2025 ISPE Aseptic Conference

Advances in pharmaceutical regulation and pharmaceutical technology don’t always coincide. Each advancement moves on its own schedule, driven by its own unique forces. But sometimes there is a synergy, when advances in technology can help regulators to achieve their objectives and changes in regulation come at just the right time to enable a technology to be impactful. This interplay between innovation and compliance will take center stage at the 2025 ISPE Aseptic Conference, particularly in the "Regulations and Pharma 4.0" track.

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.

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.