About 4th Gene and Cell Therapy: Quality Developments, Manufacturing & Commercialization Event

The gene and cell therapy markets continue to grow, and gene and cell therapies clinical trials are expanding, although companies are struggling to overcome new CMC, analytical, process development, and manufacturing constraints.

What are the major challenges, opportunities and milestones facing the cell and gene therapy industry in 2022? Which steps can be taken to advance gene and cell therapies progress from preclinical to manufacturing and commercialisation? How to assure that production processes meet technical, regulatory, and cost-efficiency excellence for manufacturing safe products, and commercially viable CGTPs are delivered?

The cell and gene therapy (CGTs) developers in 2022 will continue facing unique difficulties and perspectives:

• The extended collaboration around gene and cell therapy science, technologies, manufacturing, and commercialisation is accelerated
• Gene and cellular therapy-related research and development continue to expand rapidly, with numerous products advancing in clinical development
• Manufacturers produce and commercialise cell and gene therapy products faster, as a result of being supported by regulatory bodies cell and gene therapy approvals and fast-track product designations
• Large-scale commercial production, especially viral vector manufacturing, is minimal because of insufficient flexibility, process control, speed, sustainability, and capital costs
• Manufacturing process enhancements are required to advance production and to deliver cost-efficient CGTPs at a commercial scale
• Numerous manufacturing platforms are developed, but the significant differences between GCT and traditional biopharmaceuticals are influencing the right choice of commercialisation strategy
• Manufacturing decisions, being taken in partnership of various stakeholders, should be in line with the commercialisation objectives
• The link between manufacturing and commercialisation of cell and gene therapy is strengthening, as strategies are planned and deployed from the earliest stages of development

At the 4th Gene and Cell Therapy: Quality Developments, Manufacturing & Commercialization Summit on 8-9 June 2022, while addressing manufacturing controls, cell and gene therapies experts will exchange valuable insights and expectations on:

• Successful strategies to accelerate CGT process development from preclinical to manufacturing and commercialisation
• Efficient enabling novel technologies and resources
• Defining optimal regulatory pathways
• Critical elements of establishing a robust CMC (chemistry manufacturing controls) strategy
• Identifying and measuring of CQAs (critical quality attributes) and determining CPPs (critical process parameters)
• Crucial factors in easing the complexity of vector development and production
• Sophistication of production processes and performance of CGTP (cell and gene therapy products)
• Achieving technical, regulatory, and cost efficiency for manufacturing safe gene and cell therapy products

At the #VLGeneCell in June 2022, the leading experts and advisers will focus on the recent practical experiences and perspectives towards implementing and scaling up robust cost and quality efficient process development and manufacturing, leveraging highly appropriate emerging technologies in the field.

Who should attend

• Adenovirus
• Adeno-Associated Virus (AAA)
• Advanced Therapy Medicinal Product (ATMP)
• Analytics
• Analytical
• Bioprocessing
• Biotherapeutics
• Chimeric Antigen Receptor T-Cells (CAR-T)
• Cell Engineering
• Cell Therapy
• Cellular Immunotherapy
• Cellular Therapy
• Clinical Development
• Chemistry, Manufacturing, and Control (CMC)
• Commercialisation
• Comparability
• Compliance
• Gene Therapy
• GMP (Good Manufacturing Practices)
• Gene Therapy Medicinal Products (GTMPs)
• Cell-Based Medicinal Products (CBMPs)
• Immuno-Oncology
• Immunology
• Immunology Chemistry
• Immunotherapy
• Lentivirus (LV)
• Manufacturing
• Market Access
• Medical Affairs
• Non-Viral Vectors
• Oncology
• Product Characterisation
• Process Development
• Production Engineering
• Quality Assurance
• Quality Control
• Research and Development (R&D)
• Regenerative Medicine
• Regulatory
• Safety
• Scale Up
• Stem Cell
• Supply Chain
• Viral Vector