Single‐Use Process Platforms for Responsive and Cost‐Effective Manufacturing

Gupta, Priyanka; Monge, Miriam; Boulais, Amélie; Chopra, Nitin; Hutchinson, Nick

doi:10.1002/9781119477891.ch16

Cited by 3 publications

(4 citation statements)

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“…104,105 Like with mammalian viral vector systems, insect cells are grown in single-use cell culture flasks and bioreactors to ensure reproducibility and sterility during manufacture for clinical use. 101,106 Viral vector purification platforms encompass purification steps to generate highly pure vector particles that comply with stringent quality, safety and efficacy standards. Historically, purification relied on ultracentrifugation to separate the large viral particles from smaller producer cell contaminants.…”

Section: Production Platformsmentioning

confidence: 99%

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Cancer gene therapy goes viral: viral vector platforms come of age

Bezeljak

2022

Radiology and Oncology

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Background Since the advent of viral vector gene therapy in 1990s, cancer treatment with viral vectors promised to revolutionize the field of oncology. Notably, viral vectors offer a unique combination of efficient gene delivery and engagement of the immune system for anti-tumour response. Despite the early potential, viral vector-based cancer treatments are only recently making a big impact, most prominently as gene delivery devices in approved CAR-T cell therapies, cancer vaccines and targeted oncolytic therapeutics. To reach this broad spectrum of applications, a number of challenges have been overcome – from our understanding of cancer biology to vector design, manufacture and engineering. Here, we take an overview of viral vector usage in cancer therapy and discuss the latest advancements. We also consider production platforms that enable mainstream adoption of viral vectors for cancer gene therapy. Conclusions Viral vectors offer numerous opportunities in cancer therapy. Recent advances in vector production platforms open new avenues in safe and efficient viral therapeutic strategies, streamlining the transition from lab bench to bedside. As viral vectors come of age, they could become a standard tool in the cancer treatment arsenal.

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Section: Production Platformsmentioning

confidence: 99%

Section: Production Platformsmentioning

confidence: 99%

Cancer gene therapy goes viral: viral vector platforms come of age

Bezeljak

2022

Radiology and Oncology

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“…The recurrent units permit efficient leveraging of prior knowledge when optimizing the production of a new product with those same characteristics. Thus, platform processing has the potential to reduce efforts in production development—one of the critical hindrances of continuous manufacturing implementation 16,17 . The adoption of continuous manufacturing is, nevertheless, proceeding slowly which can be attributed to three challenges: business, regulatory and technological.…”

Section: Introductionmentioning

confidence: 99%

“…Thus, platform processing has the potential to reduce efforts in production development-one of the critical hindrances of continuous manufacturing implementation. 16,17 The adoption of continuous manufacturing is, nevertheless, proceeding slowly which can be attributed to three challenges: business, regulatory and technological. Business and regulatory challenges are outside the scope of this paper and have been extensively reviewed elsewhere.…”

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confidence: 99%

Current challenges and recent advances on the path towards continuous biomanufacturing

Drobnjakovic

Hart²,

Kulvatunyou

et al. 2023

Biotechnology Progress

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Continuous biopharmaceutical manufacturing is currently a field of intense research due to its potential to make the entire production process more optimal for the modern, ever‐evolving biopharmaceutical market. Compared to traditional batch manufacturing, continuous bioprocessing is more efficient, adjustable, and sustainable and has reduced capital costs. However, despite its clear advantages, continuous bioprocessing is yet to be widely adopted in commercial manufacturing. This article provides an overview of the technological roadblocks for extensive adoptions and points out the recent advances that could help overcome them. In total, three key areas for improvement are identified: Quality by Design (QbD) implementation, integration of upstream and downstream technologies, and data and knowledge management. First, the challenges to QbD implementation are explored. Specifically, process control, process analytical technology (PAT), critical process parameter (CPP) identification, and mathematical models for bioprocess control and design are recognized as crucial for successful QbD realizations. Next, the difficulties of end‐to‐end process integration are examined, with a particular emphasis on downstream processing. Finally, the problem of data and knowledge management and its potential solutions are outlined where ontologies and data standards are pointed out as key drivers of progress.

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Recycling of Post-Use Bioprocessing Plastic Containers—Mechanical Recycling Technical Feasibility

Luu

Barbaroux²,

Dorez

et al. 2022

Sustainability

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Most of the plastic-based solutions used in bio-manufacturing are today incinerated after use, even the not “bio-contaminated”. Bioprocessing bags used for media and buffer preparation and storage represent the largest amount today. The aim of this work was to technically assess the feasibility of the mechanical recycling of bioprocessing bags. Materials from different sorting and recycling strategies have been characterized, for their suitability of further use. Quantitative physical and mechanical tests and analysis (FTIR, DSC, TGA, density, MFI, color, tensile, flexural, and Charpy choc) were performed. The data show that these recycled plastics could be oriented towards second use requiring physical properties similar to equivalent virgin materials. A comparative life cycle assessment, based on a theoretical framework, shows that mechanical recycling for end of life presents the advantage of keeping material in the loop, without showing a significant statistical difference compared to incineration with regards to the climate change indicator.

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Single‐Use Process Platforms for Responsive and Cost‐Effective Manufacturing

Cited by 3 publications

References 0 publications

Cancer gene therapy goes viral: viral vector platforms come of age

Cancer gene therapy goes viral: viral vector platforms come of age

Current challenges and recent advances on the path towards continuous biomanufacturing

Recycling of Post-Use Bioprocessing Plastic Containers—Mechanical Recycling Technical Feasibility

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