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Biochemical Engineering

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Dissertation on Bioprocess Design

Course Code
BENGGD99
Level MSc
Credits 60 credits
Module Tutor
Dr Dan Bracewell (course and stage 3 coordinator)
Dr Frank Baganz (stage 1 coordinator)
Professor Chris Mason (stage 2 coordinator)
Assessment
Stage 1: Oral presentation and coursework (10%)
Stage 2: Coursework (20%)
Stage 3: Design project - dissertation (10,000 words) (70%)

Module Aims

To prepare a dissertation embracing an accredited (chartered engineering status) design study on a process for the production of biomaterials arising out of life science discoveries. Such biomaterials would typically include biopharmaceutical products arising out of phase II clinical trials and the dissertation will examine the following key stages to production:

Stage 1: Whole Bioprocess Study
Stage 2: Bioprocess Entrepreneurial Business Plan
Stage 3: The Design Project:

          I. The creation and analysis of a bioprocess
          II. The design and economic appraisal of a bioprocess
          III. Safety audit of a bioprocess

Stage 1: Whole Bioprocess Study

Stage Aims

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. In addition they also engage with data analysis and results’ presentation activities. The study is a full time activity from Monday to Friday, typically from 9am to 6pm, at the end of term 2.

Students, grouped in teams of 5 or 6, will engage with the production of a wide range of products ranging from enzymes, small molecules, antibodies and virus-like particles. Some groups will also explore scale-up/down techniques. Each group is required to complete a Laboratory Book which should form a comprehensive record of the group’s. The book should have accurately recorded:

  • Equipment used
  • Experimental plan followed
  • Data gathered (e.g. print outs from the computer logging the fermentation)
  • Further observations (such as visual inspections e.g. nature of the material post centrifugation)
  • Problems and deviations from planned experimentation

Finally the groups present their findings in the form of an oral presentation on the Friday afternoon, an event to which the whole Department is invited.

Learning Outcomes

Following completion of the course, students will:

  • Scientifically describe undertaken activities, materials and methods used and equipment;
  • Understand the operation of bioprocessing lab and pilot scale equipment;
  • Analyse data, derive general correlations and compare with previously published literature;
  • Specify 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).

Syllabus

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 Plan

Stage Aims

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.

Learning Outcomes

Following completion of the course, 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

Learning Hours

Includes:
Lectures: 6h
Mentored workshops: 10h
Presentation session: 4h

Syllabus

Bioprocessing of New Medicines (Science and Engineering) BScThe 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: The Design Project

Stage Aims

i) The creation and analysis of a bioprocess
In this first part of the accredited design study students will be presented with a novel life science target with a guide to desired production scale and key literature indicating the market potential (e.g. clinical efficiency and patient scope). They will receive instruction on evaluation of the scientific background and intellectual property and prepare a literature appraisal report as the foundation to the design stages. Students will then define the process based on pilot plant experimental data and observations and on literature appraisal. The output will be completed mass and energy balances across the total process and an appraisal of equipment size/scale. A detailed description of flow (flowsheet plus report) and process recommendation report will be the key outputs.

ii) Design and economic appraisal
This section will develop abilities in fast evaluation and analysis of bioprocess design problems. It will include aspects of project scheduling and management as well as economic appraisal and take students from the specification of equipment through the stage of reconciling equipment needs with layouts and then to the scheduling and management of projects in a dynamic environment. Each team will prepare a complete design report covering the user specification for a key item of equipment; process and mechanical design with appropriate mechanical drawing; piping and instrumentation and specification of control; preparation and analysis of plant layouts; personnel and material flows; analysis of safety (HAZOP study) including biosafety and containment appraisal; analysis of environmental impact; economic appraisal and sensitivity analysis; project schedule including analysis of management and change. This section will be assessed in the form of a design report, a mechanical drawing and a process/plant layout drawing.

iii) Safety audit of a bioprocess
The dissertation will conclude with future studies, recommendation and executive summary followed by poster presentation and viva on the whole dissertation.

Summary

The bioprocess design studies will be pursued by groups of students working as teams with each member preparing a complete design dissertation comprising an individual report on the whole team studies, and an individual report on his/her own findings. In addition to a written dissertation, assessment will be via oral presentations, poster presentation and viva.