Efficient Manufacturing of Biologics

Gronemeyer, Petra; Schmidt, A.; Zobel, S.; Strube, Jochen

doi:10.1002/cite.201650296

Cited by 3 publications

(3 citation statements)

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“…However, with higher product concentrations the platform downstream process will reach its efficiency optimum. Increasing the product concentration even more leads to a significant shift of cost of goods (COGs) from upstream to downstream processing [4,[19][20][21].…”

Section: Critical View On Current Practicementioning

confidence: 99%

Accelerating Biomanufacturing by Modeling of Continuous Bioprocessing—Piloting Case Study of Monoclonal Antibody Manufacturing

et al. 2019

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An experimental feasibility study on continuous bioprocessing in pilot-scale of 1 L/day cell supernatant, that is, about 150 g/year product (monoclonal antibody) based on CHO (Chinese hamster ovary) cells for model validation is performed for about six weeks including preparation, start-up, batch, and continuous steady-state operation for at least two weeks stable operation as well as final analysis of purity and yield. A mean product concentration of around 0.4 g/L at cell densities of 25 × 106 cells/mL was achieved. After perfusion cultivation with alternating tangential flow filtration (ATF), an aqueous two-phase extraction (ATPE) followed by ultra-/diafiltration (UF/DF) towards a final integrated counter-current chromatography (iCCC) purification with an ion exchange (IEX) and a hydrophobic interaction (HIC) column prior to lyophilization were successfully operated. In accordance to prior studies, continuous operation is stable and feasible. Efforts of broadly-qualified operation personal as well as the need for an appropriate measurement and process control strategy is shown evidently.

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Section: Critical View On Current Practicementioning

confidence: 99%

Accelerating Biomanufacturing by Modeling of Continuous Bioprocessing—Piloting Case Study of Monoclonal Antibody Manufacturing

et al. 2019

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Section: Introductionmentioning

confidence: 99%

“…Increasing the product concentration even more leads to a significant shift of cost of goods (COGs) from upstream to downstream processing. 7,[21][22][23] Continuous bioprocessing circumvents the aforementioned downstream bottleneck and batch scale-up problems by increasing the productivity and flexibility of each unit operation with a simultaneous increase in product quality resulting from continuous product processing (i.e., short hold times). 4,9,16,[23][24][25][26][27][28][29][30][31][32][33][34] The Food and Drug Administration, European Medicinal Agency, International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and various industrial working groups have started to publish guidelines (ICH Q8-Q11) to increase product quality during manufacturing, thereby promoting continuous bioprocessing.…”

Section: Introductionmentioning

confidence: 99%

Process analytical technology as key‐enabler for digital twins in continuous biomanufacturing

Schmidt

Helgers

Lohmann

et al. 2022

J of Chemical Tech & Biotech

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Over the last few years rapid progress has been made in adopting well‐known process modeling techniques from chemicals to biologics manufacturing. The main challenge has been analytical methods as engineers need quantitative data for their workflow. Industrialization 4.0, Internet of Things, artificial intelligence and machine learning activities up to big data analysis have taken their share in solving fundamental problems like component‐ or at least group‐specific evaluation of spectroscopic data. Besides, concerning inline analytics methods included in process analytical technology concepts the key technology has been the generation of decisive validated digital twins based on process models. This review aims to summarize the methodology to achieve a holistic understanding of process models, control and optimization by means of digital twins using the example of recent work published in this field. © 2021 The Authors. Journal of Chemical Technology and Biotechnology published by John Wiley & Sons Ltd on behalf of Society of Chemical Industry (SCI).

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Continuous biomanufacturing in upstream and downstream processing

Schmidt,

Hengelbrock,

Strube

2023

Physical Sciences Reviews

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Continuous bioprocesses have become a significant technological change in regulated industries, with process analytical technology (PAT) and quality-by-design (QbD) being essential for enabling continuous biomanufacturing. PAT and QbD are associated with process automation and control, providing real-time key process information. Continuous manufacturing eliminates hold times and reduces processing times, providing benefits such as improved product quality, reduced waste, lower costs, and increased manufacturing flexibility and agility. Over the past decade, advancements in science and engineering, along with the adoption of QbD and the advancement of PAT, have progressed the scientific and regulatory readiness for continuous manufacturing. Regulatory authorities support the implementation of continuous manufacturing using science- and risk-based approaches, providing a great deal of potential to address issues of agility, flexibility, cost, and robustness in the development of pharmaceutical manufacturing processes.

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Efficient Manufacturing of Biologics

Cited by 3 publications

References 1 publication

Accelerating Biomanufacturing by Modeling of Continuous Bioprocessing—Piloting Case Study of Monoclonal Antibody Manufacturing

Accelerating Biomanufacturing by Modeling of Continuous Bioprocessing—Piloting Case Study of Monoclonal Antibody Manufacturing

Process analytical technology as key‐enabler for digital twins in continuous biomanufacturing

Continuous biomanufacturing in upstream and downstream processing

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