Cell characterization, biotechnology

Hoffman, L. and Carpenter, M. 2005. Characterization and culture of human embryonic stem cells. Nature Biotechnology 23(6), 699-708. 

D. Serp, E. Cantana, C. Heinzen, U. Von Stockar, and I. W. Marison. Characterization of an encapsulation device for the production of monodisperse alginate beads for cell immobilization. Biotechnology and Bioengineering, 70(l) 41-53, 2000. 

Tarui, H., Murata, M., Tani, I. et al. (2001) Establishment and characterization of cell-free translation/ glycosylation in insect cell (Spodopterafrugiperda 21) extract prepared with high pressure treatment. Applied Microbiology and Biotechnology, 55 (4), 446 453. 

TOF-SIMS has been employed for the characterization of a wide range of materials, including metallic, salt, organometallic, organic, and polymeric substances, as well as for electronics, catalysts, and forensic samples. The ability to image molecular ions with submicrometer spatial resolution makes TOF-SIMS well suited to analysis of pharmaceuticals and biological cells, as well as for use in biotechnology and molecular electronics. 

Biotechnological/Biological Products Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products Notice Draft Guidance on Specifications Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products Chemical Substances Notice... 

International Conference on Harmonization. Derivation and characterization of cell substrates used for production of biotechnological/biological products, in Harmonized Tripartite Guideline, ICH, 2001. 

Martins dos Santos, V. A. R, Vasilevska, T., Kajuk, B., Trampeg J., Wijffels, R. H. (1997) Production and characterization of double-layer beads for coimmobilization of microbial cells. Biotechnology Annu. Rev., 3, 227-44. 

ICH Q5D. Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products. (1997). 

The range of the (molecular) size of the analytes usually exceeds that which can be determined by classical laboratory analytical methods such as size exclusion chromatography, etc. [351]. Reports on investigated substances are widespread and cover applications such as the separation and characterization of proteins [450] and enzymes [240, 241], of viruses [132], the separation of human and animal cells [50, 51], the isolation of plasmid DNA [367], and the molecular weight and particle size distribution of polymers [216,217]. The approach is relatively new in biotechnology therefore, practical experiences are not yet abundant. Langwost et al. [229] have provided a comprehensive survey of various applications in bio-monitoring. 

Reardon KF, Scheper T (1991) Determination of cell concentration and characterization of cells. In Schiigerl K (ed) Biotechnology 2nd edn, vol 4. Measuring, Modelling and Control. VCH, Weinheim, pp 179... 

The ICH expectations are that acceptance criteria or limits of acceptability will be established prior to final product characterization, regardless of the host cell system. More important, with respect to system, the final product should be compared to appropriate reference standards (if available), and ideally, with the naturally occurring protein. Products should be thoroughly characterized with respect to five distinct criteria (ICH Guideline, Specification Test Procedures and Acceptance Criteria for Biotechnological/Biological Products [15]) ... 

---