Bioprocess Research Project
Dr Yuhong Zhou (course and stage 3 coordinator)
Dr Dan Bracewell (stage 1 coordinator)
Professor Chris Mason (stage 2 coordinator)
Stage 1: Oral presentation and coursework (10%)
Stage 2: Coursework, formal presentation and written report (20%)
Stage 3: Research project report - dissertation (10,000 words) (70%)
To prepare a dissertation embracing an accredited (chartered engineering status) on a research study on a novel bioprocess development for the production of biomaterials arising out of life science discoveries. The dissertation will examine the three key stages to address bioprocessing challenges:
Stage 1: Whole Bioprocess Study at Pilot Scale,
Stage 2: Bioprocess Entrepreneurial Business Plan,
Stage 3: Research Project.
Stage 1: Whole Bioprocess Study at Pilot Scale
The purpose of the study is to get students involved with the department’s research activities at pilot scale and allows them to become familiar with experiments planning, bioreactor and other downstream processing operations, analytical techniques.
Following completion of stage 1, students will have an understanding of:
- how to scientifically describe undertaken activities, materials and methods used and equipment;
- the operation of bioprocessing lab and pilot scale equipment;
- analysing data, derive general correlations and compare with previously published literature;
- specifying theoretical equations that appropriately describe the phenomena observed and test their validity under real process conditions using experimentally-obtained data (make links among different taught subjects using a real process example).
Briefing session: 1h
Supervised project work: 34h
The students will receive instruction on the appraisal of laboratory and pilot scale operations involved in bioprocess sequences and then seek to complete an original investigation into process scale performance for their target product. This will require a detailed experimental planning programme including predictions of mass and energy balances and of transport phenomena (e.g. heat transfer for removal of metabolic heat, mass transfer for oxygen supply). A week long intensive pilot scale study will follow such investigations and will be concluded by an appraisal of process options. This will be the conclusion of the experimental work.
Stage 2: Bioprocess Entrepreneurial Business Plan
Based on the knowledge, including the appropriate business tools, gained from the Commercialisation of Bioprocess Research course (BENGG006), the student will engage in a small (<5) team to apply the course material to a specific commercial opportunity. The output will be a short presentation and a business plan aimed at raising appropriate funding from either a venture capitalist or a strategic partner e.g. big pharma. The course provides the biochemical engineering student with the necessary knowledge to understand the requirements for successfully pitching a commercial vision anywhere along the spectrum of a spin-out company to within a large multinational organisation. The examples used come from pharma, biotech, vaccines, advanced biomaterials/medical devices and cell-based therapies.
Following completion of stage 2, students will have an understanding of:
- the commercialisation of a cutting-edge scientific discovery from the laboratory bench through the clinical, scalable manufacturing and commercialisation route into routine clinical practice
- the preparation of a full business plan, funding requirements and executive summary for a potentially disruptive health-care technology
- the preparation of an investor presentation and an ‘elevator pitch’ for a potentially disruptive health-care technology
- the evaluation of a potentially advanced medical technology as a commercial opportunity including understanding the Gartner Hype Cycle and producing a detailed SWOT (strengths, weaknesses, opportunities and threats) analysis
Mentored workshops: 20h
The students will work in groups of no more than five, each student undertaking a particular role within the newly formed start-up company. Workshop sessions act as mentoring sessions for the fledgling companies and are facilitated by an academic staff member and a senior industry figure. Each workshop will focus on a different aspect of company set-up including feasibility studies, financial appraisal, manufacturing, market research and sales and marketing strategy. The students will be provided with a portfolio of information of real world (but anonymous) data upon which to start to draw relevant details for their business plan.
Areas covered include:
• the basic science specific to the particular technology
• research and development, clinical translation, animal studies, clinical trials, regulation, timelines
• manufacturing/bioprocessing, outsourcing (CMOs and CROs), reimbursement
• scientific and commercial advisory boards and geographic locations
• non-dilutional funding, angel investment, venture capitalists/hedge funds and strategic partners (big pharma and medical device companies)
Throughout the course, all the material is based on real world examples and data. The challenges to successful commercialisation a potentially economically valuable research discovery are thoroughly explored including:
• the specific issues for advanced healthcare technologies; lengthy development cycle, high failure rate, product life, patent thicket/freedom to operate
• the translation cycle and translation gaps
Students are expected to produce a SWOT (strengths, weaknesses, opportunities and threats) analysis as part of the final business plan as well as an appropriate sensitivity analysis. The valuation process (e.g. discounted cash flow) is modelled together with that of potentially competing technologies.
Stage 3: Bioprocess Research Project
The course is designed to develop student’s research skills and research methods through addressing the bioprocessing challenge in the production of biological therapeutics arising out of life science discoveries, from identifying, planning and executing a research project in biochemical engineering. After completion of the course, the students will have acquired a range of research skills.
Following completion of stage 3, students will have an understanding of:
- The aim of the project and its significance
- Carrying out a critical literature review in the area of the research
- Developing research methodology to investigate underlying problem
- Devising experimental plan and conduct experiments to solve a relevant bioprocessing problem
- Analysing the data and draw conclusions
- Developing advanced communication skills through presenting their research findings and formulating a dissertation
Research planning meetings: 40h
Poster presentation: 4h
The bioprocess research studies will be pursued by individual students to develop the research skills necessary for the understanding of the issues involved in whole bioprocessing. It will provide the underlying training in conducting a literature survey of the state-of-the-art in experimental design, in experimental planning against self-set milestones, preparation of research budgets and in the collection of data and their statistical and theoretical analysis.
Research topics will be linked in with the state-of-the-art research facilities and research areas being carried out in the department and connected to the bioprocess of interest. The students will be assigned a supervisor to manage the project. This section of the dissertation will be presented via a full report, proformas, and the poster.