Mid‐UV Protein Absorption Spectra and Partial Least Squares Regression as Screening and PAT Tool

Hansen, Sigrid K.; Brestrich, Nina; Staby, Arne; Hubbuch, Jürgen

doi:10.1002/9781119031116.ch17

Cited by 3 publications

(1 citation statement)

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“…Several recent examples for the implementation of PAT have demonstrated the feasibility and benefits of investing in such approach. [2][3][4][5] While some of these examples have focused on implementing new in-line/at-line instruments and sensors, [6][7][8][9][10][11][12][13][14][15] others have focused on how to best utilize the available data to make predictions and real-time decisions using multivariate analysis. [8,[16][17][18][19][20][21][22][23][24] Biotechnology processes often consist of several unit operations fed by multiple input parameters.…”

Section: Introductionmentioning

confidence: 99%

Robust method for chromatogram shape analysis to improve early detection of performance drifts and adverse changes in process parameters during purification column operations

Torres

2023

Biotechnology Journal

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The biopharmaceutical industry is under increased pressure to maximize efficiency, enhance quality compliance, and reduce the cost of drug substance manufacturing. Ways to reduce costs associated with manufacturing of complex biological molecules include maximizing efficiency of chromatography purification steps. For example, process analytical technology (PAT) tools can be employed to improve column resin life, prevent column operating failures, and decrease the time it takes to solve investigations of process deviations. We developed a robust method to probe the shape of the chromatogram for indications of column failure or detrimental changes in the process. The approach herein utilizes raw data obtained from manufacturing followed by a pre‐processing routine to align chromatograms and patch together the different chromatogram phases in preparation for multivariate analysis. A principal component analysis (PCA) was performed on the standardized chromatograms to compare different batches, and resulted in the identification specific process change that affected the profile. In addition, changes in the chromatogram peaks were used to create predictive models for impurity clearance. This approach has the potential for early detection of column processing issues, improving timely resolution in large‐scale chromatographic operations.

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Section: Introductionmentioning

confidence: 99%

Robust method for chromatogram shape analysis to improve early detection of performance drifts and adverse changes in process parameters during purification column operations

Torres

2023

Biotechnology Journal

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Continuous integrated manufacturing for biopharmaceuticals: A new paradigm or an empty promise?

Rathore

Thakur

Kateja

2022

Biotech & Bioengineering

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Continuous integrated bioprocessing has elicited considerable interest from the biopharma industry for the many purported benefits it promises. Today many major biopharma manufacturers around the world are engaged in the development of continuous process platforms for their products. In spite of great potential, the path toward continuous integrated bioprocessing remains unclear for the biologics industry due to legacy infrastructure, process integration challenges, vague regulatory guidelines, and a diverging focus toward novel therapies. In this article, we present a review and perspective on this topic. We explore the status of the implementation of continuous integrated bioprocessing among biopharmaceutical manufacturers. We also present some of the key hurdles that manufacturers are likely to face during this implementation. Finally, we hypothesize that the real impact of continuous manufacturing is likely to come when the cost of manufacturing is a substantial portion of the cost of product development, such as in the case of biosimilar manufacturing and emerging economies.

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Challenges in process control for continuous processing for production of monoclonal antibody products

Rathore

Nikita

Thakur

et al. 2021

Current Opinion in Chemical Engineering

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Mid‐UV Protein Absorption Spectra and Partial Least Squares Regression as Screening and PAT Tool

Cited by 3 publications

References 42 publications

Robust method for chromatogram shape analysis to improve early detection of performance drifts and adverse changes in process parameters during purification column operations

Robust method for chromatogram shape analysis to improve early detection of performance drifts and adverse changes in process parameters during purification column operations

Continuous integrated manufacturing for biopharmaceuticals: A new paradigm or an empty promise?

Challenges in process control for continuous processing for production of monoclonal antibody products

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