Recent advancements in aseptic processing, such as advanced isolators, robotics, and increased automation, have transformed the industry whilst simultaneously reducing the risks of contamination for sterile products. However, modern therapies - innovative, targeted treatments that result in small-batch aseptic products - require faster speeds to market and present unique sterilization and handling challenges. This dichotomy presents unique challenges for the industry to address.
Moreover, the updated Annex 1 is impacting the manufacturing of sterile products, necessitating updated requirements such as Quality Risk Management, Contamination Control Strategy, and Data Management and Compliance for Computerized Systems.
Programme highlights for the 2024 ISPE Aseptic Conference include:
The 2024 ISPE Aseptic Conference will provide an ideal opportunity for participants to share progress, success stories, best practices, and lessons learned. Get ahead of the game with a focus on novel therapies, emerging technologies, and aseptic processing. We look forward to seeing you in Vienna, Austria!
Regulatory Presence at the 2024 ISPE Aseptic Conference:
Given the impact of the evolving pandemic, an ageing population, the increase in diseases with unmet needs, and an unprecedented rise in chronic diseases, 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.
Join industry leaders in discussions on pivotal themes, including the innovative use of Biofluorescent Particle Counters to enhance sterility assurance levels. Gain insights into the impact of Annex 1 changes on the ISPE Baseline® Guide – Sterile Product Manufacturing Facilities and explore new approaches to Contamination Control Strategy preparation, emphasizing Quality Risk Management principles.
Experience the evolution of aseptic manufacturing propelled by technologies liKe automation, robotics, and rapid microbiological monitoring, revolutionizing the pharmaceutical and biotechnology industries. Join industry experts in navigating these advancements, ensuring regulatory alignment for enhanced product safety and efficacy, while collectively shaping the future of manufacturing excellence.
Three presentations focused on latest industry trends and developments as it relates to Vapor Phase Hydrogen Peroxide (VPHP) decontamination. Learn about best practices for cycle development and validation, rapid detection methods, cycle time reliability and optimization, and other applications of H2O2 to ensure product safety.
Journey into the future of aseptic manufacturing and the sterile products industry, where innovation takes center stage. Explore key areas such as equipment, digital/automated methodologies, and biodecontamination processes, uncovering insights into process optimization through digital twins, envisioning the future of filling lines, and embracing new techniques in hydrogen peroxide decontamination for continuous processing.
Explore the impact of new Annex 1 regulations in the pharmaceutical industry, as we delve into the intricacies of incorporating lyophilization by August 2024. Join us for sessions on navigating the crucial changes, from aseptic spray freeze drying to ensuring compliance with GMP and EH&S standards for radiopharmaceutical products.
Airflow studies and environmental monitoring – two main pillars of the CCS: Airflow studies are the “gold standard” for proving a proper airflow in the aseptic core. CFD studies where you simulate airflow patterns are extremely helpful during the development phase. So, in an early stage you can already adapt your machine solution. This session will explore the use of tools that help to better understand your processes and to minimize your risk of contamination.
Discover innovative technologies and strategies for ATMP manufacturing, solving challenges in production, scale-up, aseptic fill/finish, supply chain resilience, and patient safety. Plus, gain a deeper understanding of the impact of Annex 1 regulations on process design and regulatory frameworks for point-of-care ATMP manufacturing.
The regulatory panel will include representatives from various health authorities, including AGES/Austria, WHO, FDA and Germany. The focus of the discussions will be on current pharmaceutical-technical issues in aseptic processing. Learnings from the first months of Annex 1 being effective will be shared, as well as clarifications around the right interpretation of Annex 1. As always, there will be the possibility to submit your questions to the panelist.
Embark on a comprehensive exploration within the Sterilisation track, unveiling the intricacies of releasing sterile products through parametric methods, implementing precision in production equipment sterilization aligned with contamination control, and discussing advanced steam sterilisation methods for stoppers.
Join us on a journey through the Sustainability track, where the fusion of quality and environmental responsibility propels innovation. Dive into novel solutions and state-of-the-art technologies as industry leaders champion sustainability, reduce energy consumption, and minimize environmental impact, all while paving the way for a greener, more efficient, and socially responsible future in aseptic manufacturing.
Dive into the latest trends in training, focusing on aseptic techniques and safety culture. Review industry-leading safety training resources, a validated VR training process, and a comprehensive operator aseptic qualification. Additionally, gain valuable knowledge to thrive amidst evolving regulatory requirements, including recent Annex 1 changes.
In the pharmaceutical industry, which is highly regulated, aseptic processing is a critical component that ensures the sterility of products. Regulators have a set of comprehensive requirements that minimize the risk of contamination. Regulators set the requirements; however, the industry has an obligation to the patients who rely on and expect a drug that is safe and free of contamination....
Annex 1 has been in effect since August 2023. But what has been its impact? This topic will be discussed at the 2024 ISPE Aseptic Conference in Vienna, Austria and virtually. Speakers from both industry and...
The 2024 ISPE Aseptic Conference will offer a glimpse into the best discussions on the future of aseptic manufacturing. Attendees will learn how optimization is evolving both in the form of digitalization and in...
In the intricate world of pharmaceuticals, where precision and safety are paramount, the marriage of innovation and sustainability is not just an aspiration—it's a necessity. Picture a scenario where the pursuit of product purity meets the responsibility to our planet. Welcome to the realm of "Eco-friendly Pharma: Sterilization and Sustainable Practices." As we embark on this exploration,...
As the 2024 ISPE Aseptic Conference Chair, Christa Myers, Sr. Fellow - Aseptic and Sterile Products, Vertical Market Leader at CRB gets asked many times: what’s next? What are the new trends? Can Aseptic manufacturing change be easier, more cost-effective, and manage risks better? What are the inspectors looking for? Why can this not be more clear? Let’s find those answers together.
