How are advanced therapies developed, manufactured, and brought to patients? What challenges arise when turning cutting-edge science into real-world treatments? This module introduces the principles and applications of advanced therapies and ATMPs (Advanced Therapy Medicinal Products), including gene therapy, cell therapy, and tissue engineering. You will explore how these therapies are developed, delivered, and scaled for clinical use alongside key considerations in manufacturing, regulation, and commercialisation. You will also examine delivery methods, production processes, GMP and GCP basics, and the regulatory frameworks that govern advanced therapeutics—while assessing common challenges such as cost, scalability, and reasons for failure.
Distant and Online blended learning: lectures, audio, recordings, video clips, study guides - 44 hours
'Live' contact hours: live teaching via webinars and induction - 10 hours
Extended Writing: Essay (1,600 words) worth 40%
E-portfolio (2,000 words) worth 60%
All assessments must be passed to pass the module.
Reassessment: Like-for-like
The intended subject specific learning outcomes. On successfully completing the module students will be able to:
Explain the key principles and clinical applications of advanced therapies and ATMPs, including gene therapy, cell therapy, and tissue engineering.
Identify key tools, delivery methods, and vectors used in developing and producing advanced therapies.
Apply knowledge of upstream and downstream manufacturing processes, recognising the role of GMP and GCP in ensuring product quality and patient safety.
Analyse the regulatory, commercial, and logistical challenges involved in bringing advanced therapies to market, including cost, scalability, and reasons for failure.
Compile and present information on the development and clinical relevance of specific ATMP examples, demonstrating awareness of current industry practices and legislation.
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