An environmental life cycle assessment comparison of single-use and conventional process technology for the production of monoclonal antibodies

Pietrzykowski, Matthew; Flanagan, William P.; Pizzi, Vincent; Brown, Andrew; Sinclair, Andrew H.; Monge, Miriam

doi:10.1016/j.jclepro.2012.09.048

Cited by 72 publications

(51 citation statements)

References 6 publications

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“…The CIP/SIP support systems contributed to about 38–40% of both GWP and CED. On the other hand, the supply chain requirements for single‐use systems were only slightly higher than the traditional systems and the end‐of‐life stage represented <1% of overall life cycle impacts . These results support the industry trend in moving towards single‐use systems.…”

Section: Discussionmentioning

confidence: 51%

Quantitative assessment of environmental impact of biologics manufacturing using process mass intensity analysis

Madabhushi

Gavin

et al. 2018

Biotechnology Progress

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Process mass intensity (PMI) is a benchmarking metric to evaluate the efficiency of a manufacturing process, which is indicative of the environmental impact of the process. Although this metric is commonly applied for small molecule manufacturing processes, it is less commonly applied to biologics. In this study, an Excel based tool developed by the ACS GCI Pharmaceutical Roundtable was used to calculate PMI of different manufacturing processes for a monoclonal antibody (mAb). For the upstream process, three different versions were compared: fed‐batch, fed‐batch with N‐1 perfusion, and perfusion in the N‐stage bioreactor. For each upstream process version, an appropriate downstream operational mode was evaluated from the following: a column chromatography process utilizing Protein A and anion exchange (AEX) resin, a Protein A column and an AEX membrane, and a three‐column periodic counter‐current (3C PCC) chromatography process for Protein A and an AEX membrane. The impact of these different process variations on PMI was evaluated. Of all the process inputs, water contributes about 92–94% of the overall PMI. Additionally, the upstream processes and the chromatography steps account for 32–47 and 34–54% of the overall PMI, respectively. Sensitivity analysis was performed to identify opportunities for further reducing PMI. These data indicate that a semicontinuous manufacturing process (perfusion, 3C PCC, and AEX membrane) is the most efficient process, resulting in a 23% reduction of PMI when compared with the fed batch and two‐column chromatography process. Together, PMI can be used to guide the development of efficient and environmentally sustainable mAb manufacturing processes. © 2018 American Institute of Chemical Engineers Biotechnol. Prog., 34:1566–1573, 2018

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Section: Discussionmentioning

confidence: 51%

Quantitative assessment of environmental impact of biologics manufacturing using process mass intensity analysis

Madabhushi

Gavin

et al. 2018

Biotechnology Progress

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“…The inclusion of the precipitant in the buffer cost is the reason for the large "DSP buffer cost difference". Water volumes are significantly lower for the new compared to the traditional template because of reduced cleaning requirements, as has been well established in the case of single-use devices (Pietrzykowski et al, 2011). The contribution to process cost is, however, relatively small, as water is produced in the plant and most of the cost is included in the utilities.…”

Section: Integrated Processmentioning

confidence: 99%

A new, integrated, continuous purification process template for monoclonal antibodies: Process modeling and cost of goods studies

Xenopoulos¹

2015

Journal of Biotechnology

116

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“…Vergleichsstudien zur Produktion monoklonaler Antikörper in Edelstahl‐ und Einweg‐Bioreaktoren haben gezeigt, dass sich letztere durch ein geringeres Kontaminationsrisiko auszeichnen, und Prozess‐ sowie Produktwechsel schneller vollzogen werden können. Außerdem wurde ihnen eine höhere Umweltverträglichkeit (Wasser‐, Energie‐ und CO 2 –Reduktion) und das Potential für Zeit‐ und Kosteneinsparungen bescheinigt. So werden die Entwicklungszeiten für neue Produkte verkürzt, und die Kosten für die Investition, Infrastruktur und Wartung sind geringer.…”

Section: Das Für Und Wider Der Einweg‐technologieunclassified

Einweg‐Bioreaktoren

Eibl-Schindler¹,

Jossen²,

Eibl³

2018

Chemie in nserer Zeit

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Zusammenfassung Einweg‐Bioreaktoren sind in der Entwicklung und Produktion von monoklonalen Antikörpern angekommen. Studien belegen, dass sie richtig ausgewählt und eingesetzt sicherere, schnellere, grünere und kleinere Produktionsverfahren als ihre wiederverwendbaren Gegenspieler erlauben und zu Kosteneinsparungen beitragen. In der Inokulumproduktion haben sich wellendurchmischte Einweg‐Bioreaktoren durchgesetzt, während die Anwender in der Fermentation mehrheitlich mit gerührten Einweg‐Bioreaktoren arbeiten. Es wird prognostiziert, dass die Anzahl der Einweg‐Bioreaktoren weiter zunehmen wird.

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An environmental life cycle assessment comparison of single-use and conventional process technology for the production of monoclonal antibodies

Cited by 72 publications

References 6 publications

Quantitative assessment of environmental impact of biologics manufacturing using process mass intensity analysis

Quantitative assessment of environmental impact of biologics manufacturing using process mass intensity analysis

A new, integrated, continuous purification process template for monoclonal antibodies: Process modeling and cost of goods studies

Einweg‐Bioreaktoren

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