Sensors for biomanufacturing process development: facilitating the shift from batch to continuous manufacturing

Holzberg, Timothy; Watson, Valencia; Brown, Sheniqua; Andar, Abhay; Ge, Xudong; Kostov, Yordan; Tolosa, Leah; Rao, Govind

doi:10.1016/j.coche.2018.09.008

Cited by 26 publications

(33 citation statements)

References 46 publications

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“…Modern techniques in bioengineering are urgently needed for a total bioprocess assessment, aiming significant transitions from batch to on-line and instantaneous monitoring (Teixeira et al, 2009 ; Roch and Mandenius, 2016 ; Holzberg et al, 2018 ). Conventional techniques constantly used for bioprocess monitoring are well-established yet relatively outdated (e.g., the classical Clark electrodes), thus demanding the invention of novel and easy-to-use devices.…”

Section: Methodsmentioning

confidence: 99%

Portable Analytical Techniques for Monitoring Volatile Organic Chemicals in Biomanufacturing Processes: Recent Advances and Limitations

Chen

et al. 2020

Front. Chem.

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Section: Methodsmentioning

confidence: 99%

Portable Analytical Techniques for Monitoring Volatile Organic Chemicals in Biomanufacturing Processes: Recent Advances and Limitations

Chen

et al. 2020

Front. Chem.

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“…Process Analytical Technology (PAT) is a system that designs, analyzes, and manages the manufacturing process by real-time monitoring (Holzberg et al, 2018). In order to conduct measurements in real time, PAT must be incorporated into the manufacturing line (in-line), or can be conducted immediately after sampling of process solutions near the manufacturing line (at-line/on-line).…”

Section: Application To Process Analytical Technologymentioning

confidence: 99%

Antibody Concentration Measurement Using Optical Rotation: Toward Process Analytical Technology

et al. 2021

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The antibody manufacturing process consists of the cell culture process using animal cells and the purification process including several chromatography steps and filtration steps. The purification process is important to obtain high quality bio-pharmaceutical products by removing impurities, and measurement of antibody concentrations is a fundamental and essential factor to control the manufacturing process and to confirm the yield of each purification step. Here we introduce the optical rotation method as a resolution for measuring antibody concentrations in the manufacturing process. Feasibility evaluation showed that optical rotation is applicable for measuring a wide range of antibody concentrations even in cell culture supernatants containing various contaminants. In addition, as examples of application to the process analytical technology, we show the possibility of the optical rotation method in the continuous cell culture and chromatography process, and the tangential flow filtration concentration process.

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“…Opto-chemical sensors have gained considerable importance in the analytical sciences. Principles of methodology and technologies for measurement are well established [33,34]. Sensors for O 2 are widely applied in the environmental sciences, in (bio)process engineering and in the life sciences.…”

Section: Opto-chemical Sensing Within Solid Particlesmentioning

confidence: 99%

“…Based on experience with the opto-chemical sensing of oxygen, strategies for measuring other analytes (e.g., pH) have been developed. Principles have been extended to the determination of CO 2 , NH 4 , glucose, alcohols, amines and a variety of ions [33,35]. Temperature can be also measured [36].…”

Section: Opto-chemical Sensing Within Solid Particlesmentioning

confidence: 99%

The Microenvironment in Immobilized Enzymes: Methods of Characterization and Its Role in Determining Enzyme Performance

Bolívar

Nidetzky

2019

Molecules

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The liquid milieu in which enzymes operate when they are immobilized in solid materials can be quite different from the milieu in bulk solution. Important differences are in the substrate and product concentration but also in pH and ionic strength. The internal milieu for immobilized enzymes is affected by the chemical properties of the solid material and by the interplay of reaction and diffusion. Enzyme performance is influenced by the internal milieu in terms of catalytic rate (“activity”) and stability. Elucidation, through direct measurement of differences in the internal as compared to the bulk milieu is, therefore, fundamentally important in the mechanistic characterization of immobilized enzymes. The deepened understanding thus acquired is critical for the rational development of immobilized enzyme preparations with optimized properties. Herein we review approaches by opto-chemical sensing to determine the internal milieu of enzymes immobilized in porous particles. We describe analytical principles applied to immobilized enzymes and focus on the determination of pH and the O2 concentration. We show measurements of pH and [O2] with spatiotemporal resolution, using in operando analysis for immobilized preparations of industrially important enzymes. The effect of concentration gradients between solid particle and liquid bulk on enzyme performance is made evident and quantified. Besides its use in enzyme characterization, the method can be applied to the development of process control strategies.

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Sensors for biomanufacturing process development: facilitating the shift from batch to continuous manufacturing

Cited by 26 publications

References 46 publications

Portable Analytical Techniques for Monitoring Volatile Organic Chemicals in Biomanufacturing Processes: Recent Advances and Limitations

Portable Analytical Techniques for Monitoring Volatile Organic Chemicals in Biomanufacturing Processes: Recent Advances and Limitations

Antibody Concentration Measurement Using Optical Rotation: Toward Process Analytical Technology

The Microenvironment in Immobilized Enzymes: Methods of Characterization and Its Role in Determining Enzyme Performance

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