Featured Topics

This track showcases cutting-edge advancements in large molecules, cell and gene therapies, and advanced therapy medicinal products. Sessions explore critical industry challenges and innovative solutions that are transforming patient care. 

Key focus areas: 

• Cost reduction strategies for ATMP manufacturing through automation
• Modular and scalable production approaches for cell therapies
• Regulatory navigation for advanced therapy development
• Process optimization for biopharmaceutical manufacturing
• Continuous manufacturing technologies and closed systems 

Highlight sessions include presentations on reducing ATMP costs through automation, matrix production with modular minifactories, and the integration of robotics in cellular and gene therapies. Industry experts from organizations like Fraunhofer IPA, Catapult Cell and Gene Therapy, and Eli Lilly share valuable insights on contamination control, cleaning optimization, and regulatory compliance specific to these advanced therapeutic modalities.

This track explores cutting-edge digital technologies revolutionizing pharmaceutical manufacturing and operations. Sessions highlight practical implementations, strategic approaches, and emerging innovations that are reshaping the industry landscape.

Key focus areas:

• Digital transformation strategy and implementation
• Model-based development and digital twins
• Autonomous mobile robots for cleanroom applications
• RFID-based unit level traceability systems
• AI and advanced data analytics in manufacturing
• Digital validation and paperless quality management

Highlight sessions include presentations on navigating digital transformation journeys, implementing digital twins across complete batch plant lifecycles, and leveraging AI for operational excellence. Industry leaders from organizations like GSK, CSL Behring, Takeda, and Eli Lilly share real-world case studies demonstrating how digital technologies are enhancing efficiency, quality, and regulatory compliance while addressing implementation challenges and change management.

This track focuses on optimizing engineering approaches and capital investments in pharmaceutical facilities to enhance efficiency, compliance, and return on investment. Sessions explore innovative project management methodologies, facility design strategies, and emerging technologies that drive operational excellence.

Key focus areas:

• Risk-based commissioning and qualification approaches
• Multi-product facility design and management
• Innovative project execution models
• Capital expenditure optimization
• Artificial intelligence applications in project management
• Fleet management for distributed manufacturing

Highlight sessions include presentations on bridging innovation with compliance in fast-track projects, revolutionizing pharmaceutical production through fleet management, and optimizing legacy processes through advanced risk assessment. Industry experts from organizations like GSK, Eli Lilly, Takeda, and Bayer share practical case studies demonstrating how good engineering practices can accelerate project delivery, reduce risks, and maximize investment value while maintaining regulatory compliance.

This track explores transformative approaches to pharmaceutical business processes that address critical industry challenges related to drug availability, market access, and development timelines. Sessions highlight innovative strategies that enhance supply chain resilience, optimize product lifecycles, and accelerate knowledge transfer.

Key focus areas:

• Supply chain resilience and drug shortage prevention
• Implementation of ICHQ12 for effective pharmaceutical product lifecycle management
• Knowledge transfer methodologies for accelerating product development and site transfers
• Innovative approaches to reduce manufacturing costs while maintaining quality
• Cross-functional collaboration to enhance time-to-market
• Regulatory strategies that support business process innovation

Highlight sessions include presentations on fleet management for distributed manufacturing, digital transformation strategies, and disaster recovery approaches that demonstrate how innovative business processes can address industry-wide challenges. The track features case studies and practical examples from leading pharmaceutical companies that have successfully implemented process innovations to improve drug availability, enhance market access, and accelerate time-to-market while maintaining regulatory compliance.

This track explores evolving regulatory frameworks and compliance strategies that shape pharmaceutical development and manufacturing. Sessions highlight practical approaches to implementing new guidelines while maintaining operational excellence and patient safety.

Key focus areas:

• Annex 1 implementation case studies for sterile products and ATMPs
• Drug shortage prevention initiatives and supply chain resilience strategies
• ICH Q9R1 implementation and quality risk management approaches
• Updates on pharma GMP standards and EudraLex revisions
• Regulatory inspection trends and collaborative approaches

Highlight sessions include presentations on navigating ATMP guidance and regulations, innovative approaches to Annex 1 compliance, and collaborative inspection models. Regulatory experts from agencies like EMA and MHRA join industry professionals to share insights on emerging regulatory requirements and their practical implementation. The track features case studies demonstrating how companies are successfully adapting to regulatory changes while enhancing patient access to medicines and maintaining product quality.

This track explores innovative approaches to environmental stewardship and sustainable practices in pharmaceutical manufacturing. Sessions highlight strategies for reducing environmental impact while maintaining product quality and regulatory compliance.

Key focus areas:

• Energy-efficient HVAC design aligned with Annex 1 requirements
• Net-zero carbon initiatives and whole life cycle assessments
• Managing materials of concern (PFAS, EtO, Triton X-100)
• EU chemicals legislation and its impact on pharmaceutical manufacturing
• Cleanroom airflow optimization for energy reduction
• Alternative refrigerants and heat pump technologies

Highlight sessions include presentations on transforming pharmaceutical plants for enhanced sustainability, navigating regulatory challenges related to materials of concern, and implementing energy-efficient HVAC systems that comply with Annex 1. Industry experts share case studies demonstrating successful integration of sustainability objectives from facility design through construction and operation, with quantifiable reductions in carbon emissions, energy consumption, and resource usage while maintaining GMP compliance.