Call for Proposals

Learn more about our Call for Proposals

The 2025 ISPE Aseptic Conference hosts the newest developments in aseptic processing and technologies. The complexity of aseptic processing is changing and includes advanced technologies such as robotics, advanced automation, and process improvements. It addresses the complex challenges of the manufacturing of aseptic and sterile products, mainly driven by product quality and safety, in a market where time to clinic and time to market is critical.

The conference will continue to examine the implications of the revised Annex 1, as it is setting new benchmarks for aseptic and sterile product manufacturing, Quality Risk Management, Contamination Control Strategy, and technological advancements.

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Call for Proposals Timeline

Date	Action
10 June 2024	Opens
29 July 2024	Submission Deadline
24 September 2024	Notifications

Presentation Type

Abstract submissions are to be submitted as individual, 30-minute presentations:

Presentations should focus on new and innovative approaches, a specific real-world strategy or campaign (case study), a “how-to" presentation intended to help attendees gain a better understanding of the initiative and best practices that they can apply to their day-to-day objectives or overall missions.

Content Areas

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.

The 2025 Aseptic Program Committee is requesting proposals aligning with the following content areas:

1. Regulatory, Compliance & Quality

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. Specifically, we are interested in proposals that elaborate on:

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)

2. Sustainability/Environmental

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.

3. Robotization and Digital Revolution of Aseptic Processing

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.