Analytical Development and Testing

1997 ◽  
pp. 147-185
Author(s):  
R Cummings ◽  
Alfred Childers
1988 ◽  
Author(s):  
Alexander H. Levis ◽  
Jeff T. Casey ◽  
Anne-Claire Louvet

Author(s):  
Matthew J. Smith ◽  
Carl S. Byington ◽  
Matthew J. Watson ◽  
Sudarshan Bharadwaj ◽  
Genna Swerdon ◽  
...  

AIAA Journal ◽  
10.2514/2.511 ◽  
1998 ◽  
Vol 36 (7) ◽  
pp. 1279-1285 ◽  
Author(s):  
Hiroshi Suemasu ◽  
Tatsuya Kumagai ◽  
Katsuhisa Gozu

1998 ◽  
Vol 20 (3) ◽  
pp. 87-89
Author(s):  
Stephen Scypinski ◽  
John Baiano ◽  
Theodore Sadlowski

Projects that require analytical support can evolve from a number of different situations, for example new molecular entities from drug discovery; process changes; packaging changes; site changes; line extensions; and inlicensed projects and compounds. Laboratory automation has been shown to provide a viable and practical solution to assisting in analytical development. However, it is not always the most logical answer. A truly flexible and responsive analytical unit will make a decision on a case-by-case basis, when faced with a new project, whether it is best to: automate some or all aspects/testing involved; contract out to a reputable and approved contract research organization (CRO); hire temporary help; use available in-house resources; use a combination of the options shown above (for example to evaluate the complexity of the new project versus what the in-house resources are currently working on). The paper discusses the advantages and disadvantages of the various options with respect to providing analytical support and suggests optionsfor the most effective use of resources. The role of automation as one of the important tools in the arsenal of these options is highlighted.


Author(s):  
Roger G. Harrison ◽  
Paul W. Todd ◽  
Scott R. Rudge ◽  
Demetri P. Petrides

The development of efficient and reliable processes for bioseparations is dependent on the availability of suitable analytical methods. This means it is important that work on analytical methodology for the bioproduct of interest starts at the very beginning of process development. Analytical studies are important throughout the development and scale up of the process, as changes can occur either to the product or to its associated impurities from what may be thought of as minor changes in the process. This chapter gives access to the vocabulary and techniques used in quality control and analytical development activities, starting with a description of specifications typically set for a pharmaceutical and the rationale behind them. Then, before discussing the assays themselves, we describe assay attributes, which can be measured and used to help not only the assay developer but also the biochemist and engineer responsible for developing downstream processes determine the usefulness and meaning of the assay. Finally, we turn to assays that are commonly applied in biotechnology, as they apply to biological activity, identity, and purity. These assays are the ultimate yardsticks by which the process is measured. Purification methods are developed for their ability to remove a contaminant from the product of interest, whether it is a related molecule, a contaminant related to a host organism, such as DNA or endotoxin, or a process contaminant, such as a residual solvent or water. Critical to understanding process performance is an understanding of how the assays that measure these contaminants have been developed, what the assay strengths and limitations are, and what they indicate and why. Electrophoresis and magnetic separation are two methods that are now used for the bench scale preparative purification of bioproducts, including living cells. The electrophoresis systems with the highest capacity are free-flow electrophoresis, density gradient electrophoresis, recycling free-flow isoelectric focusing, and rotating isoelectric focusing, and the principles of operation of these are discussed. The physical principles of magnetic separations are presented, as well as magnetic reagents and applications of magnetic separators.


2009 ◽  
Vol 6 (4) ◽  
pp. 240-249 ◽  
Author(s):  
Ala'aldeen T. Al-Halhouli

This work surveys recent advances of experimental and analytical development progress of the on-disk viscous micro-pumps: spiral channel, single disk, and double disk micropumps. These micropumps have attractive advantages for handling particle-laden fluids which make them key components in laboratory-on-a-chip applications. This study builds upon existing reviews and reports on the on-disk viscous micropump concept and analytical and experimental tests. It also presents a general analytical solution that estimates for the combined effect of operational and geometrical design parameters on the flow performance of on-disk viscous micropumps. This model enables microfluidic systems designers and developers to predict flow rates and pressures according to certain geometrical or operational conditions. Quantitative comparison and verifications are provided in tabular and graphical forms.


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