2023 ISPE Aseptic Conference
The need to take advantage of new technologies and explore new ways for process control and efficiency permeates all areas of pharmaceutical manufacturing. Recent emerging technologies in aseptic processing such as advanced isolators, robotics, and increased automation have changed the industry and reduced contamination risks for sterile products. Simultaneously, modern therapies - new, targeted approaches to treatment resulting in small-batch aseptic products - are proving more difficult to sterilize and handle and requiring faster speeds to market. Furthermore, the updated Annex 1 will impact the manufacture of sterile products, setting new requirements for Quality Risk Management, Contamination Control Strategy, and Data Management and Compliance for Computerized Systems. The requirement to re-think the existing standards is becoming more urgent.
Watch this clip to hear from Program Chair Jörg Zimmermann, Vice President, Vetter Development Service, External Affairs, Vetter Pharma, as he shares his favorite event highlight.
Watch this clip to hear what Program Co-Chair Christa Myers, Senior Associate, Aseptic & Sterile Products Market Director, CRB, had to say. Plus, she gives all a heads up that you should start prepping your proposal for the 2023 ISPE Aseptic Conference shortly!
Keynote Joyce Hansen, Vice President of J&J Microbiological Quality and Sterility Assurance, Johnson & Johnson, shared her perspective on this during the #ISPEAseptic session “Microbiological Quality and Cultivating Emerging Leaders.”
Robotics provide various benefits, from implementing new strategies and methods to process monitoring. In the #ISPEAseptic session "Robotics and Implementation of New Strategies," speakers shared insights into the benefits of gloveless, robotic isolators, and advantages from the resulting risk reductions.
Watch this clip to hear from Ruth Barensteiner, Dipl.-Ing. (FH), Principal Scientist Compliance, The Janssen Pharmaceutical Companies of Johnson & Johnson, as session leader Klaus Ullherr, Senior Product Manager, Syntegon poses a question around troubleshooting for gloveless isolators.
During the #ISPEAseptic closing industry panel on day 1, Sumit Verma, Senior Vice President, Commercial Manufacturing, Iovance Biotherapeutics, Inc., gave attendees a look into the Iovance Cell Therapy Center (ICTC) in Philadelphia, Pennsylvania.