Case study and application of process analytical technology (PAT) towards bioprocessing: Use of on‐line high‐performance liquid chromatography (HPLC) for making real‐time pooling decisions for process chromatography

Rathore, Anurag S.; Yu, Marcella; Yeboah, Samuel O.; Sharma, Ashutosh

doi:10.1002/bit.21759

Cited by 111 publications

(83 citation statements)

References 15 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…An example for a PAT-tool for glucose measurement is a continuous flow injection analysis based on chemiluminescence [Huang et al, 1991]. In-line methods to determine the concentration of glucose, glutamate, prolin, lactic acid, ammonia, and dissolved carbon dioxide are photometric infrared (IR) and near-infrared (NIR) spectroscopy which both conform to PAT requirements [Rathore et al, 2008]. Infrared spectroscopy suffers significantly from possible interference of background compounds [Boudreau andBenton, 2008, Vojinovic, et al, 2006].…”

Section: Substrate and Metabolite Concentrationmentioning

confidence: 99%

“…Product (protein) concentration is commonly measured by HPLC, which conforms to PAT requirements [Rathore, et al, 2008] or ELISA [Li, et al, 2006]. Raman spectroscopy can be used inline to monitor the homogenization process of an active pharmaceutical ingredient (API) according to Beer et al, 2006.…”

Section: Protein Concentrationmentioning

confidence: 99%

“…Here the method also helped to understand the production process better [De Beer et al, 2006]. Several applications of Raman spectroscopy are reported as a PAT tool for process optimization, understanding, monitoring, and control [Rathore, et al, 2008].…”

Section: Protein Concentrationmentioning

confidence: 99%

“…The Process Analytical Technology (PAT) initiative was introduced by the FDA in 2004 and has been supported by the EMA, the Japanese Ministry of Health, Labor and Welfare (MHLW), and by the International Conference on Harmonization (ICH) guidelines [Rathore et al, 2008]. With this initiative, increased requirements for bioprocess monitoring were implemented to improve the understanding and control of biology-based manufacturing processes [Clementschitsch and Bayer, 2006].…”

Section: Process Analytical Technologymentioning

confidence: 99%

“…A better process understanding, improved yields, and minimization of waste, rejects and reprocessing will result in overall cost reduction and on-time release of batches [Rathore et al, 2008]. The FDA suggests key PAT technologies: near infra-red spectroscopy (NIR), UV-VIS, NMR, MS, HPLC, fluorescence measurements, and imaging technology [Boudreau and Benton, 2008, FDA, 2004, Kourti, 2006, Rathore et al, 2008 promoting process understanding and process control for improved consistency of process performance and product consistency [Rathore et al, 2008]. Recent reviews on trends in PAT and PAT in biopharmaceutical processes are available [Chew andSharratt, 2010, Rathore et al, 2008].…”

Section: Process Analytical Technologymentioning

confidence: 99%

See 4 more Smart Citations

Process control in cell culture technology using dielectric spectroscopy

Justice¹,

Brix

Freimark³

et al. 2011

Biotechnology Advances

106

View full text Add to dashboard Cite

Section: Substrate and Metabolite Concentrationmentioning

confidence: 99%

Section: Protein Concentrationmentioning

confidence: 99%

Section: Protein Concentrationmentioning

confidence: 99%

Section: Process Analytical Technologymentioning

confidence: 99%

Section: Process Analytical Technologymentioning

confidence: 99%

See 3 more Smart Citations

Process control in cell culture technology using dielectric spectroscopy

Justice¹,

Brix

Freimark³

et al. 2011

Biotechnology Advances

106

View full text Add to dashboard Cite

Process Systems Engineering, 9. Domain Engineering

Economou¹,

Pistikopoulos

Liu

et al. 2012

Ullmann's Encyclopedia of Industrial Chemistry

View full text Add to dashboard Cite

The article contains sections titled: 1. Molecular Modeling and Simulation for Chemical Product and Process Design 1.1. Introduction 1.2. Elementary Statistical Mechanics 1.3. Major Molecular Simulation Methods 1.3.1. Molecular Dynamics (MD) 1.3.2. Metropolis Monte Carlo Simulation 1.4. Applications 1.4.1. Pharmaceuticals 1.4.2. Polymer Membranes for Gas Separation 1.4.3. Ionic Liquids for Sustainable Chemical Processes 1.5. Conclusions 2. Energy Systems Engineering 2.1. Introduction 2.2. Methods/Tools/Algorithm 2.2.1. Superstructure‐Based Modeling 2.2.2. Mixed‐Integer Programming (MIP) 2.2.3. Multiobjective Optimization 2.2.4. Optimization under Uncertainty 2.2.5. Life‐Cycle Assessment 2.3. Energy Systems Examples 2.3.1. Example 1–Polygeneration Energy Systems 2.3.2. Example 2–Hydrogen Infrastructure Planning 2.3.3. Example 3–Energy Systems in Commercial Buildings 2.4. Conclusions and Future Directions 3. Pharmaceutical Processes 3.1. Introduction 3.2. Pharmaceutical Process Development and Operation 3.2.1. Crystallization 3.2.2. Chromatography 3.3. Conclusion 4. Biochemical Engineering 4.1. Introduction 4.2. Industrial Biotechnology Processes 4.2.1. Fermentation Processes 4.2.2. Microbial Catalysis 4.2.3. Enzyme Processes 4.3. Modeling of Bioprocesses 4.3.1. Modeling of Bioprocesses–Mechanistic Models 4.3.2. Modeling of Bioprocesses–Data‐Driven Models 4.4. The Role of Process Systems Engineering 4.4.1. Evaluation of Process Options 4.4.2. Evaluation of Platform Chemicals 4.4.3. Process Integration 4.4.4. Biorefinery Design 4.4.5. Biocatalyst Design 4.5. Assessing the Sustainability of Bioprocesses 4.5.1. Life‐Cycle Inventory and Assessment 4.6. Future Outlook and Perspectives 5. Policies and Policy Making 5.1. Introduction 5.2. Policies and Policy Measures 5.3. Policy Making and the Systems Approach 5.4. Similarities between Policy Formulation and Conceptual Process Design 5.5. The Nature of Policy Formulation 5.6. The Nature of Sociotechnical Systems 5.7. Challenges for Modelers of Sociotechnical Systems 5.7.1. Multiple Stakeholders 5.7.2. Incommensurable Values 5.7.3. Externalities 5.7.4. Uncertainty 5.7.5. Emergent Behavior 5.7.6. Complexity of Causation 5.7.7. Objectivity in Policy Analysis 5.8. Types of Models used in the Analysis of Policies 5.8.1. Macroeconomic Models (Mainstream, Descriptive, Aggregated, Mechanistic) 5.8.2. Optimization Models (Mainstream, Normative, Aggregated, Mechanistic) 5.8.3. Control Models (Mainstream, Normative, Aggregated, Mechanistic) 5.8.4. Data‐Based Models 5.8.5. Game Theory (Descriptive) 5.8.6. System Dynamics (Aggregated, Mechanistic) 5.8.7. Network Theory (Descriptive) 5.8.8. Agent‐Based Approaches 5.8.9. Some Conclusions on Models for the Analysis of Policies 5.9. Synthesis of Policies 5.10. Future Directions 6. Acknowledgments

show abstract

Process Analytical Technology: Strategies for Biopharmaceuticals

Rathore

Kapoor

2013

Encyclopedia of Industrial Biotechnology

View full text Add to dashboard Cite

In recent times, there is a growing need in the biopharmaceutical industry for improved process understanding to enhance productivity and product quality. Process Analytical Technology (PAT) is a system for designing, analyzing and controlling manufacturing processes based on an understanding of the engineering and scientific principles involved and identification of variables that affect product quality. It is based on the US FDA's belief that: “quality cannot be tested into products; it should be built‐in or should be by design.” This article provides the reader with an overview of the evolution of this technology, its key benefits and the challenges faced in its implementation. It then explains how PAT can be applied to a typical biopharmaceutical manufacturing process involving upstream and downstream processing, drug product manufacturing and chemometrics.

show abstract

Case study and application of process analytical technology (PAT) towards bioprocessing: Use of on‐line high‐performance liquid chromatography (HPLC) for making real‐time pooling decisions for process chromatography

Cited by 111 publications

References 15 publications

Process control in cell culture technology using dielectric spectroscopy

Process control in cell culture technology using dielectric spectroscopy

Process Systems Engineering, 9. Domain Engineering

Process Analytical Technology: Strategies for Biopharmaceuticals

Contact Info

Product

Resources

About