Production of Protein Therapeutics in the Quality by Design (QbD) Paradigm

Rathore, Anurag S.; Singh, Sumit

doi:10.1007/7355_2015_5004

Cited by 7 publications

(2 citation statements)

References 118 publications

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“…Hence, this industry is driven by two opposing objectives: ensuring high drug quality and safety to patients, while competitively reducing time to market and process development and manufacturing costs . Hundreds of potentially influential factors in the production process can be taken into account and many tens of them are being broadly monitored and controlled . The main engineering challenges ,− are to (1) robustly control the behavior of the living organism involved in the process, (2) efficiently align the often heterogeneous data generated across different process units and scales, (3) include all available prior know-how and experience into the decision process, (4) reduce human errors and introduced inconsistency, and (5) enable an automated and adaptive procedure to assess the critical process characteristics.…”

Section: The Problem: Decision Making Under Uncertaintymentioning

confidence: 99%

“…9 Hundreds of potentially influential factors in the production process can be taken into account and many tens of them are being broadly monitored and controlled. 10 The main engineering challenges 9,11−13 experience into the decision process, (4) reduce human errors and introduced inconsistency, and ( 5) enable an automated and adaptive procedure to assess the critical process characteristics. This commentary takes the Covid-19 pandemic as an illustrative example of decision making under uncertainty based on a daily increasing number of available data and know-how.…”

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Decision Making and Risk Management in Biopharmaceutical Engineering—Opportunities in the Age of Covid-19 and Digitalization

Sokolov

2020

Ind. Eng. Chem. Res.

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In 2020, the Covid-19 pandemic resulted in a worldwide challenge without an evident solution. Many persons and authorities involved befriended the value of available data and established expertise to make decisions under time pressure. This omnipresent example is used to illustrate the decision-making procedure in biopharmaceutical manufacturing. This commentary addresses important challenges and opportunities to support risk management in biomanufacturing through a process-centered digitalization approach combining two vital worlds—formalized engineering fundamentals and data empowerment through customized machine learning. With many enabling technologies already available and first success stories reported, it will depend on the interaction of different groups of stakeholders how and when the huge potential of the discussed technologies will be broadly and systematically realized.

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Section: The Problem: Decision Making Under Uncertaintymentioning

confidence: 99%

mentioning

confidence: 99%

Decision Making and Risk Management in Biopharmaceutical Engineering—Opportunities in the Age of Covid-19 and Digitalization

Sokolov

2020

Ind. Eng. Chem. Res.

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High-Throughput Process Development: I—Process Chromatography

Rathore¹,

Bhambure²

2020

Methods in Molecular Biology

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Identification of multiple sources of the acidic charge variants in an IgG1 monoclonal antibody

Miao

Xie

Zou

et al. 2017

Appl Microbiol Biotechnol

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Charge variants, especially acidic charge variants, of recombinant monoclonal antibodies are the major critical quality attributes in the biotechnology industry due to their potential influence on stability and biological activity. The chemical properties of the acidic charge variants have been challenging to fully characterize, and it is critical for process development and optimization. To completely understand the multiple sources of acidic charge variants, the major charge forms of an IgG1 monoclonal antibody were firstly isolated and then analyzed by a battery of characterization tools. It was found that various degrees of disulfide bond reduction, the deamination of HC-T8 Asn84 and HC-T35 Asn388 and aggregation account for the majority of acidic charge heterogeneity and the terminal galactosylation content was in relation to the acidic charge heterogeneity. The correlation between acidic charge heterogeneity and galactosylation content was further explored by weak cation exchange chromatography with the use of β1-4 galactosidase digestion. The results showed that galactosylation was not the source of the acidic charge variants per se. Meanwhile, to gain insights into the impact on binding affinity of monoclonal antibody to IgE and FcRn, charge variants were also analyzed by competitive ELISA and surface plasmon resonance, respectively. All isolated charge variants had similar affinity binding to IgE and FcRn binding relative to the starting material.

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Production of Protein Therapeutics in the Quality by Design (QbD) Paradigm

Cited by 7 publications

References 118 publications

Decision Making and Risk Management in Biopharmaceutical Engineering—Opportunities in the Age of Covid-19 and Digitalization

Decision Making and Risk Management in Biopharmaceutical Engineering—Opportunities in the Age of Covid-19 and Digitalization

High-Throughput Process Development: I—Process Chromatography

Identification of multiple sources of the acidic charge variants in an IgG1 monoclonal antibody

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