2025 ISPE Aseptic Conference
The 2025 ISPE Aseptic Conference serves as a platform where the newest developments in aseptic processing, robotics, and automation are explored in depth. It addresses the complex challenges associated with sterilizing small-batch aseptic products and accelerating their time-to-market.
Hear From Top Industry Thought Leaders on the Challenges and Solutions Impacting the Pharmaceutical
Why attend?
The conference will explore the revised Annex 1’s impact on sterile product manufacturing, Quality Risk Management, Contamination Control Strategy, and computerized systems compliance. Attendees will gain insights into emerging aseptic technologies, flexible and multi-product facilities, small-scale manufacturing, managing high potent compounds, containment strategies, and ensuring sterility. Additionally, the conference will address fill-finish tech transfer challenges, robotics integration, optimal primary packing options, and aseptic procedure implementation. With sessions on parenteral production, lyophilization, sterilization processes, and GMP practices, participants will also benefit from networking and collaboration opportunities with industry peers and leaders, enhancing their professional network and gaining valuable industry insights.
Featured Speakers
Drug National Expert
FDA/ORA
Senior Vice President, Indianapolis Parenteral Manufacturing
Eli Lilly and Company
Senior Director, Quality Strategy & Operations
Alnylam Pharmaceuticals
Director, Division of Case Management
FDA/CBER/OMPT/OCBQ
CEO
TAG1 Inc.
Your Conference Experience
Expo Hall
Expo Hall
Explore groundbreaking innovations and network with industry leaders at our dynamic expo hall.
Networking
Networking
Connect with top industry experts and expand your professional network at our exclusive networking sessions.
Live Streams
Live Streams
Experience the conference from anywhere with our interactive live stream.
On-Demand Content
On-Demand Content
Access exclusive conference content anytime with our on-demand library for 90 days.
Conference Highlights
Advancing Precision Medicine with ADCs and Radiopharmaceuticals
The pharmaceutical industry is undergoing a remarkable transformation, with advanced modalities like antibody-drug conjugates (ADCs) and radiopharmaceuticals driving the evolution of precision medicine. These innovations are not only redefining drug development but are also improving patient outcomes through targeted therapies, reduced side effects, and expanded treatment options. The integration of these next-generation modalities introduces unique challenges in manufacturing, regulatory compliance, and operational efficiency—but also immense opportunities for advancing healthcare.
A Message from the 2025 ISPE Aseptic Conference Chair
The 2025 ISPE Aseptic Conference, taking place 17 – 18 March 2025 in Washington, D.C., USA, has always been one of the more future-focused technical conferences within ISPE. Originally called the ISPE Barrier Conference, its emphasis lies on the procedures and technology of restricted access barrier systems (RABS) and isolators.
Building Resilience in Atmp Manufacturing: Insights and Innovations at the 2025 ISPE Aseptic Conference
Advanced therapy medicinal products (ATMPs) are medicines based on genes, tissues, or cells. This class of products cannot be terminally sterilized and, in many cases, cannot be filtered and are manufactured by Aseptic processing. The increase in demand for these life-changing products has been fraught with technical and regulatory challenges as laboratory processes are scaled to commercial manufacturing. As an industry, we need to address ATMP resiliency in its many forms. The 2025 ISPE Aseptic Conference Committee is proud to present the track ATMPs. This track will showcase case studies of manufacturing resiliency and technical presentations addressing lessons learned from manufacturing ATMPs.
Conference Gallery
International Program Committee
Chair
Sr. Fellow - Aseptic and Sterile Products, Vertical Market Leader
CRB
International Board and Foundation Liaison
President
Genesis AEC
Women in Pharma® Liaison
Senior Director, Value Stream CAR - T Manufacturing Operations
Bristol Myers Squibb
Chapter Board Liaison
Energy Program (Sustainability) Lead
AstraZeneca
Associate Director Process Engineering, Regenerative Medicine
United Therapeutics
Managing Director - Life Sciences
Omnia Technologies
Senior Consultant Aseptic Processing & Containment
SKAN AG
Director of Business Development
GBA Life Sciences
Global Head Compliance and Inspection Management
Moderna
Senior Product Manager
Syntegon Technology GmbH
Advisor - Project Management
Eli Lilly & Company
Vice President Vetter Development Service External Affairs
Vetter Pharma Fertigung GmbH & Co KG
Emerging Leader
3P Innovation
Emerging Leader
Process Engineer II
Genesis AEC
Emerging Leader
Process Engineer III
CRB