For over two decades, the ISPE Barrier Isolator Survey has gathered meaningful data on the applications of barrier technology and been a resource for the fill-finish pharmaceutical industry community. This article provides context for the latest survey, the first in several years, and presents its...
Online Live Overview Driven by biopharmaceuticals but also prominent in small molecules drug manufacturing as well as for APIs, aseptic processing will undergo a technology jump start driven by the new EC GMP Guide Annex...
How will the new EC GMP Guide Annex 1 impact the future of aseptic processing? What are some of the latest developments in barrier/isolator technology? Jörg Zimmermann, 2020 ISPE Aseptic Conference Chair, Vice President...
Aseptic filling of parenterals is one the most challenging tasks within pharmaceutical manufacturing. There is a wide range of topics that fall under this umbrella, from more engineer-driven topics like filling accuracy and machine performance to key...
Aseptic processing of parenterals is one of the most challenging tasks within pharmaceutical manufacturing. Join us along with federal and state regulators at the 2019 ISPE South Asia Pharmaceutical Manufacturing Conference on 25 – 27 September, at the...
The Interactive Regulatory Panel session at the end of the 2019 ISPE Aseptic Conference is one of the most popular conference sessions each year, and the 19 March session at this year’s conference was no exception.
ISPE has teamed up with presenters from the 2019 ISPE Aseptic Conference to record 6 sessions totaling a 8 hours of dynamic content address a wide range of topics pertinent to aseptic processing in pharmaceutical...
Tremendous advances in aseptic processing technology have been made and many operations have been modernized, said Richard Friedman, Deputy Director, Science and Regulatory Policy, Office of Manufacturing Quality, FDA/Center for Drug Evaluation and...
Are you awake and alert? – It’s hard to stay awake and alert to what’s important in the world of sterile pharmaceutical manufacturing. Challenging. A big world. A lot is happening. But the 2019 ISPE Aseptic Conference captures what’s important: