Foundations and Manufacturing in Cell and Gene Therapies (Online)

Online, self-paced course focusing on the development of gene therapeutics with emphasis on viral delivery, GMP, process and facility design as well as manufacture and commercialisation

The aim of course is to provide learners with a comprehensive and up-to-date development of the gene therapy area with specific reference to the development, manufacturing and commercialisation of gene therapies. The topics will be addressed using a combination of lectures, training and animation videos and an assessed quiz.

The learning outcomes are as follows:

· Identify diseases where gene therapies are applicable

· Understand key elements in virology to create gene therapies

· Identify potential application of stem cells to treat diseases

· Understand ethical and regulatory implications of gene therapies

· Identify and recognise challenges in gene therapy development and manufacture

Course delivery

Enabling self-paced learning through a series of lectures. Delegates can access materials for up to 9 months allowing for flexible study.

Who should attend?

The course is designed for engineers who would like to pursue a career in Gene therapy as well as life scientists and clinicians working in the field of regenerative medicine and cell and gene therapy. It will also be particular interest to project managers, funders and policy makers wanting to gain an understanding in this field. It also provides a fundamental base for life scientists and engineers from biopharma who wish to repurpose skills for the cell and gene therapy sector. By attending the course, the learner will network with sector leaders and subject matter experts (from academia and industry) and also increase the learners’ creativity and professional status.

Key Topics

Viruses as gene delivery vectors
Viral vector production
Vectors in clinical Evaluation
Emerging Tools & Technologies
ATMP Manufacturing
Facility Design & Manufacturing
Bioreactors & Biomanufacture
Quality by Design
Tissue Engineering & Regenerative Medicine

Other topics in development include:

Gene Therapy Fundamentals
Upstream and Downstream Processing
Quality Risk Management
Design of Experiments
Commercialisation of Gene Therapies

Professor Qasim Rafiq is an Associate Professor at University College London in Cell and Gene Therapy Bioprocessing. He is a multidisciplinary engineer working at the life science, engineering and commercial interfaces and his research focuses on the bioprocessing, automation and biomanufacture of cell and gene-based therapies. Prior to joining UCL, he was an Assistant Professor at Aston University where he established the Bioprocess Engineering Group. He completed his PhD at Loughborough University investigating the scalable manufacture of human mesenchymal stem cells in bioreactors.

He has specific interest in addressing the large-scale manufacturing challenges and enhancing process and product understanding to enable successful translation from the laboratory to the clinic. He is both a Chartered Engineer (CEng) and Chartered Scientist (CSci) and sits on multiple scientific and engineering committees including ESACT-UK, the IChemE Biochemical Engineering Subject Interest Group and The BIA’s Cell and Gene Therapy Advisory Committee.