Validation and Digitalisation Technologies

Master of Science

Course Details

Course Code	SG_SVALI_M09
Level	9
Duration	3 years
Credits	90
Method of Delivery	Online
Campus Locations	Sligo
Mode of Delivery	Part Time

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Course Overview

The Medical Biotechnology and Biopharmaceutical sectors are among the fastest growing in the Life Sciences area both nationally and internationally.

This programme is jointly offered by ATU Sligo and NIBRT (National Institute for Bioprocessing Research and Training).

This Masters programme in Science in Validation and Digitalisation aims to provide students with a comprehensive grounding in critical aspects of Biopharmaceutical Processing and Support Services, with specific focus on the validation of equipment and facilities and understating of the applications of BioIndustry 4.0.

The programmes are aimed at manufacturing, quality, engineering and site management personnel who are looking to increase their understanding and application of the latest digital trends and technologies in the validation and digitalisation fields and who already hold a Level 8 qualification in science or engineering disciplines.

It will provide a postgraduate qualification in the area of digitalisation that will form both an introduction for new or proposed entrants to the area and additional skills and knowledge to those working in the area.

NIBRT/ATU Sligo have consulted extensively with biopharmaceutical employers located both regionally and nationally to determine the types of skills and training needs required for this sector and all have indicated that there are skills shortages emerging in certain areas and occupations, in particular around validation and data analytics. Senior management, who have responsibility for training and hiring within these organisations, have indicated that significant job openings will arise in the biosciences industry in the next few years, between expansion and replacement demand and a highly skilled pool of graduates will be needed to fill their manufacturing roles.

These proposed programmes are a joint initiative by ATU Sligo and NIBRT who have enjoyed a long-standing working relationship with the shared vision of offering targeted training aligned to and directly addressing the skills requirements of the Biopharma/Pharmachem sector, identified in the Expert Group on Future Skills Needs report on the Future Skills Needs of the Biopharma Industry in Ireland.

In Q4 2020, Boston Consulting Group and NIBRT have opened the worlds first Innovation Centre, in Dublin, dedicated to Biopharma Operations. The Innovation Centre showcases the latest Industry 4.0 (I4.0) technologies in Biopharma manufacturing, quality control and training excellence. These technologies are integrated with core operating processes to enable proof-of-concept use cases on new innovations and new ways of working, situated in a Good Manufacturing Practice (GMP) simulated environment.

The biopharmaceutical industry is among Irelands most significant investors. There are 84,000 highly skilled people directly and indirectly employed in the sector and the expectation is that this will increase by up to 10,000 jobs over the next 5 years, (NIBRT Annual Report, 2022).

Course Details

Year 1

Semester	Module Details	Credits	Mandatory / Elective
1	Biologics Manufacturing This module examines all aspects of a typical biopharmaceutical production process. The primary focus of the module will be on the main operations involved in the production, purification and aseptic filling of a biologic drug product. Key topics covered throughout the module include upstream, downstream and formulation/fill finish manufacturing processes, with a focus on the main unit operations involved in each of these areas. Learning Outcomes 1. Appraisethe key features that are involved in the design of an upstream bioprocessing operation, including cell line choice, cell banking and cell culture scale-up. Interpret regulatory requirements for manufacturing biopharmaceutical drug products produced by aseptic processing. 2. Critically evaluate the various bioreactor designs available for production, and their key features, including the advantages and disadvantages of each. 3. Debate the main aspects of bioreactor control and operation, including the key instrumentation types found on the systems. 4. Recognise and describethe design features that should be considered for the effective purification of a biopharmaceutical drug product. Evaluate the different chromatography techniques available for purification and their modes of operation, including the advantages and disadvantages of each. 5. Critically evaluate the different chromatography techniques available for purification and their modes of operation, including the advantages and disadvantages of each. 6. Outline the use of other purification technologies used in downstream processing including ultrafiltration diafiltration, viral inactivation and viral clearance. Explain the principal methods of filling biopharmaceutical drug products aseptically.	05	Mandatory
1	Facility Design and Operation This module will provide students with an overview of the technical and managerial challenges associated with the design and construction of a biopharmaceutical manufacturing facility. It will address all the major elements of these projects from site master planning through conceptual and detailed design and onto commissioning and qualification. It will also cover such associated project aspects as overall planning, budgeting and the organisational systems and structures required to successfully execute such major investments. An overview of how biopharmaceutical manufacturing facilities operate will also be addressed so as the design of the facility from the material and personnel flows through to the process controls and automation, meet the needs of the operations personnel after the facility is brought into production. Learning Outcomes 1. Effectively plan the major elements of an investment in a biopharmaceutical manufacturing facility. 2. Evaluate and communicate the complex interconnecting elements of these major capital projects. 3. Identify and address the operational requirements for the manufacturing facility within the design. 4. Recognise and describethe main stages of facility design including cleanrooms and associated technology. 5. Critically evaluatethe principal steps involved in the overall commissioning and qualification of a new or modified biopharmaceutical facility. 6. Appraisethe typical organisational control systems and structures required for biopharmaceutical facility design and operation.	05	Mandatory
1	Regulation, Risk and Compliance This module aims to provide students with an understanding of the main regulations and regulatory bodies associated with biopharmaceutical manufacturing, with a focus on Bio-Industry 4.0. It also provides students with the application of the validation concepts and how risk management is an integral part of this. Learning Outcomes 1. Demonstrate an understanding of the global regulatory framework for biotechnology derived products 2. Discuss how the nature and production of biotechnology products affects quality, safety and efficacy and Engage in and demonstrate independent learning as well as communicate effectively as an Individual and ora member of a team 3. Differentiate the applications of EU & US regulations for biopharmaceutical marketing authorisations 4. Categorise the principal risks associated with the manufacture of modern biopharmaceuticals and tools to evaluate them including the latest digital trends and technologies 5. Critically evaluate the main steps involved in the validation of upstream (cell culture processing) and downstream (protein purification) processes as well as cleaning, sterilisation, and viral control technologies in the manufacture of biopharmaceuticals including trends in digitalisation.	05	Mandatory
2	Commissioning, Qualification and Validation This module is designed to provide an overview of the principles behind the commissioning and qualification of a biopharmaceutical production facility. The processes involved in the commissioning and qualification of the utilities and equipment used in a biopharmaceutical production plant will be covered throughout the module. A practical element is incorporated into the module, whereby students will gain an insight into the installation, commissioning and testing of the equipment and utilities used in biopharmaceutical manufacturing. It will equip students with the knowledge and skills required to perform commissioning of a bioprocessing plant, and the equipment related to the biotechnology industry. Learning Outcomes 1. Outline and evaluatethe stages involved in pre-commissioning, commissioning and start-up of facilities 2. Debatethe principles involved in commissioning planning. 3. Evaluatethe steps involved in testing of equipment 4. Outline and Evaluate the safety aspects of commissioning and installation of equipment 5. Critically evaluatethe key industry guidelines and regulations that are used for CQV and differentiate CQV activities 6. Actively Participate in the activities designed to start-up and check a system in a logical, organised, safe, and controlled manner in a simulated GMP environment.	10	Mandatory
2	Scale-Up and Technology Transfer This module will provide an overview of the regulatory, technical and management issues associated with the scale-up and technology transfer of industrial bioprocesses. The focus will be on giving a clear understanding of the technical and regulatory requirements and approaches necessary to obtain regulatory approval for product scale-up and transfer. It will provide guidance on how to implement efficient and effective projects and will also address such areas as process validation and the typical costs associated with these projects. Learning Outcomes 1. Discuss and evaluate the important process, engineering and regulatory aspects of technology transfer. 2. Formulate and communicate effective planning of a technology transfer process. 3. Provide some practical examples of technology transfer aspects and features.	05	Mandatory

Year 2

Semester	Module Details	Credits	Mandatory / Elective
1	Introduction to BioIndustry 4.0 This module aims to provide students with the background of Industry 4.0 and how this conceptual framework can be applied in the biopharmaceutical sector. The course will provide students with the knowledge and understanding of the emerging needs of the biopharmaceutical sector as it progresses towards greater integration of technology and data, to become more agile, to increase productivity and competitiveness. Learning Outcomes 1. Demonstrate they have detailed knowledge and understanding of the background to Industry 4.0 and emerging needs in the biopharma sector, the source and quality of existing data and applicability of industry4.0 2. Demonstrate they have detailed knowledge and understanding of the application of predictive modelling, automation systems, PLCs, robotics, vision systems 3. Evaluate embedded systems, the internet of things (IoT) and the cyber-physical systems (sensors, control boards) necessary for data acquisition 4. Formulate judgements on the relevant value and application of existing data sources, design tools, digital twins, simulation models, and augmented reality/virtual reality. 5. Integrate knowledge and formulate judgements onthe application of robotics and industrial vision systems to biomanufacturing operations.	05	Mandatory
1	Biologics Manufacturing: Current and Future This module aims to provide students with a detailed knowledge and understanding of the future needs of the biopharmaceutical sector beyond Industry 4.0, and includes approaches such as continuous manufacturing, single-use optimization, modular facility design; ATMPs, Cell & Gene therapy; Novel technologies. Learning Outcomes 1. Demonstrate a detailed knowledge of current manufacturing processes for upstream, downstream and fill finish operations. 2. Evaluate novel technologies in upstream and downstream to implement continuous and intensified processes. 3. Demonstrate an understanding of Advanced Therapy Medicinal Products (ATMPs), including biomedical science, molecular basis of disease, stem cell biology and tissue repair, and clinical applications for ATMP 4. Integrate knowledge and formulate judgements onATMP manufacturing challenges, current and developing technologies, and quality control / quality affairs.	05	Mandatory
1	Research Methods Biopharma The purpose of this module is to complete a research proposal which may subsequently form part of the MSc thesis. Students will have the opportunity to formulate a research topic, develop a research schedule and select appropriate methodologies for a research project. The learner will study different research methods, ethical considerations, learn how to critically analyse scientific documents, disseminate research in terms of reports, and communicate effectively. Learning Outcomes 1. Produce a research proposal document. 2. Undertake a focused literature search and generate a literature review on a research topic. 3. Select and apply an appropriate research methodology while adhering to ethical considerations. 4. Communicate effectively their research outcomes.	05	Mandatory
2	Bio-Industry 4.0 Theory and Practice This module aims to provide students with an understanding of the key concepts of Industry 4.0 and outlines the application of the latest digital trends and technologies in the Bio-Industry 4.0 field, and how they can be practically applied. Learning Outcomes 1. Critically assess the smart factory concept in the biopharma industry, considering digital supply network, real-time data, optimised and predictive production. 2. Evaluate the role of PAT in the implementation of the smart factory concept, focusing on efficient use of data from different sources old and new, to bring about measured efficiencies and controls. 3. Evaluate the current applications of automation and the future potential applications and benefits of automation and data integration in the implementation of the smart factory including theidentification of challenges. 4. Demonstrate an understanding of the ISA-95 model, the international standard for the integration of enterprise and control systems, along with other automation standards such as NAMUR and Profinet. 5. Covering the entire bioproduction supply-chain from design to delivery of the product to the patient, learn to evaluate various digital tools reproducing essential production elements (digital twins, serious games, immersive reality, virtual reality, and augmented reality) and cognitive approaches supported by artificial intelligence to promote understanding of processes and the appropriation of professional practices, using case studies where appropriate. 6. Engage in and demonstrate independent learning as well as communicate effectively as an Individual and ora member of a team	10	Mandatory
2	Bio-Industry Data and Digital Technologies This module aims to provide students with a detailed knowledge and understanding of the future needs of the biopharmaceutical sector developing data literacy and skills vital for ensuring that biopharma organisations can transform large, complex, disconnect data sets into tangible business assets. Learning Outcomes 1. Demonstrate a knowledge of the theories, techniques and models for data identification, acquisition, cleaning, and aggregation of the range of biopharma data types 2. Critically assess a range of BioPharma data management systems architectures (ERP, MES, LIMS) in terms of their suitability to acquire, process and manage large data collections 3. Evaluate the challenges with data integrity, storage, security, management, cybersecurity, and data ethics 4. Research and assess a range of architecture models considering future positive impact on the biopharma business. Assessment of company requirements for implementation of architectural models. 5. Prepare data for use in industry 4.0 analytical use cases to support data driven business insights. Overview of key trends in the application of data and analytics to pharma analytics use cases, including business continuity.	05	Mandatory

Year 3

Semester	Module Details	Credits	Mandatory / Elective
Year	Biopharmaceutical Dissertation This module aims to equip participants with the requisite advanced knowledge, understanding and skills to perform bioprocessing related research using traditional and emerging research designs informed by a critical awareness of developments at the forefront of legislation and practice in the bioprocessing industry. Learning Outcomes 1. Articulate and elaborate an understanding of current thinking on the nature of bioprocessing challenges and the value of related research in that context, whilst showing awareness of the ethical dimensions. 2. Manage a research project combining independent study, support sessions and supervision effectively. 3. Write a coherent research proposal with an acceptable research question or hypothesis and conduct a critically focused literature review. 4. Analyse data according to accepted models of analysis, showing awareness of alternative models of analysis and theoretical frameworks.Sustain from the evidence obtained, a reasoned argument and draw consistent and coherent conclusions from the research evidence 5. Reflect self-critically on the significance of the outcomes/conclusions of the enquiry and on the research process itself. 6. Write a dissertation which meets postgraduate standards of technical expertise investigating the subject area or testing the hypothesis outlined in the research proposal.	30	Mandatory

Recommended Study Hours per week

It is recommended that students allow for 6 hours on average per week per 5 credit module. This includes contact time (lectures) and self directed study, along with time for completion of assignments.

Examination and Assessment

100% continuous assessment. Some or all of the following assessment modes may apply: examinations, practical work, projects, essays, vivas, seminars, and various forms of assignment.

On-Campus Attendance Requirement

No attendance required.
Note: Check programme Examination and Assessment requirements, as they may involve examinations to be taken on campus.

Download a prospectus

Postgraduate Prospectus Online, Flexible & Professional Development Prospectus

Entry Requirements

The programme is open to students who have obtained an Honours degree or its equivalent in an appropriate discipline (i.e. Engineering or Life Sciences). Other candidates with alternative Honours degrees and experience in the BioProcessing industry may apply for consideration (typically 5 Years duration in a GMP environment).

The entry requirements will encompass recognition of prior accredited learning in other third level institutions, in accordance with ATU procedures. RPL is a process that may allow you to gain admission to a programme or to receive exemptions / credit from some parts of a programme based on demonstrated learning that you may have achieved through another programme of study or through your work and career. Further information is available through www.a tu.ie/rpl which is our dedicated RPL portal.

English Requirement

Applicants whose first language is not English should provide evidence of English language proficiency.

Fees

Total Fees EU: €12000

Further information on fees

Careers

Graduates from this programme can expect to find employment in the Biopharmaceutical, Biotechnology, Medical Diagnostics, Medical Devices and Pharmaceutical sectors, at the appropriate level. In the development of this programme emphasis has been placed on aligning the course content with the skills required by the Biopharmaceutical industry, whilst ensuring that there is sufficient flexibility to allow students to move laterally into associated careers including Research and Development opportunities. Graduates are typically employed in managerial positions in Scientific, Operations and Quality Assurance / Control positions in the Biopharmaceutical and Biotechnology industry sectors both in Ireland and abroad.

Further Information

Who Should Apply?

This programme is aimed at manufacturing, quality, engineering and site management personnel who are looking to increase their understanding and application of the latest digital trends and technologies in the validation and digitalisation fields and who already hold a Level 8 qualification in science or engineering disciplines.