Process Analytical Technologies – Advances in bioprocess integration and future perspectives

Gerzon, Gabriella; Sheng, Yi; Kirkitadze, Marina

doi:10.1016/j.jpba.2021.114379

Cited by 69 publications

(33 citation statements)

References 70 publications

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“…Existing alternatives can be found in process analytical technology (PAT) systems [83]. By enabling real-time or timely quality assurance and release testing, they open new avenues for streamlining production process and automation [84]. PAT also provides tools and reliable data to develop advanced modeling techniques, notably through the identification and characterization of underlying kinetic parameters [85].…”

Section: Trends In Biotechnologymentioning

confidence: 99%

Quality by Design for enabling RNA platform production processes

Daniel¹,

Kis²,

Kontoravdi³

et al. 2022

Trends in Biotechnology

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Section: Trends In Biotechnologymentioning

confidence: 99%

Quality by Design for enabling RNA platform production processes

Daniel¹,

Kis²,

Kontoravdi³

et al. 2022

Trends in Biotechnology

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“…Currently, this knowledge is often lacking. This knowledge gap could be filled by PAT solutions that monitor the process in real time [5].…”

Section: Process Monitoringmentioning

confidence: 99%

Method development for quantitative monitoring of monoclonal antibodies in upstream cell‐culture process samples with limited sample preparation – An evaluation of various capillary coatings

Burg

Wätzig

Griend³

2022

Electrophoresis

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Monoclonal antibodies (mAbs) have become an important class of biopharmaceuticals used for the treatment of various diseases. Their quantification during the manufacturing process is important. In this work, a capillary zone electrophoresis (CZE) method was developed for the monitoring of the mAb concentration during cell‐culture processes. CZE method development rules are outlined, particularly discussing various capillary coatings, such as a neutral covalent polyvinyl alcohol coating, a dynamic successive multiple ionic‐polymer coating, and dynamic coatings using background electrolyte additives such as triethanolamine (T‐EthA) and triethylamine. The dynamic T‐EthA coating resulted in most stable electro‐osmotic flows and most efficient peak shapes. The method is validated over the range 0.1–10 mg/ml, with a linear range of 0.08–1.3 mg/ml and an extended range of 1–10 mg/ml by diluting samples in the latter concentration range 10‐fold in water. The intraday precision and accuracy were 2%–12% and 88%–107%, respectively, and inter‐day precision and accuracy were 4%–9% and 93%–104%, respectively. The precision and accuracy of the lowest concentration level (0.08 mg/ml) were slightly worse and still well in scope for monitoring purposes. The presented method proved applicable for analysing in‐process cell‐culture samples from different cell‐culture processes and is possibly well suited as platform method.

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“…A more modern approach called Process Analytical Technology (PAT) involves at-line (analysis performed with a sample that is removed from the process stream but is in proximity to the unit operation), on-line (analysis performed using a sample that is diverted from and may be returned to the process stream), or in-line analysis (direct monitoring using a sensor located in the process stream) and sampling. This allows for real-time or near real-time analytical data on product critical quality attributes (CQAs) (reviewed in [ 56 , 57 , 58 , 59 , 60 ]. PAT takes advantage of modern sensors, sampling, and analytical technologies in combination with data management and data mining tools and strategies to gain deeper and more thorough product and process understanding, consistent with QbD expectations.…”

Section: Process Analytical Technologiesmentioning

confidence: 99%

Recent Advances and Future Directions in Downstream Processing of Therapeutic Antibodies

Matte¹

2022

IJMS

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Despite the advent of many new therapies, therapeutic monoclonal antibodies remain a prominent biologics product, with a market value of billions of dollars annually. A variety of downstream processing technological advances have led to a paradigm shift in how therapeutic antibodies are developed and manufactured. A key driver of change has been the increased adoption of single-use technologies for process development and manufacturing. An early-stage developability assessment of potential lead antibodies, using both in silico and high-throughput experimental approaches, is critical to de-risk development and identify molecules amenable to manufacturing. Both statistical and mechanistic modelling approaches are being increasingly applied to downstream process development, allowing for deeper process understanding of chromatographic unit operations. Given the greater adoption of perfusion processes for antibody production, continuous and semi-continuous downstream processes are being increasingly explored as alternatives to batch processes. As part of the Quality by Design (QbD) paradigm, ever more sophisticated process analytical technologies play a key role in understanding antibody product quality in real-time. We should expect that computational prediction and modelling approaches will continue to be advanced and exploited, given the increasing sophistication and robustness of predictive methods compared to the costs, time, and resources required for experimental studies.

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Process Analytical Technologies – Advances in bioprocess integration and future perspectives

Cited by 69 publications

References 70 publications

Quality by Design for enabling RNA platform production processes

Quality by Design for enabling RNA platform production processes

Method development for quantitative monitoring of monoclonal antibodies in upstream cell‐culture process samples with limited sample preparation – An evaluation of various capillary coatings

Recent Advances and Future Directions in Downstream Processing of Therapeutic Antibodies

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