Key Learning Points

The summit will offer insights into several critical areas of aseptic processing:

1. Regulatory Alignment and Challenges: Understanding and navigating the new Annex 1 regulations for sterile medicinal products.
2. Innovative Technologies: Embracing advanced technologies like automation, robotics, virtual reality, AI, and machine learning to enhance aseptic processes.
3. Inspection Preparedness: Strategies to avoid common pitfalls during manufacturing inspections and understanding the future landscape of GMPs.
4. Contamination Control: Developing robust contamination control strategies leveraging the latest technological advancements.
5. Highly Potent Manufacturing: Addressing the unique requirements of highly potent aseptic production.
6. ATMPs: Developing and qualifying aseptic processes for Advanced Therapy Medicinal Products, including cell and gene therapies and mRNA vaccines.
7. Risk-Based Approaches: Implementing risk-based approaches to process design and control for enhanced safety and efficiency.
8. Sterility Assurance: Ensuring sterility assurance of finished products through key insights and implementations.

Featured Speakers

The summit will feature presentations and case studies from leading experts in the field, including:

• Richard Denk, Senior Consultant at Skan AG, known for his expertise in aseptic processing and containment.
• James L. Drinkwater, Head of GMP Compliance at Franz Ziel GmbH, who brings a wealth of knowledge on contamination control strategies.
• Anne Orillo, Site Validation Lead at Novartis, with extensive experience in process transfer and regulatory filings.
• Sergio Cuevas Luján, Packaging Materials Engineer at Boehringer Ingelheim, specializing in pharmaceutical packaging for aseptic processing.
• Alberto Gonzalez, Global Sterility Assurance Associate Director at Takeda, an expert in aseptic process simulations and contamination control.

Program Highlights

• Case Study by Dr. Anne Orillo on process validation for sterile drug products.
• Case Study on developing aseptic manufacturing processes for ATMPs.
• Presentation by Terri Love from Merck on smooth tech transfer and scale-up processes.
• Presentation on pharmaceutical packaging design for aseptic processing by Sergio Cuevas Luján.
• Case Study by Ulrich Herber on microbiological contamination incidents and root cause analysis.
• Presentation on robotics technology in aseptic processing by Alan Kelly.
• Case Study by Alberto Gonzalez on using risk management to design aseptic process simulations.
• Case Study on protective airflow visualisation and qualification by James L. Drinkwater.
• Presentation by Steve Marnach on validating protective cleanroom garments per the 2022 GMP Annex 1.
• Case Study by James Smith on the role of detergents in biopharmaceutical applications.

Event Insights

Attendees of the 7th Aseptic Processing Summit 2024 will gain exclusive insights into:

• Best Practices: Learn the latest best practices in aseptic processing to enhance manufacturing efficiency and product quality.
• Technological Advancements: Discover cutting-edge technologies that are transforming aseptic processing, including AI, machine learning, and robotics.
• Regulatory Updates: Stay updated on the latest regulatory changes and how to ensure compliance with new standards.
• Networking Opportunities: Connect with industry leaders, peers, and experts to exchange ideas and build valuable professional relationships.
• Practical Implementations: Gain practical knowledge from real-world case studies and presentations that can be applied directly to your operations.

Conclusion

The 7th Aseptic Processing Summit 2024 in Munich is an essential event for professionals in the pharmaceutical industry looking to stay ahead in aseptic manufacturing. With a focus on regulatory compliance, technological innovation, and practical implementation strategies, this summit promises to equip attendees with the knowledge and tools necessary to navigate the complexities of aseptic processing effectively.

For more information and to register, visit the official summit website.