Gene and cell products are paving the way towards more effective therapeutics for unmet medical needs. Currently, one of the main translational challenges is a consistent and cost-effective supply of these complex medicinal products. Taking into account the interest raised by ESACT members and other learned societies, we are organizing the 4^th Bioprocessing and Manufacturing of Gene and Cell Therapy Products Course in Llafranc, Costa Brava/Spain, in September 2024. ESACT is introducing this activity as one more contribution to the community targeting the use of viral vectors, stem cells and immune cells for therapy. This course is intended for Ph.D. students, post-docs, junior scientists, engineers and clinicians searching to improve their understanding of the development and manufacturing of gene and cell therapy products.

GRANTS

A limited number of grants, covering the course fee are provided by ESACT and ACTIP. Applicants to the grants should indicate it in the course application, together with a motivation statement. Priority will be given to young PhD students from Academia but ACTIP will provide several grants for participants from industry, too.

LECTURES

The speakers will address key bioprocessing aspects, analytical toolsets to assess the quantity and quality attributes, and regulatory challenges for the manufacturing of ATMPs, providing also a solid fundamental basis on vectorology and stem cell biology. The course is designed as an interactive 5-day program with the number of participants restricted to 30 to foster interaction among speakers and attendees. The course comprises lectures covering the main topics of Gene & Cell Therapy:

The course comprises lectures covering the main topics of Animal Cell Technology:

• Introduction to Gene Therapy & to Cell Therapy
• Immunology, Virology & Vectorology
• Cell Line Development for Viruses Production
• Stem Cell Biology
• Gene Modification of Cells for Therapy
• Bioreactor scale-up, scale down and single use Bioreactor for Cells based Products & Viral Vectors
• Downstream processing for Cells based Products & Viral Vectors
• Omics in Bioprocess Development
• Manufacturing Cells based Products & Viral Vectors
• Novel Modalities in Gene & Cell Therapy
• Scale-up and the Role of Automation in Gene & Cell Therapy
• Process & Product Analytics
• Health Technology Assessment/Economics
• Decision Tools

The program has also slots dedicated to presentation of case studies by lecturers, workshops, exercises and discussion groups with the lecturers.

Lecturers: Eric Kremer (EK; CNRS, France), Joaquim Vives (JV; BST, Spain), Margarida Serra (GS; iBET, Portugal), Ana Coroadinha (AC; ITQB NOVA, Portugal), Chantal Martin (CM; Turnstone, Canada), Eoin McGrath (EM; ICCBBA, USA/Spain), Ioannis Papantouniou (IP; KU Leuven, Belgium), Kerry Fisher (KF; Univ. Oxford, UK), Mercedes Segura (MS; ElevateBio, USA), Dominik Bruecher (Vector Biopharma, CH).