Dissertations - Pharmaceutical Business & Technology
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Item Adoption and Manufacturing of Biosimilars for Autoimmune Diseases in Jordan and the Middle East: Key Barriers, Opportunities, and Global Collaboration Models(2025) Abu Sadaa, MohammadBiologic medicines have transformed the treatment of autoimmune and chronic diseases, but their development is highly complex, time-consuming, and costly. Biosimilars, offering comparable safety and efficacy at lower cost, provide an important opportunity to expand patient access, particularly in low- and middle-income countries. This study examines the barriers and opportunities for biosimilar adoption and manufacturing in Jordan and the wider Middle East, with a focus on autoimmune diseases. A mixed-methods approach was applied, combining survey data from 87 pharmaceutical, healthcare, and regulatory professionals with seven expert interviews. Analysis centred on four domains: regulation, manufacturing, market readiness, and international collaboration, benchmarked against global models. Results indicate that although Jordan has had biosimilar guidelines aligned with EMA and WHO standards since 2015, practical implementation remains limited. Local firms are mainly engaged in final product operations and analytical testing, with no upstream capacity. Key challenges include high entry costs, a shortage of specialised expertise, limited physician confidence, pricing pressures, and low public awareness. The study concludes that Jordan’s biosimilar sector is still at an early stage. Progress requires phased development, beginning with stronger regulatory practice and fill-finish partnerships, and moving towards upstream capability through education, targeted training, and collaboration between academia, industry, and international suppliers. Such a framework could position Jordan as a credible regional contributor to biosimilar development.Item Optimisation of Blend Uniformity in a Low Dose Dry Powder Inhaler Formulation: Investigating API and Excipient Interactions and Process Parameters(2025) Grant , MichelleThis dissertation investigates the optimisation of blend uniformity in low dose dry powder inhaler (DPI) formulations, focusing on the interplay between active pharmaceutical ingredient (API) and excipient interactions, as well as critical process parameters such as blending time and speed. Through a combination of literature review, experimental analysis, and scale up studies, the research explores how material properties and mechanical energy inputs influence blend performance. Findings revealed that while process optimisation reduced variability (%RSD) and improved uniformity in several batches, three out of eight failed to meet acceptance criteria, and most exhibited high maximum API content values. Particle size distribution (PSD) and scanning electron microscopy (SEM) analysis confirmed that excipient morphology played a key role in API adhesion and dispersion, with coarse lactose enhancing flow and fine lactose improving binding. Successful scale up from low shear to high shear blending using matched tip speeds demonstrated reproducibility and robustness, validating the hypothesis that mechanical energy translation supports consistent blend quality. However, limitations such as manual sampling bias, narrow material scope, and lack of real-time analytical tools were acknowledged. This study contributes a scalable framework for DPI blend optimisation, emphasising the need for integrated formulation and process development. It advocates for a flexible, science-driven approach to manufacturing that enhances product quality and supports commercial feasibility.Item Investigation of Periodic Review Validation Practices on Small Scale and Vendor Process Equipment in Pharmaceutical Manufacturing in Ireland(2025) Devlin, StephenIntegration of infrastructure and interconnection of computerised systems in pharmaceutical manufacturing in Ireland is ever-increasing. Organisations are collating data from multiple GxP (Good Practice) systems to generate large datasets from computerised systems. This collation of data is to support the drive for increased contextualisation of the entire manufacturing process for the purpose of delivering increased efficiencies and exploring new methods of production. Despite these advances, and to satisfy current regulatory requirements manual review of systems events continue to be the norm, formerly isolated systems critical to the development of pharmaceutical product can interface to archives and historians but the event logs and audit trails, crucial in maintaining compliance and quality are largely required to be manually investigated by trained personnel. This research was undertaken to investigate current practices of this type of review and capture the awareness of professionals tasked with supporting, executing or reviewing these tasks. The research also explores modern solutions, attitudes and concerns to using advanced technologies such as validated scripting tools and AI models to understand how academic research, industry practices and professionals tasked with supporting these logs for regulatory purposes feel about their use. The research also proposes a framework for the implementation of different methods of review to increase the efficiency, consistency and effectiveness of the task, to assign potential owners and distribute actions.Item Cross-Cultural Perceptions of Clinical Trials Among Young Adults (20-35) in Mumbai and Dublin: A Comparative Study of Awareness and Participation Willingness(2025) Rajaram Vishe, KetkiThis dissertation looks at how young adults (aged 20–35) in Mumbai and Dublin think about clinical trials. The aim was to compare their awareness, willingness to participate, and the barriers they face. To achieve this aim, the research followed a mixed-methods design. A total of 120 participants (60 from Mumbai and 60 from Dublin, with equal representation from healthcare and non-healthcare backgrounds) completed an online survey. In addition, qualitative insights were gathered through open-ended responses from 10 participants to capture deeper reflections on trust, safety concerns, and cultural influences. This approach provided both a broad overview of patterns and richer, context-specific perspectives. The findings revealed that while general awareness of clinical trials was high in both cities (83.3% of respondents had heard of them), detailed understanding of processes, ethical oversight, and participant rights remained moderate. Trust and safety emerged as the most decisive factors in shaping willingness to participate. Fear of side effects (reported by 75% of respondents) and concerns about being “treated like a test subject” were key barriers, while family influence also played a role in both cultural settings. Interestingly, the comparison showed that young adults in Mumbai and Dublin shared more similarities than differences: both groups displayed cautious willingness, similar reliance on healthcare professionals for information, and skepticism towards social media advertisements. The most striking difference was that healthcare-educated participants in both cities consistently showed higher levels of understanding, trust, and willingness to participate than their non-healthcare counterparts, highlighting the importance of education over cultural background. The study concludes that while culture influences perceptions to some extent, globalization, digital access, and shared concerns about safety and trust have created strong cross-cultural similarities. The findings suggest that improving youth participation in clinical trials requires transparent communication, trust-building initiatives, and targeted education rather than relying solely on cultural tailoring. Practical recommendations include using healthcare professionals as primary communicators, integrating clinical trial literacy into educational programs, and leveraging digital platforms for awareness while avoiding over-reliance on advertising. This research contributes to the growing body of literature by filling a gap in understanding young, healthy adults’ views in a cross-cultural context. It emphasizes that education and trust are more critical than nationality in determining willingness to engage in clinical trials. For industry and regulators, these insights provide valuable guidance on designing recruitment strategies that are both ethical and effective. For me as a student, the dissertation was a meaningful learning process, as it connected pharmaceutical business and technology with real-world challenges of clinical research engagement.Item Evaluating the Role of ICH Q9-Based Quality Risk Management in Reducing CAPA Recurrence Rates: A Study of GMP-Regulated Pharmaceutical Companies in Ireland(2025) Cladissophiya , GeorgeThis research examines the contribution that Quality Risk Management (QRM) under the ICH Q9 framework can make to resolving the long-standing problem of recurring Corrective and Preventive Actions (CAPAs) in Irish pharmaceutical manufacturing. Even with good regulatory management that is seen with EU GMP, the repeated occurrence of problems within many sites remains to be a source of disappointment to product quality and efficiency within the operations. This research study conducted a systematic survey of 109 quality professionals to investigate the maturity of QRM practices in use, perceived utility of QRM tools, and the degree to which regulatory alignment can be used to impact the results of CAPAs. The results point out that greater QRM maturity is strongly linked to increased CAPA success and lower recurrence. The respondents in the locations that have high integration of QRM practices gave higher ratings to the effectiveness of CAPA processes and those with low levels documented recurring issues. The regression analysis also showed that the alignment of regulatory practices to the EU GMP and ICH Q9 regulations significantly affected the decline of CAPA recurrence, but the actual presence of formal QRM policies did not cause significant difference. The work has academic and practical contributions by highlighting the importance of a better integration of QRM into CAPA investigations, as opposed to policy-based adoption. Practitioner recommendations to the industry, as well as academic recommendations on the longitudinal effects, are given.