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Article ; Online: Anticipatory regulation for pandemic responses: are we there yet?

Oyola-Lozada, Maria Giuliana / Pregelj, Lisette / Jenkins, Anna / Siegel, Evan / Munro, Trent / Hine, Damian

2024

Abstract: Can drug and vaccine regulatory agencies leverage their experience during the coronavirus disease 2019 (COVID-19) pandemic to advance from reactive regulation to adaptive regulation and beyond to anticipatory regulation to prevent or curb future ... ...

Abstract	Can drug and vaccine regulatory agencies leverage their experience during the coronavirus disease 2019 (COVID-19) pandemic to advance from reactive regulation to adaptive regulation and beyond to anticipatory regulation to prevent or curb future pandemics?
Language	English
Publishing date	2024-03-27
Publishing country	England
Document type	Journal Article
ZDB-ID	47474-5
ISSN	1879-3096 ; 0167-7799
ISSN (online)	1879-3096
ISSN	0167-7799
DOI	10.1016/j.tibtech.2024.02.016
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Article ; Online: Are Manufacturing Patents to Blame for Biosimilar Market Launch Delays?

Williamson, Rhys / Munro, Trent / Ascher, David / Robertson, Avril / Pregelj, Lisette

Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research

2023 Volume 27, Issue 3, Page(s) 287–293

Abstract: Objectives: Biosimilar market launch delays are likely costing healthcare systems billions of dollars and preventing patients accessing affordable biologic therapies sooner. Many claim these delays are mostly caused by originator biologics' large patent ...

Abstract	Objectives: Biosimilar market launch delays are likely costing healthcare systems billions of dollars and preventing patients accessing affordable biologic therapies sooner. Many claim these delays are mostly caused by originator biologics' large patent portfolios asserted during litigation against biosimilar developers, particularly that the manufacturing patents filed after the originator is approved is an important driver of these delays. Our objective was to investigate the accuracy of these claims. Methods: We reviewed US Court document submissions for litigation data, including the details of patents asserted against biosimilar owners, and collated biosimilar market launch dates from publicly available databases. Results: We find that, although approximately half of all patents asserted in litigation were manufacturing patents, a greater proportion of composition, active pharmaceutical ingredient, and treatment patents are associated with longer market launch delays, whereas a greater proportion of manufacturing patents are associated with shorter market launch delays. Conclusions: Our results suggest that manufacturing patents were having less of an impact on market launch delays than other types of patents. Our findings have implications for both biosimilar and originator developers, as well as patent policy and its association with healthcare accessibility.
MeSH term(s)	Humans ; Biosimilar Pharmaceuticals ; Commerce ; Costs and Cost Analysis
Chemical Substances	Biosimilar Pharmaceuticals
Language	English
Publishing date	2023-12-21
Publishing country	United States
Document type	Review ; Journal Article
ZDB-ID	1471745-1
ISSN	1524-4733 ; 1098-3015
ISSN (online)	1524-4733
ISSN	1098-3015
DOI	10.1016/j.jval.2023.12.005
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Zs.A 5904: Show issues

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Article ; Online: The potential of long noncoding RNA therapies.

Mercer, Tim R / Munro, Trent / Mattick, John S

Trends in pharmacological sciences

2022 Volume 43, Issue 4, Page(s) 269–280

Abstract: The human genome expresses vast numbers of long noncoding RNAs (lncRNA) that fulfil diverse roles in gene regulation, cell biology, development, and human disease. These roles are often mediated by sequence motifs and secondary structures bound by ... ...

Abstract	The human genome expresses vast numbers of long noncoding RNAs (lncRNA) that fulfil diverse roles in gene regulation, cell biology, development, and human disease. These roles are often mediated by sequence motifs and secondary structures bound by proteins and can regulate epigenetic, transcriptional, and translational pathways. These functional domains can be further optimised and engineered into RNA devices that are widely used in synthetic biology. We propose that natural lncRNA structures can be explored and exploited for the rational design and assembly of synthetic RNA therapies. This potential has been enabled by advances in the stability, immunogenicity, manufacture, and delivery of other RNA-based therapies, from which we can anticipate the pharmacological properties of lncRNA therapies that have not yet otherwise entered clinical trials.
MeSH term(s)	Gene Expression Regulation ; Genome, Human ; Humans ; RNA, Long Noncoding/genetics
Chemical Substances	RNA, Long Noncoding
Language	English
Publishing date	2022-02-10
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	282846-7
ISSN	1873-3735 ; 0165-6147
ISSN (online)	1873-3735
ISSN	0165-6147
DOI	10.1016/j.tips.2022.01.008
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Article ; Online: Amino acid degradation pathway inhibitory by-products trigger apoptosis in CHO cells.

Martínez, Verónica S / Rodriguez, Karen / McCubbin, Timothy / Tong, Junjie / Mahler, Stephen / Shave, Evan / Baker, Kym / Munro, Trent P / Marcellin, Esteban

Biotechnology journal

2024 Volume 19, Issue 2, Page(s) e2300338

Abstract: Chinese hamster ovary (CHO) cells are widely used to produce complex biopharmaceuticals. Improving their productivity is necessary to fulfill the growing demand for such products. One way to enhance productivity is by cultivating cells at high densities, ...

Abstract	Chinese hamster ovary (CHO) cells are widely used to produce complex biopharmaceuticals. Improving their productivity is necessary to fulfill the growing demand for such products. One way to enhance productivity is by cultivating cells at high densities, but inhibitory by-products, such as metabolite derivatives from amino acid degradation, can hinder achieving high cell densities. This research examines the impact of these inhibitory by-products on high-density cultures. We cultured X1 and X2 CHO cell lines in a small-scale semi-perfusion system and introduced a mix of inhibitory by-products on day 10. The X1 and X2 cell lines were chosen for their varied responses to the by-products; X2 was susceptible, while X1 survived. Proteomics revealed that the X2 cell line presented changes in the proteins linked to apoptosis regulation, cell building block synthesis, cell growth, DNA repair, and energy metabolism. We later used the AB cell line, an apoptosis-resistant cell line, to validate the results. AB behaved similar to X1 under stress. We confirmed the activation of apoptosis in X2 using a caspase assay. This research provides insights into the mechanisms of cell death triggered by inhibitory by-products and can guide the optimization of CHO cell culture for biopharmaceutical manufacturing.
MeSH term(s)	Cricetinae ; Animals ; Cricetulus ; CHO Cells ; Apoptosis/genetics ; Cell Proliferation ; Amino Acids
Chemical Substances	Amino Acids
Language	English
Publishing date	2024-02-17
Publishing country	Germany
Document type	Journal Article
ZDB-ID	2221885-3
ISSN	1860-7314 ; 1860-6768
ISSN (online)	1860-7314
ISSN	1860-6768
DOI	10.1002/biot.202300338
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Article ; Online: Strategies for developing a recombinant butyrylcholinesterase medical countermeasure for Organophosphorus poisoning.

Allard, Joanne L / Shields, Katherine A / Munro, Trent P / Lua, Linda H L

Chemico-biological interactions

2022 Volume 363, Page(s) 109996

Abstract: Organophosphorus nerve agents represent a serious chemical threat due to their ease of production and scale of impact. The recent use of the nerve agent Novichok has re-emphasised the need for broad-spectrum medical countermeasures (MCMs) to these agents. ...

Abstract	Organophosphorus nerve agents represent a serious chemical threat due to their ease of production and scale of impact. The recent use of the nerve agent Novichok has re-emphasised the need for broad-spectrum medical countermeasures (MCMs) to these agents. However, current MCMs are limited. Plasma derived human butyrylcholinesterase (huBChE) is a promising novel bioscavenger MCM strategy, but is prohibitively expensive to isolate from human plasma at scale. Efforts to produce recombinant huBChE (rBChE) in various protein expression platforms have failed to achieve key critical attributes of huBChE such as circulatory half-life. These proteins often lack critical features such as tetrameric structure and requisite post-translational modifications. This review evaluates previous attempts to generate rBChE and assesses recent advances in mammalian cell expression and protein engineering strategies that could be deployed to achieve the required half-life and yield for a viable rBChE MCM. This includes the addition of a proline-rich attachment domain, fusion proteins, post translational modifications, expression system selection and optimised downstream processes. Whilst challenges remain, a combinatorial application of these strategies demonstrates potential as a technically feasible approach to achieving a bioactive and cost effective bioscavenger MCM.
MeSH term(s)	Animals ; Butyrylcholinesterase/chemistry ; Humans ; Mammals/metabolism ; Medical Countermeasures ; Nerve Agents ; Organophosphate Poisoning/drug therapy ; Organophosphorus Compounds ; Recombinant Proteins/chemistry
Chemical Substances	Nerve Agents ; Organophosphorus Compounds ; Recombinant Proteins ; Butyrylcholinesterase (EC 3.1.1.8)
Language	English
Publishing date	2022-05-30
Publishing country	Ireland
Document type	Journal Article ; Review
ZDB-ID	218799-1
ISSN	1872-7786 ; 0009-2797
ISSN (online)	1872-7786
ISSN	0009-2797
DOI	10.1016/j.cbi.2022.109996
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Zs.A 686: Show issues

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Article ; Online: Introduction to special section on using pools to generate Good Laboratory Practice tox or other non-clinical material to accelerate development timelines.

DeMaria, Christine / Munro, Trent

Biotechnology progress

2017 Volume 33, Issue 6, Page(s) 1435

MeSH term(s)	Animals ; Biotechnology/trends ; CHO Cells/drug effects ; CHO Cells/metabolism ; Cricetulus ; Drug Therapy/trends ; Drug-Related Side Effects and Adverse Reactions/metabolism ; Humans ; Toxicology/trends
Language	English
Publishing date	2017
Publishing country	United States
Document type	Editorial
ZDB-ID	165657-0
ISSN	1520-6033 ; 8756-7938
ISSN (online)	1520-6033
ISSN	8756-7938
DOI	10.1002/btpr.2583
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Zs.A 4253: Show issues

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Article: Working Hard or Hardly Working? Regulatory Bottlenecks in Developing a COVID-19 Vaccine

Pregelj, Lisette / Hine, Damian C / Oyola-Lozada, Maria G / Munro, Trent P

Trends in biotechnology. 2020 Sept., v. 38, no. 9

2020

Abstract: Vaccine solutions rarely reach the public until after an outbreak abates; an Ebola vaccine was approved 5 years after peak outbreak and SARS, MERS, and Zika vaccines are still in clinical development. Despite massive leaps forward in rapid science, other ...

Abstract	Vaccine solutions rarely reach the public until after an outbreak abates; an Ebola vaccine was approved 5 years after peak outbreak and SARS, MERS, and Zika vaccines are still in clinical development. Despite massive leaps forward in rapid science, other regulatory bottlenecks are hamstringing the global effort for pandemic vaccines.
Keywords	COVID-19 infection ; biotechnology ; pandemic ; vaccines
Language	English
Dates of publication	2020-09
Size	p. 943-947.
Publishing place	Elsevier Ltd
Document type	Article
Note	NAL-AP-2-clean
ZDB-ID	47474-5
ISSN	1879-3096 ; 0167-7799
ISSN (online)	1879-3096
ISSN	0167-7799
DOI	10.1016/j.tibtech.2020.06.004
Database	NAL-Catalogue (AGRICOLA)

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Article ; Online: Harnessing metabolic plasticity in CHO cells for enhanced perfusion cultivation.

Nöbel, Matthias / Barry, Craig / MacDonald, Michael A / Baker, Kym / Shave, Evan / Mahler, Stephen / Munro, Trent / Martínez, Verónica S / Nielsen, Lars K / Marcellin, Esteban

Biotechnology and bioengineering

2023 Volume 121, Issue 4, Page(s) 1371–1383

Abstract: Chinese Hamster Ovary (CHO) cells have rapidly become a cornerstone in biopharmaceutical production. Recently, a reinvigoration of perfusion culture mode in CHO cell cultivation has been observed. However, most cell lines currently in use have been ... ...

Abstract	Chinese Hamster Ovary (CHO) cells have rapidly become a cornerstone in biopharmaceutical production. Recently, a reinvigoration of perfusion culture mode in CHO cell cultivation has been observed. However, most cell lines currently in use have been engineered and adapted for fed-batch culture methods, and may not perform optimally under perfusion conditions. To improve the cell's resilience and viability during perfusion culture, we cultured a triple knockout CHO cell line, deficient in three apoptosis related genes BAX, BAK, and BOK in a perfusion system. After 20 days of culture, the cells exhibited a halt in cell proliferation. Interestingly, following this phase of growth arrest, the cells entered a second growth phase. During this phase, the cell numbers nearly doubled, but cell specific productivity decreased. We performed a proteomics investigation, elucidating a distinct correlation between growth arrest and cell cycle arrest and showing an upregulation of the central carbon metabolism and oxidative phosphorylation. The upregulation was partially reverted during the second growth phase, likely caused by intragenerational adaptations to stresses encountered. A phase-dependent response to oxidative stress was noted, indicating glutathione has only a secondary role during cell cycle arrest. Our data provides evidence of metabolic regulation under high cell density culturing conditions and demonstrates that cell growth arrest can be overcome. The acquired insights have the potential to not only enhance our understanding of cellular metabolism but also contribute to the development of superior cell lines for perfusion cultivation.
MeSH term(s)	Cricetinae ; Animals ; Cricetulus ; CHO Cells ; Bioreactors ; Batch Cell Culture Techniques/methods ; Perfusion
Language	English
Publishing date	2023-12-11
Publishing country	United States
Document type	Journal Article
ZDB-ID	280318-5
ISSN	1097-0290 ; 0006-3592
ISSN (online)	1097-0290
ISSN	0006-3592
DOI	10.1002/bit.28613
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Zs.B 960: Show issues

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Article ; Online: Working Hard or Hardly Working? Regulatory Bottlenecks in Developing a COVID-19 Vaccine.

Pregelj, Lisette / Hine, Damian C / Oyola-Lozada, Maria G / Munro, Trent P

Trends in biotechnology

2020 Volume 38, Issue 9, Page(s) 943–947

Abstract	Vaccine solutions rarely reach the public until after an outbreak abates; an Ebola vaccine was approved 5 years after peak outbreak and SARS, MERS, and Zika vaccines are still in clinical development. Despite massive leaps forward in rapid science, other regulatory bottlenecks are hamstringing the global effort for pandemic vaccines.
MeSH term(s)	Betacoronavirus/drug effects ; Betacoronavirus/immunology ; Betacoronavirus/pathogenicity ; COVID-19 ; COVID-19 Vaccines ; Coronavirus Infections/epidemiology ; Coronavirus Infections/immunology ; Coronavirus Infections/prevention & control ; Coronavirus Infections/virology ; Drug Approval/organization & administration ; Ebola Vaccines/administration & dosage ; Ebola Vaccines/biosynthesis ; Ebolavirus/drug effects ; Ebolavirus/immunology ; Ebolavirus/pathogenicity ; Europe/epidemiology ; Global Health/trends ; Government Regulation ; Hemorrhagic Fever, Ebola/epidemiology ; Hemorrhagic Fever, Ebola/immunology ; Hemorrhagic Fever, Ebola/prevention & control ; Hemorrhagic Fever, Ebola/virology ; Humans ; Influenza A Virus, H1N1 Subtype/genetics ; Influenza A Virus, H1N1 Subtype/immunology ; Influenza Vaccines/administration & dosage ; Influenza Vaccines/biosynthesis ; Influenza, Human/epidemiology ; Influenza, Human/immunology ; Influenza, Human/prevention & control ; Influenza, Human/virology ; Middle East Respiratory Syndrome Coronavirus/drug effects ; Middle East Respiratory Syndrome Coronavirus/immunology ; Middle East Respiratory Syndrome Coronavirus/pathogenicity ; Pandemics/prevention & control ; Pneumonia, Viral/epidemiology ; Pneumonia, Viral/immunology ; Pneumonia, Viral/prevention & control ; Pneumonia, Viral/virology ; SARS Virus/drug effects ; SARS Virus/immunology ; SARS Virus/pathogenicity ; SARS-CoV-2 ; Severe Acute Respiratory Syndrome/epidemiology ; Severe Acute Respiratory Syndrome/immunology ; Severe Acute Respiratory Syndrome/prevention & control ; Severe Acute Respiratory Syndrome/virology ; United States/epidemiology ; Viral Vaccines/administration & dosage ; Viral Vaccines/biosynthesis ; Zika Virus/drug effects ; Zika Virus/immunology ; Zika Virus/pathogenicity ; Zika Virus Infection/epidemiology ; Zika Virus Infection/immunology ; Zika Virus Infection/prevention & control ; Zika Virus Infection/virology
Chemical Substances	COVID-19 Vaccines ; Ebola Vaccines ; Influenza Vaccines ; Viral Vaccines
Keywords	covid19
Language	English
Publishing date	2020-06-13
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	47474-5
ISSN	1879-3096 ; 0167-7799
ISSN (online)	1879-3096
ISSN	0167-7799
DOI	10.1016/j.tibtech.2020.06.004
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Article ; Online: mRNA vaccine quality analysis using RNA sequencing.

Gunter, Helen M / Idrisoglu, Senel / Singh, Swati / Han, Dae Jong / Ariens, Emily / Peters, Jonathan R / Wong, Ted / Cheetham, Seth W / Xu, Jun / Rai, Subash Kumar / Feldman, Robert / Herbert, Andy / Marcellin, Esteban / Tropee, Romain / Munro, Trent / Mercer, Tim R

Nature communications

2023 Volume 14, Issue 1, Page(s) 5663

Abstract: The success of mRNA vaccines has been realised, in part, by advances in manufacturing that enabled billions of doses to be produced at sufficient quality and safety. However, mRNA vaccines must be rigorously analysed to measure their integrity and detect ...

Abstract	The success of mRNA vaccines has been realised, in part, by advances in manufacturing that enabled billions of doses to be produced at sufficient quality and safety. However, mRNA vaccines must be rigorously analysed to measure their integrity and detect contaminants that reduce their effectiveness and induce side-effects. Currently, mRNA vaccines and therapies are analysed using a range of time-consuming and costly methods. Here we describe a streamlined method to analyse mRNA vaccines and therapies using long-read nanopore sequencing. Compared to other industry-standard techniques, VAX-seq can comprehensively measure key mRNA vaccine quality attributes, including sequence, length, integrity, and purity. We also show how direct RNA sequencing can analyse mRNA chemistry, including the detection of nucleoside modifications. To support this approach, we provide supporting software to automatically report on mRNA and plasmid template quality and integrity. Given these advantages, we anticipate that RNA sequencing methods, such as VAX-seq, will become central to the development and manufacture of mRNA drugs.
MeSH term(s)	Commerce ; RNA, Messenger/genetics ; mRNA Vaccines ; Sequence Analysis, RNA
Chemical Substances	RNA, Messenger ; mRNA Vaccines
Language	English
Publishing date	2023-09-21
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2553671-0
ISSN	2041-1723 ; 2041-1723
ISSN (online)	2041-1723
ISSN	2041-1723
DOI	10.1038/s41467-023-41354-y
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