2023 Annual GENAP Summit - Aseptic Processing Technology (APT) | Gene & Cell Therapy (GCT)

2023 Annual GENAP Summit - Aseptic Processing Technology (APT) | Gene & Cell Therapy (GCT) is organized by EPM Group and will be held from Feb 23 - 24, 2023 at Melia Milano, Milan, Lombardia, Italy.

GCT Track
Requirements in bringing drugs to market
Vector serotypes to produce more durable gene expression
Vector Design and Development for Gene and Cell Therapies
Current challenges and future of gene therapy technical development
Lessons learnt from commercial products/ late-stage products
The complexity of vector development and production
Investors perspective of gene therapy development
Reducing timelines for cell and gene therapy drug development
CMC strategies for rare diseases
Qualifying starting materials/intermediary materials
Developing novel vectors to reduce immunogenicity
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 strategy
Identifying and measuring of CQAs and determining CPPs
Crucial factors in easing the complexity of vector development and production
Achieving technical, regulatory, and cost efficiency for manufacturing safe gene and cell therapy products
Critical aspects of establishing an efficient, consistent, and flexible CMC strategy
Controlling a product’s CQAs by controlling the process’ CPPs
Emerging technologies improving effectiveness and CGTPs manufacturing processes and production
Crucial components of controlling and scaling manufacturing process and operations for CGTPs
Development of Pediatric Gene Therapy Using Nuclease-Free Genomic Editing Technology

APT Track
The Evolution of Aseptic Technologies
Cleanrooms for the Annex 1 updates
Implementation of quality risk management
Regulatory framework
Antibody Drug Conjugates / HPAPIs production
Lyophilization of highly potent products and aseptic processing.
Occupational safety requirements
Aseptic process development, validation and evaluation.
Highly potent facility design and engineering considerations
Isolator Technology use in aseptic processing for loss minimization/elimination.
Overcoming technical challenges in decontamination processes and material transfers.
Cleaning and disinfection programs for aseptic facilities.
Cross contamination prevention and control for highly potent products.
Robotics in aseptic processing
Gloveless Isolators and dose control
ADC/HPAPI aseptic processing fill and finish
Challenges for manufacturers in cell and gene therapy production systems
Airflow visualization for contamination risks assessment.
Implementing containment technologies in aseptic processing
Boosting sterilization: successful strategies, advanced technologies implementation.
Cleaning automation and technologies.
Gowning: procedures, training, personnel qualification.
Microbiology techniques use in aseptic processing.
Integrating sanitization techniques to empower contamination control.
Filtration: filter integrity testing in aseptic processing.
Single-use systems implementation.
Assess airflow visualization to limit risk for product contamination
Describe the importance of filter integrity testing for aseptic operations