scholarly journals Manufacturing readiness assessment for evaluation of the microneedle array patch industry: an exploration of barriers to full-scale manufacturing

2021 ◽  
Author(s):  
Ben Creelman ◽  
Collrane Frivold ◽  
Sierra Jessup ◽  
Gene Saxon ◽  
Courtney Jarrahian
Keyword(s):  
Full Scale ◽  
Investment Risk ◽  
Microneedle Array ◽  
Product Lines ◽  
Readiness Assessment ◽  
Contract Manufacturing ◽  
Production Methods ◽  
Manufacturing Organizations ◽  
Manufacturing Readiness

AbstractMicroneedle array patch (MAP) technology is a promising new delivery technology for vaccines and pharmaceuticals, yet due to several differing and novel production methods, barriers to full-scale manufacturing exist. PATH conducted a manufacturing readiness assessment and follow-up interviews to identify both the current manufacturing readiness of the industry as well as how readiness varies by developer type and MAP type. Follow-up interviews identified barriers the industry faces in reaching full manufacturing readiness, including the perceived regulatory and investment risk of manufacturing MAPs at scale due to quality requirements and control methods, uncertain sterility requirements, lack of standard production methods (especially around dissolvable MAP drying methods), and the lack of available contract manufacturing organizations with MAP manufacturing capabilities. A Regulatory Working Group has been established to identify and address critical quality issues specific to MAP manufacturing with the aim of providing developers insight into what will be expected for MAP product approvals. Standardizing MAP production equipment and automatic, visual quality control could reduce the overall investment risk to developers and contract manufacturing organizations in pursuing pilot-scale manufacturing capabilities and ultimately lower barriers to the scale-up of full medical MAP product lines. Graphical abstract

scholarly journals Manufacturing Readiness Assessment for Evaluation of the Microarray Patch Industry: An Exploration of Barriers to Full-Scale Manufacturing

2021 ◽  
Author(s):  
Ben Creelman ◽  
Collrane Frivold ◽  
Sierra Jessup ◽  
Gene Saxon ◽  
Courtney Jarrahian
Keyword(s):  
Scale Up ◽  
Full Scale ◽  
Drying Methods ◽  
Product Lines ◽  
Readiness Assessment ◽  
Contract Manufacturing ◽  
Production Methods ◽  
Manufacturing Organizations ◽  
Manufacturing Readiness

Abstract Microarray patch (MAP) technology is a promising new delivery technology for vaccines and pharmaceuticals. Yet due to several differing and novel production methods, barriers to full-scale manufacturing exist. PATH conducted a manufacturing readiness assessment and follow-up interviews to identify both the current manufacturing readiness of the industry as well as how readiness varies by developer type and MAP type. Follow-up interviews identified barriers the industry faces in reaching full manufacturing readiness, including the perceived regulatory and investment risk of manufacturing MAPs at scale due to quality requirements and control methods, uncertain sterility requirements, lack of standard production methods (especially around dissolvable MAP drying methods), and the lack of available contract manufacturing organizations with MAP manufacturing capabilities. A Regulatory Working Group has been established to identify and address critical quality issues specific to MAP manufacturing with the aim of providing developers insight into what will be expected for MAP product approvals. Standardizing MAP production equipment and automatic, visual quality control could reduce the overall risk to developers and contract manufacturing organizations in pursuing pilot-scale manufacturing capabilities and ultimately lower barriers to the scale-up of full medical MAP product lines.

Follow-up of a full-scale network assembly

1984 ◽  
Vol 6 (2) ◽  
pp. 102-113 ◽  
Author(s):  
David W. Trimble ◽  
Jodie Kliman ◽  
Albert Villapiano ◽  
William Beckett
Keyword(s):  
Full Scale ◽  
Scale Network

Intelligence at Six Years in Relation to Neonatal Bilirubin Level: Follow-up of The National Institute of Child Health and Human Development Clinical Trial of Phototherapy

PEDIATRICS ◽  
1991 ◽  
Vol 87 (6) ◽  
pp. 797-805
Author(s):  
Peter C. Scheidt ◽  
Barry I. Graubard ◽  
Howard J. Hoffman ◽  
Dolores A. Bryla ◽  
Karin B. Nelson ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Birth Weight ◽  
Child Health ◽  
Human Development ◽  
Bilirubin Level ◽  
Controlled Trial ◽  
Full Scale ◽  
The Central Nervous System ◽  
Bilirubin Toxicity

Results of the National Institute of Child Health and Human Development Randomized Controlled Trial of Phototherapy were examined for the relationship of neonatal bilirubin level to neurological and developmental outcome at 6-year follow-up. This analysis focused on 224 control children with birth weight of less than 2000 g. Bilirubin levels were maintained below previously specified levels by the use of exchange transfusion only (24%). Rates of cerebral palsy were not significantly higher for children with elevated maximum bilirubin level than for those whose level remained low. No association was evident between maximum bilirubin level and IQ (Full Scale, Verbal, or Performance) by simple correlation analysis (r = -.087, P = .2 for Full Scale) or by multiple linear regression adjusting for factors that covary with IQ (β = -.15, P = .58). IQ was not associated with mean bilirubin level, time and duration of exposure to bilirubin, or measures of bilirubin-albumin binding. Thus, over the range of bilirubin levels permitted in this clinical trial, there was no evidence of bilirubin toxicity to the central nervous system. Measures used to control the level of bilirubin in low birth weight neonates appear to prevent effectively the risk of bilirubin-induced neurotoxicity.

scholarly journals Further Aspects of the UK Engine Technology Demonstrator Programme

1988 ◽  
Author(s):  
D. W. Hughes ◽  
W. J. Chrispin
Keyword(s):  
United Kingdom ◽  
Scale Development ◽  
Gas Turbine ◽  
Full Scale ◽  
Cost Overrun ◽  
The United Kingdom ◽  
Technology Demonstration ◽  
The Uk ◽  
Technology Demonstrator

In 1987, a paper entitled ‘The United Kingdom Engine Technology Demonstrator Programme’ (ASME 87-GT-203) was presented at the Gas Turbine Conference in Anaheim. That paper postulated that a programme of engine technology demonstration ahead of commitment to full-scale development was essential if past problems of cost overrun and inadequate performance at service entry were to be avoided. The paper concluded that the UK had established a balanced programme of technology demonstration, emphasising that Industry and Government must invest this activity with the same commitment traditionally given to projects if the full benefits were to be realised. This follow-up paper presents an expanded view of future programme objectives and how the programme elements formulated for their achievement are to be managed.

The Evolving State of Continuous Processing in Pharmaceutical API Manufacturing: A Survey of Pharmaceutical Companies and Contract Manufacturing Organizations

2018 ◽  
Vol 22 (9) ◽  
pp. 1143-1166 ◽  
Author(s):  
J. Christopher McWilliams ◽  
Ayman D. Allian ◽  
Suzanne M. Opalka ◽  
Scott A. May ◽  
Michel Journet ◽  
...  
Keyword(s):  
Pharmaceutical Companies ◽  
Continuous Processing ◽  
Contract Manufacturing ◽  
Manufacturing Organizations

Human Readiness Assessment: A Multivariate Approach

2017 ◽  
Vol 61 (1) ◽  
pp. 106-109 ◽  
Author(s):  
Andre Garcia ◽  
Neil Ganey ◽  
Jeff Wilbert
Keyword(s):  
Human Factors ◽  
Situation Awareness ◽  
Department Of Defense ◽  
Technology Readiness ◽  
Multivariate Approach ◽  
Readiness Assessment ◽  
The Us ◽  
Readiness Level ◽  
System Readiness ◽  
Manufacturing Readiness

Technology Readiness Levels (TRL) are a framework, originally created by NASA and later adopted and tailored by the US Department of Defense (Graettinger, Garcia, Siviy, Schenk, Van Syckle, 2002) to track the progress and maturity of a given technology. There are a number of derivative readiness level frameworks that have spun off the original TRL framework such as System Readiness Levels, Software Readiness Levels, Integration Readiness Levels, and Manufacturing Readiness Levels, just to name a few. Most of the time, these frameworks have an associated readiness assessment used to identify or assess the precise readiness level status. Human Readiness Levels (HRLs) are a framework used to identify the level of readiness or maturity of a given technology as it relates to its usability and its refinement to be used by a human(s) (Phillips, 2010). There are a number of HRL frameworks or similar (e.g. Human Factors Readiness Levels), yet little attention has been paid to Human Readiness Assessments (HRAs). The purpose of this paper is to review the literature of Human Readiness Levels and introduce a new multivariate Human Readiness Assessment that emphasizes workload, situation awareness (SA), and usability.

scholarly journals Long-term outcomes of resective epilepsy surgery after invasive presurgical evaluation in children with tuberous sclerosis complex and bilateral multiple lesions

2015 ◽  
Vol 15 (1) ◽  
pp. 26-33 ◽  
Author(s):  
Ravindra Arya ◽  
Jeffrey R. Tenney ◽  
Paul S. Horn ◽  
Hansel M. Greiner ◽  
Katherine D. Holland ◽  
...  
Keyword(s):  
Tuberous Sclerosis ◽  
Epilepsy Surgery ◽  
Tuberous Sclerosis Complex ◽  
Refractory Epilepsy ◽  
Full Scale ◽  
Secondary Outcome ◽  
Resective Surgery ◽  
Class 1 ◽  
Medically Refractory Epilepsy

OBJECT Tuberous sclerosis complex (TSC) with medically refractory epilepsy is characterized by multifocal brain abnormalities, traditionally indicating poor surgical candidacy. This single-center, retrospective study appraised seizurerelated, neuropsychological, and other outcomes of resective surgery in TSC patients with medically refractory epilepsy, and analyzed predictors for these outcomes. METHODS Patients with multilesional TSC who underwent epilepsy surgery between 2007 and 2012 were identified from an electronic database. All patients underwent multimodality noninvasive and subsequent invasive evaluation. Seizure outcomes were classified using the International League Against Epilepsy (ILAE) scale. The primary outcome measure was complete seizure remission (ILAE Class 1). Secondary outcome measures included 50% responder rate, change in full-scale IQ, electroencephalography improvement, and reduction in antiepileptic drug (AED) burden. RESULTS A total of 37 patients with TSC underwent resective surgery during the study period. After a mean follow-up of 5.68 ± 3.67 years, 56.8% achieved complete seizure freedom (ILAE Class 1) and 86.5% had ILAE Class 4 outcomes or better. The full-scale IQ on follow-up was significantly higher in patients with ILAE Class 1 outcome (66.70 ± 12.36) compared with those with ILAE Class 2 or worse outcomes (56.00 ± 1.41, p = 0.025). In 62.5% of the patients with ILAE Class 2 or worse outcomes, the number of AEDs were found to be significantly reduced (p = 0.004). CONCLUSIONS This study substantiates the evidence for efficacy of resective epilepsy surgery in patients with bilateral multilesional TSC. More than half of the patients were completely seizure free. Additionally, a high proportion achieved clinically meaningful reduction in seizure burden and the number of AEDs.

scholarly journals Educational attainment and trajectories of cognitive decline during four decades—The Glostrup 1914 cohort

PLoS ONE ◽  
2021 ◽  
Vol 16 (8) ◽  
pp. e0255449
Author(s):  
Kristine Harrsen ◽  
Kaare Christensen ◽  
Rikke Lund ◽  
Erik Lykke Mortensen
Keyword(s):  
Cognitive Decline ◽  
Full Scale ◽  
Community Dwelling ◽  
Clinical Test ◽  
Adult Intelligence Scale ◽  
Verbal Iq ◽  
Age Related ◽  
Formal School ◽  
Verbal Performance

Background The potential association between level of education and age-related cognitive decline remains an open question, partly because of a lack of studies including large subsamples with low education and follow-up intervals covering a substantial part of the adult lifespan. Objectives To examine cognitive decline assessed by a comprehensive clinical test of intelligence over a 35-year period of follow-up from ages 50 to 85 and to analyze the effect of education on trajectories of cognitive decline, including the effects of selective attrition. Methods A longitudinal cohort study with a 35-year follow-up of community dwelling members of the Glostrup 1914 cohort. The study sample comprised 697 men and women at the 50-year baseline assessment and additional participants recruited at later follow-ups. Verbal, Performance, and Full Scale IQs were assessed using the Wechsler Adult Intelligence Scale at ages 50, 60, 70, 80, and 85. To be able to track cognitive changes between successive WAIS assessments, all IQs were based on the Danish 50-year norms. Information on school education was self-reported. The association between education and cognitive decline over time was examined in growth curve models. Selective attrition was investigated in subsamples of participants who dropped out at early or later follow-ups. Results The trajectories for Verbal, Performance, and Full Scale IQ showed higher initial cognitive performance, but also revealed steeper decline among participants with a formal school exam compared to participants without a formal exam. Verbal IQ showed the largest difference in level between the two educational groups, whereas the interaction between education and age was stronger for Performance IQ than for Verbal IQ. In spite of the difference in trajectories, higher mean IQ was observed among participants with a formal school exam compared to those without across all ages, including the 85-year follow-up. Further analyses revealed that early dropout was associated with steeper decline, but that this effect was unrelated to education. Conclusion Comprehensive cognitive assessment over a 35-year period suggests that higher education is associated with steeper decline in IQ, but also higher mean IQ at all follow-ups. These findings are unlikely to reflect regression towards the mean, other characteristics of the employed test battery or associations between educational level and study dropout.

Sustainability assessment in manufacturing organizations

2018 ◽  
Vol 25 (3) ◽  
pp. 994-1027 ◽  
Author(s):  
Kuldip Singh Sangwan ◽  
Vikrant Bhakar ◽  
Abhijeet K. Digalwar
Keyword(s):  
Supply Chain ◽  
Life Cycle ◽  
Sustainability Assessment ◽  
Assessment Model ◽  
Critical Factors ◽  
Readiness Assessment ◽  
Content Type ◽  
Manufacturing Organizations ◽  
Manufacturing Organization ◽  
Integrated Supply Chain

Purpose The purpose of this paper is to develop a sustainability readiness assessment model and a sustainability assessment model for manufacturing organizations. Design/methodology/approach The proposed models have been developed using resource-based theory along the integrated supply chain. The models are based on resources sustainability (people, money, material, energy, infrastructure, water, and air), critical factors of sustainability (product, process and policies), sustainability dimensions (environment, economic, and social), and life cycle sustainability (integrated supply chain). Findings The paper presents an integrated assessment system which includes: product life cycle, resources, critical factors (product, process, and policy), key performance indicators, and their interrelationship with sustainability dimensions. The three critical factors and all the important resources required by a manufacturing organization along the integrated supply chain are identified. The readiness assessment model is user friendly and effective to guide the managers to identify the weak areas of sustainability. Research limitations/implications The proposed model for readiness assessment is tested and in an automotive manufacturing organization but the sustainability assessment model is conceptual and it requires validation by implementing the same in an organization to understand its effectiveness. Practical implications The readiness assessment model can help the top management to decide whether the organizational orientation is correct to improve sustainability. The easy to use models can be used by the decision/policy makers and independent bodies to assess, compare and benchmark the products, processes or organizations and thus affect public policies and attitudes. Originality/value This study has developed, for the first time, a sustainability readiness assessment model. The resource-based theory has been applied along the integrated supply chain.

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