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Article ; Online: The mediating role of reflective functioning and general psychopathology in the relationship between childhood conduct disorder and adult aggression among offenders.

Yirmiya, Karen / Constantinou, Matthew / Simes, Elizabeth / Bateman, Anthony / Wason, James / Yakeley, Jessica / McMurran, Mary / Crawford, Mike / Frater, Alison / Moran, Paul / Barrett, Barbara / Cameron, Angus / Hoare, Zoe / Allison, Elizabeth / Pilling, Stephen / Butler, Stephen / Fonagy, Peter

Psychological medicine

2024 , Page(s) 1–12

Abstract: Background: The nature of the pathway from conduct disorder (CD) in adolescence to antisocial behavior in adulthood has been debated and the role of certain mediators remains unclear. One perspective is that CD forms part of a general psychopathology ... ...

Abstract	Background: The nature of the pathway from conduct disorder (CD) in adolescence to antisocial behavior in adulthood has been debated and the role of certain mediators remains unclear. One perspective is that CD forms part of a general psychopathology dimension, playing a central role in the developmental trajectory. Impairment in reflective functioning (RF), i.e., the capacity to understand one's own and others' mental states, may relate to CD, psychopathology, and aggression. Here, we characterized the structure of psychopathology in adult male-offenders and its role, along with RF, in mediating the relationship between CD in their adolescence and current aggression. Methods: A secondary analysis of pre-treatment data from 313 probation-supervised offenders was conducted, and measures of CD symptoms, general and specific psychopathology factors, RF, and aggression were evaluated through clinical interviews and questionnaires. Results: Confirmatory factor analyses indicated that a bifactor model best fitted the sample's psychopathology structure, including a general psychopathology factor (p factor) and five specific factors: internalizing, disinhibition, detachment, antagonism, and psychoticism. The structure of RF was fitted to the data using a one-factor model. According to our mediation model, CD significantly predicted the p factor, which was positively linked to RF impairments, resulting in increased aggression. Conclusions: These findings highlight the critical role of a transdiagnostic approach provided by RF and general psychopathology in explaining the link between CD and aggression. Furthermore, they underscore the potential utility of treatments focusing on RF, such as mentalization-based treatment, in mitigating aggression in offenders with diverse psychopathologies.
Language	English
Publishing date	2024-04-02
Publishing country	England
Document type	Journal Article
ZDB-ID	217420-0
ISSN	1469-8978 ; 0033-2917
ISSN (online)	1469-8978
ISSN	0033-2917
DOI	10.1017/S003329172400062X
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Article ; Online: The use of a surface active agent in the protection of a fusion protein during bioprocessing.

Blas, Peter / Tolner, Berend / Ward, John / Chester, Kerry / Hoare, Mike

Biotechnology and bioengineering

2018 Volume 115, Issue 11, Page(s) 2760–2770

Abstract: The bioprocessing of a fusion protein is characterised by low yields and at a series of recovery and purification stages that leads to an overall 90% loss. Much of this apparent loss is due to the denaturation of a protein, missing a vital affinity ... ...

Abstract	The bioprocessing of a fusion protein is characterised by low yields and at a series of recovery and purification stages that leads to an overall 90% loss. Much of this apparent loss is due to the denaturation of a protein, missing a vital affinity ligand. However, there is evidence of the protection of degradation products which occurs in the presence of shear plus air/liquid interfaces. This study seeks out to characterise the loss and use ultra-scale-down studies to predict its occurrence and hence shows these may be diminished by the use of protective reagents such as Pluronic F68.
MeSH term(s)	Bioreactors ; Pichia/growth & development ; Pichia/metabolism ; Poloxamer/metabolism ; Protein Denaturation ; Recombinant Fusion Proteins/chemistry ; Recombinant Fusion Proteins/isolation & purification ; Recombinant Fusion Proteins/metabolism ; Surface-Active Agents/metabolism
Chemical Substances	Recombinant Fusion Proteins ; Surface-Active Agents ; Poloxamer (106392-12-5)
Language	English
Publishing date	2018-09-08
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.26817
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Article ; Online: Randomised controlled trial of population screening for atrial fibrillation in people aged 70 years and over to reduce stroke: protocol for the SAFER trial.

Mant, Jonathan / Modi, Rakesh N / Dymond, Andrew / Armstrong, Natalie / Burt, Jenni / Calvert, Peter / Cowie, Martin / Ding, Wern Yew / Edwards, Duncan / Freedman, Ben / Griffin, Simon J / Hoare, Sarah / Hobbs, F D Richard / Johnson, Rachel / Kaptoge, Stephen / Lip, Gregory Y H / Lobban, Trudie / Lown, Mark / Lund, Jenny /

McManus, Richard J / Mills, Mark T / Morris, Stephen / Powell, Alison / Proietti, Riccardo / Sutton, Stephen / Sweeting, Mike / Thom, Howard / Williams, Kate

BMJ open

2024 Volume 14, Issue 4, Page(s) e082047

Abstract: Introduction: There is a lack of evidence that the benefits of screening for atrial fibrillation (AF) outweigh the harms. Following the completion of the Screening for Atrial Fibrillation with ECG to Reduce stroke (SAFER) pilot trial, the aim of the ... ...

Abstract	Introduction: There is a lack of evidence that the benefits of screening for atrial fibrillation (AF) outweigh the harms. Following the completion of the Screening for Atrial Fibrillation with ECG to Reduce stroke (SAFER) pilot trial, the aim of the main SAFER trial is to establish whether population screening for AF reduces incidence of stroke risk. Methods and analysis: Approximately 82 000 people aged 70 years and over and not on oral anticoagulation are being recruited from general practices in England. Patients on the palliative care register or residents in a nursing home are excluded. Eligible people are identified using electronic patient records from general practices and sent an invitation and consent form to participate by post. Consenting participants are randomised at a ratio of 2:1 (control:intervention) with clustering by household. Those randomised to the intervention arm are sent an information leaflet inviting them to participate in screening, which involves use of a handheld single-lead ECG four times a day for 3 weeks. ECG traces identified by an algorithm as possible AF are reviewed by cardiologists. Participants with AF are seen by a general practitioner for consideration of anticoagulation. The primary outcome is stroke. Major secondary outcomes are: death, major bleeding and cardiovascular events. Follow-up will be via electronic health records for an average of 4 years. The primary analysis will be by intention-to-treat using time-to-event modelling. Results from this trial will be combined with follow-up data from the cluster-randomised pilot trial by fixed-effects meta-analysis. Ethics and dissemination: The London-Central National Health Service Research Ethics Committee (19/LO/1597) provided ethical approval. Dissemination will include public-friendly summaries, reports and engagement with the UK National Screening Committee. Trial registration number: ISRCTN72104369.
MeSH term(s)	Humans ; Atrial Fibrillation/diagnosis ; Atrial Fibrillation/complications ; Aged ; Stroke/prevention & control ; Mass Screening/methods ; Electrocardiography ; England/epidemiology ; Female ; Male ; Randomized Controlled Trials as Topic ; Aged, 80 and over ; Anticoagulants/therapeutic use
Chemical Substances	Anticoagulants
Language	English
Publishing date	2024-04-25
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Clinical Trial Protocol ; Randomized Controlled Trial
ZDB-ID	2599832-8
ISSN	2044-6055 ; 2044-6055
ISSN (online)	2044-6055
ISSN	2044-6055
DOI	10.1136/bmjopen-2023-082047
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Article ; Online: Enhancing the selective extracellular location of a recombinant E. coli domain antibody by management of fermentation conditions.

Voulgaris, Ioannis / Finka, Gary / Uden, Mark / Hoare, Mike

Applied microbiology and biotechnology

2015 Volume 99, Issue 20, Page(s) 8441–8453

Abstract: The preparation of a recombinant protein using Escherichia coli often involves a challenging primary recovery sequence. This is due to the inability to secrete the protein to the extracellular space without a significant degree of cell lysis. This ... ...

Abstract	The preparation of a recombinant protein using Escherichia coli often involves a challenging primary recovery sequence. This is due to the inability to secrete the protein to the extracellular space without a significant degree of cell lysis. This results in the release of nucleic acids, leading to a high viscosity, difficulty to clarify, broth and also to contamination with cell materials such as lipopolysaccharides and host cell proteins. In this paper, we present different fermentation strategies to facilitate the recovery of a V H domain antibody (13.1 kDa) by directing it selectively to the extracellular space and changing the balance between domain antibody to nucleic acid release. The manipulation of the cell growth rate in order to increase the outer cell membrane permeability gave a small ~1.5-fold improvement in released domain antibody to nucleic acid ratio without overall loss of yield. The introduction during fermentation of release agents such as EDTA gave no improvement in the ratio of released domain antibody to nucleic acid and a loss of overall productivity. The use of polyethyleneimine (PEI) during fermentation was with the aim to (a) permeabilise the outer bacterial membrane to release selectively domain antibody and (b) remove selectively by precipitation nucleic acids released during cell lysis. This strategy resulted in up to ~4-fold increase in the ratio of domain antibody to soluble nucleic acid with no reduction in domain antibody overall titre. In addition, a reduction in host cell protein contamination was achieved and there was no increase in endotoxin levels. Similar results were demonstrated with a range of other antibody products prepared in E. coli.
MeSH term(s)	Antibodies/genetics ; Antibodies/metabolism ; Culture Media/chemistry ; Escherichia coli/drug effects ; Escherichia coli/genetics ; Escherichia coli/growth & development ; Escherichia coli/metabolism ; Fermentation ; Permeability/drug effects ; Polyethyleneimine/metabolism ; Protein Transport ; Recombinant Proteins/genetics ; Recombinant Proteins/secretion
Chemical Substances	Antibodies ; Culture Media ; Recombinant Proteins ; Polyethyleneimine (9002-98-6)
Language	English
Publishing date	2015-10
Publishing country	Germany
Document type	Journal Article
ZDB-ID	392453-1
ISSN	1432-0614 ; 0171-1741 ; 0175-7598
ISSN (online)	1432-0614
ISSN	0171-1741 ; 0175-7598
DOI	10.1007/s00253-015-6799-3
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Article ; Online: Evaluation of options for harvest of a recombinant E. Coli fermentation producing a domain antibody using ultra scale-down techniques and pilot-scale verification.

Voulgaris, Ioannis / Chatel, Alex / Hoare, Mike / Finka, Gary / Uden, Mark

Biotechnology progress

2016 Volume 32, Issue 2, Page(s) 382–392

Abstract: Ultra scale-down (USD) methods operating at the millilitre scale were used to characterise full-scale processing of E. coli fermentation broths autolysed to different extents for release of a domain antibody. The focus was on the primary clarification ... ...

Abstract	Ultra scale-down (USD) methods operating at the millilitre scale were used to characterise full-scale processing of E. coli fermentation broths autolysed to different extents for release of a domain antibody. The focus was on the primary clarification stages involving continuous centrifugation followed by depth filtration. The performance of this sequence was predicted by USD studies to decrease significantly with increased extents of cell lysis. The use of polyethyleneimine reagent was studied to treat the lysed cell broth by precipitation of soluble contaminants such as DNA and flocculation of cell debris material. The USD studies were used to predict the impact of this treatment on the performance and here it was found that the fermentation could be run to maximum productivity using an acceptable clarification process (e.g., a centrifugation stage operating at 0.11 L/m(2) equivalent gravity settling area per hour followed by a resultant required depth filter area of 0.07 m(2) /L supernatant). A range of USD predictions was verified at the pilot scale for centrifugation followed by depth filtration. © 2015 American Institute of Chemical Engineers Biotechnol. Prog., 32:382-392, 2016.
Language	English
Publishing date	2016-03
Publishing country	United States
Document type	Journal Article
ZDB-ID	165657-0
ISSN	1520-6033 ; 8756-7938
ISSN (online)	1520-6033
ISSN	8756-7938
DOI	10.1002/btpr.2220
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Article: Liposome Sterile Filtration Characterization via X-ray Computed Tomography and Confocal Microscopy.

Johnson, Thomas F / Jones, Kyle / Iacoviello, Francesco / Turner, Stephen / Jackson, Nigel B / Zourna, Kalliopi / Welsh, John H / Shearing, Paul R / Hoare, Mike / Bracewell, Daniel G

Membranes

2021 Volume 11, Issue 11

Abstract: Two high resolution, 3D imaging techniques were applied to visualize and characterize sterilizing grade dual-layer filtration of liposomes, enabling membrane structure to be related with function and performance. Two polyethersulfone membranes with ... ...

Abstract	Two high resolution, 3D imaging techniques were applied to visualize and characterize sterilizing grade dual-layer filtration of liposomes, enabling membrane structure to be related with function and performance. Two polyethersulfone membranes with nominal retention ratings of 650 nm and 200 nm were used to filter liposomes of an average diameter of 143 nm and a polydispersity index of 0.1. Operating conditions including differential pressure were evaluated. X-ray computed tomography at a pixel size of 63 nm was capable of resolving the internal geometry of each membrane. The respective asymmetry and symmetry of the upstream and downstream membranes could be measured, with pore network modeling used to identify pore sizes as a function of distance through the imaged volume. Reconstructed 3D digital datasets were the basis of tortuous flow simulation through each porous structure. Confocal microscopy visualized liposome retention within each membrane using fluorescent dyes, with bacterial challenges also performed. It was found that increasing pressure drop from 0.07 MPa to 0.21 MPa resulted in differing fluorescent retention profiles in the upstream membrane. These results highlighted the capability for complementary imaging approaches to deepen understanding of liposome sterilizing grade filtration.
Language	English
Publishing date	2021-11-22
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2614641-1
ISSN	2077-0375
ISSN	2077-0375
DOI	10.3390/membranes11110905
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Article ; Online: Superiority and cost-effectiveness of monthly extended-release buprenorphine versus daily standard of care medication: a pragmatic, parallel-group, open-label, multicentre, randomised, controlled, phase 3 trial.

EClinicalMedicine

2023 Volume 66, Page(s) 102311

Abstract: Background: Daily methadone maintenance or buprenorphine treatment is the standard-of-care (SoC) medication for opioid use disorder (OUD). Subcutaneously injected, extended-release buprenorphine (BUP-XR) may be more effective-but there has been no ... ...

Abstract	Background: Daily methadone maintenance or buprenorphine treatment is the standard-of-care (SoC) medication for opioid use disorder (OUD). Subcutaneously injected, extended-release buprenorphine (BUP-XR) may be more effective-but there has been no superiority evaluation. Methods: This pragmatic, parallel-group, open-label, multi-centre, effectiveness superiority randomised, controlled, phase 3 trial was conducted at five National Health Service community-based treatment clinics in England and Scotland. Participants (adults aged ≥ 18 years; all meeting DSM-5 diagnostic criteria for moderate or severe OUD at admission to their current maintenance treatment episode) were randomly assigned (1:1) to receive continued daily SoC (liquid methadone (usual dose range: 60-120 mg) or sublingual/transmucosal buprenorphine (usual dose range: 8-24 mg) for 24 weeks; or monthly BUP-XR (Sublocade;® two injections of 300 mg, then four maintenance injections of 100 mg or 300 mg, with maintenance dose selected by response and preference) for 24 weeks. In the intent-to-treat population (senior statistician blinded to blinded to treatment group allocation), and with a seven-day grace period after randomisation, the primary endpoint was the count of days abstinent from non-medical opioids between days 8-168 (i.e., weeks 2-24; range: 0-161 days). Safety was reported for the intention-to- treat population. Adopting a broad societal perspective inclusive of criminal justice, NHS and personal social service costs, a trial-based cost-utility analysis estimated the Incremental Cost-effectiveness Ratio (ICER) per quality-adjusted life year (QALY) of BUP-XR versus SoC at the National Institute for Health and Care Excellence threshold. The study was registered EudraCT (2018-004460-63) and ClinicalTrials.gov (NCT05164549), and is completed. Findings: Between Aug 9, 2019 and Nov 2, 2021, 314 participants were randomly allocated to receive SoC (n = 156) or BUP-XR (n = 158). Participants were abstinent from opioids for an adjusted mean of 104.37 days (standard error [SE] 9.89; range: 0-161 days) in the SoC group and an adjusted mean of 123.43 days (SE 4.76; range: 24-161 days) in the BUP-XR group (adjusted incident rate ratio [IRR] 1.18, 95% confidence interval [CI] 1.05-1.33; p-value 0.004). The incidence of any adverse event was higher in the BUP-XR group than the SoC group (128 [81.0%] of 158 participants versus 67 [42.9%] of 156 participants, respectively-most commonly rapidly-resolving (mild-moderate range) pain from drug administration in the BUP-XR group (121 [26.9%] of 450 adverse events). There were 11 serious adverse events (7.0%) in the 158 participants in the BUP-XR group, and 18 serious adverse events (11.5%) in the 156 participants in the SoC group-none judged to be related to study treatment. The BUP-XR treatment group had a mean incremental cost of £1033 (95% central range [CR] -1189 to 3225) and was associated with a mean incremental QALY of 0.02 (95% CR 0.00-0.05), and an ICER of £47,540 (0.37 probability of being cost-effective at the £30,000/QALY gained willingness-to-pay threshold). However, BUP-XR dominated the SoC among participants who were rated more severe at study baseline, and among participants in maintenance treatment for more that 28 days at study enrolment. Interpretation: Evaluated against the daily oral SoC, monthly BUP-XR is clinically superior, delivering greater abstinence from opioids, and with a comparable safety profile. BUP-XR was not cost-effective in a base case cost-utility analysis using the societal perspective, but it was more effective and less costly (dominant) among participants with more severe OUD, or those whose current treatment episode was longer than 28 days. Further trials are needed to evaluate if BUP-XR is associated with better clinical and health economic outcomes over the longer term. Funding: Indivior.
Language	English
Publishing date	2023-11-17
Publishing country	England
Document type	Journal Article
ISSN	2589-5370
ISSN (online)	2589-5370
DOI	10.1016/j.eclinm.2023.102311
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Article ; Online: Ultra scale-down characterization of the impact of conditioning methods for harvested cell broths on clarification by continuous centrifugation-Recovery of domain antibodies from rec E. coli.

Chatel, Alex / Kumpalume, Peter / Hoare, Mike

Biotechnology and bioengineering

2013 Volume 111, Issue 5, Page(s) 913–924

Abstract: The processing of harvested E. coli cell broths is examined where the expressed protein product has been released into the extracellular space. Pre-treatment methods such as freeze-thaw, flocculation, and homogenization are studied. The resultant ... ...

Abstract	The processing of harvested E. coli cell broths is examined where the expressed protein product has been released into the extracellular space. Pre-treatment methods such as freeze-thaw, flocculation, and homogenization are studied. The resultant suspensions are characterized in terms of the particle size distribution, sensitivity to shear stress, rheology and solids volume fraction, and, using ultra scale-down methods, the predicted ability to clarify the material using industrial scale continuous flow centrifugation. A key finding was the potential of flocculation methods both to aid the recovery of the particles and to cause the selective precipitation of soluble contaminants. While the flocculated material is severely affected by process shear stress, the impact on the very fine end of the size distribution is relatively minor and hence the predicted performance was only diminished to a small extent, for example, from 99.9% to 99.7% clarification compared with 95% for autolysate and 65% for homogenate at equivalent centrifugation conditions. The lumped properties as represented by ultra scale-down centrifugation results were correlated with the basic properties affecting sedimentation including particle size distribution, suspension viscosity, and solids volume fraction. Grade efficiency relationships were used to allow for the particle and flow dynamics affecting capture in the centrifuge. The size distribution below a critical diameter dependent on the broth pre-treatment type was shown to be the main determining factor affecting the clarification achieved.
MeSH term(s)	Biotechnology ; Centrifugation/methods ; Culture Media, Conditioned ; Escherichia coli/genetics ; Escherichia coli/metabolism ; Flocculation ; Particle Size ; Recombinant Proteins/chemistry ; Recombinant Proteins/isolation & purification ; Single-Domain Antibodies/chemistry ; Single-Domain Antibodies/isolation & purification
Chemical Substances	Culture Media, Conditioned ; Recombinant Proteins ; Single-Domain Antibodies
Language	English
Publishing date	2013-12-28
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	280318-5
ISSN	1097-0290 ; 0006-3592
ISSN (online)	1097-0290
ISSN	0006-3592
DOI	10.1002/bit.25164
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Article: The clinical effectiveness and cost effectiveness of clozapine for inpatients with severe borderline personality disorder (CALMED study): a randomised placebo-controlled trial.

Therapeutic advances in psychopharmacology

2022 Volume 12, Page(s) 20451253221090832

Abstract: Background: Data from case series suggest that clozapine may benefit inpatients with borderline personality disorder (BPD), but randomised trials have not been conducted.: Methods: Multicentre, double-blind, placebo-controlled trial. We aimed to ... ...

Abstract	Background: Data from case series suggest that clozapine may benefit inpatients with borderline personality disorder (BPD), but randomised trials have not been conducted. Methods: Multicentre, double-blind, placebo-controlled trial. We aimed to recruit 222 inpatients with severe BPD aged 18 or over, who had failed to respond to other antipsychotic medications. We randomly allocated participants on a 1:1 ratio to receive up to 400 mg of clozapine per day or an inert placebo using a remote web-based randomisation service. The primary outcome was total score on the Zanarini Rating scale for Borderline Personality Disorder (ZAN-BPD) at 6 months. Secondary outcomes included self-harm, aggression, resource use and costs, side effects and adverse events. We used a modified intention to treat analysis (mITT) restricted to those who took one or more dose of trial medication, using a general linear model fitted at 6 months adjusted for baseline score, allocation group and site. Results: The study closed early due to poor recruitment and the impact of the COVID-19 pandemic. Of 29 study participants, 24 (83%) were followed up at 6 months, of whom 21 (72%) were included in the mITT analysis. At 6 months, 11 (73%) participants assigned to clozapine and 6 (43%) of those assigned to placebo were still taking trial medication. Adjusted difference in mean total ZAN-BPD score at 6 months was -3.86 (95% Confidence Intervals = -10.04 to 2.32). There were 14 serious adverse events; 6 in the clozapine arm and 8 in the placebo arm of the trial. There was little difference in the cost of care between groups. Interpretation: We recruited insufficient participants to test the primary hypothesis. The study findings highlight problems in conducting placebo-controlled trials of clozapine and in using clozapine for people with BPD, outside specialist inpatient mental health units. Trial registration: ISRCTN18352058. https://doi.org/10.1186/ISRCTN18352058.
Language	English
Publishing date	2022-04-29
Publishing country	England
Document type	Journal Article
ZDB-ID	2646542-5
ISSN	2045-1261 ; 2045-1253
ISSN (online)	2045-1261
ISSN	2045-1253
DOI	10.1177/20451253221090832
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Article: Regenerative medicine bioprocessing: building a conceptual framework based on early studies.

Mason, Chris / Hoare, Mike

Tissue engineering

2007 Volume 13, Issue 2, Page(s) 301–311

Abstract: This paper reviews early studies of regenerative medicine using human cells and engineered tissues progressing from a laboratory-centered manual procedure toward automated manufacture. It then examines the distinctive bioprocesses by which autologous ... ...

Abstract	This paper reviews early studies of regenerative medicine using human cells and engineered tissues progressing from a laboratory-centered manual procedure toward automated manufacture. It then examines the distinctive bioprocesses by which autologous human material must be produced, the degree of simplification allowed by use of allogeneic cell lines and engineered tissue derived from them, and issues that affect both cell types. The paper concludes by drawing upon this discussion to suggest some factors that will determine how regenerative medicine bioprocessing can progress to provide many units of material economically.
MeSH term(s)	Cell Culture Techniques/methods ; Cell Culture Techniques/trends ; Regeneration ; Regenerative Medicine/methods ; Regenerative Medicine/trends ; Tissue Engineering/methods ; Tissue Engineering/trends
Language	English
Publishing date	2007-02
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Review
ZDB-ID	1310000-2
ISSN	1557-8690 ; 1076-3279
ISSN (online)	1557-8690
ISSN	1076-3279
DOI	10.1089/ten.2006.0177
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