All second year MEng students will complete the capstone Team Design Project (TDP), which is intended to provide students with “real-life” experience of taking a drug molecule candidate to a pharmaceutical therapy. Students will work in small teams, typically 4 to 5, to design a complete biomanufacturing process capable of producing commercial quantities of a drug substance (DS) or drug product (DP). Teams will be supervised by a panel of academic and industry experts. Each team will work on a separate design project based on bioindustry best practice, methods and techniques.
Projects will progress from the conception to final product and process design for supply of a potential drug molecule candidate for early- to late-phase clinical studies, as well as process and product development studies needed to for transfer the process to manufacturing. Key deliverables will include project management updates and timelines, detailed process flowsheets for the DS and DP, individual unit operations and process integration, process scale-up, tech transfer and validation, economic analysis, facility design and raw material supply chain, and phase-appropriate CMC regulatory and quality considerations for Biologics License Application (BLA) submissions.
Typical examples of target molecules for TDP include insulin, human growth hormone, tissue plasminogen activator, monoclonal antibodies for cancers, and autoimmune diseases. Process design will be approached systematically using a risk-based approach based on Quality-by-Design (QbD) methodology. Students will evaluate potential commercial opportunities and biomanufacturing options, select the most appropriate expression system, define a platform process most appropriate for the molecule, design and specify upstream and downstream sequence of operations. A detailed market analysis will be included based on best industry practices.
Team discussion and consultation with subject matter experts within KGI and with external company partners will then be followed leading to specification of the purity profile for the product. This is then followed by preparation of detailed engineering flow sheet that includes each unit operation. Selection and sizing of major unit operations will then be carried to meet a specified annual demand for the product. The final design will be evaluated and interpreted using available simulation and modelling techniques. Group and individual reports will be submitted by each student in the team.