The module provides an insight into advanced therapies and ATMPs. It covers the basic principles and key tools, associated with advanced therapies (gene therapy, cell therapy, and tissue engineering), and their application and development. It also covers the manufacturing and industrialisation of advanced therapies, and their commercialisation, and regulation. This will include the use of various vectors in advanced therapies, the techniques involved in advanced therapies including specific examples of ATMPs and the clinical relevance of ATMPs; delivery methods of various advanced therapies; upstream and downstream processes. It will assess reasons for failure, scale and costs, commercial opportunities, good manufacturing practice (GMP) and good clinical practice (GCP) basics and apply relevant regulation and legislation.
Total Hours: 150 including: "off the job" learning (approximately 73 hours) and on the job learning.
Essay 1 worth 30% (500 words)
Essay 2 worth 30% (500 words)
Portfolio worth 40% (1,800 words)
All assessments must be passed to pass the module.
Reassessment: Like-for-like
See the library reading list for this module (Medway)
The intended subject specific learning outcomes.
On successfully completing the module students will be able to:
Understand the basic principles involved in advanced therapies.
Apply the underlying concepts and principles associated with in gene therapy, cell therapy, and tissue engineering.
Understand the basics concepts involved in the development of viral vectors, tissue engineering, and cell therapy.
Demonstrate knowledge of the underlying concepts and principles associated with manufacture and industrialisaton of advanced therapies.
Understand the key concepts associated with commercialisation, clinical aspects, and regulation of advanced therapies.
The intended generic learning outcomes.
On successfully completing the module students will be able to:
Work and communicate effectively with others.
Analyse, evaluate and correctly interpret data.
Present and communicate data effectively.
Demonstrate the ability to obtain and use information from a variety of sources as part of self-directed learning.
Manage their time and use their organisation skills within the context of self-directed learning.
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