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2021/22 Taught Postgraduate Programme Catalogue

MSc Biopharmaceutical Development

Programme code:MSC-BSG/BDUCAS code:
Duration:12 Months Method of Attendance: Full Time
Programme manager:Professor John Colyer Contact address:j.colyer@leeds.ac.uk

Total credits: 180

Entry requirements:

Normally a 2:1 honours degree or equivalent in a Biological Sciences subject, Bioprocessing or Biochemical Engineering, but relevant experience may be taken into account. In addition, applicants will need to demonstrate leadership potential, which might be evidenced from academic, sporting, volunteering or other professional experience.

School/Unit responsible for the parenting of students and programme:

Faculty of Biological Sciences

Examination board through which the programme will be considered:

The Masters Bioscience Exam Board

Relevant QAA Subject Benchmark Groups:

Subject benchmark statements for biological sciences Masters programmes do not exist. However, students will be expected to demonstrate the characteristics embodied in the QAA Qualifications Frameworks level descriptors for Masters degrees (https://www.qaa.ac.uk/docs/qaa/quality-code/master's-degree-characteristics-statement.pdf?sfvrsn=6ca2f981_10)

Programme specification:

The programme will provide integrated understanding of the industrial pathway of biological drug discovery, development and exploitation. Modules exist for each of the major technical functions of this industry (discovery, manufacturing, pre-clinical testing, clinical safety and efficacy, laboratory analytical skills). Further modules introduce the course & industry (pathway, regulatory framework, economic value, and societal drivers), to address commercialisation of biopharmaceutical products and a final taught module that integrates topics in the form of project work submitting a new biochemical entity to a regulatory body. This will provide students with a deep understanding of core elements of the discipline, and a good appreciation of the broader context and regulatory framework of the industry. It is highly interdisciplinary, and will equip students to work in such teams.

There will be a strong emphasis on the acquisition of technical skills necessary for biological drug development and so a substantial component of the programme will be devoted to practical training including a taught practical skills module (Practical Skills for a Regulatory Environment). The practical skills module will introduce students to the techniques used in the biopharma industry and the standards to which they are applied within a regulatory environment. Thus students will perform a series of experiments demonstrating stages along the drug development pathway working under GLP/GMP/GCP instruction as far as is possible within university laboratories. Topics covered will include: assay validation (accuracy, precision, robustness, in-specification), followed by two practical strands; one focusing on molecular/biophysical protein characterisation (GMP-focus; antibody purification, SDS-PAGE, bio-potency activity assay by ELISA, binding assay by e.g. SPR) and the second on cell-based assays (GCP-focus; flow cytometry, confocal microscopy, cell growth/viability). During the research project, students will have the opportunity to apply this training, thus building on, and extending these skills.



Year1 - View timetable

[Learning Outcomes, Transferable (Key) Skills, Assessment]

Compulsory modules:

Candidates will be required to study the following compulsory modules:

BIOL5164MBiopharmaceutical Development Pathway5 creditsSemester 1 (Sep to Jan)
BIOL5180MBiopharmaceutical Drug Discovery and Non-clinical testing20 creditsSemester 1 (Sep to Jan)
BIOL5181MManufacturing Biopharmaceuticals15 creditsSemester 1 (Sep to Jan)
BIOL5267MBiopharmaceutical Development: Clinical10 creditsSemester 2 (Jan to Jun)
BIOL5269MCommercialising Biopharmaceutical Products10 creditsSemesters 1 & 2 (Sep to Jun)
BIOL5280MIntegrated Drug Development Plan20 creditsSemester 2 (Jan to Jun)
BIOL5320MPractical Skills for a Regulatory Environment
Pre-requisite for: BiOL5392M
20 creditsSemesters 1 & 2 (Sep to Jun)
BIOL5392MBioscience MSc Research Project80 credits1 Apr to 31 Aug

Last updated: 30/06/2021 16:10:09

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