Advanced control strategies for bioprocess chromatography: Challenges and opportunities for intensified processes and next generation products

Armstrong, A.; Horry, Kieran; Cui, Tingting; Hulley, Martyn; Turner, Richard; Farid, Suzanne S.; Goldrick, Stephen; Bracewell, Daniel G.

doi:10.1016/j.chroma.2021.461914

Cited by 22 publications

(11 citation statements)

References 100 publications

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“…As a result, a 14-fold higher productivity of the convecdiff membrane compared to the standard resin was achieved. This is an increasingly important aspect in the purification of biopharmaceuticals, enabling substantial cost, time and space savings, as well as process intensification of future processes [ 21 , 22 , 23 ].…”

Section: Discussionmentioning

confidence: 99%

Scalable, Robust and Highly Productive Novel Convecdiff Membrane Platform for mAb Capture

et al. 2022

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The recombinant monoclonal antibody capture step represents the current bottleneck in downstream processing. Protein A resins are diffusion-limited chromatography materials which require low flow rates to achieve a binding capacity above 30 g L−1 with the result of low productivity. Here, we present a novel chromatography membrane combining superior binding capacities with high flow rates for high productivity while achieving comparable product quality as state-of-the-art protein A resins. Further, we demonstrate full scalability of this convecdiff technology with experimental data demonstrating suitability for bioprocessing at different scales. This technology results in more than 10-fold higher productivity compared to Protein A resins, which is maintained during scale up. We demonstrate the influence of residence times, feed titers and the cleaning regime on productivity and indicate optimal utilization of the convecdiff membrane based on feed titer availability. The underlying high productivity and short cycle times of this material enable the purification of monoclonal antibodies with 10-times less chromatography material used per batch and utilization of the membrane within one batch. Provided in disposable consumables, this novel technology will remove column handling in bioprocesses and resin re-use over multiple batches.

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Section: Discussionmentioning

confidence: 99%

Scalable, Robust and Highly Productive Novel Convecdiff Membrane Platform for mAb Capture

et al. 2022

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“…A similar trend was identified by Armstrong et al in bioprocess chromatography systems where there was a clear gap between the number of PAT applications used for monitoring in comparison to control. One of the challenges they discussed was related to lack of confidence in the application of these technologies from a regulatory approval perspective in comparison to the standard off-line quantification methods [ 43 • ]. While there are no control applications appearing in the analysis of the top cited literature, ML is still being utilised in the sector to optimise the performance of existing processes.…”

Section: Resultsmentioning

confidence: 99%

A decade in review: use of data analytics within the biopharmaceutical sector

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Alosert

Spencer

et al. 2021

Current Opinion in Chemical Engineering

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Highlights Data analytics has increasing significantly in recent years in the biopharma sector. No clear trend observed between algorithm utilisation and data size. PLS was found to be most applied algorithm within the biopharmaceutical sector. Majority of the data analytics applications are focused on USP operations. Data analytics will play a key role as the sector transitions towards Industry 4.0.

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“…New adsorbents have also been assessed [246]. Additionally, improved control strategies leading to intensified unit operations, for example for chromatography have also been explored through modelling [247]. Several challenges remain in the modelling field including the need to describe in a suitable mathematical notation the phenomena in a given system.…”

Section: Bioprocess Intensification Modelling Toolsmentioning

confidence: 99%

Bioprocess intensification: A route to efficient and sustainable biocatalytic transformations for the future

Boodhoo

Flickinger

Woodley

et al. 2022

Chemical Engineering and Processing - Process Intensification

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Advanced control strategies for bioprocess chromatography: Challenges and opportunities for intensified processes and next generation products

Cited by 22 publications

References 100 publications

Scalable, Robust and Highly Productive Novel Convecdiff Membrane Platform for mAb Capture

Scalable, Robust and Highly Productive Novel Convecdiff Membrane Platform for mAb Capture

A decade in review: use of data analytics within the biopharmaceutical sector

Bioprocess intensification: A route to efficient and sustainable biocatalytic transformations for the future

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