MSc in Clinical Cell & Tissue Engineering
Educational Aims of the program
The MSc Clinical Cell & Tissue Engineering (CCTE) program is a course designed to educate scientists, technicians and clinicians in this rapidly expanding field in which UCL is a World leader. The program is taught by research scientists and academic clinicians from the UK and other EU countries who are actively involved in frontline research delivery. Students learn about the basic science behind cell and tissue engineering and receive practical tuition in production of advanced medicinal products, so-called "ATMPs" to EU GMP. The course covers regulation of procurement, manufacture, delivery and clinical trials and will include course units in pre-clinical research, validation of GMP processes, quality control, facility design/layout, process development as well as clinical presentations on the latest trials.
Who is the course for?
The program is designed for those with undergraduate qualifications in the life sciences, scientists, clinicians, and other healthcare professionals and especially individuals from the pharmaceutical and biotech industries. The knowledge and transferable skills developed in the course will be suitable for those in an industrial or healthcare setting, as well as those individuals contemplating further PhD or medical studies and especially those working in or planning careers in the biopharmaceutical industry or the blood and tissue services sector.
Uniquely this is offered as either full-time or as a 2-year part-time MSc programme. All MSc students will be required to complete a laboratory research project in their final year. Postgraduate Diploma students will complete the taught aspects of the course but will not be required to complete the research project. A shorter, Postgraduate Certificate course is also offered over the taught modules in year 1.
Tel:+44 (0)20 7830 2183
Program Coordinator & Tutor
Dr Julie Olszewski
Tel:+44 (0)20 7679 6911
How to Apply
Applications should be submitted directly to UCL admissions. Applications will be accepted from October 15th for the 2015-2016 academic year. Please apply early to avoid disappointment. The closing date for applications is 1st August 2015 (to be confirmed by UCL admissions). There is a maximum of 20 students accepted onto the program per annum.
|MSc||Postgraduate Diploma||Postgraduate Certificate|
1 year full-time OR 2 years part-time
9 months full-time OR 20 months part-time
9 months full-time or 27 weeks part-time
Course Structure and Curriculum
- Mode of study: full-time for one year or part-time for two years
- Eight required modules of 15 credits each. Consisting of 30 hours teaching and assessed by written exam (50%) and coursework (50%). A Postgraduate Diploma (120 credits – all modules) and a Postgraduate Certificate (60 credits – modules 1-4) are offered.
- Foundation of cell and tissue therapies
- Development of cell and tissue therapies and clinical trials of ATMPs
- Quality and validation in ATMP manufacturing and development
- The global regulation of advanced cell, gene and tissue therapies
- The clinical application of cell and gene therapies and tissue engineered products
- Commercialisation of ATMPs and the role of Qualified Persons in ATMP supply
- Basic laboratory methodology used in the manufacture of ATMPs
- Designing and commissioning a GMP facility for ATMP manufacture
- Laboratory based project of 60 credits
All students undertake an independent research project and are assessed by a written dissertation (75%) and an oral presentation (25%) about their research project.
- The format of lectures will be 1 full day of teaching on a Tuesday in year 1 and Thursday in year 2
1. Foundation of cell and tissue therapies
This module provides students with an introduction to the underlying principles of clinical cell and tissue engineering by means of a historical overview from the onset of the first clinical cell therapy to the present state. As an introductory module, students are provided with the basic concepts in the manufacture and regulation of cell and tissue therapies and the basic materials to increase their understanding of the field of immunology, cell and developmental biology with regard to cellular therapies.
- Hematopoietic stem cell transplantation and adoptive therapy
- Introduction to HLA and the basis of cell and tissue compatibility
- Introduction to the blood grouping system and the clinical and immunological aspects of blood transfusion
- Immunology of graft rejection in solid organ and stem cell transplantation
- Cell progenitors, stem cells and the stem cell niche
- Cell proliferation and differentiation
- Introduction to tissue engineering constructs
- Introduction to the regulation of cell and tissue therapies
- Introduction to basic methodology in cell and tissue culture
- Introduction to Advanced Therapeutic Medicinal Products (ATMPs)
2. Development of cell and tissue therapies and clinical trials of ATMPs
This module introduces the development of a new ATMP for clinical trial and prepare students in the design and conduct of clinical trials. Particular emphasis is directed towards understanding the pathway from pre-clinical testing and animal models through to process engineering and validation in order to bring an ATMP into phase I/II clinical trials. Students develop the required skills for both creating an investigational medicinal product dossier (IMPD), product specification file (PSF) and a clinical trial authorization (CTA) whilst understanding the management of ATMPs in early phase trials.
- Development pathway for an ATMP
- Introduction to the definition of medicines versus transplants versus ATMPs
- Pre-clinical models – in vitro and animal
- Designing process development, process engineering and process validation
- Introduction to clinical trials: phases, ethics, CTA
- Ethics of early phase trials of ATMPs
- Documentation in early phase trials of ATMPs – IMPD, PSF and CTA
- Introduction to Good manufacturing practice (GMP)
- Management of ATMPs from manufacture to patient administration including transport and end user handling
- Introduction to scale-up and scale-out of ATMP manufacture
3. Quality and validation in ATMP manufacturing and development
The purpose of this module is to introduce the major criteria underpinning quality control and validation of ATMPs under GMP regulation, to include characterisation of cell and gene therapies and tissue engineered products. Students develop an understanding of product testing in process and at final release and the documentation required for maintaining quality during both product development and manufacturing. The role of quality persons will be introduced and students are expected to be able to understand how to develop their own validation master files, quality control and final release of ATMPs.
- Introduction to validation
- The validation master file – specifications
- DQ, IQ and PQ validation
- In process quality control and release criteria
- ATMP characterisation: potency, identity, purity and comparability
- Open versus closed procedures in ATMP manufacture
- Selection of raw materials in ATMP design and manufacture
- Introduction to the role of qualified persons
- Quality control of ATMPs: sterility, viability, environmental monitoring
- Batch manufacturing record (BMR) design and standard operating procedures (SOPs)
4. The global regulation of advanced cell, gene and tissue therapies
This module covers European regulation of cell, gene and tissue engineered therapies as laid down in EU legislation, with a focus on the implementation by the designated UK competent regulatory authorities. Students develop an understanding of the differences in how ATMPs are regulated in Europe compared to the regulation of cell and gene therapies and TEPs in the US and Asia. The module provides students with the specialist regulatory knowledge to translate issues related to specific therapeutic approaches and their classification as a medicinal product or non-medicinal and the legislation of clinical trials.
- EU legislation covering ATMP manufacture
- Introduction into regulation of ATMPs in the UK by the MHRA
- Use of the hospital exemption clause (HEC) and its national interpretation "Specials"
- What is and what is not a medical product
- Medical devices regulation
- Global regulation of advanced therapies – US, Asia and Australasia
- The clinical trials legislation
- GMP requirements for ATMP manufacture
- Service level agreements and material transfer agreements for clinical trials
- Severe adverse event (SAE) reporting requirements
5. The clinical application of cell and gene therapies and tissue engineered products
This module develops the students understanding of the potential applications of ATMPs and how they have been introduced into the clinic and build on the concepts introduced in module 1. Students are introduced to the application of gene therapy in ATMPs and the use of biomaterials in tissue engineered products. Students develop an understanding of current issues in the development and production of biologic and biocompatible scaffolds used for TEPs and approaches using nanotechnology for scaffold manufacture. Finally the emerging field of inducible pluripotent stem cells (iPSs) is introduced and new approaches using iPS cell technology in ATMP manufacture for clinical application.
- Somatic cell therapies: adoptive immunotherapy for viruses & cancer – T cells, NK cells, DC vaccines
- Somatic cell therapies for ophthalmic diseases
- Somatic cell therapies: Mesenchymal stromal cells (MSCs) and their cell source
- Differentiated MSCs as somatic cell therapies
- Embryonic stem cells and inducible pluripotent stem cells
- Gene modified therapies: T cells and CARs for viruses and cancer
- Tissue engineered products: Airways and would healing
- Decellularisation strategies for human/animal tissues
- Biocompatible materials for scaffolds
- Bioreactors for recellularisation of TEPs
6. Commercialisation of ATMPs and the role of Qualified Persons in ATMP supply
This module aims to develop understanding of downstream processing and production of ATMPs and review the models for early phase production to facilitate late phase and finally commercial production. It provides view points from academia, biotech, pharmaceutical and regulatory stakeholders in the path to commercialisation and market authorization of ATMPs. Future perspectives in the commercialisation of advanced therapies are explored in both Europe and the US. This module also provides students with an extensive understanding of the role of Qualified Persons (QP) in the supply of both commercial ATMPs and ATMPs in clinical trial.
- Scale-up, scale-out and costing models in ATMP manufacture
- Determining re-imbursement
- Business model specificities when preparing to commercialise ATMPs
- The role of contract manufacturing organisations (CMO) and technology transfer
- The European Medicines Agency (EMA) and Marketing Authorisation (MA) applications
- Future perspectives in the commercialisation of advanced therapies
- Definition and the role the QP in investigation medicinal product (IMP) design and supply
- Training for QP eligibility – an ATMP perspective
- Due diligence of a CMO: facilities and quality systems
- The role of the QP in packaging, transport and supply of licensed ATMPs
7. Basic laboratory methodology used in the manufacture of ATMPs
This laboratory skills module covers all aspects of basic cell culture and some techniques for characterising cells. The module comprises both lectures on laboratory methods and practical tutorials to allow students to become familiar with more routine techniques used in cell culture and tissue laboratories. Students develop an understanding of some of the more advanced cell culture techniques related to isolation, expansion and differentiation and the current methods and technology available for manufacturing tissue engineered products.
- Introduction to cell and tissue culture
- Cell Expansion and differentiation of MSCs
- Magnetic enrichment and flow based isolation of cells
- Up-scaling of cell culture – flasks, cell stacks and bioreactors
- Introduction to flow cytometery for cell characterisation
- Testing potency – assays for killing, proliferation and cytokine profiling
- Decellularisation and recellularisation of human tissue
- Quality control of TEPs and cell cultures
- Cell counting, yield and population doubling of cell cultures
8. Designing and commissioning a GMP facility for ATMP manufacture
The aim of this module is to prepare students to be able to engage with design and build professionals in the creation of a purpose-built GMP facility for the manufacture of ATMPs, to match user requirements. Students develop an understanding of the maintenance and validation of a GMP facility with regard to regulation and commissioning following construction. The module provides the student with an introduction to the typical air classifications of cleanrooms and the type of manufacturing they can support. Students are required to plan and design their own GMP facility to meet the specific requirements of a commercialised ATMP.
- The regulations covering GMP facilities
- Design and considerations for constructing a GMP facility
- Air pressure cascades/air sensors/process flow versus personnel flow
- Air grade classification for the manufacture of medicinal products
- Isolator technology and sterilisation
- Commissioning, qualification, validation and maintenance of a GMP facility
- Environmental monitoring – standards and requirements of GMP facilities
A minimum of an upper second-class Honours degree in a relevant discipline from a UK university or an overseas qualification of an equivalent standard or an appropriate professional qualification or work experience.
How To Apply
Applications should be submitted directly to UCL admissions. Applications will be accepted from October 15th for the 2015-2016 academic year. Please apply early to avoid disappointment. The closing date for applications is 31st July 2015.
There is a maximum of 20 students accepted onto the program per annum.
Fees and Funding
Programme fees: http://www.ucl.ac.uk/current-students/money/2015-2016_fees/2015-16_postgrad_taught
For those students working to organize scholarship funding (particularly overseas applicants), early application for admission is strongly encouraged.