Certificate in Bioprocessing
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Course Overview
The aim of the programme is to provide students with an in-depth knowledge of the upstream and downstream processing of biopharmaceuticals (both theoretical pertained to the development, production and purification of biopharmaceuticals.
What makes this course different
Knowledge and critical thinking
Students will apply scientific knowledge, health and safety principles, and critical thinking to evaluate plasmid vectors, expression methods and production systems, used to produce recombinant proteins.
Understanding the Industry
Industry has highlighted through SECBA project engagement that there is a significant need for specialised expertise in many fields such as bioinformatics, analytical chemistry and biotechnology. Quality assurance and control are particularly crucial, with industry seeking competent analysts, Qualified Persons (QPs), and professionals skilled in Quality Management Systems (QMS) and ISO standards.
The growing reliance on technology, including computerised information management, automation and digital skills like bioinformatics and statistical analysis, further underscores the need for graduates with strong tech proficiency. Regulatory compliance, especially in Quality Control, validation, and adherence to standards, is also a priority. However, a noticeable talent gap exists, particularly for roles requiring specialised skills (e.g. Bioprocessing). This highlights the importance of ongoing education and training in related fields to address the skills shortage and ensure a steady pipeline of qualified professionals for the sector.
Career Opportunities
Learners could gain employment within the sector (e.g. Wu-Xi Biologics, Pfizer, Almac, MSD, AbbVie, Grifols, Amryt Pharma etc.) and undertake the programme to obtain a recognised qualification.
Some learners may undertake the programme to ‘re-skill’ and move into the area, they are not employed, or perhaps employed in other Biopharmaceutical areas.
Course Delivery and Modules
This course will be delivered using a combination of online and face-to-face (labs), delivered over one semester.
Online Lectures typically take place on Tuesdays and Thursdays with designated lab days scheduled at the end of the semester.
Module Learning Outcomes
- Critique the choice of expression systems used for the production of recombinant proteins.
- Evaluate how plasmid vectors can be modified and utilised to produce high, and sustainable, production levels of recombinant biopharmaceuticals.
- Critique how Genetically Modified Organisms can be cultured on a large scale in a bioreactor to maximize their growth and formation of product.
- Evaluate different chromatography and electrophoretic techniques in downstream processing for optimal purification for recombinant proteins.
- Appraise filtration systems for recovery, purification, concentration and final polishing of biopharmaceuticals and viral clearance.
- Characterise finished biopharmaceutical products.
Upstream Processing
- Upstream processing of Biologics/Large Molecule Manufacturing (including Advanced Therapeutic Medicinal Products and Cell and Gene Therapies).
- Upstream MSC manufacturing process - tissue procurement, MSC isolation. AAV manufacturing process - large-scale plasmid production and purification. LV manufacturing process - culture and large-scale expansion of an LV-producer cell line, such as HEK293T. CAR-T cell manufacturing - leukapheresis, enrichment and isolation of T cells. T cell transduction. Evaluation of different expression systems (bacteria, yeast, insect, plant, mammalian).
Cell culture (small scale) and aseptic technique
Nutritional requirements of mammalian cells: growth media preparation, sterilisation and quality control. Adherent vs suspension cells. Generation of cell banks. Sub-culturing and
cryopreservation techniques. Methods for monitoring the growth and viability of mammalian cells. Aseptic requirements for cell culture: sources of contamination, processes and techniques involved in maintaining culture sterility.
Cell culture control
- Monitoring / optimisation of expression system growth and product formation (pH, temperature, dissolved O2, nutrients, agitation, biomass, contamination, protein stability).
Large scale cell expansion
- Stirred tank fermenter, bioreactors, airlift, packed bed (microcarriers) and hybrid systems. Single use/disposable bioreactors. Bioreactor components and their functions. Scale-up scaledown strategies. Media feed (Batch, Fed batch, Continuous culturing (perfusion with TFF); hybrid feeding systems).
Downstream Processing
Capture & Harvest
- Compare and contrast methods for intracellular and extracellular biopharmaceutical recovery - cell disruption (physico-mechanical and chemical), centrifugation eg. disk stack centrifuge & single use, filtration (normal flow filtration (NFF), tangential flow filtration (TFF), single path TFF).
Chromatography
- Evaluate chromatographic techniques for recombinant protein separation and purification (Protein A affinity, ion exchange, hydrophobic interaction and size exclusion).
Filtration
- Compare and contrast filtration systems for product concentration & buffer exchange (Ultra/Diafiltration). Integrity testing of filters. Evaluate filtration systems for viral clearance & final polishing. Viral inactivation and removal.
Fill finish
- Methods for aqueous and freeze dried products. Vial filling, stoppering, capping, labelling & packaging. Depyrogenation.
Protein characterisation
- Characterisation of finished biopharmaceutical products - in-process and final product testing. Detection and determination of yield, purity, concentration and biological activity.
Electrophoretic methods (SDS-PAGE, UV spectroscopy, protein assays).
Practical competence
Introduction to essential cell culture techniques and skills i.e. focusing on aseptic techniques, cell handling, and maintenance. Extraction and purification of a recombinant protein using
chromatographic techniques and filtration. Investigation of bioactivity following purification (for example electrophoresis, protein assays, spectroscopy).
Education Progression
Graduates of the this course may progress to the Higher Certificate/ Diploma in Science in Biopharmaceutical Manufacturing or similar level 8 programmes.
Graduates of the Higher Diploma will be able to progress to level 9 taught postgraduate and Level 9 and 10 research programmes, including Level 9 and 10 research opportunities in DkIT.
Higher Diploma in Science in Biopharmaceutical Manufacturing
Certificate in Science in Biopharmaceutical Manufacturing New course
Fees and Funding
This programme is funded through the South East Cross Border Alliance (SECBA) project, supported by PEACEPLUS, a programme managed by the Special EU Programmes Body (SEUPB).
Fees
Entry requirements
Standard Entry Requirements
- Applicants for all the programmes should have a level 8 major award in Engineering / Science (or equivalent)
or - a Level 7 award in a cognate Science discipline (or equivalent)
or - a Level 7 award in Engineering with a minimum of 2 years’ experience in the Pharmaceutical / Biopharmaceutical Industry (or equivalent)
- Applicants for whom English is not their first language must have English level of IELTS 6.0 or equivalent.
Non-Standard Entry Requirements
Any non-standard entries will be covered by Recognition of Prior Learning.
The part-time programmes are not available to international applicants (the programme includes delivery of practical content on campus, part-time programmes do not fulfil visa requirements).
Recognition of Prior Learning
Applicants who do not meet the standard academic entry requirements but have significant relevant experience (certified and/or experiential) may apply to access this programme via the Recognition of Prior Learning (RPL) route. Learn more about RPL at DkIT
How to apply
Applications will open soon. Register your interest below and we’ll notify you once they open.
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Disclaimer: All module titles are subject to change and for indicative purposes only. All courses are delivered subject to demand and timetables are subject to change. Elective Module options will only run subject to student numbers. The relevant Department will determine the viability of each elective module option proceeding depending on the number of students who choose that option. Students will be offered alternative elective modules on their programme should their preferred elective option not be proceeding. Award Options for Common Entry Programmes: The relevant Department will determine the viability of each award option proceeding depending on the number of students who choose either option. If the numbers for one of the Award options exceed available places, students for this option will be selected based on Academic Merit (highest grades).