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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. 

Focused Areas Include:

• The latest industry feedback on Annex 1 (inspections, case studies, implementation)
• 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 sterile products industry has and should continue to put patient safety and quality of products as the ultimate priority. At times, this has led to sacrifices in other areas that should not be neglected also considering the newly developed technologies available today. For example, the industry is responsible for significant HVAC use, high amounts of water consumption, and the use of virgin polymers destined for single use with impacts on waste streams.

As a response to these issues stated above, some pharma manufacturers are looking to increase the focal areas to concurrently consider environmental and public health impacts when designing and managing operations. The 2025 ISPE Aseptic Conference will showcase how we/they/ are leading the way in facility designs, equipment and process innovation as well as data management and use to also have a positive impact on:

• The amount and type of energy, water and material consumed.
• Waste generation and management.
• Process and utility emissions as well as lifecycle considerations that may impact health and the environment.
• Carbon footprint and life-cycle costs and savings
• The impact of PFAS regulation on the pharmaceutical manufacturing industry.
• Come share and learn new ideas you, your team, and your company could consider for your future projects.

The enormous advantages automation brings to aseptic processing in terms of reducing the impact of human interactions, minimizing contamination risk, and improving OEE, have driven the development of new solutions in the last decade. In 2025 Artificial Intelligence/Machine Learning has become, for some of us, a work companion in daily life; the same and eventually greater potential stands also in aseptic processing among the different GMP operations advancements; in this sense, they are of extreme interest in this session.

Examples of case studies/use cases include:

• Robotics and advanced automation in Aseptic Processing
• AI/Pharma 4.0/Digitalization in Aseptic and Sterile Products Manufacturing
• Automation and Minimization of Operator Interaction
• Life cycle costs savings of highly automated systems
• Expectations for growth of advanced automation within the manufacturing of Aseptically produced products.

The advancement of technology continues to change the way our facilities operate. The regulatory agencies are expecting systems to provide an approach that drives the highest levels of quality and safety for the patient. The long-term expectation is that this approach will have higher efficiency and lead to reduced drug shortages. Contamination Control Strategy and advanced monitoring supports aseptic processing. What is the current, and what will the future bring?

Examples of case studies/use cases include the following:

• Contamination Control Strategy and Implementation
• Cross Contamination Control Strategies and impacts on operations and facility design
• Emerging Aseptic Technologies: Rapid Microbiological and Online Testing
• Material transfers into Grade A spaces and monitoring of Sterility Assurance Levels
• Sterility Testing and changes in product release
• Robust Surface Decontamination – existing and new methodologies

The future of aseptic manufacturing holds tremendous potential for revolutionizing the pharmaceutical and biotechnology industries. Advancements in drug delivery, technology, increased automation, and innovative processes are poised to transform the way drugs and biologics are produced, ensuring higher quality, safety, and efficiency. To meet the increasing regulatory requirements and market demand, aseptic facilities will need to embrace isolators, robotics, automated filling and material handling and transfers, chain of custody, control systems, and real-time monitoring. This includes facility utilization in a volatile real-estate market.

Examples of case studies/use cases include the following:

• Upgrades and Renovations of Aging Facilities: Case Studies
• Sustainable Facility Design in Aseptic Manufacturing
• Implementation of Robotics into Facilities
• Implementation of Single-Use Systems in Aseptic Manufacturing
• Execution of Manufacturing Execution Systems (MES)
• Automated Filling Line of the Future: Case Studies
• Closing of Open Processes into Isolators: Case Studies
• Automated Inspection with Machine Learning: Case Studies
• Lyophilization

In aseptic pharmaceutical manufacturing, ATMPs present unique challenges due to their complex production processes and the need to maintain strict aseptic practices throughout the manufacturing process. This requires specialized facilities, equipment, and expertise to ensure that the final product is safe, effective, and free from contamination.

Examples of case studies/use cases include the following:

• Novel aseptic processing related to Cell & Gene Therapies/ATMPs
• Advanced Therapy Medicinal Products (ATMPs) and cell/gene therapy in aseptic manufacturing
• Innovation in technology to close and automate the production (risk, time and cost)
• Rapid methods, real time release, and personalised medicine
• Multi-product/multi-jurisdictions facilities and interactions with various GMP codes
• Cell & Gene technology industry in emerging markets
• How does the industry deliver the flexibility demanded of cell/gene therapy products
• Aseptic processing in decentralized manufacturing
• Contamination Control Strategies (particularly addressing viral contamination) for ATMPs

Antibody Drug Conjugates is a growing platform for drug delivery for many types of drug compounds. Most but not all ADCs are used to treat cancers. We continue to see a rise in both the number and types of cancers. Significant advances have been made in therapies, particularly in the field of Antibody Drug Conjugates (ADCs). These innovative treatments allow for the targeted delivery of potent therapeutic agents directly to tumor cells via specific Antibodies. By selectively targeting cancer cells, ADC enables physicians to use highly potent drugs while minimizing potential damage to healthy tissues. Manufacturing these complex products requires advanced engineering, specialized equipment, and stringent procedures. Topics relevant to this track will include updates on the trends, discussions on the future of equipment and facilities to protect the products and the operators of the equipment, and possibly even some case studies on how groups are manufacturing these products today.

Examples of case studies/use cases include the following:

• Occupational Exposure requirements and monitoring
• Singe use System management considerations, from storage to waste
• Personal training for working with high potent products
• Facility and process design
• Cleaning requirements to prevent cross-contamination
• Maintenance program for high potent facilities and equipment

Radiopharmaceuticals are a field that is growing rapidly at the moment, but which also presents new challenges. Containment is of utmost importance as operator protection is paramount. All production processes need to be designed to prevent radioactive contamination, including the adjacent processes to production like cleaning and sterilization, but also quality control labs.

Examples of case studies include the following:

• Overview on the current landscape for radiopharmaceuticals
• Diagnostics versus therapeutic radiopharmaceuticals
• Targeted therapies Design considerations for facilities for the production of sterile radiopharmaceuticals
• Regulatory challenges in a global setting
• Contamination Control Strategies with a special focus on radioactive contamination
• Case studies on new facilities
• Technical solutions for containment, sterilization, and HVAC systems