Physical Sciences and Mathematics Commons^™

Emerging Technologies: Empowering People To Capture, Share And Transfer Tacit Knowledge, Donncadh J. Nagle, Melanie J. Adams

Level 3

ICH Q10 was published in 2008, and presented a model for an effective Pharmaceutical Quality System (PQS). However, the industry still has some way to go in embracing and implementing its principles in order to achieve greater product realisation, to establish and maintain a state of control, and to facilitate continual improvement.

ICH Q10 introduced us to two key enablers: Knowledge Management (KM) and Quality Risk Management (QRM).^[1] While the pharmaceutical industry has made progress in implementing the principles of QRM since 2008, there has been significantly slower progress in implementing knowledge management practices. However, there may be solutions …

Managing Risk And Knowledge: Frameworks To Guide Knowledge-Enabled Technology Transfer, Martin Lipa Dr, Anne Greene

Level 3

Technology transfer is not only about the transfer of technology, but also about the transfer of knowledge, as evidenced by definitions of KM within the biopharma industry and beyond. However, knowledge transfer is often not well structured and its effectiveness – in particular for tacit knowledge (i.e., know how) – is an opportunity for improvement which can lead to many benefits. This article profiles recent research into the topic of improving knowledge transfer during technology transfer and presents several recently developed frameworks for improving such. The article furthermore explains how the frameworks can be co-deployed in support of robust knowledge …

Limits Of Detection Of Mycotoxins By Laminar Flow Strips: A Review, Xinyi Zhao, Hugh Byrne, Christine M. O’Connor, James Curtin, Furong Tian

Articles

Mycotoxins are secondary metabolic products of fungi. They are poisonous, carcinogenic, and mutagenic in nature and pose a serious health threat to both humans and animals, causing severe illnesses and even death. Rapid, simple and low-cost methods of detection of mycotoxins are of immense importance and in great demand in the food and beverage industry, as well as in agriculture and environmental monitoring, and, for this purpose, lateral flow immunochromatographic strips (ICSTs) have been widely used in food safety and environmental monitoring. The literature to date describing the development of ICSTs for the detection of different types of mycotoxins using …

Exploring Pathways From Data To Knowledge To Insights In The Pharmaceutical Industry: ‘Introducing The Pharmaceutical Knowledge Ecosystem’, Melanie J. Adams, Paige E. Kane, Anne Greene (Editor), Martin Lipa

Level 3

The ecosystem of how the pharmaceutical industry acquires data, transforms these data into tangible knowledge, and derives valuable insights throughout the process, is highly complex. Data, information, knowledge, and the resulting insights, are necessary to support decision- making, manage risk, problem solve, ensure product realisation, enable continual improvement, and enhance operational effectiveness. Building on the fundamental concepts established in the well-known Data Information Knowledge Wisdom (DIKW) hierarchy, this paper reviews the basic concepts involved in the DIKW pathway and begins to relate these concepts to both established capabilities (e.g., PAT), existing requirements (e.g., data integrity), and emerging trends in the …

Improving Risk-Based Decision Making (Rbdm) Effectiveness Through A Framework Which Integrates Knowledge And Risk, Martin Lipa, Valerie Mulholland, Anne Greene (Editor)

Level 3

This paper explores the emergence of the importance of knowledge in Risk-Based Decision Making (RBDM) and Quality Risk Management (QRM) through a detailed review of ICH Q9(R1) (Step 2) and presents a framework(the RKI cycle) to integrate knowledge and risk and associated six principles to operationalise it.

A Microfluidic Approach For Synthesis And Kinetic Profiling Of Branched Gold Nanostructures, Qi Cai, Valentina Castagnola, Luca Boselli, Alirio Moura, Hender Lopez, Wei Zhang, João M. De Araújo, Kenneth A. Dawson

Articles

Automatized approaches for nanoparticle synthesis and characterization represent a great asset to their applicability in the biomedical field by improving reproducibility and standardization, which help to meet the selection criteria of regulatory authorities. The scaled-up production of nanoparticles with carefully defined characteristics, including intrinsic morphological features, and minimal intra-batch, batch-to-batch, and operator variability, is an urgent requirement to elevate nanotechnology towards more trustable biological and technological applications. In this work, microfluidic approaches were employed to achieve fast mixing and good reproducibility in synthesizing a variety of gold nanostructures. The microfluidic setup allowed exploiting spatial resolution to investigate the growth evolution …

Mapping The Dna Damaging Effects Of Polypyridyl Copper Complexes With Dna Electrochemical Biosensors, Anna Banasiak, Nicolò Zuin Fantoni, Andrew Kellett, John Colleran

Articles

Several classes of copper complexes are known to induce oxidative DNA damage that mediates cell death. These compounds are potentially useful anticancer agents and detailed investigation can reveal the mode of DNA interaction, binding strength, and type of oxidative lesion formed. We recently reported the development of a DNA electrochemical biosensor employed to quantify the DNA cleavage activity of the well-studied [Cu(phen)₂]²⁺ chemical nuclease. However, to validate the broader compatibility of this sensor for use with more diverse—and biologically compatible—copper complexes, and to probe its use from a drug discovery perspective, analysis involving new compound libraries is …

Micro-Rna And Proteomic Profiles Of Plasma-Derived Exosomes From Irradiated Mice Reveal Molecular Changes Preventing Apoptosis In Neonatal Cerebellum, Simonetta Pazzaglia, Barbara Tanno, Ilaria De Stefano, Paola Giardullo, Simona Leonardi, Caterina Merla, Gabriele Babini, Seda Tuncay Cagatay, Ammar Mayah, Munira Kadhim, Fiona Lyng, Christine Von Toerne, Zohaib N. Khan, Prabal Subedi, Soile Tapio, Anna Saran, Mariateresa Mancuso

Articles

Cell communication via exosomes is capable of influencing cell fate in stress situations such as exposure to ionizing radiation. In vitro and in vivo studies have shown that exosomes might play a role in out-of-target radiation effects by carrying molecular signaling mediators of radiation damage, as well as opposite protective functions resulting in resistance to radiotherapy. However, a global understanding of exosomes and their radiation-induced regulation, especially within the context of an intact mammalian organism, has been lacking. In this in vivo study, we demonstrate that, compared to sham-irradiated (SI) mice, a distinct pattern of proteins and miRNAs is found …

First Long-Time Airborne Fungal Spores Study In Dublin, Ireland (1978–1980), Moisés Martínez-Bracero, Emma Markey, Jerry Hourihane Clancy, John Sodeau, David J. O'Connor

Articles

Ambient fungal spores within the atmosphere can contribute to a range of negative human, animal and plant health conditions and diseases. However, trends in fungal spore seasonality, species prevalence, and geographical origin have been significantly understudied in Ireland. Previously unpublished data from the late 1970s have recently been collected and analysed to establish historical fungal spore trends/characteristics for Dublin. Historical spore concentrations were largely dominated by Alternaria, Ascospores, Basidiospores, Botrytis, Cladosporium, Erysiphe and Rusts. The main fungal spore season for Dublin commenced in April with the fructification of Scopulariopsis and Ganoderma. However, the vast majority of other spore types did …

Trends In Biomedical Analysis Of Red Blood Cells – Raman Spectroscopy Against Other Spectroscopic, Microscopic And Classical Techniques, Jakub Dybas, Fatih Celal Alcicek, Aleksandra Wajda, Magdalena Kaczmarska, Anna Zimna, Katarzyna Bulat, Aneta Blat, Tetiana Stepanenko, Tasnim Mohaissen, Ewa Szczesny-Malysiak, David Perez-Guaita, Bayden R. Wood, Katarzyna Maria Marzec

Articles

Application of modern and innovative spectroscopic and microscopic approaches to biomedical analysis opens new horizons and sheds new light on many unexplored scientific territories. In this review, we critically summarize up-to-date Raman-based methodologies for red blood cells (RBCs) analysis used in biology and medicine, and compare them with both classical, as well as other spectroscopic and microscopic approaches. The main emphasis is placed on the advantages, disadvantages and capabilities of each technique for detection of RBC deteriorations and RBC-related diseases. Although currently used classical techniques of medical analysts serve as a gold standard for clinicians in diagnosis of erythropathies, they …

Biomolecular Corona Stability In Association With Plasma Cholesterol Level, Duong N. Trinh, Meda Radlinskaite, Jack Cheeseman, Gunther Kuhnle, Helen M.I. Osborn, Paula Meleady, Daniel I.R. Spencer, Marco P. Monopoli

Articles

Biomolecular corona is spontaneously formed on the surface of nanoparticles (NPs) when they are in contact with biological fluids. It plays an important role in the colloidal stability of NPs, which is of importance for most of their medical applications and toxicity assessment. While typical studies use either blood plasma or serum from a pooled biobank, it is unclear whether differences in the media, such as cholesterol level or protein concentration, might affect the NP colloidal stability and corona composition. In this study, the silica corona was prepared at particularly low plasma concentrations (3%, v/v–1.98 mg/mL) to identify the critical …

Partially Oxidised Boron Nitride As A 2d Nanomaterial For Nanofiltration Applications, Natalia Garcıa Domenech, Aine Coogan, Finn Purcell Milton, María Luisa Casasín Garcia, Adrián Sanz Arjona, Marc Brunet Cabré, Aran Rafferty, Kim Mckelvey, Peter Dunne, Yurii K. Gun'ko

Articles

Access to clean water has become increasingly scarce in recent years due to various factors, such as increasing population density, urbanisation, and inequality, among others.1 The development of new, inexpensive, and reliable methods for the removal of various impurities and toxins from water is therefore vital. In recent years, the emergence of nanofiltration (NF) membranes has become an exciting prospect for water purification. NF can be described as a type of filtration which exhibits separation characteristics in between reverse osmosis and ultrafiltration, and typically has molecular weight cut-offs in the region of 200–1000 Daltons.2,3 Various nanomaterials have been implemented in …

Advancing Competency In Managing Risk And Knowledge: Steps Toward Operationalisation Of The Risk-Knowledge Infinity Cycle (Rki Cycle) Part 3: Uncovering Knowledge For Qrm Through Knowledge Mapping At Node 1, Martin Lipa, Valerie Mulholland, Anne Greene

Articles

To date, literature on the Risk-Knowledge Infinity Cycle (RKI Cycle) has mainly been theoretical. This paper series intent is to focus on the operationalisation of the RKI Cycle by describing a series of steps – the “How to” – for RKI Cycle deployment, to help move the RKI Cycle from theory to practice. The third paper in this series focuses on ensuring the best available knowledge flows into QRM through a case study demonstrating knowledge mapping to support effective quality risk assessment during commissioning and qualification activities.

Advancing Competency In Managing Risk And Knowledge: Steps Toward Operationalisation Of The Risk-Knowledge Infinity Cycle (Rki Cycle) - Part 1: Improving Effectiveness Of Risk-Based Decision Making (Rbdm), Martin Lipa, Paige Kane, Anne Green

Articles

To date, literature on the Risk-Knowledge Infinity Cycle (RKI Cycle) has mainly been theoretical. This paper series intent is to focus on the operationalisation of the RKI Cycle by describing a series of steps – the “How to” – for RKI Cycle deployment, to help move the RKI Cycle from theory to practice. The first paper in this series focuses on how the RKI Cycle can support effective Risk-Based Decision Making (RBDM).

Airborne Fungal Spore Review, New Advances And Automatisation, Moisés Martínez-Bracero, Emma Markey, Jerry Hourihane Clancy, Eoin Mcgillicuddy, Gavin Sewell, David J. O'Connor

Articles

Fungal spores make up a significant portion of Primary Biological Aerosol Particles (PBAPs) with large quantities of such particles noted in the air. Fungal particles are of interest because of their potential to affect the health of both plants and humans. They are omnipresent in the atmosphere year-round, with concentrations varying due to meteorological parameters and location. Equally, differences between indoor and outdoor fungal spore concentrations and dispersal play an important role in occupational health. This review attempts to summarise the different spore sampling methods, identify the most important spore types in terms of negative effects on crops and the …

Analysis Of Copper(Ii) Using The Ascorbate/Oxygen System – A Valuable Undergraduate Resource, Sean Tobin, John Cassidy, Kevin Kurian, Tony Betts

Articles

In deionised water, ascorbic acid (AH−), through oxidation by oxygen in the presence of copper(II), was found to degrade with zero-order kinetics. The magnitude of the reaction rate varied directly with the copper(II) concentration. At a higher pH (7.4), the same reaction was found to be pseudo-first order. Once again, the magnitude of the rate increased linearly with copper(II) concentration at a micromolar level. Dissolved oxygen levels, in excess AH− and trace copper(II), displayed similar kinetics under both conditions. Monitoring of either AH− levels or dissolved oxygen concentration was found to be a useful novel undergraduate practical laboratory for trace …

Charge Transfer Mediated Triplet Excited State Formation In Donor-Acceptor-Donor Bodipy: Application For Recording Of Holographic Structures In Photopolymerizable Glass, Tatsiana Mikulchyk, Safakath Karuthedath, Catherine S.P. De Castro, Andrey A. Buglak, Aimee Sheehan, Aaron Wieder, FréDéRic Laquai, Izabela Naydenova, Mikhail Filatov

Articles

Donor–acceptor–donor BODIPY triads bearing anthracene or pyrene as electron donating subunits were prepared through a stepwise synthesis. Photoinduced electron transfer and formation of long-lived triplet excited states via spin–orbit charge transfer intersystem crossing (SOCT-ISC) was studied by steady-state and ultrafast pump-probe spectroscopy and further supported by DFT computations. New BODIPYs were found to form triplet states and sensitize singlet oxygen in both polar and non-polar solvents which is unusual for photosensitizers operating via SOCT-ISC. BODIPY-anthracene triad (ABA) was used as a photosensitizer component in a photopolymerizable glass that was prepared by a four-step sol–gel process. ABA in combination with N …

Copper(Ii) And Silver(I)‑1,10‑Phenanthroline‑5,6‑Dione Complexes Interact With Double‑Stranded Dna: Further Evidence Of Their Apparent Multi‑Modal Activity Towards Pseudomonas Aeruginosa, Anna Clara Milesi Galdino, Lívia Viganor, Matheus Mendonça Pereira, Michael Devereux, Malachy Mccann, Marta Helena Branquinha, Zara Molphy, Sinéad O'Carroll, Conor Bain, Georgia Menounou, Andrew Kellett, André Luis Souza Dos Santos

Articles

Tackling microbial resistance requires continuous efforts for the development of new molecules with novel mechanisms of action and potent antimicrobial activity. Our group has previously identified metal-based compounds, [Ag(1,10-phenanthroline-5,6-dione)2]ClO4 (Ag-phendione) and [Cu(1,10-phenanthroline-5,6-dione)3](ClO4)2.4H2O (Cu-phendione), with efficient antimicrobial action against multidrug-resistant species. Herein, we investigated the ability of Ag-phendione and Cu-phendione to bind with double-stranded DNA using a combination of in silico and in vitro approaches. Molecular docking revealed that both phendione derivatives can interact with the DNA by hydrogen bonding, hydrophobic and electrostatic interactions. Cu-phendione exhibited the highest binding affinity to either major (− 7.9 kcal/mol) or minor (− 7.2 kcal/mol) …

A Core–Shell Au@Tio2 And Multi-Walled Carbon Nanotube-Based Sensor For The Electroanalytical Determination Of H2o2 In Human Blood Serum And Saliva, Ayman Ali Saeed, Mohammed Nooredeen Abbas, Waheed Fathi El-Hawary, Yousry Moustafa Issa, Baljit Singh

Articles

A hydrogen peroxide (H2O2) sensor was developed based on core–shell gold@ titanium dioxide nanoparticles and multi-walled carbon nanotubes modified glassy carbon electrode (Au@TiO2/MWCNTs/GCE). Core–shell Au@TiO2 material was prepared and characterized using a scanning electron microscopy and energy dispersive X-ray analysis (SEM/EDX), transmission electron microscopy (TEM), atomic force microscopy (AFM), Raman spectroscopy, X-ray diffraction (XRD) and Zeta-potential analyzer. The proposed sensor (Au@TiO2/MWCNTs/GCE) was investigated electrochemically using cyclic voltammetry (CV) and electrochemical impedance spectroscopy (EIS). The analytical performance of the sensor was evaluated towards H2O2 using differential pulse voltammetry (DPV). The proposed sensor exhibited excellent stability and sensitivity with a linear concentration …