Pharmacy and Pharmaceutical Sciences Commons^™

Evaluation Of Lc-Uv Data For Method Validation, Maeve Scott

Case studies: Digital Education

The module was co-delivered in face-to-face mode to three Science programmes (typically 70 students) in year three, many of whom apply to industries where the learning outcome of the video is a key competency. Analytical methods used in a regulated or accredited testing environment must be validated in line with international guidelines. A science graduate who intends to work in a pharmaceutical or related industry should understand how to interpret test results to demonstrate an analytical method is reliable and fit for purpose. A screen pal video was generated to support an introduction to the theory of method validation delivered …

Investigating The Expression Of C-Myc And Birc5 In Trail And Pbox-15 Treated Metastatic Prostate Cancer Cells, Corinne Kai Leng Chew, Hannah O'Toole, Daniela M. Zisterer, Seema M. Nathwani, Jade K. Pollock

SURE Journal: Science Undergraduate Research Experience Journal

Purpose Metastatic prostate cancer is associated with poor survival rate and limited treatment options. Overexpression of c-Myc and BIRC5 has been reported in prostate cancer cells which contribute to the development of the tumour environment. The specific tumour receptor mechanism of the death ligand TRAIL (tumour necrosis factor related apoptosis inducing ligand) has attracted remarkable therapeutic interest. However, many cancer cells are resistant to TRAIL monotherapy. A novel microtubule-targeting agent, PBOX-15 is known to exhibit anti-tumour activity in cancer cell lines including those with multi-drug resistance. Previous studies demonstrated that PBOX-15 is capable in sensitising cancer cells to TRAIL-mediated cell …

Comparing Multivalent Cross-Linked Sodium Alginate/ Montmorillonite Beads Containing Curcumin Or Cayenne Pepper As Drug Carriers And Their Antimicrobial Resistance, Shionainn Traynor, Shubham Sharma

SURE Journal: Science Undergraduate Research Experience Journal

The aim of the following work was to investigate and compare curcumin and cayenne pepper in microbeads composed of sodium alginate (SA) crosslinked with montmorillonite (MMT) to act as drug carriers and their antimicrobial resistance. The microbeads were prepared through ion-exchange in multivalent solutions of CaCl₂, MgCl₂ and AlCl₃. The microbeads were characterized by Scanning Electron Microscopy (SEM), Energy Dispersive X-ray analysis (EDX) and the time required for intercalation of curcumin and cayenne pepper with MMT. Simulated intestinal fluid (pH 7.3) and gastric fluid (pH 1.2) at 37°C were used for comparison in swelling studies. …

Tension Recordings From Primary Bronchi In Acta2-Gcamp8.1-Mvermilion Transgenic Mice, Qais Khalaf, Srijit Ghosh, Keith Thornbury

SURE Journal: Science Undergraduate Research Experience Journal

Contractions in smooth muscle cells are initiated by elevation of cytosolic Ca²⁺. It is of interest to measure Ca²⁺ signals in these cells. Transgenic Acta2-GCaMP8.1-mVermilion (GCaMP) mice express a genetically encoded intracellular fluorescent Ca²⁺ indicator in smooth muscle cells, have been developed to facilitate the study of Ca²⁺. However, there is a concern that the GCaMP Ca²⁺ indicator might buffer Ca²⁺ and interfere with the signals it is designed to measure. Therefore, the aim of this study was to compare tension responses in GCaMP and wild type (WT) mice to determine if …

Total Organic Carbon Analysis Of Residual Contaminants In Bioreactor Equipment: A Cleaning Verification Study Using Surface Swabbing, Ciara E. Fitzpatrick, James J. Roche

SURE Journal: Science Undergraduate Research Experience Journal

Contamination is a major issue in the biopharmaceutical industry. Bioreactors must be meticulously cleaned to remove residual impurities and avoid cross-contamination. Cleaning validation is necessary to ensure residual contaminants are reduced to the lowest acceptable limits. Bacterial cells represent the paramount challenge in manufacturing equipment cleaning because they are composed of insoluble organic contaminants. Total organic carbon (TOC) analysis is a fast, highly sensitive, and inexpensive analytical technique commonly used to evaluate the approximate level of organic contamination.

A study was conducted to assess the effectiveness of cleaning procedures in the removal of contaminants from bioreactor equipment by measuring the …

Editorial - Sure Journal Vol 6, Anne M. Friel, Eva Campion, Sinead Loughran

SURE Journal: Science Undergraduate Research Experience Journal

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Effective Risk-Based Decision Making In Quality Risk Management, Valerie Mulholland

Dissertations

Patients expect safe, effective, high-quality medicines that are available when needed. Meeting these expectations is increasingly challenging in a global pharmaceutical supply chain, as evidenced by persistent product quality and supply issues. A key contributory factor to these issues is disruptions in manufacturing operations, which in turn are often caused by a hesitancy to change and to continuously improve approved processes. Regulatory agencies repeatedly indicate that they will consider increased autonomy for post-approval changes, if pharmaceutical manufacturing operations can demonstrate the effectiveness of Quality Risk Management (QRM) within the Pharmaceutical Quality System (PQS). Thus, the question was posed by Dr …

Enhancing Organisational Performance Through Patient-Focused Learning Excellence In The Biopharmaceutical Industry, Lori Richter

Dissertations

Drug shortages, quality defects and challenges regarding innovation within the biopharmaceutical industry pose significant risks to patient safety and organisational performance. These problems persist despite the many scientific, technological and economic advances over the past several years in a well-funded, high-revenue industry operated by highly qualified personnel. Evidence suggests that the industry has yet to fully realise the potential for building organisational capabilities to enable learning from mistakes to enhance performance outcomes. This research study explored how biopharmaceutical companies can learn from their mistakes and embrace a culture of learning in order to reduce quality defects and drug shortages by …

Smart Missions That Enable Innovation In High-Risk Environments., Ed Hoffman

Level 3

This article is a lightly edited version of Ed Hoffman’s talk on to the 01-June-2023 seminar hosted by the PRST entitled ICH Q9(R1): The Next Frontier – An audience with international thought leaders exploring how the effective use of knowledge can enhance QRM outcomes to benefit the patient. Ed’s remarks are focused on the future of work, and the needs for relationships, storytelling, and understanding the mission to get the best out of our collective intelligence and navigate the future of work.

The Potential Of Stem Cell Therapy In Multiple Sclerosis Treatment: A Review, Sorina Amarculesei, Ava O'Meara Cushen, Cathy Brougham

SURE Journal: Science Undergraduate Research Experience Journal

Multiple Sclerosis is an autoimmune and neurodegenerative disease of the central nervous system. There are currently 2.8 million people living with Multiple Sclerosis worldwide, including 9000 people in Ireland, with a prevalence of 193 per 100,000 people. Symptoms of Multiple Sclerosis include sensory loss, fatigue, cognitive dysfunction, spasticity, depression, optic neuritis, gait ataxia, diplopia, and loss of bladder control. Currently, there is no standardised treatment or cure for Multiple Sclerosis with many strategies focusing on symptoms. Stem cells have emerged as promising approaches for Multiple Sclerosis therapeutics. Clinical trials primarily focus on mesenchymal stem cell-based therapies for Multiple Sclerosis. Furthermore, …

Tiny But Mighty, An Exploration Of Microbes And Plants As Sources Of Small Novel Bioactive Compounds Against Invasive Mycoses., Hannah Mai Peacock, James Anthony O'Connor

SURE Journal: Science Undergraduate Research Experience Journal

Despite the high mortality rate involved with invasive cerebral mycoses, there is a relative lack of research available around antifungals capable of crossing the blood brain barrier.

In this study the metabolites of four plants (Crocus vernus, Miniature Narcissus (daffodil), Osmanthus delavayi and Taraxacum officinale (common dandelion)) and two bacteria (Lacticaseibacillus paracasei and Staphylococcus epidermidis) were extracted and assayed for antifungal activity against Candida albicans and Saccharomyces cerevisiae. Thin layer chromatography and bioautography were then employed to assess the activity of the constituent components of sources showing antifungal activity.

Metabolites of S.epidermidis, and extracts …

Responsiveness Of Higher Education Programs To Policy And Recommendations In The Biopharmaceutical Sector, Maeve Scott

Other resources

This essay will review the business and government policies relevant to the biopharmaceutical sector which influence higher education programs. The mechanisms which enable higher education to adapt to policy will be summarised and the pace of the response estimated.

Higher education (HE) programs need to respond in a timely manner to dynamic industries to maximise opportunities for graduates and support the Irish economy. The author manages internships and teaches on pharmaceutical science programs and aims to ensure the program is current to maximise student success. This review intends to identify the most relevant policy sources that can inform the Pharmaceutical …

Portable Hepa Filtration Successfully Augments Natural-Ventilation-Mediated Airborne Particle Clearance In A Legacy Design Hospital Ward, Mehael Fennelly, S. Hellebust, J. Wenger, D. O'Connor, G.W. Griffith, B.J. Plant, A.P.C. Microbiome Institute

Articles

As the severe acute respiratory syndrome coronavirus-2 pandemic has proceeded, ventilation has been recognized increasingly as an important tool in infection control. Many hospitals in Ireland and the UK do not have mechanical ventilation and depend on natural ventilation. The effectiveness of natural ventilation varies with atmospheric conditions and building design. In a challenge test of a legacy design ward, this study showed that portable air filtration significantly increased the clearance of pollutant aerosols of respirable size compared with natural ventilation, and reduced spatial variation in particle persistence. A combination of natural ventilation and portable air filtration is significantly more …

Evaluation Of Selenomethionine Entrapped In Nanoparticles For Oral Supplementation Using In Vitro, Ex Vivo And In Vivo Models, Shane Forde, Giuliana Vozza, David J. Brayden, Jesus Maria Frias, Sinead M. Ryan

Articles

Selenium methionine (Se Met) is an essential micronutrient required for normal body function and is associated with additional health benefits. However, oral administration of Se Met can be challenging due to its purported narrow therapeutic index, low oral bioavailability, and high susceptibility to oxidation. To address these issues, Se Met was entrapped in z e i n-coated nanoparticles made from chitosan using an ionic gelation formulation. The high stability of both the Se Met and s e l e n o methionine nanoparticles (Se Met-NPs) was established using cultured human intestinal and liver epithelial cells, rat liver homogenates, and rat …

Industry Update October 2022, Elaine Harris

Articles

Company news Bend Bioscience invests in expansion of drug-delivery capabilities Bend Bioscience (OR, USA) and NovaQuest Private Equity, have announced plans on 11 October 2022 to invest in a new facility in Bend, Oregon. The group will focus on developing new R&D partnerships, and early phase manufacturing and development activities based on proprietary particle engineering-based drug-delivery technologies. This new facility will consist of approximately 20,000 square feet of laboratory and processing areas and it is anticipated that manufacturing and analytical capabilities will operational by the end of Q2 2023. Announcing the investment decision, Dan Dobry, Bend Bioscience’s co-founder said “We …

Electrochemical Biosensors For The Detection Of Antibiotics In Milk: Recent Trends And Future Perspectives, Baljit Singh Dr., Abhijnan Bhat, Lesa Dutta, Kumari Riya Pati, Yaroslav Korpan, Isha Dahiya

Articles

Antibiotics have emerged as ground-breaking medications for the treatment of infectious diseases, but due to the excessive use of antibiotics, some drugs have developed resistance to microorganisms. Because of their structural complexity, most antibiotics are excreted unchanged, polluting the water, soil, and natural resources. Additionally, food items are being polluted through the widespread use of antibiotics in animal feed. The normal concentrations of antibiotics in environmental samples typically vary from ng to g/L. Antibiotic residues in excess of these values can pose major risks the development of illnesses and infections/diseases. According to estimates, 300 million people will die prematurely in …

Peptidases Are Potential Targets Of Copper(Ii)-1,10-Phenanthroline-5,6-Dione Complex, A Promising And Potent New Drug Against Trichomonas Vaginalis, Graziela Vargas Rigo, Fernando Gomes Cardoso, Matheus Menonca Pereira, Michael Devereux, Malachy Mccann, Andre L.S. Santos, Tiana Tasca

Articles

Trichomonas vaginalis is responsible for 156 million new cases per year worldwide. When present asymptomatically, the parasite can lead to serious complications, such as development of cervical and prostate cancer. As infection increases the acquisition and transmission of HIV, the control of trichomoniasis represents an important niche for the discovery and development of new antiparasitic molecules. This urogenital parasite synthesizes several molecules that allow the establishment and pathogenesis of infection. Among them, peptidases occupy key roles as virulence factors, and the inhibition of these enzymes has become an important mechanism for modulating pathogenesis. Based on these premises, our group recently …

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 …

People Perspectives In The Deployment Of Data Analytics For New Knowledge Generation In Pharmaceutical Manufacturing, Marcus O'Mahony Dr.

Level 3

Digital medicine manufacturing of the future will almost certainly involve greater use of advanced analytics tools for more data-driven decision-making. In this article, the role of people in the deployment of data analytics tools within the pharmaceutical manufacturing setting is explored. Some perspectives are presented for how people can make sense of working cross-functionally on the analytics journey to deliver new knowledge and insights that enable data-driven decisions to be made. Data analytics is defined and is proposed as a critical common ground between the “on-the-ground” data practitioners and the decision-makers who act on new knowledge. Reference is made to …

Steps Towards Digital Transformation In The Pharmaceutical Manufacturing Landscape Knowledge-Enabled Technology Transfer, Anne Greene Professor, Martin Lipa Dr

Level 3

No abstract provided.

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 …

The Implications Of Tacit & Explicit Knowledge For Technology Transfer: When It Goes Well & When It Goes Wrong & What Can Digital Do To Help!, Paige Kane Dr., David Twohig Dr.

Level 3

No abstract provided.

At War With A Silent Killer: An Ipa Study Of The Lived Experiences Of Community Pharmacists In Ireland During Covid-19, Regina Brady, Niamh Imbusch

Articles

Objectives: The purpose of this research was to give voice to the unique lived experiences of community pharmacists who continued to work in patient-facing roles throughout the COVID-19 pandemic. Research objectives sought to understand how they felt about working during this time including any risks felt, why they choose to continue working, and what the post-COVID future might hold for them and their profession. Method: The study was guided by the principles of traditional interpretative phenomenological analysis (IPA). Primary research was collated using semi-structured interviews of a small, purposively selected homogenous group of pharmacists. The research context was a …

Formulation, Characterisation And Evaluation Of The Antihypertensive Peptides, Isoleucine-Proline-Proline And Leucine-Lysine-Proline In Chitosan Nanoparticles Coated With Zein For Oral Drug Delivery, Minna Khalid Danish, John P. Gleeson, David J. Brayden, Hugh Byrne, Jesus Maria Frias, Sinead Ryan

Articles

Isoleucine-Proline-Proline (IPP) and Leucine-Lysine-Proline (LKP) are food-derived tripeptides whose antihypertensive functions have been demonstrated in hypertensive rat models. However, peptides display low oral bioavailability due to poor intestinal epithelial permeability and instability. IPP and LKP were formulated into nanoparticles (NP) using chitosan (CL113) via ionotropic gelation and then coated with zein. Following addition of zein, a high encapsulation efficiency (EE) (>80%) was obtained for the NP. In simulated gastric fluid (SGF), 20% cumulative release of the peptides was achieved after 2 h, whereas in simulated intestinal fluid (SIF), ~90% cumulative release was observed after 6 h. Higher colloidal stability …

“Holistic Risk-Based Site Surveillance – A Data-Based Approach To Site Quality Risk Identification And Assessment In The Pharmaceutical Industry”, Matteo Bernasconi, Thomas Friedli, Nuala Calnan (Editor)

Level 3

Effective quality risk management is fundamental in guaranteeing the development and manufacture of high-quality drugs, reducing drug shortages, and avoiding harm to patients’ health. The ability to accurately assess the actual risk environment, predict potential product quality or supply disruption issues and act to eliminate, prevent, reduce or mitigate them is key to improvements in quality management maturity. This paper illustrates a just-launched research project aimed at developing a comprehensive framework for how to assess and predict risks by leveraging a range of diverse factors.

“Gaining Organisational Acceptance Of A Data Analytics Programme In Eli Lilly”, Anthony Maguire, Marcus O'Mahony

Level 3

This paper describes how Eli Lilly overcame barriers to enable new use of data. This was achieved by adopting a deep understanding of end-user needs and the support of site leaders and end-users to standardise process monitoring. A standard approach of ‘Contexting’, ‘Data-Extraction’, ‘Model build’, ‘On-line Config’, ‘Deploy’, was utilised, using a commercial off-the-shelf software. The paper describes proof of concept demonstrations undertaken and discusses the ingredients to make the journey a success.

Unlocking Knowledge To Benefit The Patient : How Connecting Km And Qrm Can Strengthen Science And Risk-Based Decision Making, Martin J. Lipa

Doctoral

This thesis explored knowledge management effectiveness in the pharmaceutical sector and included an examination of the critical relationship between knowledge management (KM) and quality risk management (QRM) as the dual enablers of an effective pharmaceutical quality system. The primary research objectives were to improve understanding and effectiveness of the interdependency between KM and QRM and to improve knowledge management across the pharmaceutical product lifecycle, starting with a focus on knowledge transfer during technology transfer. The thesis explored how improved KM across the product lifecycle coupled with thoughtful and intentional connectivity between KM and QRM as defined by this study could …

A Survey Report On The Current State Of Quality Risk Management (Qrm) And Knowledge Management (Km) Integration, Martin Lipa, Kevin O'Donnell, Anne Greene

Level 3

As part of research to better define and improve the integration between quality risk management (QRM) and knowledge management (KM) as dual enablers of an effective pharmaceutical quality system, a survey was conducted in February 2021 to explore this relationship. The survey explored the current state relationship in theory and in practice, solicited feedback on a proposed framework, the Risk-Knowledge Infinity Cycle, to improve the connection between QRM and KM, associated benefits and potential actions to make progress in this regard. The results suggest QRM and KM are highly interdependent in theory but much less so in practice. Further, …

Mapping Km Methods And Tools Across The Pharmaceutical Product Lifecycle, Martin Lipa, Paige Kane

Level 3

Knowledge management is positioned as an enabler of ICH Q10, and the visibility and availability of product and process knowledge across the entire pharmaceutical product lifecycle is vital to the sustained success of an organization and to the effectiveness of an organization’s pharmaceutical quality system as defined by ICH Q10. This paper illustrates where knowledge management has a role to play within each product lifecycle phase. This paper goes on to further define phase-appropriate KM methods and tools to help address these needs and create end-to-end product and process knowledge visibility and availability.

Solving The Continual Improvement And Innovation Challenge For The Benefit Of Patients: How An Effective Pharmaceutical Quality System (Pqs) And Risk-Based Approach Could Transform Post-Approval Change (Pac) Management, Emabelle Ramnarine

Dissertations

Patients deserve their medicines on time every time. Regulators safeguard public health by ensuring availability of safe, effective, high-quality medicines. Pharmaceutical companies must continually improve and innovate to deliver such medicines. In spite of these patient-centric objectives, drug shortages have continued to grow as a global public health concern. The drug shortage problem has existed for decades though there has been no shortage of effort, recommendations, papers, and expectations to resolve it. During the ongoing COVID-19 pandemic even exceptional measures were rapidly implemented to prevent shortages, yet no long-term solutions have been found.

This research hypothesis was that due to …