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Course modules

The course contains areas of core knowledge and skills with an emphasis on application of Quality by Design (QbD) principles and continuous improvement activities to the development and manufacture of pharmaceutical products. The course will provide you with a coherent and balanced programme of study in the following areas:

Block 1: Quality by Design: Fundamental principles (30 credits)

This module introduces modern approaches to pharmaceutical development and manufacture based on the International Conference for Harmonization (ICH) guidelines for Quality. Research design methods including experimental design, data collection, presentation, analysis and writing up of research results are included. You will learn about a variety of guidelines and regulations relating to the quality of pharmaceutical products.

Block 2: Prod Design: Formulation Development (30 credits)

The aim of this module is to apply QbD tools to pre-formulation and formulation of pharmaceutical products. You will learn about a variety of techniques and methods to formulate and produce safe medicines. The principles of Quality by Design (QbD) and its approaches will be applied and evaluated against alternative approaches. Critical quality attributes of drug product and drug substances that have a direct impact on product quality, safety and efficacy will be studied and critiqued.

Block 3: Process Design: Manufacturing & Process Analytical Technologies (30 credits)

The aim of this module is to present the elements of quality by design in process selection, design, and product manufacturing to ensure pharmaceutical quality. The process control and advanced process control methods and analytical techniques used in pharmaceutical product manufacturing and characterization will be discussed. You will learn about design and control of manufacturing process based on the understanding of material properties and critical process parameters. Process control and advanced process control methods during product manufacturing are introduced, and Process Analytical Technology (PAT) is discussed to advance pharmaceutical process identification, simulation, and control.

Block 4: Biopharmaceuticals (30 credits)

This module introduces the use of large, complex molecules in therapeutics and presents new drug delivery strategies for biologics. The module also covers the use of large biologically active molecules such as hormones, monoclonal antibodies, vaccines, and gene therapy. You will also learn about regulatory concepts for marketing authorisation of biopharmaceutical products. Additionally, elements of intellectual property and patency procedures in the module will benefit you if you are considering entrepreneurship for your future career.

Block 5 and 6: Dissertation (60 credits)

The dissertation provides you with an opportunity to consolidate your knowledge of quality by design applied to pharmaceutical science by conducting a research or development project in an area related to pharmaceutical manufacturing. The dissertation requires the application of many of the skills and knowledge acquired in the subjects studied on the Pharmaceutical Quality by Design Programme and provides you with the opportunity to consider the integrated nature of the pharmaceutical industry areas.

Teaching and assessment

The learning environment for the first two semesters is varied with lectures, tutorials, seminars, laboratory-based practical’s and computer laboratories. In the third semester the learning venue will depend on your dissertation topic and will be much more aimed at guided self-study.

The course uses a variety of assessment methods relevant to a master’s level of study. The assessments include oral presentations, group work assignments, case study reports, essay writing, a research proposal and a final dissertation. 

Teaching contact hours

Contact hours in a typical week will depend to some extent on the optional modules you choose to study. However, typically you will have an average of 15 contact hours of teaching and this will break down as:

Personal tutorial/small group teaching: 1 hour of tutorials (or later, project supervision) each week

Medium group teaching: 4 hours of practical classes, workshops or seminars each week

Large group teaching: 10 hours of lectures each week

Personal study: 10 hours studying and revising in your own time each week, including some guided study using hand-outs and online activities.

Academic expertise

We have received major funds for development of our laboratories and equipment. This has allowed the purchase of equipment that matches those in the best industrial laboratories including:

• Twin-screw extrusion for continuous process manufacture
• Powder flow analysis
• Nanoparticle characterisation
• Terahertz imaging and spectroscopy
• NIR and Raman spectroscopy
• Dynamic dissolution USP IV and imaging dissolution tests
• Electro-hydrodynamic spraying of micro-particles
• Thermal analysis;
• Rheology
• Atomic force microscopy and SEM.

The core staff have been teaching for many years and have academic and industrial experiences in areas that underpin the QbD principles. These are product formulation, material science, advanced analytical sciences, and process engineering and control.

The group has evidenced its capability in this regard through recent success with the Technology Strategy Board (TSB), and Engineering and Physical Science Research Council (EPSRC) and the Biotechnology and Biological Sciences Research Council (BBSRC) grant-funded collaborative research and development, aimed to improve industrial process quality and efficiency.

Pharmacy has been taught in the faculty for over 100 years and we have gained a reputation for producing high quality graduates. Teaching expertise is of the highest calibre and many academics have experience working in the sector.