Featured Topics

Given the impact of an aging population, the increase in chronic diseases or those yet to have therapies, the need for a constant focus on collaborative innovation and agility will shape Pharma's priorities in the foreseeable future. ISPE will be the leader in setting the pace for knowledge sharing that speaks to the current and future needs of the industry.

Proper airflow visualization and testing are critical components of contamination control in aseptic manufacturing. With the revised Annex 1 placing increased emphasis on demonstrating unidirectional airflow and First Air principles, pharmaceutical manufacturers must adopt rigorous testing methodologies to ensure compliance and product safety. This track explores state-of-the-art techniques for smoke studies, computational fluid dynamics (CFD) modeling, and real-time airflow monitoring in Grade A environments.

Topics and case studies will cover:

• Good practices for conducting smoke studies in aseptic fill-finish operations
• Airflow visualization techniques according to Annex 1 requirements
• Advanced tracer delivery methods and illumination techniques for optimal visibility
• CFD and AI modeling for parenteral fill-finish development
• ASTM standards for critical airflow visualization
• Video documentation requirements for qualification and regulatory inspections
• Optimization of filling parameters through simulation and digital twins
• Validation of unidirectional airflow in isolators and RABS environments

The revised EU GMP Annex 1 has fundamentally reshaped expectations for sterile medicinal product manufacturing. This track addresses the broad implications of Annex 1 implementation, including Quality Risk Management, Contamination Control Strategy, and technological innovations that support compliance. Sessions will explore practical challenges, regulatory interpretations, and emerging technologies that help manufacturers meet the new benchmarks for aseptic processing.

Topics and case studies will cover:

• Implementation of Contamination Control Strategies (CCS)
• Quality Risk Management (QRM) frameworks and risk-based approaches
• RTP (Rapid Transfer Port) integrity testing as part of CCS
• Reducing fill weight deviations through process optimization
• Material compatibility and equipment design considerations
• Advanced monitoring systems and real-time testing methodologies
• Regulatory expectations for environmental monitoring and process validation
• Integration of new technologies to support Annex 1 compliance

Real-world implementation of Annex 1 requirements presents unique challenges across different facility types, equipment configurations, and organizational structures. This track features detailed case studies from pharmaceutical manufacturers who have successfully navigated the complexities of Annex 1 compliance. Attendees will gain practical insights into GAP analyses, facility upgrades, equipment modifications, and procedural changes that have proven effective in meeting regulatory expectations.

Topics and case studies will cover:

• Global implementation challenges and harmonization across multiple sites
• Interpreting regulatory requirements and addressing inspection findings
• Implementing Annex 1 in legacy facilities with existing equipment
• Evolution from RABs to isolators: a decade of aseptic manufacturing advancement
• High-speed isolator filling line implementation and qualification
• Steam-sterilized isolator design and qualification
• Overcoming technical challenges during line commissioning
• Developing compliant aseptic behaviors and operator training programs
• Vendor relationships and project management for successful implementation

Advanced Therapy Medicinal Products represent the cutting edge of pharmaceutical innovation, offering transformative treatments for patients with rare and life-threatening diseases. However, the complexity of ATMP manufacturing—involving living cells, genetic material, and personalized medicine approaches—creates unique aseptic processing challenges. This track examines the specialized facilities, equipment, and procedures required to manufacture ATMPs safely and effectively while maintaining strict contamination control.

Topics and case studies will cover:

• Materials transfer and risk assessment for ATMP cleanrooms
• Contamination control strategies specific to cell and gene therapies
• Maximizing gene therapy doses through optimized fill-finish processes
• Implementation of flexible, single-use systems in ATMP manufacturing
• Rapid safety testing methods for products with short shelf lives
• Alternative sterility and mycoplasma testing approaches
• BSC hood operations and Grade B cleanroom material transfer
• Patient safety and operator safety considerations
• Regulatory compliance for cell and tissue-based products

The economic and operational realities of ATMP manufacturing often require facilities to handle multiple products and therapeutic modalities within the same space. This creates additional complexity in terms of cross-contamination prevention, cleaning validation, equipment changeover, and regulatory compliance. This track focuses on strategies for designing and operating multiproduct ATMP facilities that maintain the highest standards of quality while achieving operational efficiency.

Topics and case studies will cover:

• Rapid safety testing approaches for ATMPs with short expiration dates
• Multi-product facility design considerations and lessons learned
• Organizational structure for commercial ATMP manufacturing
• Digital twin technology for optimizing aseptic ATMP processes
• AI tools for improving training quality and procedure development
• Material movement validation using digital data collection
• Floor space optimization and risk mitigation strategies
• Regulatory and quality aspects of multiproduct operations
• Transition from academic research to commercial manufacturing
• Patient-driven timelines and achieving operational readiness

Primary packaging components play a critical role in maintaining drug product quality, yet they can also be a source of contamination if not properly controlled. With Annex 1 emphasizing Contamination Control Strategies throughout the entire aseptic process, component quality has become a focal point for manufacturers seeking to reduce defects, improve yields, and ensure patient safety. This track explores innovations in component design, sterilization methods, and quality assessment.

Topics and case studies will cover:

• Impact of premium components on final drug product quality and yield
• Particle reduction strategies for RTU/RTF (Ready-to-Use/Ready-to-Fill) containers
• Cost-benefit analysis of high-quality packaging components
• Sustainable sterilization methods using vaporized hydrogen peroxide
• Design of Experiments for RTU/RTF production process optimization
• Shipping and handling impacts on component quality
• Mitigation strategies for particle contamination
• Facility and filling equipment design considerations
• Regulatory expectations for component qualification
• Total cost of ownership versus component costs

The design of aseptic manufacturing facilities must balance multiple competing priorities: regulatory compliance, operational efficiency, flexibility for future products, sustainability, and cost-effectiveness. Modern facility design incorporates advanced technologies such as isolators, robotics, automated material handling, and real-time monitoring systems. This track examines best practices for designing facilities that meet current and future manufacturing needs while optimizing facility utilization in a volatile real estate market.

Topics and case studies will cover:

• Regulatory compliance and quality system integration in facility design
• GAP analysis frameworks for legacy facility assessment
• Fast-track delivery strategies for fill-finish manufacturing sites
• Contamination Control Strategy implementation in facility design
• Integration of isolators, robotics, and automation
• Sustainable facility design principles for aseptic manufacturing
• Multi-product facility considerations and changeover strategies
• Material flow and personnel flow optimization
• HVAC system design and environmental control
• Modular design approaches for scalability and flexibility
• Real-world lessons from greenfield and brownfield projects

Isolator technology has become the gold standard for aseptic processing, offering superior contamination control compared to traditional cleanroom environments. However, isolator design requires careful consideration of numerous factors including airflow patterns, material transfer systems, decontamination cycles, operator interface, and integration with filling equipment. This track showcases the latest innovations in isolator design and practical case studies demonstrating successful implementation.

Topics and case studies will cover:

• Use of extended reality (XR) and virtual reality for isolator design
• Gloveless isolator systems with advanced robotics and automation
• RDS (Rapid Decontamination Station) integration in isolator filling lines
• Material transfer strategies and alpha-beta port connections
• VPHP (vaporized hydrogen peroxide) cycle optimization
• Steam-sterilized isolator design and qualification
• Pressure balancing systems for technical and process chambers
• Unidirectional airflow verification under dynamic conditions
• Operator training for gloveless and traditional isolator systems
• Integration with automated filling lines and inspection systems
• Real-time environmental monitoring within isolators

Lyophilization (freeze-drying) is a critical process for stabilizing biologics and other moisture-sensitive pharmaceutical products. The aseptic loading and unloading of freeze-dryers presents unique contamination control challenges, particularly under the revised Annex 1 requirements. This track explores innovations in lyophilization technology, controlled nucleation techniques, and equipment design that improve process efficiency while maintaining sterility assurance.

Topics and case studies will cover:

• Upgrading freeze-dryer loading systems for Annex 1 compliance
• Semi-automatic loading configurations with Grade A airflow
• Controlled nucleation techniques using ice-fog technology
• Reduction of inter-vial heterogeneity and process variability
• Optimization of primary drying cycles through controlled nucleation
• Sterilized frame handling and automated support systems
• Maintaining Grade A continuity throughout the loading/unloading lifecycle
• Integration of loading systems with existing filling and capping equipment
• Process robustness and recipe transferability improvements
• Scale-up considerations for GMP production environments

Innovation in aseptic processing often comes from unexpected sources and creative problem-solving approaches. This track features diverse case studies that don't fit neatly into other categories but offer valuable lessons for the industry. From implementing new monitoring technologies to rethinking fundamental assumptions about aseptic processing, these presentations challenge conventional thinking and showcase emerging best practices.

Topics and case studies will cover:

• Implementation of biofluorescent particle counters (BFPC) in isolators
• Gloveless aseptic filling workcell qualification and validation
• Real-time environmental monitoring using advanced technologies
• Accelerated paths to GMP certification for new technologies
• Setting baselines and handling interference in BFPC monitoring
• Practical approaches to Grade A monitoring compliance
• Reducing validation burden through standardized approaches
• Inspection readiness for novel monitoring technologies
• Risk-based approaches to aseptic processing under regulatory scrutiny
• Industry debate on the future of aseptic versus sterile processing

Radiopharmaceuticals and high potent compounds present unique challenges that combine the complexity of aseptic processing with the critical need for containment and operator protection. The rapid growth of targeted radiopharmaceutical therapies, combined with increasing use of antibody-drug conjugates and other potent compounds, requires specialized facility design, equipment, and procedures. This track addresses the technical and regulatory considerations for safely manufacturing these challenging products.

Topics and case studies will cover:

• Aseptic potent compound and flammable solvent processing
• Containment strategies for OEB 4/5 compounds
• Hot cell and filling isolator technology for radiopharmaceuticals
• Contamination Control Strategies with focus on radioactive contamination
• ATEX-aligned explosion-resistant equipment design
• Multi-product operations with potent compounds
• Cross-contamination prevention and cleaning validation
• VPHP cycle optimization for potency management
• Kill tank design and washdown approaches
• Occupational exposure monitoring and personnel training
• Diagnostic versus therapeutic radiopharmaceutical manufacturing
• Regulatory challenges in global radiopharmaceutical production
• Just-in-time production and expedited QA/QC processes
• Technical solutions for containment, sterilization, and HVAC systems

Regulatory and quality challenges, learnings, and opportunities which might include the current speed to market expectations, regulatory harmonization initiatives, and guidance updates. This content area will explore the implementation of European regulatory changes and the industry's feedback on the revised guidelines for sterile medicinal products. Topics include:

• The latest industry feedback on Annex 1 (inspections, case studies, implementation)
• The challenges and solutions to implementing Annex 1 in legacy facilities
• The best practices of conducting a thorough GAP analysis in Annex 1 implementation
• Effective strategies for Contamination Control, including environmental monitoring, process validation, and personnel training
• QRM & Risk-based approaches (risk assessments, risk management plans, and continuous improvement programs)

The pharmaceutical industry is at a crossroads regarding aseptic processing. Increasing regulatory scrutiny of barrier isolator-based filling lines, particularly around sterilized part setup, First Air principles, and glove use near critical zones, is causing manufacturers to re-evaluate long-standing procedures and validated solutions. This track examines whether the industry can continue relying on risk-based approaches to aseptic processing or whether a fundamental shift toward truly sterile processing is inevitable.

Topics and case studies will cover:

• Current regulatory expectations for barrier isolator systems
• Historical approaches to ensuring product sterility through VPHP bio-decontamination
• Recent inspection findings and their operational impacts
• Validated preparatory procedures for aseptic environments
• Real-world experiences from CDMOs navigating regulatory challenges
• Cost of goods implications of changing regulatory expectations
• Impact on reliable medicine supply
• Industry debate on the future of aseptic processing
• Risk-based approaches under increased scrutiny
• Balancing innovation with regulatory compliance
• Lessons learned from inspection outcomes
• Strategies for maintaining validated state under evolving requirements