Why should you attend?

The best executive event on Aspetic Processing | Gene & Cell Therapies

Key Learning Points

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

Who should attend?

Members of board, C-level, Senior Vice Presidents, Vice Presidents, Directors and Heads of departments from pharmaceutical/biotechnology industry / industries involved in:

  • Adenovirus
  • Advanced Therapy Medicinal Product
  • Analytics
  • Bioprocess Research
  • Bioprocessing
  • Biotechnology
  • Biotherapeutics
  • Cell Engineering
  • Cell Therapy
  • Cell-Based Medicinal Products
  • Cellular Immunotherapy
  • Cellular Therapy
  • CMC
  • CAR-T
  • Clinical Development
  • Commercialisation
  • Comparability
  • Compliance
  • Container Development
  • Drug Development
  • Engineering
  • Fill and Finish
  • Formulation
  • Freeze-Drying
  • Gene Therapy
  • GMP
  • Immuno-Oncology
  • Immunology
  • Immunotherapy
  • Lentivirus
  • Licensing
  • Lyophilisation
  • Manufacturing
  • Market Access
  • Medical Affairs
  • Medical Devices
  • Nanomaterials
  • Non-Viral Vectors
  • Oncology
  • Packaging and Labelling
  • Parenterals
  • Pharmaceutical Process and Technology
  • Process Analytics
  • Process Development
  • Process Monitoring and Control
  • Product Characterisation
  • Product Innovation
  • Production Engineering
  • QA/QC
  • Quality Assurance
  • Quality Control
  • R&D
  • Regenerative Medicine
  • Regulatory Affairs
  • Research and Development
  • Risk Management
  • Safety
  • Scale Up
  • Stability
  • Standardisation Science
  • Stem Cell
  • Sterilization
  • Supply Chain
  • Vaccine/Antibody/Cell Manufacturing
  • Validation
  • Viral Vector

What can you expect?


➜ 100+ industry delegates

➜ 60%+ C-suite executives & SP-VP

➜ 10+ Exhibitors & Sponsors

➜ Experts on APT | GCT | CMC | Bioprocessing and many more…

➜ 5+ hours of networking events

➜ Exclusive innovative data

➜ Delegates contact information

Companies Represented on our events

Our Clients


Several major clients have trusted on us making BPS one of the best conferences for executives in the World.

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