High throughput process development in biomanufacturing

A brief overview of the high throughput process development field as related to biopharmaceutical manufacturing is provided. The overview outlines available high-throughput techniques used during process development of upstream and downstream unit operations that might become a part of a bio-manufacturing process. Although the main focus of this review relates to process development, a short summary of the analytical challenges and available solutions associated with high throughput experimentation, and on data analysis are also offered. Examples of published studies utilizing high throughput methods are given and their significances highlighted. Finally, the review ends with a paragraph focusing on current gaps and future trends in the high throughput process development field as applied in areas related to bio-manufacturing.

[1]  Malin Eriksson,et al.  A tool for increasing the lifetime of chromatography resins , 2011, mAbs.

[2]  Lisa Connell-Crowley,et al.  Using high throughput screening to define virus clearance by chromatography resins , 2013, Biotechnology and bioengineering.

[3]  Kaushal Kumar,et al.  High-throughput process development for biopharmaceutical drug substances. , 2011, Trends in biotechnology.

[4]  Yu Isakari,et al.  High‐throughput process development methods for chromatography and precipitation of proteins: Advantages and precautions , 2013 .

[5]  Krist V Gernaey,et al.  Application of microbioreactors in fermentation process development: a review , 2009, Analytical and bioanalytical chemistry.

[6]  N. Sanaie,et al.  Applying high-throughput methods to develop a purification process for a highly glycosylated protein. , 2012, Biotechnology journal.

[7]  B. Kelley,et al.  High-throughput screening of chromatographic separations: I. Method development and column modeling. , 2008, Biotechnology and bioengineering.

[8]  John P Welsh,et al.  A practical strategy for using miniature chromatography columns in a standardized high‐throughput workflow for purification development of monoclonal antibodies , 2014, Biotechnology progress.

[9]  Christopher Miller,et al.  High‐throughput miniaturized bioreactors for cell culture process development: Reproducibility, scalability, and control , 2014, Biotechnology progress.

[10]  Jürgen Hubbuch,et al.  High‐throughput methods for miniaturization and automation of monoclonal antibody purification processes , 2012, Biotechnology progress.

[11]  Zhong Liu,et al.  Fluorinert, an oxygen carrier, improves cell culture performance in deep square 96‐well plates by facilitating oxygen transfer , 2012, Biotechnology progress.

[12]  Jürgen Hubbuch,et al.  Editorial: High‐throughput process development , 2012 .

[13]  Nigel Titchener-Hooker,et al.  Quantitative high throughput analytics to support polysaccharide production process development. , 2014, Vaccine.

[14]  Guillaume Rey,et al.  Full automation and validation of a flexible ELISA platform for host cell protein and protein A impurity detection in biopharmaceuticals. , 2012, Journal of pharmaceutical and biomedical analysis.

[15]  Alain Van Dorsselaer,et al.  Characterization of therapeutic antibodies and related products. , 2013, Analytical chemistry.

[16]  John M. Woodley,et al.  Fluid mixing in shaken bioreactors: Implications for scale-up predictions from microlitre-scale microbial and mammalian cell cultures , 2006 .

[17]  J. Hubbuch,et al.  Development and characterization of an automated high throughput screening method for optimization of protein refolding processes. , 2012, Journal of separation science.

[18]  Jon Coffman,et al.  High‐throughput screening of chromatographic separations: IV. Ion‐exchange , 2008, Biotechnology and bioengineering.

[19]  Martina Micheletti,et al.  A generic hierarchical screening method for the analysis of microscale refolds using an automated robotic platform , 2012, Biotechnology progress.

[20]  Jürgen Hubbuch,et al.  High throughput screening based selection of phases for aqueous two-phase system-centrifugal partitioning chromatography of monoclonal antibodies. , 2012, Journal of chromatography. A.

[21]  Ranga Godavarti,et al.  Weak partitioning chromatography for anion exchange purification of monoclonal antibodies , 2008, Biotechnology and bioengineering.

[22]  J. Hubbuch,et al.  Optimization of random PEGylation reactions by means of high throughput screening , 2014, Biotechnology and bioengineering.

[23]  Steven M Cramer,et al.  High‐throughput screening for the development of a monoclonal antibody affinity precipitation step using ELP‐z stimuli responsive biopolymers , 2013, Biotechnology and bioengineering.

[24]  J. Persson,et al.  Effects of resin ligand density on yield and impurity clearance in preparative cation exchange chromatography. II. Process characterization. , 2012, Journal of chromatography. A.

[25]  Tryggve Bergander,et al.  High‐Throughput Process Development: Determination of Dynamic Binding Capacity Using Microtiter Filter Plates Filled with Chromatography Resin , 2008, Biotechnology progress.

[26]  G. Carta.  Predicting protein dynamic binding capacity from batch adsorption tests. , 2012, Biotechnology journal.

[27]  Marcel Ottens,et al.  Model-based high-throughput process development for chromatographic whey proteins separation. , 2012, Biotechnology journal.

[28]  Sunil Chhatre,et al.  Strategic assay deployment as a method for countering analytical bottlenecks in high throughput process development: Case studies in ion exchange chromatography , 2012, Biotechnology progress.

[29]  Rachel Bareither,et al.  Automated disposable small scale reactor for high throughput bioprocess development: A proof of concept study , 2013, Biotechnology and bioengineering.

[30]  Sunil Chhatre,et al.  Strategic Assay Selection for analytics in high-throughput process development: case studies for downstream processing of monoclonal antibodies. , 2012, Biotechnology journal.

[31]  Sigrid K Hansen,et al.  Meeting report: High-throughput process development--HTPD 2012: June 4-7, 2012, Avignon, France. , 2012, Biotechnology journal.

[32]  A. Rathore,et al.  Chromatography process development in the quality by design paradigm I: Establishing a high‐throughput process development platform as a tool for estimating “characterization space” for an ion exchange chromatography step , 2013, Biotechnology progress.

[33]  Daniel G Bracewell,et al.  An automated microscale chromatographic purification of virus‐like particles as a strategy for process development , 2007, Biotechnology and applied biochemistry.

[34]  J. Hubbuch,et al.  A sub-two minutes method for monoclonal antibody-aggregate quantification using parallel interlaced size exclusion high performance liquid chromatography. , 2011, Journal of chromatography. A.

[35]  Nicolas Szita,et al.  Oxygen Transfer Characteristics of Miniaturized Bioreactor Systems , 2013, Biotechnology and bioengineering.

[36]  Kaushal Rege,et al.  High‐throughput process development for recombinant protein purification , 2006, Biotechnology and bioengineering.

[37]  Jürgen Hubbuch,et al.  High Throughput Screening for the Design and Optimization of Chromatographic Processes: Automated Optimization of Chromatographic Phase Systems , 2009 .

[38]  Alois Jungbauer,et al.  Harnessing Candida tenuis and Pichia stipitis in whole‐cell bioreductions of o‐chloroacetophenone: Stereoselectivity, cell activity, in situ substrate supply and product removal , 2013, Biotechnology journal.

[39]  Karol M Łącki,et al.  High-throughput process development of chromatography steps: advantages and limitations of different formats used. , 2012, Biotechnology journal.

[40]  Rachel Legmann,et al.  A predictive high‐throughput scale‐down model of monoclonal antibody production in CHO cells , 2009, Biotechnology and bioengineering.

[41]  Marco Oldiges,et al.  An automated workflow for enhancing microbial bioprocess optimization on a novel microbioreactor platform , 2012, Microbial Cell Factories.

[42]  Jürgen Hubbuch,et al.  Examination of a genetic algorithm for the application in high-throughput downstream process development. , 2012, Biotechnology journal.

[43]  Marcel Ottens,et al.  Purifying biopharmaceuticals: knowledge-based chromatographic process development. , 2014, Trends in biotechnology.

[44]  Brian D. Kelley,et al.  High‐throughput screening of chromatographic separations: II. Hydrophobic interaction , 2008, Biotechnology and bioengineering.

[45]  Ashraf Amanullah,et al.  Novel micro‐bioreactor high throughput technology for cell culture process development: Reproducibility and scalability assessment of fed‐batch CHO cultures , 2010, Biotechnology and bioengineering.

[46]  Günter Jagschies.  Bright Future Outlook and Huge Challenges to Overcome: An Attempt to Write the Short Story of the Biopharma Industry with Current Status, Selected Issues, and Potential Solutions in Discovery, R&D, and Manufacturing , 2013 .

[47]  Anurag S. Rathore,et al.  High throughput process development (HTPD) platform for membrane chromatography , 2013 .

[48]  Kristala L J Prather,et al.  Fed‐batch microbioreactor platform for scale down and analysis of a plasmid DNA production process , 2012, Biotechnology and bioengineering.

[49]  Jürgen Hubbuch,et al.  High-throughput screening-based selection and scale-up of aqueous two-phase systems for pDNA purification. , 2012, Journal of separation science.

[50]  Harry L. T. Lee,et al.  Microbioreactor arrays with integrated mixers and fluid injectors for high-throughput experimentation with pH and dissolved oxygen control. , 2006, Lab on a chip.

[51]  David Pollard,et al.  A review of advanced small‐scale parallel bioreactor technology for accelerated process development: Current state and future need , 2011, Biotechnology progress.