It was March 2020 and my first year serving on the ISPE Aseptic Conference Planning Committee. I was brimming with excitement of the possibility to introduce speakers and facilitate discussions at this conference I had enjoyed and learned from multiple times as an attendee. Little did I know how much I would get to participate, as my fellow committee members were restricted from traveling to...
The ISPE 2022 Facilities of the Future Conference Opening Plenary provided views of lessons learned during the pandemic that will help the pharmaceutical industry to accelerate development of new...
Aseptic filling of parenterals is one of the most challenging tasks within pharmaceutical manufacturing. A wide range of topics falls under this umbrella, from more engineer-driven topics (e.g., filling accuracy and machine performance) to key production questions (such as how to ensure the process remains sterile and compliant within the law and regulatory guidelines). All this is influenced...
The ATMPs - Autologous Cell Therapy Guide focuses primarily on manufacturing facility development and design for autologous cell therapies for parenteral use. This Guide provides an overview of the critical aspects of ATMP facility design as well as the key relationship between current process/facility attribute alignment and how that changes in the ATMP space.
Biotech is adapting and evolving to have more automation, digitalization, and we need to be ready for the new challenges. Join us at the 2022 ISPE Facility of the Future Conference...
