Economic assessment of continuous processing for manufacturing of biotherapeutics

Gupta, Priyanka; Kateja, Nikhil; Mishra, Somesh; Kaur, Harmeet; Rathore, Anurag S.

doi:10.1002/btpr.3108

Cited by 31 publications

(36 citation statements)

References 35 publications

(73 reference statements)

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“…While this range has yet to account for the capital cost and processes other than the cultivation unit, this value is still less than 1% of the market price of Opdivo. Our result agrees with other studies that manufacturing cost presents a trivial fraction of the final selling value . However, lowering the manufacturing cost can contribute to higher flexibility in price setting, increased drug access in lower income regions, and fending off competition after patent expiry.…”

Section: Resultssupporting

confidence: 92%

“…Our result agrees with other studies that manufacturing cost presents a trivial fraction of the final selling value. 60 However, lowering the manufacturing cost can contribute to higher flexibility in price setting, increased drug access in lower income regions, and fending off competition after patent expiry. Therefore, cost reductions must be achieved wherever possible.…”

Section: ■ Results and Discussionmentioning

confidence: 99%

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Cost–Benefit Analysis of Monoclonal Antibody Cultivation Scenarios in Terms of Life Cycle Environmental Impact and Operating Cost

Amasawa

Kuroda

Okamura

et al. 2021

ACS Sustainable Chem. Eng.

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Pharmaceuticals represent a significant contributor to the environmental impact of healthcare. Biopharmaceuticals are a rapidly growing category in that industry. They provide considerable health benefits, but the environmental impact to produce them is still largely unclear. In this paper, we examined the cost–benefit of monoclonal antibody (mAb) production in terms of operating cost and environmental impact through an extended life cycle assessment including 15 environmental categories, disability-adjusted life years, and Eco-index. Based on a detailed kinetic model, we assessed the impacts of four production scenarios at a commercial scale of batch and continuous production using single-use and multi-use equipment. We further performed a sensitivity analysis on the cost–benefit analysis results to determine elements with the highest impact on process improvement. The results showed that there is a trade-off between the operating cost and human health among the four process scenarios. Continuous modes (i.e., perfusion cultivation) have the least human health damage but with the highest operating costs, while the combination of fed-batch and multi-use equipment yields the lowest operating cost with the highest human health damage. To improve the cost–benefit of mAb cultivation, the sensitivity analysis showed the high effectiveness of potential improvements to cell’s growth characteristics such as the specific production rate.

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Section: Resultssupporting

confidence: 92%

Section: ■ Results and Discussionmentioning

confidence: 99%

Cost–Benefit Analysis of Monoclonal Antibody Cultivation Scenarios in Terms of Life Cycle Environmental Impact and Operating Cost

Amasawa

Kuroda

Okamura

et al. 2021

ACS Sustainable Chem. Eng.

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show abstract

“…Economic analyses of continuous biomanufacturing coupled with continuous chromatographic processes (referred to as integrated continuous processing) can reduce costs by 55% compared to conventional batch processing, when both capital and operating expenses are considered. 59,60 Indeed, a recent analysis suggests that commercial scale continuous process production could achieve COGs of $25/g. 60 Historically, 12-18 months has been the rule of thumb for estimating the time from the availability of mAb genes to release of GMP material; however, new strategies using transient expression for supply of Phase 1 drug while establishing a GMP stable clone for later stages of development may become more common and is the strategy that enabled multiple mAb drugs to rapidly enter clinical trials for COVID-19.…”

Section: Mammalian Cell Culturementioning

confidence: 99%

“…59,60 Indeed, a recent analysis suggests that commercial scale continuous process production could achieve COGs of $25/g. 60 Historically, 12-18 months has been the rule of thumb for estimating the time from the availability of mAb genes to release of GMP material; however, new strategies using transient expression for supply of Phase 1 drug while establishing a GMP stable clone for later stages of development may become more common and is the strategy that enabled multiple mAb drugs to rapidly enter clinical trials for COVID-19.…”

Section: Mammalian Cell Culturementioning

confidence: 99%

Emerging antibody-based products for infectious diseases: Planning for metric ton manufacturing

Whaley

Zeitlin

2021

Human Vaccines & Immunotherapeutics

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This review focuses on the emerging monoclonal antibody market for infectious diseases and the metric ton scale manufacturing requirements to meet global demand. Increasing access to existing antibodybased products coupled with the unmet need in infectious disease will likely exceed the current existing global manufacturing capacity. Further, the large numbers of individuals infected during epidemics such as the ongoing COVID-19 pandemic emphasizes the need to plan for metric ton manufacturing of monoclonal antibodies by expanding infrastructure and exploring alternative production systems.

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“…Over the last 10 years, considerable work has been done in this field by both academia and industry. It has been demonstrated that switching from batch to continuous processing can increase productivity by about 10× and reduce the cost of goods by 50-70% [27]. These benefits are realizable based on the need for a significantly smaller facility (and thereby reduced capital cost), improved facility utilization, streamlined process flow, improved process control, and more consistent product quality.…”

Section: Improving Manufacturing Technology For Biopharmaceutical Productionmentioning

confidence: 99%

Biopharmaceutical Industry Capability Building in India: Report from a Symposium

Uppal¹,

Chakrabarti²,

Chirmule³

et al. 2021

J Pharm Innov

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The biopharmaceutical industry is evolving with a shift in focus from recombinant proteins and antibodies towards more complex cell and gene therapies. To be competitive globally, biomanufacturers need to focus on aligning with global standards with regard to drug quality, reducing manufacturing failures and delivering drugs to market quickly. Building these capabilities requires a multifaceted approach that includes improvements in operations, quality compliance, and control strategies. To address these needs, the US Pharmacopeia (USP), the Department of Biotechnology (DBT) India, and the Confederation of Indian Industry (CII) held a symposium to discuss the requirements and gaps in the biotechnology and pharmaceutical sectors in India and other developing countries. A panel of experts from academia, manufacturing, and governmental agencies identified several drivers needed for capability building, including a skilled workforce, public–private partnerships, advanced manufacturing technologies, novel biologics, and favorable policies. This article summarizes the recommendations put forward by this panel.

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Economic assessment of continuous processing for manufacturing of biotherapeutics

Cited by 31 publications

References 35 publications

Cost–Benefit Analysis of Monoclonal Antibody Cultivation Scenarios in Terms of Life Cycle Environmental Impact and Operating Cost

Cost–Benefit Analysis of Monoclonal Antibody Cultivation Scenarios in Terms of Life Cycle Environmental Impact and Operating Cost

Emerging antibody-based products for infectious diseases: Planning for metric ton manufacturing

Biopharmaceutical Industry Capability Building in India: Report from a Symposium

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