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...
Over the past decade, companies worldwide have faced increased scrutiny from consumers, investors, and regulators over how they treat the environment. They are questioned about where and how they source raw materials, the packaging they use, power consumption levels, and waste generated. Many companies understand these concerns and have taken active steps to be sustainable. Building industry...
ISPE published the 2nd Edition of the ISPE Good Practice Guide: Controlled Temperature Chambers – Commissioning and Qualification, Mapping and Monitoring in...
