Biopharmaceutical products are highly important in today’s global healthcare systems in treating illnesses and disease. The industry in the British Isles has seen significant investment, particularly in the Republic of Ireland (RoI) where there has been capital investment of approximately £7.97 billion in new facilities, mostly in the last 10 years. The global market for biopharmaceuticals was valued at £149 billion in 2017, and is projected to reach £419 billion by 2025, growing at an annual rate of 13.8% from 2018 to 2025. As a result, over 30,000 highly skilled people are currently employed in Ireland north and south with new companies setting up facilities in RoI every year. The increased uptake of skilled biopharmaceutical employees has necessitated the need for a high quality education in this sector.
Queen’s University Belfast School of Chemistry and Chemical Engineering has a proven track record for delivering high quality teaching and research and has launched the options-based Postgraduate Certificate in Biopharmaceutical Engineering from this platform. This qualification will provide students with knowledge and skills which will help them to find employment in the field of biopharmaceutical production, separation and purification by applying fundamental science and engineering principles.
It is partly designed to augment skills and qualifications already gained by STEM graduates and by staff who are working in the Biopharmaceutical Engineering sector but who wish to add some specialisations in order to progress. It should also anyone seeking a career pathway change who meets he entrance criteria.
Through studying this postgraduate course students will be able to gain a highly relevant qualification which will give them greatly enhanced employability.
Through the use of theory and mathematical approaches to engineering problems, students will understand and become skilled in the development of systems which can facilitate biopharmaceuticals production and their subsequent purification.
This course is run in collaboration with our industrial partner Eli Lilly, a global company with excellent standing in the field of pharmaceutical and biopharmaceutical production and commercialisation. A collaborative course of this nature is the first of its kind in the British Isles and will provide students with real-world knowledge of how these systems are operated in an industrial setting through the case studies and first-hand knowledge imparted by the academics and industry staff delivering the course.
Q.U.B. School of Chemistry and Chemical Engineering is ranked joint 1st in the UK for research intensity and ranked 13th in the UK for studying Chemistry (Complete Universities Guide UK 2023)
Biopharmaceutical Engineering highlights
Internationally Renowned Experts
You will be taught by experts in the field of medicinal chemistry, chemical engineering, separation science and industry experts who work in Eli Lilly. Having this level of expertise will greatly enhance your understanding and experience of the course.
World Class Facilities
There will be an opportunity for you to see on-site demonstrations of the School’s state-of-the-art pharmaceutical analysis suite. This will allow you to see and experience hands-on separation science as it applies to the pharmaceutical and biopharmaceutical industries. Some work may also be undertaken on our new Solid State NMR.
Industry Links
This course is run in collaboration with the (bio)pharmaceutical company Eli Lilly, whose staff deliver one of the optional modules. This will grant you direct access to the knowledge and experience of individuals who work in the biopharmaceutical industry.
The Certificate is awarded to students who successfully complete 3 of the 6 available module choices (totalling 60 CATS points).
Introduction
This course will start in September 2024 and run until mid-May 2025. Assessment activities will be carried out throughout the course (as applicable to each module's specification). Students on the course will need to have access to a computer with internet access.
Three 20 CATS modules (60 CATS total) must be selected from a choice of six module options.
The teaching will mostly utilise online delivery and blended-learning activities to enable students to access learning materials in a highly flexible manner, compatible with a part-time mode of study. Delivery will take the form of pre-recorded lectures and reading material being made available to students on a weekly basis, followed by regular synchronous online workshops, seminars and Q&A sessions to ensure continuous engagement with the students.
Students who choose CHE7506 as an option will be required to attend classes on campus.
Module Options
CHE7501 Medicinal Chemistry
CHE7502 Biopharmaceuticals & Upstream Processing
CHE7503 Chemical Engineering Principles
CHE7504 Bioreactor Design and Bioprocess Control
CHE7505 Separations, Downstream Processing and Bioanalytical Science
CHE7506 Regulatory Affairs and Quality Systems
Students must make a choice of THREE modules from the following:
CHE7501 Medicinal Chemistry
The purpose of this module is to provide students with the knowledge of the inception of a biopharmaceutical product, what it is made from in terms of chemistry and how it will act in the body. The module is split into three lecture series: Drug Discovery, Proteins and Pharmacology.
Within each of these series there will be lectures which will look at each of the three areas in detail. This module will be delivered by staff from Chemistry and as such there will be key understanding and information imparted by leading medicinal chemists whose expertise has been instrumental in advancing the research intensity of our School.
The module is assessed on a 100% continual assessment basis - workshops, questions/problems and short essays on journals will be used.
CHE7502 Biopharmaceuticals & Upstream Processing
This module will begin the introduction of biopharmaceuticals to students, the need and context for biopharmaceutical products and also what form they may take depending on patient needs. The module is split into two lecture series (following its title) and will be assessed by a mix of formal examination (60%) and tutorials (40%).
CHE7503 Chemical Engineering Principles
The third of the first semester modules will look at the principles which are applied to chemical engineering in terms of kinetics, heat and mass transport and also thermodynamics. This module will provide students with an advanced understanding of the theory of Chemical Engineering and why these principles must be adhered to in a chemical process especially in the production of a biopharmaceutical product.
There will be a considerable mathematical element to this module and as such there is significant emphasis on the relevant workshops provided. These are assessed and will make up 75% of the available marks for the module. The remaining 25% is based on tutorial work.
CHE7504 Bioreactor Design and Bioprocess Control
The content of this module will look in detail at the design of specific reactors for the carrying out of a chemical process with particular reference being made to the production of proteins in a biopharmaceutical setting. The theory which will be applied throughout this module will align with the previous module (Chemical Engineering Principles) and use the principles of chemical engineering to inform the decisions to be made when designing a reactor for a specific function. This module will be assessed through the use of workshop problems (40%) and a design project with presentation (60%).
CHE7505 Separations, Downstream Processing and Bioanalytical Science
This module looks in detail at the different methods which are employed for the purification of the crude protein following the upstream process. The module is split into four lecture series: filtration, separations, downstream processing and bioanalytical science.
Access to the state of the art analytical suite in the School of Chemistry and Chemical Engineering will facilitate understanding and development of knowledge as students will have the opportunity to use the analytical pieces of equipment within the laboratory to perform their own separations. This will not only aid in reinforcement of the lecture content but will also give students hands-on experience in performing chromatographical separations - a highly desirable skill in industry. CHE7405 has a formal examination which will form 60% of the final mark for the module; the remaining 40% will be derived from submitted tutorial work.
CHE7506 Regulatory Affairs and Quality Systems
The last taught module in the course is delivered in its entirety by staff from Eli Lilly. They will contextualise the key regulatory bodies in detail, as well as the range of global regulations which apply to biopharmaceutical products. One of the unique features of this module is the fact that the content is delivered by industry experts who work with biopharmaceutical products on a daily basis and are consequently fully conversant with the regulatory requirements. This module is coursework assessed through compulsory Eli Lilly run workshops.
School of Chemistry & Chem Eng Dr Mark McLaughlin is a medicinal chemist.
Mark trained at The Institute of Cancer Research, London and the University of Oxford and currently teaches across the chemistry and medicinal chemistry degree pathways at QUB. His research group is actively engaged in structure-based design and synthesis of small molecules, and using these to validate new therapeutic targets in oncology, neurodegeneration, inflammation, and rare disease.
School of Chemistry & Chem Eng Nathan has a multi-disciplinary background with a degree in Molecular Biology with Biosciences and a PhD in Chemical Engineering. His research focusses on reactor engineering development for both biological and chemical based systems for deployment in a range of applications.
School of Chemistry & Chem Eng Seyed holds a BSc in Chemical Engineering, an MSc in Biotechnology and a PhD in Bioscience. His postdoctoral research in Materials Science focuses on developing engineered nanomaterials for biopharmaceutical applications.
Learning and Teaching
At Queen’s, we aim to deliver a high-quality learning environment that embeds intellectual curiosity, innovation and best practice in learning, teaching and student support to enable student to achieve their full academic potential.
VLE
Information associated with lectures and assignments is typically communicated via a Virtual Learning Environment (VLE) called Canvas.
Assessment
Assessments associated with the course are outlined below:
Two of the modules have formal examinations which will make up 60% of the respective modules (CHE7502 and CHE7505).
All other marks on the course will be made up from assessed coursework elements.
Facilities
Investment continues to be made in the School of Chemistry and Chemical Engineering extending our range of facilities. The well-equipped research laboratories are augmented by excellent computational facilities and some of the most modern instrumentation available. The School has recently invested in a lab containing 18 brand new analytical instruments, from HPLC, GC and mass spectrometers, to FT-IR, UV-Vis and Fluorescence spectroscopy, dedicated to the training of analytical techniques. https://www.qub.ac.uk/schools/SchoolofChemistryandChemicalEngineering/Discover/Facilities/
The information below is intended as an example only, featuring module details for the current year of study (2024/25). Modules are reviewed on an annual basis and may be subject to future changes – revised details will be published through Programme Specifications ahead of each academic year.
Separations, Downstream Processing and Bioanalytical Science
Overview
Summary of Lecture Content:
This module contains the methods and principles behind separations, the fundamental theories behind separating substances based on polarities and chemical properties. Filtration when applied to a biopharmaceutical process and the subsequent purification of the crude product via downstream processing. Finally the analysis when applied to biopharmaceuticals in terms of spectroscopic techniques and assays will be discussed and examples given.
Series 1: Separations
This block looks at the different methods which are employed for the separations of compounds based on their physical properties in terms of size, polarity, charge etc. Analytical and preparative chromatography using various different techniques will be discussed and students will be expected to recall these methods including the pros and cons. The use of electrophoresis for the separation of proteins is also discussed.
Series 1 Lectures:
• Lecture 1: Analytical Chromatography
• Lecture 2: Preparative Chromatography
• Lecture 3: Interactions and Polarity
• Lecture 4: Electrophoresis
Series 2: Filtration
This block looks at and discusses the importance of filtration in the biopharmaceutical process in terms of the methods employed including ultrafiltration and also the mathematical models involved in maximising the efficiency of a filtration system. The materials and types of filter used in the filtration process will also be discussed and why these different materials are key for obtaining a maximal filtration system.
Series 2 Lectures:
• Lecture 5: Principles of Filtration
• Lecture 6: Types and Materials of a Filter
• Lecture 7: Microfiltration vs. Ultrafiltration
• Lecture 8: Modelling Filtration Mathematically
Series 3: Downstream Processing
This block examines the different methods employed for the chromatographic separation of proteins, how this is done and also what the properties and classification behind the stationary phase are. Design of chromatographic columns will be discussed in detail and the methods for which a column should be packed and which combination of stationary phases are best for obtaining a high purity biopharmaceutical product.
Series 3 lectures:
• Lecture 9: Preparative Protein Chromatography (PPC)
• Lecture 10: Stationary Phase- Properties, Classification and Concepts
• Lecture 11: Types of Chromatography in PPC
• Lecture 12: Design of Chromatography Columns
Series 4: Bioanalytical Science
The discussion in this block centres around the analysis of the purified protein following the production and downstream processing, the analytical techniques employed and how the techniques used can provide information on the purity of the product. How these methods of analysis are used in an industrial plant and why it is important to ensure there is no chance of variation between batches of the biopharmaceutical produced.
Series 4 lectures:
• Lecture 13: Protein and Peptide Analysis
• Lecture 14: Hyphenated and Non-hyphenated Techniques
• Lecture 15: Ligand Binding Assays
• Lecture 16: NMR
Summary of Workshops
• Workshop 1: This workshop will focus mainly on the interactions an analyte would have and why this is important on the chromatographic separation, the methods of separation for preparative and analytical chromatography are discussed and some examples of which would be appropriate for a certain scenario
• Workshop 2: This workshop will mainly focus on the mathematical modelling when applied to a filtration system and why it is important to model it in this way to maximise the amount of filtration while remaining productive at the same time
• Workshop 3: This workshop will centre around the design of chromatography columns which would be used in an industrial setting and also the appropriate choice of stationary phase based o they types of interactions which would best separate the pure product from any present impurities
• Workshop 4: This workshop will align with Workshop 1 whereby the use of analytical procedures in particular the hyphenated and non-hyphenated techniques can be discussed and demonstrated using the Pharmaceutical Analysis suite
Summary of Module Delivery:
This block will be delivered in-person and also via recorded workshops which students can use in their own revision and study time to refer to. As there is an element of mathematics and advanced analytical techniques which will be complex to students with no background in the field workshops will be provided to allow time for discussion and work through examples in groups. It is envisioned that these workshops will be held in person and also online and be recorded and uploaded to Teams so students can refer to during their own studies.
Learning Outcomes
At the end of the module students will be able to:
• Recognise and describe the process behind separations both on an analytical and preparative scale
• List the physical properties which determine the effectiveness of a separation technique
• Describe the methods of downstream processing in terms of the chromatography stationary phases and types of column
• Understand thee processes behind protein and peptide analysis, why this is important and why it is key to eliminate the possibility of major variation
• Understand the operation and interpretation of analytical results of protein analysis in terms of hyphenated and non-hyphenated techniques including HPLC, GC, LC-MS, GC-MS, ICP-MS, CE-MS
• Model mathematically the most effective form of filtration for the separation of a protein from the living cell
Skills
Skills Associated with Module:
• Core skills in underlying physical sciences, in particular physics and chemistry as applied to solving problems
• Logical thinking
• STEM skills
• Communication and reporting writing skills
• Mathematical problem solving ability
This module will probe the key underpinnings behind reactor design and the principles behind controlling a chemical process in the chosen reactor. Within this module, choosing the correct reactor for a given process will be discussed and the kinetic modelling applied to the reactor. Alongside this, a focus on bioreactors to facilitate the production of biopharmaceuticals on a large scale will be discussed along with some of the key parameters behind maximising product yield. Finally, control of the process will be discussed along with the methods of control and process automation. Within this module, there will be a marked design project which the students will complete individually, the motivation behind this type of work is that students will be able to take ownership of a piece of work and will require thought and originality of idea in terms of what they have been taught thus far in the course. Application of knowledge gathered and also literature sources will aid in the completion of this project. Following the completion of the design project, the students will then give a short presentation of their findings and ideas about the project.
Series 1: Reactor Design
This block will probe in detail the different types of reactor and which type would be applicable to which process. Determining how to relate the different types of reactor can be related to maximal heat and mass transfer will be discussed and proven using mathematical models. Moving on from the previous module, chemical equilibria and kinetics will be discussed in more details and these when applied to different types of reactor.
Series 1 Lectures:
• Lecture 1: Types of reactor
• Lecture 2: Appropriate choice of reactor
• Lecture 3: Linking reactor design to maximal heat and mass transfer
• Lecture 4: Chemical equilibria and kinetics
Series 2: Process Control
This block will examine the methods and motivation behind process control and list the hardware required for a process to be controlled automatically. Alongside this, issues arising during an automated process will be discussed and steps taken towards remedying issues will be discussed.
Series 2 Lectures:
• Lecture 5: Why a process needs to be controlled
• Lecture 6: Hardware required for a process to be controlled
• Lecture 7: Process dynamics
• Lecture 8: Root cause analysis of system malfunction
Series 3: Bioreactors
This block discusses the key elements of a bioreactor and what the typical reactor chosen for this purpose is, the critical process parameters required for the efficient operation of a bioreactor for the maximum yield of a biopharmaceutical product. Some discussion around what other types of reactors may be suitable for a specific type of biopharmaceutical and finally the mass balance for a biopharmaceutical production process.
Series 3 Lectures
• Lecture 9: Overview of a continuous stirred-tank reactor & components
• Lecture 10: Critical process parameters
• Lecture 11: Other potential reactors for a bioprocess
• Lecture 12: Mass balance
Series 4: Bioprocess Control
This block concerns the motivation for process control and also the methods employed for the full control of a process including the inputs & outputs, the sensors required for the control and also automation of a process.
Series 4 Lectures
• Lecture 13: Methods of control
• Lecture 14: Sensors
• Lecture 15: Process automation
• Lecture 16: Inputs & Outputs
Summary of workshops
• Workshop 1: This workshop will focus on the reactor choice for a specific need within an industrial setting and linking the chosen reactor to the principles of heat and mass transfer as covered in Chemical Engineering Principles this workshop will be performed in groups which will facilitate group discussion.
• Workshop 2: The aim of this workshop is to allow students to see and understand the main methods behind controlling a process and groupwork which will reinforce the lecture material
• Workshop 3: This workshop will focus on the typical reactor which would be employed for a biopharmaceutical production and also a key discussion on the critical process parameters. There will be some overlap between Workshop 2 and Workshop 3 whereby the critical process parameters and how they are controlled will be a major part of the groupwork
• Workshop 4: This workshop will focus on the inputs and outputs when controlling a bioprocess, the main aim of the workshop will be to design a process fully controlled and specifying the inputs and outputs of the system and which sensors are required for which operations within the system.
Summary of Module Delivery:
This block will be delivered in-person and also via recorded workshops which students can use in their own revision and study time to refer to. Due to the mathematical components of this module, there will be workshops made available for all students to attend in order to have an increased knowledge in the mathematical functions and models used in the determination of quantifiable values. These workshops will be led by an academic and supported by a PhD/ PDRA who can take part in break-out rooms and stimulate discussion between members of groups.
Learning Outcomes
At the end of the module students will be able to:
• Recall the key aspects behind designing a reactor which is to be used for the production of a biopharmaceutical product
• Understand what it means and why it is necessary to control a process
• Describe the key features and components of a Continuous Stirred-Tank Reactor and why it is most commonly used for the plant-scale production of biopharmaceuticals
• Describe and explain the methods behind controlling a bioprocess including the required sensors and the inputs and outputs
Skills
Skills Associated with Module:
• Core skills in underlying physical sciences, in particular physics and chemistry as applied to solving problems
• Logical thinking
• STEM skills
• Communication and reporting writing skills
Summary of Lecture Content:
This module will focus on what biopharmaceuticals are, why they are needed and how they are produced. In further detail, the student will examine the different types of biopharmaceutical product including mABs and ADCs including what types of modifications are required to produce the latter, examples of each and what types of diseases they are employed to treat. The second part of the module will look at the upstream processing of a biopharmaceutical engineering process, cell banks and the need for different media for different cell lines.
The module is delivered over the following two lecture series:
Block 1: Biopharmaceuticals
This series contains the information and rationale for the need for biopharmaceutical products and the different types of biopharmaceutical products which are available. One of the key lectures which will be delivered will provide clarity around the difference between a standard drug and a biopharmaceutical, how a traditional drug is synthesised and why due to complexity a biopharmaceutical product cannot simply be put together in a lab in a similar way. The structures of some and also how they are biosynthesised within the host cell. Some organic chemistry will be discussed in detail with reference to Antibody-Drug Conjugates and what role they play in the treatment of disease.
• Series 1 Lectures
o Lecture 1: Traditional drugs and their limitations
o Lecture 2: What is a biopharmaceutical?
o Lecture 3: Context and case-studies in today’s world of medicine
o Lecture 4: Types of biopharmaceuticals
o Lecture 5: Monoclonal antibodies
o Lecture 6: Glycosylation and QbD
o Lecture 7: Modification of therapeutic proteins
Block 2: Upstream processing
This lecture series will focus on the practical side of biopharmaceutical production, from looking at cell growth, cell death, cell metabolites and also some kinetic modelling when applied to mass balance.
• Series 2 Lectures:
o Lecture 8: Cell death: Why and how to manage it
o Lecture 9: Cell proliferation
o Lecture 10: Metabolites of a cell when producing a biopharmaceutical
o Lecture 11: Conditions of upstream processing
o Lecture 12: Mass balance
o Lecture 13: Scale-up from batch to plant
o Lecture 14: Controlling pathogens
Summary of Workshops:
• Workshop 1: Introduction to drugs and the need for biopharmaceuticals
• Workshop 2: mABs and Glycosylation mechanisms
• Workshop 3: Cell metabolites and significance
• Workshop 4: Scaling up considerations
Summary of Module Delivery:
The two lecture series described herein will be delivered in person on campus, this will allow students to approach the relevant academic should any queries arise. it will also provide a more seamless transition into discussion between academic and student. The workshops will be designed in a way that will allow either a Teams format, on-campus format or blended. The blended approach will be beneficial as the workshops on Teams will be recorded and therefore will allow reference during private study time.
Learning Outcomes
At the end of the module the students are expected to:
• Understand that traditional drugs which are available on the market in terms of their ability to treat illnesses
• Critically analyse the need for biopharmaceuticals when it comes to illnesses that traditional drugs cant treat- compare the two types of product in detail
• Recall and describe in detail the different types of biopharmaceutical product which is available on the market
• Analyse the components of a medium and comment on efficiency and whether or not it can be classified as being ‘nutrient-rich’ and sufficient for cell proliferation
• Create a plan for the scale-up of an upstream process
Skills
Skills Associated with Module:
• Logical thinking
• Critical and interdisciplinary thinking.
• Ability to review literature, to produce written documents and reports.
• Analytical skills
Summary of Lecture Content:
The purpose of this module is to provide students with the knowledge of the beginning of a biopharmaceutical product, what it is made from in terms of chemistry and how it will act in the body. The module is split into three lecture series, Drug Discovery, Biomacromolecules and Pharmacology, within each of these series there will be 5 lectures which will walk through the topics in significant detail. As there will be some organic chemistry associated with the second lecture series in the module, there will be an increased number of workshops which will aid in the understanding of the topics and provide students a space to discuss or raise queries with the academic. One of the marked assessment pieces of this module will be written reports by the students on a journal article aligned with each of the lecture series titles, e.g. the first report will be on a journal article about drug discovery etc. n.b. these journal articles will be provided by the academic. Furthermore, another assessed aspect of this course is the literature review, each student will be given a topic and they will be given a period of time to perform the literature searching. Following this, the students will compile their findings and provide a report which must include critical analysis and a short presentation on what they found during their literature search.
Series 1: Drug Discovery
This series will look at the processes behind the discovery of drugs, both in a traditional sense and also the discovery of biopharmaceutical products. Student will gain knowledge and understanding of the target ID & validation within a biological system, why this is necessary and the techniques involved in this process. Other aspects of the drug discovery regime are discussed in detail, including lead generation, optimisation and candidate selection. Throughout the discussion around these themes within drug discovery, the ethics which must be considered will also be spoken about in detail. This series will include two seminars where questions will be uploaded and worked through during the seminar.
Series 1 Lectures:
• Lecture 1: Target ID & Validation
• Lecture 2: Lead Generation
• Lecture 3: Lead Optimisation
• Lecture 4: Candidate Selection
• Lecture 5: Ethics
Series 2: Proteins- Uses, Structure and Function
The content of this series will be mainly involved with macromolecules which are found naturally and also synthesised in vivo, the focus in the beginning of this series will be the understanding of the basic building blocks of proteins. An in-depth look at the type of bonding and interactions between amino acids, what the features are and how they react with each other potentially. This series will be challenging for students from a non-chemistry background and as such will be supported by extra workshops to reinforce learning and understanding of theoretical organic chemistry. This series will include two seminars where questions will be uploaded and worked through during the seminar.
Series 2 Lectures:
• Lecture 6: Amino acids- Structure and bonding
• Lecture 7: Amino Acid Sequence
• Lecture 8: Proteins-Structure
• Lecture 9: Proteins-Uses
• Lecture 10: Protein interactions
Series 3: Pharmacology Introduction
This series will introduce the theories behind pharmacology and their importance when thinking about designing a drug for administration. The emphasis on this block is the consideration of pharmacokinetics and pharmacodynamics for a drug on the human body. These topics will involve the interpretation and understanding of curves showing effect vs time and concentration vs time and as such students will also be expected to apply mathematical knowledge for the determination of models which apply to drug administration and distribution. Also discussed is the use of prodrugs for treatment of illness for the human body, why these are important and their mechanism of liberation. Workshops will facilitate and reinforce learning in these new topics including the application of specific mathematical models.
Series 3 Lectures:
• Lecture 11: Biopharmacology
• Lecture 12: Pharmacokinetics
• Lecture 13: Pharmacodynamics
• Lecture 14: Mechanisms of action
• Lecture 15: Receptors and systems
Summary of Workshops:
• Workshop 1: Drug discovery breakdown, processes and guidelines
• Workshop 2: Amino acids and their Chemistry
• Workshop 3: Bonding and Structure in Proteins
• Workshop 4: Pharmacokinetics and pharmacodynamics
• Workshop 5: Mechanisms and receptors
Summary of Module Delivery:
The three lecture series described above will be delivered in a blended fashion, they will be delivered over a period of twelve weeks. All workshops will be held either in person or via Teams so discussion of points and questions can be facilitated, ideally this will be done with a PDRA or PhD student who can move between break-out rooms when group work is underway.
Learning Outcomes
At the end of the module students will be able to:
• Understand the need for the processes in drug discovery
• Critically evaluate the drug discovery process
• Rationally describe the ethics of the drug discovery process
• Create a structure from a given name of a biomacromolecule including the key bonding pattern and features
• Given appropriate structures, give rationale for reactivity
• Understand and explain the structures of a protein and the bonding both inter- and intramolecularly
• Understand and apply knowledge of the key principles of pharmacology
• Recall the principles of ADME
• Categorise and evaluate a drug in terms of Lipinski’s rule of 5
• Understand and extract data from graphs relating pharmacokinetics and pharmacodynamics
• Using rationale, provide mechanisms of action for a given pharmaceutical
• Understand and describe the processes in a system in terms of receptor and ligand etc
Skills
Skills associated with this module:
• Core skills in STEM
• Critical evaluation
• Analytical skills
• Communication and report writing skills
• Logical understanding
• Problem solving ability
Summary of Lecture Content:
This module will examine the process which runs parallel to the production of the biopharmaceutical product. The need for regulatory alignment with a body to ensure that a product which is being marketed is of the highest quality and safe for use. Within the series the students will be taught in detail the different regulations which must be met in order for a biopharmaceutical product to be marketed. How these regulations may differ when moving from continent to continent and also why they are needed with reference to case studies. Throughout the prior five modules, students will have looked at the different techniques and strategies employed for the production of a biopharmaceutical on a technical, scientific level, however this module will provide context to why some of the processes are carried out in a certain way and why this is the case. In terms of aligning this theory learnt with the real world scenarios and how the process and regulation must go hand-in-hand, discussion of the regulations set by the European Medicines Agency (EMA) and the Food and Drugs Administration (FDA) on both sides of the Atlantic being two of the biggest regulatory bodies with regards biopharmaceutical products in the world. Some of the hands-on experience that the students will gain will be in terms of preparing documents which would be needed for a biopharmaceutical drug to be put into market and ensuring that these documents are filled in correctly to align with each regulatory body. With regards the quality assurance section of the module, students will examine the key processes behind the assurance side of biopharmaceutical production. By identifying the difference between quality assurance and quality control, students will be able to discuss what a quality assurance organisation is and defining the specific functions of each. Again also, there will be examination of instances when quality assurance failed and why this was a major problem when a drug had been put to market. Following the failure of a quality assurance, students will learn about the types of investigation which must be conducted to determine the severity of the failure and what must be done to rectify the issue. The assessment for this module will consist of examination and coursework to be completed by students and submitted, each component is worth 50% of the module score. This module will be delivered in its entirety by staff from our industrial partner Eli Lilly.
Series 1: Regulatory frameworks
This series will introduce the topic of the frameworks in place throughout the world which govern the production and marketing of biopharmaceutical products. Following this, a more in-depth discussion around the role of the FDA and EMA on both sides of the Atlantic and the need for transparency in their protocols with regards to the production of biopharma products.
Block 2: Quality Assurance
This series will look at what it takes to have an organised structure when it comes to quality assurance within a biopharma production plant. Students will look at the key differences between the acronyms associated with QA in the biopharma industry, know the difference between them all and be able to define each. How a process is designed according to standards set by international bodies (ISO) and ensuring that good practices to maintain these standards are met at all times within the process.
Block 3: Quality Control
This lecture series will look at the key aspects behind the quality control carried out within a biopharma industry. On a more practical level, students will be taught about the types of testing which are carried out on a daily basis in a biopharma plant to ensure products ready for market all meet a specific criteria. Following this, understanding the need for investigations to be carried out when a test is failed is also discussed in detail. This series will require students to critically evaluate and think about ways in which a product may have failed a test and how to design experiment which would allow a more robust set of results.
Summary of Workshops:
These workshops will facilitate discussion between academics and students, during the workshops students will go through questions with the academic and this will give students an opportunity to see how the examination questions will be formatted and the best way to approach these questions.
• Workshop 1: Regulatory Frameworks
• Workshop 2: Quality Assurance
• Workshop 3: Quality Control
Summary of Module Delivery:
The three series above will be delivered in a face-to-face manner and as such a significant attendance will be required to ensure high scoring in examinations. Workshops will be mandatory attendance with registers being taken.
Learning Outcomes
At the end of the module students will be able to:
• Understand the need for regulatory frameworks throughout the world when applied to biopharma products
• Create mock documents which are like those to be submitted in a real world scenario to a regulatory body
• Recognise how recent political decisions (Brexit) will necessitate the need for a new regulatory body within the UK and how this may apply to Northern Ireland
• Be able to expand and define acronyms which are used extensively within the industry
• Understand that regulator bodies such as ISO are key to ensuring that good practice is maintained at all times in an industrial process
• Critically examine a scenario where good and bad practices are being followed and discuss what needs to be improved/ maintained
• Define the difference between QC and QA and how it leads to an effective, safely run process and delivers the highest quality of product for marketing
• Examine tests of products and given appropriate information design experiments which could be used to tests products and investigations following test failure
Skills
Skills associated with this module:
• Core skills in STEM
• Critical evaluation
• Analytical skills
• Communication and report writing skills
• Logical understanding
• Problem solving ability
This module concerns the core principles behind a chemical process in terms of the heat and mass transfer and how these relate to the kinetics of a process. In terms of the breakdown of the module there will be four blocks which each in detail will examine the theory behind chemical engineering and how mathematical models can be applied to processes in order to quantify information about a chemical process. Within this module there will be key mathematical formulae and knowledge which will be transferable to other modules within the course. In order to support the delivery of the content in these following four blocks, there will be additional workshops made available which will aid in the understanding of the mathematical models used when thinking about the key processes which underpin fundamental chemical engineering.
Series 1: Thermodynamics
This block will introduce the students to the laws of thermodynamics and how these will apply to chemical engineering systems, students will learn also about how these link to entropy and ultimately how thermodynamics dictates the feasibility of reaction. Activation energy of a chemical process will also be discussed and using mathematical models the calculation of values will be done in detail. A key section of this block is the determination of units and the interconversion between units, this will be a transferable skill within the course as there will be other areas where units will be considered and expected to be converted.
• Series 1 Lectures:
o Lecture 1: Units & Unit Conversion
o Lecture 2: Laws
o Lecture 3: Entropy
o Lecture 4: Feasibility of Reactions & Activation Energy
Series 2: Heat Transfer
This block will examine the transfer of heat and the exchange of heat within a chemical system or process, some of the key aspects of the course will be looking at the different methods by which heat can be transferred and the laws which govern the change of phase.
• Series 2 Lectures:
o Lecture 5: Transport Phenomena
o Lecture 6: Heat Transfer by Conduction & Convection
o Lecture 7: Heat Exchanger Design
o Lecture 8: Phase Changes- Raoult’s, Dalton’s and Henry’s Laws
Series 3: Mass Transfer
This block discusses the theory behind the mass movement of particles within a chemical system or process, the theory behind the mass movement including the different types of mass transfer. Looking at Fick’s law and using it to explain adaptations in organisms and how it can be used to achieve maximal diffusion within a process.
• Series 3 Lectures
o Lecture 9: Introduction to Mass Transfer
o Lecture 10: Diffusion- Fick’s Law
o Lecture 11: Collision Theory
o Lecture 12: Types of Mass Transfer
Series 4: Kinetics & Rates
The content of this block will examine the theory behind the rate of a chemical process and why this is important, the determination of quantifiable values from information gained from the process. The importance of designing experiments which can probe the rate of a process and determining what values are used and the appropriate equations to allow rate calculations. Finally an introduction to chemical equilibria as applied to a chemical process and the introduction of the equilibrium constant Kc and its significance in a reaction at equilibrium.
• Series 4 Lectures:
o Lecture 13: Determining Rates, Rate Constants & Order
o Lecture 14: Molecularity of Reactions
o Lecture 15: Probing Rates in Terms of Designing Experiments
o Lecture 16: Introduction to Equilibrium- Kc and determination of units
Summary of Workshops
• Workshop 1: This workshop will revisit the core principles of the first block with much of the emphasis of the workshop being on the understanding portion of the block including unit interconversion and mathematical skills involved with thermodynamic calculations
• Workshop 2: The second workshop will focus on the understanding behind the movement and transfer of heat throughout a body or system, there will be much emphasis on the design section of this block and the students will be split into groups to facilitate discussion and understanding of the topics between peers
• Workshop 3: This workshop will build upon the previous workshop where the use of group activities will facilitate the understanding and support the lectures of mass transfer and the related principles
• Workshop 4: The focus of this workshop will be to fully support the theoretical aspect of rates of reactions and processes including the determination of quantifiable values from the system including rate law, overall order etc. much of the workshop will focus on the design of experiments which will probe rate values
Summary of Module Delivery:
This block will be delivered via pre-recorded lectures due to the more challenging aspects of the course, this gives the students an opportunity to refer back to the lectures in order to fully support their lone revision and study. Alongside these pre-recorded lectures there will be in-person workshops which will allow for questions about the module to be raised and facilitate discussion between student and academic. These academic leading these workshops will be supported by a PhD/ PDRA who can facilitate group discussion between the students in break-out groups.
Learning Outcomes
At the end of the module students will be able to:
• Understand, recall and use the laws of thermodynamics when describing a chemical process, use the values obtained from calculations to determine the feasibility and also the energy required for a reaction to occur
• Understand and apply knowledge required for the determination of units and the interconversion between units using the base units system
• Describe and explain the theory behind heat transfer and why it is important in a chemical process
• Understand and apply examples of mass transfer when considering a chemical process
• Understand and recall the calculations involved in the determination of a rate, rate constant and order of a reaction/ reactant
• Have an understanding of being able to devise experiments which can be employed for the determination of a reaction rate
Skills
Skills Associated with Module:
* Core skills in underlying physical sciences, in particular physics and chemistry as applied to solving problems
* Logical thinking
* STEM skills
* Communication and reporting writing skills
Normally a 2.2 Honours degree or equivalent qualification acceptable to the University in Chemical Engineering, Chemistry, Pharmacy, Biochemistry or closely allied subject. Applicants with relevant work experience will be considered on a case-by-case basis.
The University's Recognition of Prior Learning Policy provides guidance on the assessment of experiential learning (RPEL). Please visit http://go.qub.ac.uk/RPLpolicy for more information.
A limited number of fully funded places (provided by the Department for the Economy) are available for this programme. Where there are more eligible applications received than places available, the academic selectors for this programme will make offers in rank order based on academic merit and potential as evidenced in the totality of the information provided in each application. We will operate a waiting list as required to allow us to fill all available funded places. If you have not been selected for a funded place, we will accept self-funded or employer-funded applicants, if spaces are available.
If you have already applied for this course but did not know about the funded places available, your original application will still be considered equally for a funded place. We will contact you if this applies to you.
Further information is available at the link below.
Closing date for applications is Friday 16th August 2024 at 12 noon. However, we encourage applicants to apply as early as possible. In the event that any programme receives a high number of applications, the University reserves the right to close the application portal earlier than the deadline. Notifications to this effect will appear on the Direct Application Portal against the programme application page. https://www.qub.ac.uk/Study/skill-up-flexible-skills-fund/
International Students
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English Language Requirements
Evidence of an IELTS* score of 6.0, with not less than 5.5 in any component, or an equivalent qualification acceptable to the University is required. *Taken within the last 2 years.
International students wishing to apply to Queen's University Belfast (and for whom English is not their first language), must be able to demonstrate their proficiency in English in order to benefit fully from their course of study or research. Non-EEA nationals must also satisfy UK Visas and Immigration (UKVI) immigration requirements for English language for visa purposes.
If you need to improve your English language skills before you enter this degree programme, INTO Queen's University Belfast offers a range of English language courses. These intensive and flexible courses are designed to improve your English ability for admission to this degree.
Academic English: an intensive English language and study skills course for successful university study at degree level
Pre-sessional English: a short intensive academic English course for students starting a degree programme at Queen's University Belfast and who need to improve their English.
This course will develop your biopharmaceutical engineering knowledge and skills increasing your opportunity of being employed in many roles in the industry. You may be already in employment and want to skill up and equip yourself with the knowledge to either progress on or seek employment in a biopharma company.
Employment after the Course
With a course like this, you will gain highly desirable skills which will feed into the rapidly expanding industry which is biopharmaceutical production. With the vast investment on the island of Ireland alone, there will be many companies for students to gain employment in.
Alongside working in the field of biopharmaceutical production, the skills and knowledge gained through this course will also give students the opportunities to work in a chemical engineering role more widely (subject to options taken).
Employment Links
Eli Lilly, Alexion and WuXi are among the employers who regularly recruit our Chemical Engineering graduates in RoI and locally we also have good links with Almac, Norbrook, Eakin and Teva.
Graduate Plus/Future Ready Award for extra-curricular skills
In addition to your degree programme, at Queen's you can have the opportunity to gain wider life, academic and employability skills. For example, placements, voluntary work, clubs, societies, sports and lots more. So not only do you graduate with a degree recognised from a world leading university, you'll have practical national and international experience plus a wider exposure to life overall. We call this Graduate Plus/Future Ready Award. It's what makes studying at Queen's University Belfast special.
1EU citizens in the EU Settlement Scheme, with settled status, will be charged the NI or GB tuition fee based on where they are ordinarily resident. Students who are ROI nationals resident in GB will be charged the GB fee.
2 EU students who are ROI nationals resident in ROI are eligible for NI tuition fees.
3 EU Other students (excludes Republic of Ireland nationals living in GB, NI or ROI) are charged tuition fees in line with international fees.
All tuition fees quoted relate to a single year of study unless stated otherwise. Tuition fees will be subject to an annual inflationary increase, unless explicitly stated otherwise.
Depending on the programme of study, there may be extra costs which are not covered by tuition fees, which students will need to consider when planning their studies.
Students can borrow books and access online learning resources from any Queen's library. If students wish to purchase recommended texts, rather than borrow them from the University Library, prices per text can range from £30 to £100. Students should also budget between £30 to £75 per year for photocopying, memory sticks and printing charges.
Students undertaking a period of work placement or study abroad, as either a compulsory or optional part of their programme, should be aware that they will have to fund additional travel and living costs.
If a programme includes a major project or dissertation, there may be costs associated with transport, accommodation and/or materials. The amount will depend on the project chosen. There may also be additional costs for printing and binding.
Students may wish to consider purchasing an electronic device; costs will vary depending on the specification of the model chosen.
There are also additional charges for graduation ceremonies, examination resits and library fines.
How do I fund my study?
The Department for the Economy will provide a tuition fee loan of up to £6,500 per NI / EU student for postgraduate study. Tuition fee loan information.
A postgraduate loans system in the UK offers government-backed student loans of up to £11,836 for taught and research Masters courses in all subject areas (excluding Initial Teacher Education/PGCE, where undergraduate student finance is available). Criteria, eligibility, repayment and application information are available on the UK government website.