Role of raw materials in biopharmaceutical manufacturing: risk analysis and fingerprinting

Rathore, Anurag S.; Kumar, Deepak; Kateja, Nikhil

doi:10.1016/j.copbio.2017.12.022

Cited by 19 publications

(8 citation statements)

References 39 publications

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“…It usually contains various substances (>50) in a relatively low concentration. Thus, to characterize media quality, NMR, HPLC-MS/MS, and spectroscopic methods, such as fluorescence- (2D, 3D), infrared- (NIR, MIR, FT-IR), or Raman spectroscopy are used, resulting in complex multi-dimensional data [ 49 , 50 , 51 , 52 , 53 , 54 ]. In addition, the advantages of multivariate data analysis and DF methods can be utilized to gain accurate information on media quality [ 55 ].…”

Section: Data Types In the Pharmaceutical Industrymentioning

confidence: 99%

Challenges and Opportunities of Implementing Data Fusion in Process Analytical Technology—A Review

et al. 2022

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The release of the FDA’s guidance on Process Analytical Technology has motivated and supported the pharmaceutical industry to deliver consistent quality medicine by acquiring a deeper understanding of the product performance and process interplay. The technical opportunities to reach this high-level control have considerably evolved since 2004 due to the development of advanced analytical sensors and chemometric tools. However, their transfer to the highly regulated pharmaceutical sector has been limited. To this respect, data fusion strategies have been extensively applied in different sectors, such as food or chemical, to provide a more robust performance of the analytical platforms. This survey evaluates the challenges and opportunities of implementing data fusion within the PAT concept by identifying transfer opportunities from other sectors. Special attention is given to the data types available from pharmaceutical manufacturing and their compatibility with data fusion strategies. Furthermore, the integration into Pharma 4.0 is discussed.

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Section: Data Types In the Pharmaceutical Industrymentioning

confidence: 99%

Challenges and Opportunities of Implementing Data Fusion in Process Analytical Technology—A Review

et al. 2022

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“…Fourier transform near‐IR spectroscopy is widely used for raw material characterization in combination with MVDA analysis (Rathore et al, 2018; Ryder, 2018; Trunfio et al, 2017) near‐IR spectroscopy coupled with PCA has been demonstrated to be effective in qualitative analysis of cell culture media components and thereby to delineate lot‐to‐lot variability through spectral fingerprinting (Rathore et al, 2018). Kambayashi and coworkers recently reported an on‐line ultrasound‐assisted near‐IR technique for glucose monitoring in bioreactors (Kambayashi et al, 2020).…”

Section: Process Analytical Technologiesmentioning

confidence: 99%

Technology outlook for real‐time quality attribute and process parameter monitoring in biopharmaceutical development—A review

Wasalathanthri

Rehmann

Song

et al. 2020

Biotech & Bioengineering

114

101

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Real‐time monitoring of bioprocesses by the integration of analytics at critical unit operations is one of the paramount necessities for quality by design manufacturing and real‐time release (RTR) of biopharmaceuticals. A well‐defined process analytical technology (PAT) roadmap enables the monitoring of critical process parameters and quality attributes at appropriate unit operations to develop an analytical paradigm that is capable of providing real‐time data. We believe a comprehensive PAT roadmap should entail not only integration of analytical tools into the bioprocess but also should address automated‐data piping, analysis, aggregation, visualization, and smart utility of data for advanced‐data analytics such as machine and deep learning for holistic process understanding. In this review, we discuss a broad spectrum of PAT technologies spanning from vibrational spectroscopy, multivariate data analysis, multiattribute chromatography, mass spectrometry, sensors, and automated‐sampling technologies. We also provide insights, based on our experience in clinical and commercial manufacturing, into data automation, data visualization, and smart utility of data for advanced‐analytics in PAT. This review is catered for a broad audience, including those new to the field to those well versed in applying these technologies. The article is also intended to give some insight into the strategies we have undertaken to implement PAT tools in biologics process development with the vision of realizing RTR testing in biomanufacturing and to meet regulatory expectations.

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“…The above flowchart shows a typical fermentation process broken down in steps. Glycerol fermentation process is taken as example for the illustration [19].…”

Section: Process: Fermentationmentioning

confidence: 99%

Untitled

2018

OMCIJ

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Quality by Design is the new-age path chosen towards achieving the demanding quality standards in pharmaceutical industry. The present paper aims to throw light on Pharmaceutical Quality byDesign (QbD) and how its implementation will help manufacture better quality of Pharmaceuticals. Quality by Design is introduced along with its key elements to help make the understanding process easier. To attain built-in quality is the primary objective of Quality by Design. Finally, it can be said that the quality that is achieved by end product testing is not something that can be guaranteed unlike the quality assurance that can be provided by Quality by Design.

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Role of raw materials in biopharmaceutical manufacturing: risk analysis and fingerprinting

Cited by 19 publications

References 39 publications

Challenges and Opportunities of Implementing Data Fusion in Process Analytical Technology—A Review

Challenges and Opportunities of Implementing Data Fusion in Process Analytical Technology—A Review

Technology outlook for real‐time quality attribute and process parameter monitoring in biopharmaceutical development—A review

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