Welcome to the 2025 ISPE Aseptic Conference

Thank you to all who made the 2025 ISPE Aseptic Conference such a big success!

Conference Attendees

Navigate the conference platform via the listed links.

Attendee Roster: View the full list of conference attendees - platform
Presentation: Presentations received from speakers before the conference who have agreed to make them available are currently posted on the conference platform.
Featured Speakers: View all session speakers

Featured Sessions

Case Study: A New Benchmark for Aseptic Manufacturing

Explore the future of aseptic manufacturing firsthand with a virtual tour of Kindeva's state-of-the-art Bridgeton, Missouri facility. Recently completed in 2024, this cutting-edge sterile fill-finish site spans over 155,000 sq. ft. and features dedicated aseptic operations, labs, formulation suites, and 11,000 sq. ft. of advanced fill suites. Attendees will navigate through the facility, gaining insights into the strategic decisions that enabled its design, construction, and rapid operationalization within just one year

Case Study Moving from a RABS to an Isolator

This presentation will review challenges and successes with installing, validating and implementing a new isolator filling line including strategic regulatory filing strategies to assess moving commerical and clinical clients from the RABS to the isolator. A panel presentation with the manufacturing site, sterility assurance consultant supporting line aseptic readiness, Jeff Yuen (former FDA) regulatory strategy, and Merritt Postma SKAN isolator vendor.

Fireside Chat: Annex 1 Experiences

In this session industry leaders will discuss their view of Annex 1’s impact on different modalities, their experiences implementing changes to align with the revision, and how inspectors have reacted to these changes.

Women in Pharma® Supported Presentation | Workforce of the future

Designed for all attendees at any level of work role or life phase the session will highlight how core skills can help navigate innovation challenges, build stronger teams, and ensure successful outcomes. The presentation will conclude with key takeaways on the poll results and how Workforce skills can be harnessed, adapted and strengthened.

Social Media

Use the hashtag #ISPEAseptic and tag @ISPE in your posts highlighting your conference experience. Plus, follow the official hashtag #ISPEAseptic to stay up to date on activities and events throughout the conference and include it in your social media posts.