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Detailed overview of gene requirements for expression of a recombinant gene, e.g. promotor, enhancer, selection, suppression, on/off on demand expression etc. Genetic manipulation of cells; expression vectors, transfection, selection, cloning, and characterisation. Recombinant E. coli and other recombinant prokaryotic systems. Yeast and fungal cell culture systems. Recombinant mammalian cell lines and hybridoma cell lines. Post-translational modifications of recombinant proteins and metabolic engineering to control glycosylation with a focus on fucosylation of monoclonal antibodies. Dihydrofolate reductase based gene amplification and its advantages in recombinant gene expression. The rise of the generic and biosimilar era and the challenges ahead for the blockbuster-drug producing companies.

CHOs as expression systems. CHO genomics. Impact of temperature shifts and miRNAs on the CHO proteome. Signalling pathways in CHO cells.

Design a cell culture facility incorporating equipment and protocols. Understand the generation and maintenance of master cell banks, and working cell banks; theory, practice and regulations, freezing/thawing cells, maintaining a cell line, characterisation of cells, sub-culture of cells, monitoring growth and viability. Growth media, serum-free media, media development will also be discussed. Types of culture systems: attached cells (cell factories, roller bottles, hollow fibre bioreactors), suspension cells (stirred tank, airlift and wave bioreactors) and hybrid systems. Problems of scale up from laboratory to pilot plant to industrial scale. Fed batch vs Perfusion/Continuous culturing.

A detailed overview of the cell cycle and its checkpoints will be presented. This will be linked to the effect on diseases such as cancer in addition to learning about how cells grow in culture, i.e. cell stages, mitotic index relevance etc. A detailed overview of Apoptosis is presented, with a view to extending the life cycle of cells in a batch environment to increase protein production.

Gene targeting, small interfering RNA (siRNA), applications of restriction enzymes in building cell lines, ligations, transformations, transfection technology, gene recombination using recombinases. Methods to combat 'the position effect' to increase product titre (e.g. S/MARs, Barrier elements, insulators sequences placed in plasmids etc. in addition to various gene targeting methods). The use of microRNA in the Biopharm/CHO industry.

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Lecture delivery will comprise a range of methodology including on-line movie animations, visual demonstrations, large diagrams for illustration purposes as well as information and slide handouts. Novel methods using Classroom Response Systems (CRS) will also be utilised. Course material and revision quizzes will be made readily available on a virtual learning environment (VLE) for student access. The combination of these methods will facilitate in re-enforcing the student’s understanding of some of the technical and mechanistic processes involved. Various aligned classroom assessment techniques will also be employed. These will include the background knowledge probe, the one minute paper, small group interaction and discussion, question & answer sessions, team presentations to class colleagues, pop-quizzes and open ended questioning. Access to course textbooks will be provided through the DkIT eBrary service (access to more than 50,000 multidisciplinary e-books), which will allow students 24/7 access to suitable reading material. A range of self-assessment, self-reflection and peer learning exercises will be built in to deliveries of both lectures and practical sessions.

Students will attend weekly practical sessions during the module to improve their practical knowledge and skill set. These practicals build on the laboratory experience gained over the previous three years of the students' time in college. In these sessions, topics will be delivered using various approaches, e.g., via by instructor led 'dry' lab practical sessions covering theoretical examples/overviews/audiovisual content/demonstrations showing techniques in detail, via practical sessions at the National Institute for Bioprocessing Research and Training (NIBRT) at UCD in addition to 'wet' lab practical sessions in DkIT. Using instructor led demonstrations/audiovisual content/formative exercises, students will be gain an overview of the details in involved in growing, splitting, waking & freezing cells in culture in addition to aseptic technique and cell culture etiquette. Students will also learn about adherent vs suspension cells, media components, monitoring cell growth, generating master and working cell banks, reducing risks of contamination, detecting contamination (e.g. mycoplasma detection using PCR). As an exercise, students will design a cell culture facility, providing explanations for the layout design and the equipment included. In the DkIT 'wet' labs of the module, students will use antibodies to detect presence/absence of proteins in cell samples using ELISAs, use PCR as a detection tool to test for the presence/absence of specific target sequences in samples, build plasmids through ligations to contain a gene of interest and perform blue/white screening in E.coli to ensure gene of interest is cloned correctly (this builds the student's knowledge of plasmid generation ahead of our lecture series on transfection technology). At the NIBRT facility, students will perform two practical sessions. In session 1, students will thaw a vial of suspension Chinese Hamster Ovary (CHO) cells and inoculate shake flasks; perform routine passage of cells using aseptic technique; count cells using automatic and manual methods; analyse CHO cell culture using Nova bioprofiler; analyse cells after trypan blue staining. In session 2 at NIBRT, students will set-up a 150L Bioreactor for SIP - includes removing sprayballs, changing sparger, put elbows in place, calibrate probes etc; students will identify SIP protocol using P&ID; run pressure test and SIP of the 150L bioreactor; disassemble SIP equipment and prepare bioreactor for CIP by fitting spray balls etc. Where possible, a site-visit to a local industry plant is also performed/or guest speakers will be invited to DkIT. A video-based project is also performed to improve teamwork, communication skills while also stimulating creativity.

Students will work in teams of three and will have one week to record a digital high-definition 2-4 minute video explaining a scientific topic of relevance to a general audience. The video is submitted as part of the CA component of the module. Its design engages the students with teamwork, brain storming, creativity, technology and also improves their science communication skills.

All lecture notes will be provided to the students through a VLE. This VLE will also be used for access to helpful YouTube video clips and peer reviewed publications of interest to the course. Students will have 24/7 access to the VLE allowing them to download and study at their own pace and in their own time. Screencast and Podcast tutorials will also be made available to the students to download and listen to in their own time. This will facilitate learning and understanding for all students, but in particular the international students who may not possess fluent English.

Throughout the semester, students will be provided with formative assessments both in lectures and in laboratory environments. These are designed to facilitate group work in problem solving situations. These assessments are built in to the lecture and practical components.

Break throughs in the Biopharmaceutical field will be sent to the students on a regular basis. This will involve novel developments in the field in addition to postings on jobs/careers in the industry. This concept facilitates the students in preparing for life after college in the Biopharm industry.

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Students will participate in weekly laboratory-based practical sessions as outlined above. Students will perform formal written lab reports in addition to various formative skill tests throughout the module to improve their communication and practical abilities. During the module, the students will spend one day at the National Institute for Bioprocessing Research and Training (NIBRT) at University College Dublin. This day will expose the students to pharmaceutical plant equipment and systems involved in Upstream Processing. Formative assessments will be performed during the practical sessions which will centre around group work and peer assisted learning. The summative laboratory reports will be joined by a summative video project assessment. Students will work in teams of three and will have one week to record a digital high-definition 2-4 minute video clip explaining a scientific topic of relevance to a general audience. The video is submitted as part of the CA component of the module. It's design engages the students with teamwork, brain storming, creativity, technology and also improves their science communication skills.