Single‐Use Technologies in Biopharmaceutical Manufacturing

Rader, Ronald A.; Langer, Eric S.

doi:10.1002/9781119477891.ch15

Cited by 10 publications

(8 citation statements)

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“…Even though single‐use technologies present numerous advantages for mixing, several issues remain. In particular, the inability to adequately mix large volumes in a reasonable time, and the limited availability to pre‐test the single‐use systems after installation still represent major concerns 4, 5, 11. Users also require biocontainer bags of higher quality, which should be easy to install without any risks of leaks or tears and tested for leachables.…”

Section: From Trend To Industry Standard In Biomanufacturingmentioning

confidence: 99%

“…Nowadays, most biomanufacturing steps can be performed routinely in single‐use equipment up to 3000 L 1; thus, it is not surprising to see a wider adoption of single‐use technologies for clinical and commercial manufacturing 2–5. Single‐use systems, which are usually composed of an outer steel compartment where a gamma‐irradiated tubing or biocontainer is inserted, present multiple advantages.…”

Section: From Trend To Industry Standard In Biomanufacturingmentioning

confidence: 99%

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Trends in Single‐Use Mixing for Biomanufacturing with an Insight Into Lonza Ibex® Solutions

Boulard¹,

Kienle²

2022

Chemie Ingenieur Technik

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Biologics manufacturing has seen many new developments in recent years. The industry is moving away from processing systems based on stainless steel (with cleaning and validation requirements) to single‐use systems (sterilized, disposable plastics). This communication presents an overview of the current single‐use mixing technology landscape, requirements and challenges driven by the need for versatile biomanufacturing platforms with increased productivity. A case study is presented with an insight into Lonza Ibex® Solutions.

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Section: From Trend To Industry Standard In Biomanufacturingmentioning

confidence: 99%

Section: From Trend To Industry Standard In Biomanufacturingmentioning

confidence: 99%

Trends in Single‐Use Mixing for Biomanufacturing with an Insight Into Lonza Ibex® Solutions

Boulard¹,

Kienle²

2022

Chemie Ingenieur Technik

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“…Both stirred tank and rocking platform BRs can be made as single-use bioreactors (SUBs), equipped with a disposable bag. From the economical point of view, the SUBs have several advantages, such as minimal cleaning required, fewer contamination risks due to the use of the sterile bags, and reduced downtime between batches [ 69 ]. Importantly, SUBs offer good scalability based on the already commercially available SUB configurations up to several m 3 and versatile design options enabling a variety of mixing principles.…”

Section: Bioreactors and Scaffoldingmentioning

confidence: 99%

Cultivating Multidisciplinarity: Manufacturing and Sensing Challenges in Cultured Meat Production

Djisalov

Knežić

Podunavac

et al. 2021

Biology

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Meat cultivation via cellular agriculture holds great promise as a method for future food production. In theory, it is an ideal way of meat production, humane to the animals and sustainable for the environment, while keeping the same taste and nutritional values as traditional meat and having additional benefits such as controlled fat content and absence of antibiotics and hormones used in the traditional meat industry. However, in practice, there is still a number of challenges, such as those associated with the upscale of cultured meat (CM). CM food safety monitoring is a necessary factor when envisioning both the regulatory compliance and consumer acceptance. To achieve this, a multidisciplinary approach is necessary. This includes extensive development of the sensitive and specific analytical devices i.e., sensors to enable reliable food safety monitoring throughout the whole future food supply chain. In addition, advanced monitoring options can help in the further optimization of the meat cultivation which may reduce the currently still high costs of production. This review presents an overview of the sensor monitoring options for the most relevant parameters of importance for meat cultivation. Examples of the various types of sensors that can potentially be used in CM production are provided and the options for their integration into bioreactors, as well as suggestions on further improvements and more advanced integration approaches. In favor of the multidisciplinary approach, we also include an overview of the bioreactor types, scaffolding options as well as imaging techniques relevant for CM research. Furthermore, we briefly present the current status of the CM research and related regulation, societal aspects and challenges to its upscaling and commercialization.

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“…As biomedical tools, lectins are considered promising contributors to diagnosis, treatment, and prevention of infectious diseases (Dan et al 2016). We found patents of lectins with antimicrobial applications since 1988, but only a vaccine formulated with the recombinant influenza virus hemagglutinin has been approved so far for the United States and European biopharmaceutical markets (Rader 2021). Anti-infective medicines accounted for the second most expensive investment on new therapeutic agents approved by the Food and Drug Administration (FDA) between 2009 and 2018 (US$ 1,260 million) (Wouters et al 2020).…”

Section: Accepted Articlementioning

confidence: 99%

A patent review of the antimicrobial applications of lectins: Perspectives on therapy of infectious diseases

Carneiro

Fernandez

Monteiro-Cunha

et al. 2021

J of Applied Microbiology

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Patents of lectins with antiviral, antibacterial, and antifungal applications were searched and reviewed.Lectins are proteins that reversibly bind to specific carbohydrates and have the potential for therapy of infectious diseases as biopharmaceuticals, biomedical tools, or in drug design. Given the rising concerns over drug resistance and epidemics, our patent review aims to add information, open horizons, and indicate our view of the future perspectives about the antimicrobial applications of lectins. Patents with Accepted ArticleThis article is protected by copyright. All rights reserved publications until December 2020 were retrieved from Espacenet using defined search terms and Boolean operators. The documents were used to identify the geographical and temporal distribution of the patents, characterize their lectins, and classify and summarize their antiviral, antibiotic, and antifungal applications. Lectins are promising antiviral agents against viruses with epidemics and drug resistance concerns. Mannose-binding lectins were the most suggested antiviral agents since glycans with mannose residues are commonly involved in viral entry mechanisms. They were also applied immobilized onto surfaces to trap viral particles and inhibit their spread and replication. Many patents described the extraction, isolation, amino acid and nucleotide sequences, and expression vectors of lectins with antibiotic and/or antifungal activities in terms of MIC and IC 50 for in vitro assays. The inventions also included lectins as biological tools in nanosensors for antibiotics susceptibility tests, drug delivery systems for the treatment of resistant bacteria, diagnostics of viral diseases, and as a vaccine adjuvant. Although research and development of new medicines is highly expensive, antimicrobial lectins may be worth investments given the emergence of epidemics and drug resistance. For this purpose, less invasive routes should be developed as alternatives to the parenteral administration of biologics. While anti-glycan neutralizing antibodies are difficult to develop due to the low immunogenicity of carbohydrates, lectins can be produced more easily and have a broad-spectrum activity. Protein engineering technologies may make the antimicrobial applications of lectins more successful.

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Single‐Use Technologies in Biopharmaceutical Manufacturing

Cited by 10 publications

References 0 publications

Trends in Single‐Use Mixing for Biomanufacturing with an Insight Into Lonza Ibex® Solutions

Trends in Single‐Use Mixing for Biomanufacturing with an Insight Into Lonza Ibex® Solutions

Cultivating Multidisciplinarity: Manufacturing and Sensing Challenges in Cultured Meat Production

A patent review of the antimicrobial applications of lectins: Perspectives on therapy of infectious diseases

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