Process Analytical Technology (PAT) Implementation for Membrane Operations in Continuous Manufacturing of mAbs: Model-Based Control of Single-Pass Tangential Flow Ultrafiltration

Thakur, Garima; Masampally, Vishnu Swaroopji; Kulkarni, Amey; Rathore, Anurag S.

doi:10.1208/s12248-022-00731-z

Cited by 8 publications

(7 citation statements)

References 25 publications

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“…PAT tools enable realtime monitoring and control of critical process parameters, leading to improved product quality and reduced material wastage (McDermo , 2023;Williams et al, 2023;Xiong et al, 2023). By utilizing PAT systems, pharmaceutical companies can optimize bioprocessing operations, such as cell culture monitoring and metabolic activity assessment, resulting in increased productivity and process robustness (Kumari et al, 2023;Thakur et al, 2022). Additionally, the application of PAT in traditional Chinese medicine manufacturing facilitates quality control, process understanding, and continuous improvement throughout the product life-cycle, ultimately enhancing production efficiency and product quality.…”

Section: B Acceleration Of Drug Production Through Continuous Manufac...mentioning

confidence: 99%

Computational Pharmaceutics: A Comprehensive Review of Past Achievements, Present Applications, and Future Challenges

Chaudhari,

Puri

et al. 2024

Preprint

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This paper explores the transformative impact of computational pharmaceutics, integrating AI, multi-scale modeling, quantum computing, AI-driven drug discovery, and blockchain frameworks. Molecular dynamics simulations provide insights into atomic behaviors crucial for drug design. Quantum computing reduces computational costs for simulating protein-drug interactions. AI and Graph Neural Networks accelerate drug discovery and personalized medicine. Blockchain frameworks facilitate secure pharmacogenetic data sharing. These advancements revolutionize drug development, offering unprecedented efficiency, innovation, and personalized treatments.

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Section: B Acceleration Of Drug Production Through Continuous Manufac...mentioning

confidence: 99%

Computational Pharmaceutics: A Comprehensive Review of Past Achievements, Present Applications, and Future Challenges

Chaudhari,

Puri

et al. 2024

Preprint

View full text Add to dashboard Cite

show abstract

“…PAT tools enable realtime monitoring and control of critical process parameters, leading to improved product quality and reduced material wastage (McDermott, 2023;Williams et al, 2023;Xiong et al, 2023). By utilizing PAT systems, pharmaceutical companies can optimize bioprocessing operations, such as cell culture monitoring and metabolic activity assessment, resulting in increased productivity and process robustness (Kumari et al, 2023;Thakur et al, 2022). Additionally, the application of PAT in traditional Chinese medicine manufacturing facilitates quality control, process understanding, and continuous improvement throughout the product life-cycle, ultimately enhancing production efficiency and product quality.…”

Section: B Acceleration Of Drug Production Through Continuous Manufac...mentioning

confidence: 99%

Computational Pharmaceutics: A Comprehensive Review of Past Achievements, Present Applications, and Future Challenges

Chaudhari,

Puri

et al. 2024

Preprint

View full text Add to dashboard Cite

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“…The pressure difference formed on the membrane makes part of the liquid pass through the membrane, while the other part of the liquid flows tangentially through the membrane surface to wash away the intercepted protein molecules. The currently developed one-way tangential flow ultrafiltration technique enables the continuous ultrafiltration of mAb by increasing the surface area and the residence time ( Thakur et al, 2022 ). Ultrafiltration is also applied to the treatment of diseases such as acute heart failure ( Costanzo, 2019 ), the removal of pathogens from seawater ( Cordier et al, 2020 ), the purification of the vaccine product ( Emami et al, 2019 ) and recombinant ferritin ( Palombarini et al, 2019 ), and the treatment of galvanized waste-water ( Oztel et al, 2020 ).…”

Section: Rough Fractionationmentioning

confidence: 99%

1Progress, applications, challenges and prospects of protein purification technology

Hou

Liu

et al. 2022

Front. Bioeng. Biotechnol.

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Protein is one of the most important biological macromolecules in life, which plays a vital role in cell growth, development, movement, heredity, reproduction and other life activities. High quality isolation and purification is an essential step in the study of the structure and function of target proteins. Therefore, the development of protein purification technologies has great theoretical and practical significance in exploring the laws of life activities and guiding production practice. Up to now, there is no forthcoming method to extract any proteins from a complex system, and the field of protein purification still faces significant opportunities and challenges. Conventional protein purification generally includes three steps: pretreatment, rough fractionation, and fine fractionation. Each of the steps will significantly affect the purity, yield and the activity of target proteins. The present review focuses on the principle and process of protein purification, recent advances, and the applications of these technologies in the life and health industry as well as their far-reaching impact, so as to promote the research of protein structure and function, drug development and precision medicine, and bring new insights to researchers in related fields.

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Process Analytical Technology (PAT) Implementation for Membrane Operations in Continuous Manufacturing of mAbs: Model-Based Control of Single-Pass Tangential Flow Ultrafiltration

Cited by 8 publications

References 25 publications

Computational Pharmaceutics: A Comprehensive Review of Past Achievements, Present Applications, and Future Challenges

Computational Pharmaceutics: A Comprehensive Review of Past Achievements, Present Applications, and Future Challenges

Computational Pharmaceutics: A Comprehensive Review of Past Achievements, Present Applications, and Future Challenges

1Progress, applications, challenges and prospects of protein purification technology

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