scholarly journals Recommended Best Practices for Lyophilization Validation 2021 Part II: Process Qualification and Continued Process Verification

2021 ◽  
Vol 22 (8) ◽  
Author(s):  
Feroz Jameel ◽  
Alina Alexeenko ◽  
Akhilesh Bhambhani ◽  
Gregory Sacha ◽  
Tong Zhu ◽  
...  
Keyword(s):  
Best Practices ◽  
Process Design ◽  
Control Charts ◽  
Batch Size ◽  
Drying Time ◽  
Process Validation ◽  
Process Verification ◽  
Process Qualification ◽  
The Impact ◽  
Validation Strategy

Abstract This work describes the lyophilization process validation and consists of two parts. Part one (Part I: Process Design and Modeling) focuses on the process design and is described in the previous paper, while the current paper is devoted to process qualification and continued process verification. The goal of the study is to show the cutting edge of lyophilization validation based on the integrated community-based opinion and the industrial perspective. This study presents best practices for batch size determination and includes the effect of batch size on drying time, process parameters selection strategies, and batch size overage to compensate for losses during production. It also includes sampling strategies to demonstrate batch uniformity as well as the use of statistical models to ensure adequate sampling. Based on the LyoHUB member organizations survey, the best practices in determining the number of PPQ runs are developed including the bracketing approach with minimum and maximum loads. Standard practice around CQA and CPP selection is outlined and shows the advantages of using control charts and run charts for process trending and quality control. The case studies demonstrating the validation strategy for monoclonal antibody and the impact of the loading process on the lyophilization cycle and product quality as well as the special case of lyophilization for dual-chamber cartridge system are chosen to illustrate the process validation. The standard practices in the validation of the lyophilization process, special lyophilization processes, and their impact on the validation strategy are discussed. Graphical Abstract

scholarly journals Recommended Best Practices for Lyophilization Validation—2021 Part I: Process Design and Modeling

2021 ◽  
Vol 22 (7) ◽  
Author(s):  
Feroz Jameel ◽  
Alina Alexeenko ◽  
Akhilesh Bhambhani ◽  
Gregory Sacha ◽  
Tong Zhu ◽  
...  
Keyword(s):  
Process Design ◽  
Scale Up ◽  
Community Based ◽  
Process Verification ◽  
Fill Volume ◽  
Process Qualification ◽  
Batch Sizes ◽  
The Impact ◽  
The Relationship ◽  
Product Resistance

AbstractThis work describes lyophilization process validation and consists of two parts. Part I focuses on the process design and is described in the current paper, while part II is devoted to process qualification and continued process verification. The intent of these articles is to provide readers with recent updates on lyophilization validation in the light of community-based combined opinion on the process and reflect the industrial prospective. In this paper, the design space approach for process design is described in details, and examples from practice are provided. The approach shows the relationship between the process inputs; it is based on first principles and gives a thorough scientific understanding of process and product. The lyophilization process modeling and scale-up are also presented showing the impact of facility, equipment, and vial heat transfer coefficient. The case studies demonstrating the effect of batch sizes, fill volume, and dose strength to show the importance of modeling as well as the effect of controlled nucleation on product resistance are discussed.

scholarly journals Process Validation and Critical Regulatory Requirements in Manufacturing of Inactivated Veterinary Vaccines

2018 ◽  
Vol 3 (2) ◽  
Keyword(s):  
Process Design ◽  
Scientific Evidence ◽  
Good Manufacturing Practice ◽  
Critical Parameters ◽  
Design Stage ◽  
Vaccine Production ◽  
Regulatory Requirement ◽  
Process Validation ◽  
Veterinary Vaccine ◽  
Process Qualification

Process validation is the most critical regulatory requirement for licensed biopharmaceuticals and vaccine facilities. It is also considered as an economic issue through understanding and controlling any process and subsequently minimizing the processes failures. The process design (PD), process qualification (PQ) and continued process verification (PV) are the main three stages for industry for process validation. It was defined as the collection and evaluation of data, from the process design stage throughout production, to establishe a scientific evidence that a process is consistently delivering high quality products and in accordance with the principles of Good Manufacturing Practice (GMP). The challenges of vaccine production process are not limited to its complicated details which may change the validity of the process but also the cross process that still the biggest challenge. Therefore, process validation in biopharmaceutical industries has the high priority specially vaccine production. In conclusion, continuous monitoring and validation of inactivated veterinary vaccines has the great impact on defects, nonconformance decreasing and processes improvement. Also the critical parameters of process validation of inactivated veterinary vaccine manufacturing are highlighted.

Strategic Audit Inquiry: The Impact of Timing and the Promotion of Statutory Protections on Client Fraud Disclosures

2020 ◽  
Vol 34 (3) ◽  
pp. 153-167
Author(s):  
John R. Lauck ◽  
Stephen J. Perreault ◽  
Joseph R. Rakestraw ◽  
James S. Wainberg
Keyword(s):  
Best Practices ◽  
Audit Quality ◽  
Self Regulation ◽  
Data Availability ◽  
Audit Committees ◽  
External Auditors ◽  
Extant Literature ◽  
Psychological Theories ◽  
Inquiry Process ◽  
The Impact

SYNOPSIS Auditing standards require external auditors to inquire of client-employees regarding their knowledge of actual or suspected fraud (PCAOB 2010b; AICPA 2016). However, the extant literature provides little guidance on practical methods that auditors can employ to increase the likelihood of fraud disclosure and improve audit quality. Drawing upon best practices in the whistleblowing literature and psychological theories on self-regulation, we experimentally test the efficacy of two practical strategies that auditors can employ during the fraud inquiry process: actively promoting statutory whistleblower protections and strategically timing their fraud inquiries. Our results indicate that auditors are more likely to elicit client-employee fraud disclosures by actively promoting statutory whistleblower protections and strategically timing the fraud inquiry to take place in the afternoon, when client-employee self-regulation is more likely to be depleted. These two audit inquiry strategies should be of considerable interest to audit practitioners, audit committees, and those concerned with improving audit quality. Data Availability: From the authors by request.

Data and visual displays in the Journal of Ecology 1996–2016

2020 ◽  
pp. 147387162098012
Author(s):  
Alon Friedman
Keyword(s):  
Best Practices ◽  
Pearson Correlation ◽  
Single Species ◽  
Data Type ◽  
Reliability Test ◽  
Visual Displays ◽  
Domain Type ◽  
Academic Publications ◽  
The Creation ◽  
The Impact

Scholars in scientific disciplines face unique challenges in the creation of visualizations, especially in publications that require insights derived from analyses to be visually displayed. The literature on visualizations describes different techniques and best practices for the creation of graphs. However, these techniques have not been used to evaluate the impact of visualizations in academic publications. In the field of ecology, as in other scientific fields, graphs are an essential part of journal articles. Little is known about the connections between the kind of data presented and domain in which the researchers conducted their study that together produces the visual graphics. This study focused on articles published in the Journal of Ecology between 1996 and 2016 to explore possible connections between data type, domain, and visualization type. Specifically, this study asked three questions: How many of the graphics published between 1996 and 2016 follow a particular set of recommendations for best practices? What can Pearson correlations reveal about the relationships between type of data, domain of study, and visual displays? Can the findings be examined through an inter-reliability test lens? Out of the 20,080 visualizations assessed, 54% included unnecessary graphical elements in the early part of the study (1996–2010). The most common type of data was univariate (35%) and it was often displayed using line graphs. Twenty-one percent of the articles in the period studied could be categorized under the domain type “single species.” Pearson correlation analysis showed that data type and domain type was positively correlated ( r = 0.08; p ≤ 0.05). Cohen’s kappa for the reliability test was 0.86, suggesting good agreement between the two categories. This study provides evidence that data type and domain types are equally important in determining the type of visualizations found in scientific journals.

scholarly journals Film-Forming Systems for the Delivery of DNDI-0690 to Treat Cutaneous Leishmaniasis

Pharmaceutics ◽  
2021 ◽  
Vol 13 (4) ◽  
pp. 516
Author(s):  
Katrien Van Bocxlaer ◽  
Kerri-Nicola McArthur ◽  
Andy Harris ◽  
Mo Alavijeh ◽  
Stéphanie Braillard ◽  
...  
Keyword(s):  
Drug Delivery ◽  
Cutaneous Leishmaniasis ◽  
Mouse Skin ◽  
Parasite Load ◽  
Leishmania Species ◽  
Lesion Size ◽  
Drying Time ◽  
Sustained Drug Delivery ◽  
Film Forming ◽  
The Impact

In cutaneous leishmaniasis (CL), parasites reside in the dermis, creating an opportunity for local drug administration potentially reducing adverse effects and improving treatment adherence compared to current therapies. Polymeric film-forming systems (FFSs) are directly applied to the skin and form a thin film as the solvent evaporates. In contrast to conventional topical dosage forms, FFSs strongly adhere to the skin, favouring sustained drug delivery to the affected site, reducing the need for frequent applications, and enhancing patient compliance. This study reports the first investigation of the use of film-forming systems for the delivery of DNDI-0690, a nitroimidazole compound with potent activity against CL-causing Leishmania species. A total of seven polymers with or without plasticiser were evaluated for drying time, stickiness, film-flexibility, and cosmetic attributes; three FFSs yielded a positive evaluation for all test parameters. The impact of each of these FFSs on the permeation of the model skin permeant hydrocortisone (hydrocortisone, 1% (w/v) across the Strat-M membrane was evaluated, and the formulations resulting in the highest and lowest permeation flux (Klucel LF with triethyl citrate and Eudragit RS with dibutyl sebacate, respectively) were selected as the FFS vehicle for DNDI-0690. The release and skin distribution of the drug upon application to Leishmania-infected and uninfected BALB/c mouse skin were examined using Franz diffusion cells followed by an evaluation of the efficacy of both DNDI-0690 FFSs (1% (w/v)) in an experimental CL model. Whereas the Eudragit film resulted in a higher permeation of DNDI-0690, the Klucel film was able to deposit four times more drug into the skin, where the parasite resides. Of the FFSs formulations, only the Eudragit system resulted in a reduced parasite load, but not reduced lesion size, when compared to the vehicle only control. Whereas drug delivery into the skin was successfully modulated using different FFS systems, the FFS systems selected were not effective for the topical application of DNDI-0690. The convenience and aesthetic of FFS systems alongside their ability to modulate drug delivery to and into the skin merit further investigation using other promising antileishmanial drugs.

Best Practices for Modeling Egocentric Social Network Data and Health Outcomes

2021 ◽  
pp. 193758672110137
Author(s):  
Jacqueline M. Burgette ◽  
Jacquelin Rankine ◽  
Alison J. Culyba ◽  
Kar-Hai Chu ◽  
Kathleen M. Carley
Keyword(s):  
Social Network ◽  
Best Practices ◽  
Health Outcomes ◽  
Organizational Behavior ◽  
Network Data ◽  
Egocentric Networks ◽  
Covariate Selection ◽  
Social Network Modeling ◽  
Egocentric Network ◽  
The Impact

Objective/Aim: We describe best practices for modeling egocentric networks and health outcomes using a five-step guide. Background: Social network analysis (SNA) is common in social science fields and has more recently been used to study health-related topics including obesity, violence, substance use, health organizational behavior, and healthcare utilization. SNA, alone or in conjunction with spatial analysis, can be used to uniquely evaluate the impact of the physical or built environment on health. The environment can shape the presence, quality, and function of social relationships with spatial and network processes interacting to affect health outcomes. While there are some common measures frequently used in modeling the impact of social networks on health outcomes, there is no standard approach to social network modeling in health research, which impacts rigor and reproducibility. Methods: We provide an overview of social network concepts and terminology focused on egocentric network data. Egocentric, or personal networks, take the perspective of an individual who identifies their own connections (alters) and also the relationships between alters. Results: We describe best practices for modeling egocentric networks and health outcomes according to the following five-step guide: (1) model selection, (2) social network exposure variable and selection considerations, (3) covariate selection related to sociodemographic and health characteristics, (4) covariate selection related to social network characteristics, and (5) analytic considerations. We also present an example of SNA. Conclusions: SNA provides a powerful repertoire of techniques to examine how relationships impact attitudes, experiences, and behaviors—and subsequently health.

Patient Safety/Quality Improvement Primer, Part III: The Role of Simulation

2021 ◽  
pp. 019459982110133
Author(s):  
Ellen S. Deutsch ◽  
Sonya Malekzadeh ◽  
Cecelia E. Schmalbach
Keyword(s):  
Patient Safety ◽  
Quality Improvement ◽  
Control Charts ◽  
Neck Surgery ◽  
Resident Training ◽  
Statistical Process ◽  
Ensure Patient Safety ◽  
Statistical Process Control Charts ◽  
The Individual ◽  
The Impact

Simulation training has taken a prominent role in otolaryngology–head and neck surgery (OTO-HNS) as a means to ensure patient safety and quality improvement (PS/QI). While it is often equated to resident training, this tool has value in lifelong learning and extends beyond the individual otolaryngologists to include simulation-based learning for teams and health systems processes. Part III of this PS/QI primer provides an overview of simulation in medicine and specific applications within the field of OTO-HNS. The impact of simulation on PS/QI will be presented in an evidence-based fashion to include the use of run and statistical process control charts to assess the impact of simulation-guided initiatives. Last, steps in developing a simulation program focused on PS/QI will be outlined with future opportunities for OTO-HNS simulation.

scholarly journals UTILIZING UNDERGRADUATE RESEARCH TO INFORM COMMUNITY RESOURCES FOR OLDER ADULTS: A SERVICE-LEARNING PROJECT

2019 ◽  
Vol 3 (Supplement_1) ◽  
pp. S537-S538
Author(s):  
Amanda E Barnett ◽  
Sara Olinger
Keyword(s):  
Older Adults ◽  
Service Learning ◽  
Best Practices ◽  
Undergraduate Students ◽  
Undergraduate Research ◽  
Community Resources ◽  
Home Visitor ◽  
Aging Societies ◽  
Theory Research ◽  
The Impact

Abstract Engaging undergraduate students with aging-focused community resources is critical for preparing students to work with older adults and make positive contributions to aging societies. During the fall, 2018 semester, undergraduate students in a human development course on middle and late adulthood partnered with a county aging and disability resource center (ADRC) in Wisconsin to evaluate and update several of their existing programs and resources using empirical research. Upon completion of this project, students synthesized course material to meet all course learning objectives such as: (1) critically analyze physical, psychological, and sociological processes of aging across categories of difference (e.g. cultural, ethnic, class); (2) evaluate social policies and their multigenerational implications for midlife and older adults; and (3) construct a personal position on aging that integrates theory, research, and policy to demonstrate a sensitive and competent approach to working with midlife and older adults. Students researched, wrote reports, and presented to ADRC staff on the impact of social isolation on older adults, best practices for home visitor and transportation programs serving older adults, cognitive competency tools and best practices for utilizing memory assessments, grief supports and groups for family caregivers, and best practices for supporting veterans as they age. The outcome of these projects are research-based recommendations for any ADRC to consider when developing and implementing related programs. All stakeholders (students, professor, and ADRC staff) were satisfied with the process and outcomes of the project. Strengths and challenges of carrying out such a collaborative project will be reviewed.

scholarly journals Pricing ESG Equity Ratings and Underlying Data in Listed Real Estate Securities

2021 ◽  
Vol 13 (4) ◽  
pp. 2037 ◽  
Author(s):  
Dirk Brounen ◽  
Gianluca Marcato ◽  
Hans Op ’t Veld
Keyword(s):  
Real Estate ◽  
Best Practices ◽  
Stock Returns ◽  
The Real Estate ◽  
Public Property ◽  
European Public ◽  
Property Companies ◽  
Real Estate Securities ◽  
The Impact ◽  
European Markets

By analyzing the adoption of the European Public Real Estate Association’s (EPRA) Sustainability Best Practices Recommendations (sBPR), we examine and discuss the application of transparent environmental, social and governance (ESG) ratings and their interaction with public real estate performance across European markets. Due to increasing concerns about the environment and the impact of investment on society at large, public property companies have made significant progress in improving transparency and enhancing the protection of shareholder value by sharing and reporting ESG best practices. We explore and review the EPRA sBPR database, which is highly useful for investors who are already screening listed real estate companies. Hence, in this project, we carefully study the diffusion process of this new ESG metric as a tool to enhance informational transparency regarding public real estate investment management and assess the effects of this transparency and ESG performance for the real estate stock returns. We find evidence of a sustainability premium that investors are willing to pay to access companies with better sustainable ratings.

scholarly journals The impact of molded pulp product process on the mechanical properties of molded Bleached Chemi-Thermo-Mechanical Pulp

2021 ◽  
Vol 2 (1) ◽  
Author(s):  
Claire Dislaire ◽  
Yves Grohens ◽  
Bastien Seantier ◽  
Marion Muzy
Keyword(s):  
Mechanical Properties ◽  
Water Uptake ◽  
Process Parameters ◽  
Manufacturing Process ◽  
Water Immersion ◽  
Young Modulus ◽  
Drying Time ◽  
Mechanical Pulp ◽  
Hygroscopic Properties ◽  
The Impact

AbstractThis study was carried out using bleached softwood Chemi-Thermo-Mechanical Pulp to evaluate the influence of Molded Pulp Products’ manufacturing process parameters on the finished products’ mechanical and hygroscopic properties. A Taguchi table was done to make 8 tests with specific process parameters such as moulds temperature, pulping time, drying time, and pressing time. The results of these tests were used to obtain an optimized manufacturing process with improved mechanical properties and a lower water uptake after sorption analysis and water immersion. The optimized process parameters allowed us to improve the Young’ Modulus after 30h immersion of 58% and a water uptake reduction of 78% with the first 8 tests done.

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