Course Code:
BENG 312P
Credits:
15 UCL credits
(7.5 ECTS)
Term delivered:
Term 2
Year of study:
3
Aims and
Learning
Outcomes:
Course Title:
Design and Manufacture
of Regenerative Medicine
Drug Products
Teaching Team:
Dr Ivan Wall
Prof Chris Mason
Dr Farlan Veraitch
Pre-requisites:
The aim of the module, building on BENG212P and BENG311P, is to provide students with a
working understanding of the design challenges for manufacture of regenerative medicines,
which present unique challenges compared to existing pharma and biopharma products due to
the live nature of the product. Considerations regarding infrastructure, principles of good
manufacturing practice and the wider economic and ethical impact of their manufacture will be
incorporated into the design process. This will provide students with the skills that would be
highly desirable by a growing regenerative medicines manufacture industry and the Cell
Therapy Catapult.
By completing this module, engineering students from different disciplines will:
 Understand design requirements for regenerative medicines products manufacturing
 be able to design a whole manufacturing process and related infrastructure for a
regenerative medicine product and provide appraisal of the whole process.
 apply design principles and knowledge of process operations to multiple candidate
regenerative medicine products.
Synopsis:
This module will draw on knowledge acquired during the first two modules, BENG212P
Manufacturing Regenerative Medicines and BENG311P Advanced Materials, Devices and
Manufacturing Processes for Regenerative Medicines. Students will design a GMP
manufacturing process for defined regenerative medicine products. These products will include
autologous, personalized medicines (e.g. autologous T-cells, which are currently a significant
focus of the cell therapy industry) and allogeneic, off the shelf cell lines (embryonic stem cellderived neurons).
Process flow sheets including process options for each unit operation, in process analytics,
scale of production and end of process product release testing will be scrutinised. This will be
complemented by facility design; cost of goods assessment; and also appraisals of health and
safety and environmental impact.
Industry experts have been preliminarily contacted and have confirmed they are happy to
engage with the students. Seminars on validation, product characterization and cost of
goods/reimbursement will be organized where students will learn real case studies of the wider
considerations for manufacture. In addition an expert panel will be invited to the final
poster/presentations where the best group will be selected.
Method of
delivery:
Assessment:
Fundamental information will be delivered in the form of lectures/workshops in order to provide
an interactive forum for students to initiate their projects. The workshops will be used to develop
the student’s understanding of the benefits and limitations of different technology platforms that
then feed into their individual projects. Tutorials, student presentations and small group
meetings will provide tailored feedback at several points throughout the project. Interactions via
student-led e-learning (with a weekly 2hr online Q&A forum) will support student learning.
Project report 70%
Oral presentations 20%
Workshop engagement 10%
1