capillary electrophoresis protein applications. Methods Mol. Biol. (2004) 276 39-75. Moini M Capillary electrophoresis mass spectrometry and its application to the analysis ofbiological mixtures. Anal. Bio-anal. Chem. (2002) 373 466 180. Nemunaitis J, Holmlund JT, Kraynak M, et al. Phase I evaluation of ISIS 3521, an antisense oligodeoxynucleotide to protein kinase C-a, in patients with advanced cancer./. Clin. Oncol. (1999) 17 3586-3595. De Frutos M, Cifuentes A, Diez-Masa JC Differences in capillary electrophoresis profiles of urinary and recombinant erythropoietin. Electrophoresis (2003) 24 678-680. 

In the early days of biotechnology product development, the focus was on quality issues [4] or process-related impurities.The concerns at that time were for carryover of other cellular proteins and DNA and for contamination with endotoxins, chemicals, and viruses. Of course, these concerns still exist, but methods for purification and assays for evaluation of clearance have alleviated the need for the safety assessment scientist to focus on contaminants instead they are now asked to focus on the pharmacological activity of the molecules. An ICH guidance (Q6B Specifications Test Procedures and Acceptance Criteria for Biotechnological/Biological Products) addresses the specific issues related to the manufacturing process [6], Other product-related issues such as impurities do need to be considered by the safety assessment scientist, for... 

Although traditional medicines continue to be discovered and developed, the fields of biotechnology and gene therapy continue to advance. In addition, new methods to collect and evaluate clinical data on a real-time basis will help to speed the development process. 

During the method development in paper II we desired to perform quantification of both the fermentation product and the substrate. Both the external and the internal standard method were evaluated, respectively. The internal standard method was chosen since it resulted in a higher precision. Initially, structurally related compounds were tested as I S. in the quantitative part described in paper II, according to the above I.S.-protocol for bioana-lytical approaches. However for biotechnological analysis no recommendations exist for the selection of internal standard. Thus in paper II an investigation was performed to see if the I.S.-protocol for bioanalytical methods could be applied also for biotechnological analysis. 

Smith, P.L. (1996) Methods for evaluating intestinal permeability and metabolism in vitro. Pharmceutical Biotechnology, 8, 13-34. 

Assessment of a patient s immune function requires consideration of multiple components, including mechanical defenses, cell phenotypes and cell numbers, and soluble components. Recent developments in biotechnology made possible extraordinary progress in the characterization of immune function. Despite the technological advances, careful patient evaluations are required to assess the structure and function of the immune system accurately. Specific methods for assessment of patient immune status are discussed below. 

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