Response Surface Methodology in Biotechnology

ABSTRACT Many experiments in biotechnology exploit the principles and methods of response surface methodology (RSM). The Quality by Design initiative in pharmaceutical development will accelerate this trend. In this article we give a broad picture of the important role played by RSM in biotechnology experimentation. We give brief descriptions of a collection of studies using RSM from recent issues of biotechnology journals, present some of the issues in the design and analysis of experiments for cell media, and look in detail at one of the experiments.

[1]  Xuehong Zhang,et al.  Medium factor optimization and fermentation kinetics for phenazine‐1‐carboxylic acid production by Pseudomonas sp. M18G , 2008, Biotechnology and bioengineering.

[2]  John J. Peterson,et al.  A Bayesian Approach to the ICH Q8 Definition of Design Space , 2008, Journal of biopharmaceutical statistics.

[3]  S. Lewis,et al.  Detection of interactions in experiments on large numbers of factors , 2001 .

[4]  Carl-Fredrik Mandenius,et al.  Evaluation and optimization of hepatocyte culture media factors by design of experiments (DoE) methodology , 2008, Cytotechnology.

[5]  John J. Peterson.  A Posterior Predictive Approach to Multiple Response Surface Optimization , 2004 .

[6]  G. Box,et al.  Some New Three Level Designs for the Study of Quantitative Variables , 1960 .

[7]  A. Moreira,et al.  Application of Plackett‐Burman design and response surface methodology to achieve exponential growth for aggregated shipworm bacterium , 2004, Biotechnology and bioengineering.

[8]  Hasan Rafati,et al.  Quality by design: optimization of a liquid filled pH-responsive macroparticles using Draper-Lin composite design. , 2009, Journal of pharmaceutical sciences.

[9]  Qiu Jia,et al.  International harmonization and enligtenment of the Common Technical Document under the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use , 2005 .

[10]  J. S. Hunter,et al.  MULTIFACTOR EXPERIMENTAL DESIGN FOR EXPLORING THE RESPONSE SURFACES , 1957 .

[11]  Aili Cheng,et al.  Finding Design Space and a Reliable Operating Region Using a Multivariate Bayesian Approach with Experimental Design , 2009 .

[12]  George E. P. Box,et al.  Simplex-Sum Designs: A Class of Second Order Rotatable Designs Derivable From Those of First Order , 1960 .

[13]  G. Box,et al.  On the Experimental Attainment of Optimum Conditions , 1951 .

[14]  G. Box.  The Exploration and Exploitation of Response Surfaces: Some General Considerations and Examples , 1954 .

[15]  Yekta Göksungur,et al.  Optimization of b-galactosidase production using Kluyveromyces lactis NRRL Y-8279 by response surface methodology , 2008 .

[16]  Flávia Pereira Duta,et al.  Optimization of culture conditions for exopolysaccharides production in Rhizobium sp. using the response surface method , 2006 .

[17]  J. S. Hunter,et al.  Multi-Factor Experimental Designs for Exploring Response Surfaces , 1957 .

[18]  John J. Peterson,et al.  A Bayesian Reliability Approach to Multiple Response Optimization with Seemingly Unrelated Regression Models , 2009 .

[19]  G. Box,et al.  The Exploration and Exploitation of Response Surfaces: An Example of the Link between the Fitted Surface and the Basic Mechanism of the System , 1955 .

[20]  Hélia Harumi Sato,et al.  Optimization of medium composition for transglutaminase production by a Brazilian soil Streptomyces sp. , 2007 .

[21]  Ron S. Kenett,et al.  Quality by Design applications in biosimilar pharmaceutical products , 2008 .

[22]  Leonard A. Smith,et al.  Developement of serum-free media in CHO-DG44 cells using a central composite statistical design , 2007, Cytotechnology.

[23]  Fernando Acevedo,et al.  Optimisation of the solids suspension conditions in a continuous stirred tank reactor for the biooxidation of refractory gold concentrates , 2003 .

[24]  Ana M Azevedo,et al.  Optimisation of aqueous two-phase extraction of human antibodies. , 2007, Journal of biotechnology.

[25]  George E. P. Box,et al.  Improving Almost Anything: Ideas and Essays , 2006 .

[26]  Sila Bhattacharya,et al.  Culture media optimization for growth and phycoerythrin production from Porphyridium purpureum , 2007, Biotechnology and bioengineering.

[27]  Attilio Converti,et al.  Influence of pH, temperature, and urea molar flowrate on Arthrospira platensis fed‐batch cultivation: A kinetic and thermodynamic approach , 2007, Biotechnology and bioengineering.

[28]  G. Box,et al.  A Basis for the Selection of a Response Surface Design , 1959 .

[29]  M. Khan,et al.  Quality by design: understanding the formulation variables of a cyclosporine A self-nanoemulsified drug delivery systems by Box-Behnken design and desirability function. , 2007, International journal of pharmaceutics.

[30]  David Brunson,et al.  A Critical Assessment of Two-Stage Group Screening Through Industrial Experimentation , 2008, Technometrics.